Hello, and welcome to Movano Health Fourth Quarter 2022 Earnings Call. I would like to remind everybody that this call is being recorded and a replay of the call will be available on Movano Health's website at ir.movano.com. I would like to hand the conference over to J. Cogan, Movano Health's Chief Financial Officer. Thank you. You may begin.

Thank you, operator. Good afternoon, everyone, and thank you for joining us today. Our CEO, John Mastrototaro, will open today's call with prepared remarks about the progress we've made during the fourth quarter of 2022 and in recent weeks. Our Chief Marketing Officer, Tyla Bucher, will also join us to give an update on the upcoming launch of the Evie Ring. Afterward, I'll cover the highlights of our quarterly operating results and provide perspective on our financial position. Finally, Movano Health's Founder and Chief Technology Officer, Michael Leabman; and Stacy Salvi, our Vice President of Strategy, will join John, Tyla and me for the Q&A. Before we begin, I would like to remind everyone that we will make forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the Risk Factors section of our filings with the Securities and Exchange Commission, specifically in the company's Forms 10-Q and 10-K. 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 reflect changes in expectations with regards to those events, conditions, and circumstances. With that, I'd like to turn the call over to our CEO, John Mastrototaro.

Welcome, everyone. Thank you for joining us from Movano Health's fourth quarter earnings call. We are quickly approaching our second anniversary as the publicly traded company. It's remarkable how far we've come, and given our progress, I'm even more excited about our company's future potential. We're creating a new standard for the fast-growing health wearables category, driven by our belief that health data should be more accessible, more actionable and more accurate. We're forging new territory by developing products positioned at the intersection of medtech and consumer devices, a market opportunity we believe is conservatively worth $50 billion in the U.S. alone. We've made significant progress over the last quarter and early part of this year as we prepare for the commercial launch of the Evie Ring, and I wanted to briefly highlight some of the key milestones you'll be hearing more about in today's call that give insight into our preparedness and potential demand for the smart ring, including the following. We successfully completed our pivotal hypoxia study, which resulted in the Evie Ring having accuracy well within the FDA standards. Ahead of the planned summer launch, we announced the Evie Ring at CES in January, and the media and consumer reception was and continues to be incredibly positive. We commenced our first round of beta programs with four previously announced partners to evaluate the Evie Ring, and given continued strong interest in our solution, today, we announced the second beta program with a new slate of partners among which are a global athletic apparel company and two additional leading global medical device companies. We also continue to make progress with our proprietary RF technology, which is the engine driving our glucose and blood pressure initiatives. We will be conducting blood pressure and glucose clinical studies imminently using the…

Thanks, John. As he mentioned, Evie made an impressive debut at the beginning of the year and came away with 11 Best of CES Awards from premium media publications, including CNN, USA Today, Wired and Digital Trends. The media coverage really highlighted our focus on women, the open design of the ring, the portability of the charger, and the benefit of a sub-$300 price point, particularly with no monthly subscription. We also had many conversations about the timeliness of a device that is made specifically for women, and particularly the misnomer that women are considered a niche market. The femtech space is set to grow to $48 billion by 2030 in the U.S. alone. And when you consider women make up more than half of the U.S. population and control her influence 85% of the household spending, we see this as both a significant and a timely opportunity. So, building off the strong momentum from CES and the corresponding launch of our website, we also recently began paid ad campaigns and are seeing impressive results to date. With a relatively modest investment and in just under 10 weeks, we've driven over 300,000 people to our website and more than 50,000 people have signed up to receive our emails. We also debuted our brand spot, which collectively is nearing 2 million views, and our social channels are reaching an average of almost 100,000 consumers a day through a combination of paid and organic posts, with engagement rates that are exceeding platform benchmarks. We're focused on keeping these valuable leads engaged and are continuing to grow our user base with our email strategy, paid and organic social media campaign, and our monthly newsletter and blog. These leads constitute our early adopters, the foundation of our community and our most likely brand ambassadors,…

