Corvex, Inc.

Welcome to Movano Health Q2 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Jake Hogan, Chief Financial Officer Thank you, Mr. Kogan. You may begin.

Thanks, operator. Good afternoon, everyone, and thank you for joining us today. Movano Health CEO John Mestre-Tataro will open today's call with prepared remarks about the progress the company made during the second quarter of 2024 and in recent weeks. Our CMO, Tyler Booker, will provide some remarks on the company's upcoming D2C plans, followed again by John, and then I'll provide highlights on the company's quarterly operating results and current financial position. Then we'll open the call for Q&A. John, Jay, and Tyler will be joined by our Chief Technology Officer and Founder, Michael Liebman, Chief Commercial Officer, Michael Soule, and Vice President of Product and Strategy, Stacy Salvi. Movano Health issued a news release this afternoon detailing second quarter 2024 financial results. Before we begin, I'd like to remind everyone that the company will make forward-looking statements during today's call based on current expectations. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties, and actual results may be materially different from such statements. These risks and uncertainties are detailed in the risk factors section of Movano Health's filings with the Securities and Exchange Commission, specifically in the company's forms 10Q and 10K. Except as otherwise required by federal securities laws, Movano Health disclaims any obligation to update or make revisions to such forward-looking statements contained herein or elsewhere to reflect changes in expectations with regards to those events, conditions, and circumstances. With that, I'll turn the call over to our CEO, John Mastrositorio.

Good afternoon, everyone. Since we last reported earnings in May, we have been working diligently to prioritize the efficient use of our recent capital infusion while continuing to make progress on our key business initiatives as follows. preparing for expansion of the direct-to-consumer launch of EV Ring and taking orders again starting September 17th, continuing to work with the FDA to secure a 510K clearance for the EV Med Ring, delivering our first B2B commercial opportunities with healthcare partners, and lastly, preparing for upcoming blood pressure and glucose clinical trials using the most recent iteration of our wearable device, incorporating our proprietary RF solution. We continue to be judicious with our capital and methodical in our approach to building out our direct-to-consumer and business-to-business market opportunities. I will provide an update on our progress with the FDA and preparations for B2B launch of EVMed, and will then turn the call over to our CMO, Tyler Bucher, to discuss plans for the D2C business including our plan to begin taking orders again and shipping product in September. In preparation for the launch of EV Med, we're working closely with the FDA to secure a 510 clearance. As we highlighted in a press release last week, we plan to meet with the FDA this month. You'll recall the EV Med Ring is designed to not only provide medical device functionality with its pulse oximetry feature, but also offer numerous wellness metrics related to sleep, activity, and logging of mood, energy, and health symptoms. Subsequent to our April 510 filing, in May and early June, the FDA review team requested two minor clarifications and our team promptly responded. In late June, the FDA review team requested some additional information related to the wellness aspects of EV Med. Along with our regulatory advisors, Movano Health provided a draft response to the FDA's questions on July 10th and requested a meeting with the agency to review our draft response, which is now scheduled, as I noted earlier. We look forward to meeting with the FDA and working towards resolving this issue in order to move forward with the review process. We remain steadfast in our commitment to the opportunity EV Med could unlock given the clinical evidence provided as part of the filing related to the Pulse proximity feature and our desire to work collaboratively with the agency. With regard to the BV opportunity, we have three new B2B commercial opportunities to highlight for you today. In anticipation of an expected 510 clearance, we are engaged with two global pharmaceutical companies that could leverage EV Med in building unique solutions for both clinical and consumer applications. In the first case, we are in the agreement phase for a program that could begin in late 2024 and, assuming success, would be expected to develop into a larger commercial opportunity in 2025. In the second case, EV Med is expected to be evaluated this fall by a Tier 1 global pharmaceutical company for a clinical trial that is scheduled to commence in 2025. We are also engaged with a large payer looking to better manage high-risk populations utilizing eV Med. This opportunity is expected to kick off around the new year, and assuming a positive outcome, the commercial opportunity could build into 2025. All three of these strategic partners, as well as the others in our funnel, see eV Med as a game-changing solution that is not currently available in the market. This is in addition to our recent announcement of the partnership with the Taal Research Group at MIT to use EV rings for its maestro clinical study on the long-term health impacts of Lyme disease and long COVID. To explain these healthcare opportunities in more depth, we recently hosted our first virtual event titled B2B, the next wearables boom. where Managing Director of Allele Capital, Matt Hughes, moderated a panel that included myself, our Chief Commercial Officer, Michael Soule, and Stanford cardiologist, Dr. Fatima Rodriguez. During the event, we identified and discussed the significant B2B possibilities that could be unlocked specifically for clinical trials and remote patient monitoring following a 510 clearance. As you'll recall, The clinical trials market we seek to address consists of pharmaceutical companies that need to gather data from FDA-cleared devices as part of their drug trials for FDA and other regulatory submissions. We've identified the TAM for FDA-cleared wearables in this market to be as much as $5 billion annually. Currently, trials are often cumbersome, expensive, and suboptimal, requiring in-person checkups, which can result in poor compliance. We believe EV Med's unique offering and design aesthetic would improve compliance, lower cost significantly, and enable quicker enrollment, better data, and improved quality of results. The three examples I highlighted a few minutes ago speak to this need, and we are aggressively pursuing opportunities across clinical trials and post-market surveillance. The remote patient monitoring, or RPM, market barely existed four years ago, However, COVID unlocked the reality that RPM can reduce the need for in-office visits, expand access, and reduce costs. We believe EVMed will be able to automate the collection of more complete and accurate data, resulting in an RPM solution with meaningful advantages over RPM products on the market today. During our conversation, Dr. Rodriguez also validated the need for RPM in her role as a physician which would enable her to manage her patients in between visits and easily identify patterns. We recently completed beta testing our wearable technology with a leading US RPM company that serves over 450 healthcare organizations and is the exclusive platform for one of the largest medical device companies in the world. In anticipation of these partnerships and more, We are preparing our backend operations to be able to meet our partners' requirements, including positioning the company to scale efficiently, establishing app and labeling modifications to support a medical device, and building our API and data sharing framework. I will now turn it over to our CMO, Tyler Bucher, to provide an update on our D2C plans for the EV ring.