8/15/2022

speaker
Jamie
Conference Operator

Good day, everyone, and welcome to the Endura Life Sciences Second Quarter 2022 Financial Results Conference Call. All participants will be in a 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 and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I would like to turn the floor over to Yvonne Briggs at LHA. Ma'am, please go ahead.

speaker
Yvonne Briggs
Investor Relations, LHA

Thank you, Jamie. This is Yvonne Briggs with LHA. Good afternoon and welcome to NDRA's second quarter 2022 business update and financial results conference call. Earlier today, NDRA issued a press release on this topic, which is 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, 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 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 2021 fiscal year and subsequent Form 10-Qs 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 Mike Thornton, Endra's Chief Technology Officer. Mr. Thornton will be followed by Renaud Malaberti, Endra's Chief Commercial Officer, and then Irina Pestrikova, Senior Director of Finance, will review the second quarter financial results. With that said, I will now turn the call over to Francois Michelon. Francois?

speaker
Francois Michelon
Chairman and Chief Executive Officer

Thank you, Yvonne. Good afternoon, everyone. Thanks for joining us today to discuss UNDRA's second quarter financial results and business highlights. I'm happy to update you on our progress as we advance our business plan for the novel thermoacoustic enhanced ultrasound, known as TEIS, which facilitates the early assessment of liver disease. Despite the challenging global economy and uncertainties within the financial markets, we finished the second quarter with a strong balance sheet with $11 million in cash. This cash runway, combined with our capital efficient operating model, will enable us to achieve significant milestones in the coming months, including advancing the regulatory process in the U.S., building a base of clinical evidence for TEIS, and accelerating our commercialization activities and generating sales in Europe. Continue to be focused on the following four priority areas. Number one. We're building our base of clinical evidence to support our commercial activities and regulatory submissions in the U.S. We're ramping our global clinical evaluation sites, and I'm delighted to announce that we've recently installed another TAIS clinical study system in the U.S. We are on track to reach our goal of scanning at least 200 patients by year end. And Mike Thornton will provide more details in a few minutes. Priority number two, leveraging a portion of this clinical evidence to support our FDA de novo request, which we're diligently advancing for submission by the end of the current quarter. Priority number three, in parallel to the clinical evidence that's being generated in key commercial markets, we're accelerating our commercial activities by demonstrating our TAIS system in over 50% more clinical conferences in 2022 compared to last year. These and other activities will underpin the commercial adoption of TEAS in those markets, helping to catalyze our growing sales pipeline. Renaud will speak to our sales and marketing activities in a moment. And the fourth priority is that we're rapidly expanding the defensive and offensive capabilities of our intellectual property portfolio with the issuance of 13 patents in the first half of the year and 16 issued patents year to date. This has bolstered our IP portfolio to a total of 53 patents issued globally, of which 31 patents are issued in the US. A particular note, we recently announced several new US patents focused on cloud-enabled connectivity of medical devices. This novel technology was developed by Endra to enhance our own TEA system, but it also has the potential to help other equipment manufacturers easily collect data from their equipment, such as laboratory equipment, which may not have a direct internet connection. Ender's technology could help companies such as these reduce their service costs, and we're reaching out to potential partners for out-licensing opportunities. I'll turn the call over to Mike Thornton, our Chief Technology Officer, to provide some updates on our clinical evaluation sites and regulatory process. Mike?

Disclaimer

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