Thanks, Tyla. From an operation standpoint, we feel prepared for our intended summer launch timeline and are building out our manufacturing line in accordance with FDA standards. Our supply chain partners, including our Tier 1 contract manufacturer, distributors, direct manufacturers custom component and raw material suppliers are in position to support our launch with contracts, forecasts, purchase orders and material stocking agreements as dictated by lead times. Production capabilities, including process and test development, equipment automation, hard tooling and packaging are in the final stages, and will be positioned to support our growth and capacity expectations. Additionally, our system integration with our domestic logistics and fulfillment partners is underway and it will be fully operational for launch. In addition to working toward the launch of Evie, we are also moving at pace on our non-invasive glucose and cuffless blood pressure monitoring efforts using our patented system-on-a-chip. As you may recall, the chip is the smallest ever RF enabled integrated circuit designed specifically for blood pressure or glucose monitoring. Over the last quarter, we implemented the system-on-a-chip into a new battery-powered wrist worn device that is smaller than most wrist worn wearables today. We are set to commence blood pressure and glucose clinical studies imminently using the single chip technology for the first time. In order to protect our innovation around our RF technology, we have been prolifically filing patents and have recently been issued nine new U.S. patents, including multiple foundational patents. Of note, is a core patent related to enablement of measuring health metrics using amplitude and phase information from our proprietary system-on-a-chip. The new patents validate our cutting-edge approach to RF enabled glucose and blood pressure monitoring and extend our growing IP portfolio to 21 patents issued in the US, one patent issued in China and 36 patents pending. In summary, this year is poised to be our most exciting and anticipated year yet. With the launch of Evie quickly approaching, we are preparing our manufacturing, marketing and technology partners to be primed and ready for a summer 2023 launch. Our B2B initiatives, including our beta programs, are progressing and becoming more tangible every day. And our blood pressure and glucose monitoring solutions are consistently improving with each study. We have significant D2C and B2B business opportunities in front of us that we are ready for and excited to execute on. We look forward to sharing further updates soon. And with that, I'll turn it back to J to go over the financials.

Thanks, John. We detailed the financial results in today's fourth quarter earnings release, which you can find on our website, but I'll share a few key line items. Movano Health reported an operating loss of $8 million in the fourth quarter of 2022 compared to an operating loss as $6.3 million in the year-ago period. The increase was primarily related to the accelerated R&D and commercialization initiatives described earlier in today's call. Our cash burn in the period was $6.3 million, in line with the prior four quarters. In the fourth quarter of 2022, the burn was partially offset by $300,000 in net proceeds raised via our $50 million ATM facility. As you recall, we executed our ATM agreement in August of 2022 and raised more than $2.2 million in net proceeds at an average price of $2.83 per share over the last five months of 2022. We continue to view the ATM as an opportunistic source of capital and are pleased with the execution to date. In addition, in the first quarter of this year, we raised another $7.5 million in gross proceeds or [$6.85 million] (ph) net through an underwritten public offering of shares of Movano Health common stock and warrants. At the end of the fourth quarter of 2022, we had $10.8 million of cash, cash equivalents and short-term investments, and total assets of $13.2 million. On a pro forma basis, if one were to assume the aforementioned equity capital raise occurred on December 31 of last year, our pro forma cash on the balance sheet would have totaled $17.6 million. Speaking of cash balances, I'd like to note that Movano Health does not have any current financial exposure to Silicon Valley Bank specifically, and we also partner with multiple multinational banking institutions to minimize the potential exposure to such systemic risks in general. We will not be providing specific financial guidance, but as you've heard in today's quarterly report, as well as through our commentary on previous quarterly calls, we're making great progress towards the direct-to-consumer launch of the Evie Ring in the summer of 2023, as well as our other B2B and clinical initiatives, and doing so on a capital-efficient basis. As that concludes our formal remarks, we'd be glad to take your questions. Operator, we're ready to begin the Q&A section of the call.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions]

Okay, operator, I can see in the webcast link that we have a few questions already in queue. So, while we're waiting for the phone lines, why don't we start with the webcast link? And I can go ahead and ask those questions, and then I'll come back to you when we're ready for the phones. John, the first question is for you. Remind us of why you're so excited for this next round of clinical trials? What do you think you're going to see? How is it related to the recent press around Apple and their progress towards bringing a non-invasive glucose monitor to market?

