ENDRA Life Sciences Inc.

Good afternoon and welcome to the Endura Life Sciences second quarter 2024 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 telephone 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.

Yvonne Briggs Thank you, Operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to Endra Life Sciences' second quarter 2024 Business Update and Financial Results conference call. Earlier today, Endra issued a press release on this topic, which is available in the Investors section of Endra'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 2023 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, Alexander Tuchman, Acting Chief Executive Officer, will begin the prepared remarks, followed by Ziad Ruag, new Head of Regulatory and Clinical Affairs, and then Michael Thornton, ENDRA's Chief Technology Officer. They will be followed by Richard Jacrou, ENDRA's new CFO, to review the second quarter financial results. With that said, I will now turn it over to Alex. Alex?

Thank you, Yvonne. Good afternoon, and thank you for joining us today to discuss Indra's second quarter 2024 financial results and business highlights. Before we proceed to the business update, let me address the reverse stock split and the subsequent trading of our common stock. As you know, after receiving shareholder approval earlier this month, the company authorized 1 for 50 reverse stock split which we announced last Friday and was effective this past Tuesday. The primary goal was to keep our share price above $1 and in turn maintain the NASDAQ listing. This plan was derailed because of an extremely high volume of exercise warrants which were issued as a part of the $8 million public offering that was completed in June. This public offering was necessary in order to keep the company operational and not to lose all the progress Android made over the years. We strongly believe that this sharp decline in our stock over the past few days is completely unrelated to Android business prospects. have the intended outcome as we are trading below $1 right now. We recognize the seriousness of this situation on the company and our investors, and we will keep you apprised of our actions as we move forward. Now let's turn our attention to the second quarter results and recent changes. I would like to start by reviewing with you six specific items we intend to do differently moving forward to become more actionable and predictable as we bring Andra's differentiation thermo-acoustic technology to market. The six changes include stronger operating team, relentless prioritization of our activities, new approach with FDA, enhanced go-to-market strategy for TAS liver device, crystallization of our Android vision, and finally, improved financial execution. Let me elaborate on each. First, we enhanced our management team by adding two experienced operators. We have proven track record of success in transforming new technology companies. Richard Jacrou is a seasoned CFO with public and private company experience, and he well understands lean operations and restructuring. He is already working very closely with Irina, formerly Senior Director of Finance, to ensure a smooth transition to daily finance operations. Irina will remain as an advisor to the company moving forward. Ziad Rouak has joined us as the head of clinical and regulatory affairs. Ziad has successfully led a number of emerging medical device technology companies through regulatory process and early commercialization. And he already made a huge impact on our most recent strategy and interactions with FDA. I anticipate that both Richard and Ziad experiences will greatly benefit Andra as we move forward through this critical phase for the company. Mike Thornton, our CTO, will continue to focus on product delivery as well as enhancing Andra's technology roadmap and intellectual property. Second change, after reviewing all the priorities that we are facing, We, as the new operating team, are unanimous in our relentless prioritization and laser focus on the most critical deliverable for the company, and this is executing a statistically-powered, multi-center, prospective clinical trial to obtain the necessary data that will allow us to successfully move forward. This clinical data is a foundational element for both regulatory and commercial success. It offers three important benefits. It allows for optimization of product design for maximum user utilization. It is a necessary piece of successful de novo application. And finally, it answers the big why, as in why I as a clinician or pharmaceutical user should utilize this technology. The third change we're implementing is we've fundamentally changed our regulatory strategy under Zia's leadership. We're switching from the use of retrospective data to a hypothesis-driven, statistically-powered, prospective clinical trial, which is pre-vetted through FDA. We are therefore expanding from a single clinical site to a multicenter trial, and we're increasing the number of subjects by an order of magnitude from 20 to about 250, which is necessary to achieve acceptable statistical power. We are now fully engaged with the FDA on establishing the consensus and trial design prior to data collection. Later in this call, Ziad will elaborate further on these changes. Fourth, we are revisiting our go-to-market strategy for the TAIS liver device. We have more and more evidence that hepatology may not be the beachhead market we should pursue. primary care and segments and them over the next six to 12 months as we pursue the regulatory clearance for the TAIS waiver device. Hepatology will likely remain a market for us, but perhaps not the primary target. Fifth, or the change, initiative number five, we're preparing changes related to endostrategic directions. We will formalize our longer-term business strategy and crystallize our vision as in what's next after we commercialize our taste liver device. We have to answer questions such as how do we add more value to our customers beyond the liver fat test and become a metabolic disease biomarker company which could be a lot more valuable. All of this is expected to be developed and assessed over the next 12 months. Lastly, we are focusing on improved financial stewardship. Our goal is to scrutinize every dollar we spend, and as a result, we recently conducted significant reductions about operating expenses, and we were able to reduce them by 3 million plus, which represents approximately 26% reduction on annualized basis. all of it without impacting the primary deliverable, which is clinical data collection in preparation for our FDA submission. Richard will elaborate on this further during the financial update. Now that I outlined what we will do differently moving forward, Siad, Mike, and Richard will now highlight for you the progress we made since one conference call in three areas, clinical and regulatory, technology and IP, and financial. Ziad?