Thanks, J. Great question. First off, I just want to say that we're really excited about the robustness of our patent portfolio with nine new patents issued since our last earnings call. And these patents cover a variety of topics, but primarily it's focused on the design of this RF chip, its use in healthcare and making measurements of things like blood pressure and glucose, and lastly around the algorithms that we use to convert the measurements that we take into the metric of interest. So that is a really positive state for us right now and we're very excited about that. The second thing is as it relates to clinical trials, every time we scale down the size of the technology, we’ve gotten improved fidelity and better accuracy with our platform. We went from a pizza box-size device in the past, as you may recall, to an iPhone-size device, then to a kind of bulky wrist worn device, and now we're down to something that is the size of a bracelet, which can be worn where we have really nice connection between the RF energy and the body to be able to make the accurate measurements. And this improvement over time in terms of our hardware has been very meaningful. And every time we scale down that hardware, as I've said, we get better data. So, we're really excited about the start of this next clinical trial where we're using our integrated circuit chip. As it relates to Apple's recent press, they announced that they had started with a desktop device, and they're making optical measurements versus RF. And that desktop device, they've been trying now to scale down and they mentioned in the article and we see what you see. But they mentioned that they were in the process with their engineers of trying to get it down to the size of a device that's about the size of a iPhone, which is where we were two revisions ago. So, from a hardware perspective and a scale down perspective, we believe we've got a very significant lead because now we're down to a chip that's 4 millimeters by 6.7 millimeters in size, which could even be put into a ring form factor. So, we're pretty excited about that. And then, as it relates to the technological differences between optical and RF, I want to turn the call over to Michael Leabman, who is our CTO and Founder of the company, who is the expert in this space, and let him reply to that aspect of the question.

Yeah, thanks, John. I think first to add to what John said, we migrated technology from what was before four IC to a single IC. And I think we also mentioned before that's at 22 nanometers, which is really the cutting edge, where GlobalFoundries, our partner, our chip partner, has developed. And that's really improved our sensitivity by going to that process as well as combining all of our chips into a single IC. Our unique approach, which we now feel like we have a great moat of patents around, really focuses on millimeter wave, which has a lot of advantages from optical. And a lot of people tried optical over the last 10 years, with issues primarily related to skin thickness, freckles, tattoos, anything that light typically has issues with. On the millimeter wave, as you know, really has those advantages by not being affected by those aforementioned things. As well as being able to be extremely small, typically optical will take some size, you can't cover it. With millimeter wave, we can cover it with plastic and other things and really embed into any wearable, including our ring in the future. Thanks, John.

We actually have a couple of more questions, follow-ups on this point. So, I'm going to go ahead and ask those, and John and Michael if you want to just can decide who's going to answer. But one question is, are we able to talk a little bit more about the composition of the studies? Where are we doing the studies? How many subjects will be in the studies, et cetera? And then, another question is, when do we expect to generate some data from these studies or other future studies that we can share more broadly?

Well, I'll start. Typically, we initiate trials in house feasibility studies and we're able to bring -- for blood pressure studies, for example, bring in 100 people from our local community in and evaluate them over the course of a few weeks when we're looking at blood pressure. We compare to a hospital-grade blood pressure system when we're making those measurements. When we get to the point of conducting our pivotal trials, we will do those with third parties that are unbiased, obviously, and we want to evaluate the data like that, the same way that we did with our heart rate and SpO2 study that we conducted near the end of last year. So that's how we do that. And then I know there's a question about the number of people we evaluate and whatnot for a pivotal trial for both probably glucose and blood pressure. You're looking at somewhere between 60 and 100 people participating in the trial. This is - will be Class II, filing 510(k). When we talk about these filings typically on a 510(k), the FDA provides you feedback within 60 days of your filing, and then you work to answer any questions that they may have. If things go well, these can be cleared in three to four months. My last company I was with and this is after the start of COVID, we got two 510(k) cleared; one was done in 90 days, one in 108 days. Part of that depends upon how comprehensive your package is when you file it and the amount of questions that the agency may have in evaluating your filing. And I will pause there and see -- Michael, do you have anything else you'd like to add?

Yeah, I think the only thing to add there is, we typically start in the lab in the control environment, so we can really start optimizing, which we were doing now, our algorithms, our antennas, and really perfect that before we go live with patients. So that's usually the first step before we go with patients.

Okay. I think the next question is probably for Tyla. How are you building awareness of Evie ahead of the launch? Are most people discovering you?

Yeah, hi. So, CES was a really excellent ignition point for us. And we're continuing to build on that amazing organic press and awareness that we received following the announcement of Evie. We're also continuing to amplify that sort of post-show momentum through a strong paid and organic social campaign that's currently running across multiple channels, and it's driving ongoing traffic to our site. And then, these are leads that we're hoping to convert into emails that we can then retarget once we get ready for launch. In addition, we're seeing new [audio dip] growth on our social channels every day, not only with likes, but very positive comments and a lot of questions about when the device will be available. In addition to that, we're driving engagement through our 50,000-person strong newsletter list, and we're really encouraging our early adopters not only to follow us on social, but to share the news and excitement of the brand with others in their network. And, yeah, that's it.

Thanks, Tyla. That's awesome. I'm going to turn it over to the operator. I see there is a question on the phone lines. And so, we can do that first, and we'll come back to the webcast questions.

Our question is from Bruce Jackson with The Benchmark Company. Please proceed.

Hi, good morning, and thank you for taking my questions. I wanted to focus on the system-on-a-chip study that's about to start. From the time that you start the study, how long do you think it's going to take to complete it and get the package ready for the FDA?

Well, thanks for the question, Bruce. Typically, we evaluate somewhere between 50 to 100 folks when we first evaluate in our facility. In our upcoming study, we plan to have numbers in that range. And it takes us about three weeks to collect that data. Now, after we get that data and after we evaluate how well our algorithms are measuring blood pressure, for example, we will then look to partner with a third-party and we have third-parties in mind who would conduct the formal study for us. And that formal study could take two to three months. And then, typically to put our package together for the FDA, because we're already putting together the package for the heart rate and SpO2, we've got the bones of a package set up and naturally we're looking at some different form factors with this and obviously we've got a new clinical trial report. But overall, you're talking about a filing that would occur assuming we have the appropriate level of clinical accuracy find that would occur within two, three months of that, and then as we said before, the FDA review process can take another three to four months.

Okay. Great. And then, with the glucose measurement specifically, what is the measurement that you're using? And do you have like a target performance value that you're going after?

Yes, this is a great topic. First off, when we look at glucose, it is important for us to understand how this product is going to be used. In our clinical trials, we actually evaluate the product in people who have type 1 diabetes and we recruit people who are on a continuous glucose monitor today. So, when we conduct those trials, we have the continuous CGM waveform, we also have intermittent finger sticks that are drawn that are measured for glucose, and then we have our device. And so, we've got all three of those. And our goal in those trials is to assess how well and how accurate we're able to track trends in glucose levels in these people with type 1 diabetes who have more [liveability] (ph) in terms of glucose in general. And so, we may track them through the course of many hours, maybe after they've had a meal where they've delivered insulin, and we can track the changing glucose levels, which may go from normal range up to an elevated level and then back down again. And we want to evaluate whether we're able to track those changes. When we think about CGM devices on the market today in terms of accuracy, they all started with accuracies around 20% or 20%-plus. DexCom and Abbott who are maybe the gold standards today with accuracies within 8% of the truth. DexCom, for example, started 15 years ago with 26% average error, and Medtronic was at 21% and have gotten down to maybe 10% or 9%. It's taken them many years to improve the accuracy from the 20%-s down to sub-10% average error. When we're evaluating our product, we will not be -- although we are testing it in people with type 1 diabetes, our real focus…

It does. And congratulations on all of the progress, and thank you again for taking my questions.

Thanks, Bruce. Operator, let's go back to the webcast Q&A. Stacy, I think the next question or two can be for you. What are the goals for these product partnerships that you've launched? And can you tell us a little bit more about the Evie user experience? How are you differentiating Evie from the competition?

Sure. Thanks, J. And I'll start with the first question. So, just initially, the goals for the product partnership are really just to expand our pool of testers to make sure everything is working as expected and assess as possible. But more fundamentally, there's really a rich landscape for us when it comes to product partnerships. Of course, partners want to look at what we're building and conceptualize it how it fits in with their offering. And this reflects not just consumer retail interest, but very importantly, how the Evie Ring can serve as a complement to existing in-market medical solutions. This doesn't only raise user awareness of their own biometrics, but specifically enhances the efficacy of current treatment. And really, this is a win-win-win, right? It provides us with a robust partner channel, it provides partners with an innovation and growth story, and of course, most importantly, it provides end users with a better chance at improved health outcomes. And then, I guess I'll go ahead and jump right into the second question. The second question was about how we're differentiating from competitors. So, this is probably one of my favorite questions, in fact. But fundamentally, when we think about competitors in the space, we have a lot of the same metrics and all of the same metrics that they have brought to market. But we really differentiate out of the gate by ensuring that the device is medical grade. So, we know that accuracy is something that has been difficult for consumers in the past. And, yeah, trend data is helpful, but we really want to make sure that we are providing the best in metrics. And then, of course, also really important is that form factor. The form factor being slightly flexible, gets over the finger without discomfort, it accommodates for swelling over the course of a day or over a month. And then, the charging case is a major delighter that goes without saying. So, the experience itself is really aimed at insights and [meeting] (ph) the user where she is in any given day rather than kind of that standard 10,000 steps a day, which we all know and love, but I think doesn't appeal to majority of consumers.

Great. Thanks, Stacy. We have a couple of questions related to the launch of Evie. John, maybe you can start and if anybody else wants to add as well. One has to do with, if we're going to file -- just getting some clarification again, if we're going to file for the -- or if we've already filed for FDA clearance for the Evie Ring? Has that actually happened yet? Will it be a Class I or Class II filing? Would we launch Evie in the summer without the FDA approval? How long do you think it will take to get an answer from the FDA? I know, John, you covered some of this already, but just maybe just to reiterate that. And then, also along the same lines, what are the major tasks beyond an FDA filing are still to be completed prior to launch?

All right. There's a several question in there, but let me start at the beginning. We have not filed yet with the FDA. We're planning to file this spring. Once we file, it will be a 510(k) Class II device. There were many pulse oximeters on the market that were cleared to provide heart rate and SpO2, and that's what we're going after with the first filing. I expect to get some feedback from the agency within 60 days after the filing. And if things go well, I would expect a clearance within three to four months. If for some reason, the FDA has more questions about a product like this, which is new in terms of form factor, and it takes longer, we are prepared to launch the product has a wellness device first. And then, later on, when we do -- if assuming we do getting FDA clearance, we would then, at that point, be able to have an announcement to that effect at a later date. So that's our current strategy. At this juncture, if things go according to plan, we do think that the timing of an FDA clearance may work out very well with where we are with setting up all the manufacturing we mentioned earlier in the call, getting that established and ready to go for the launch. So that's that process. And then, any against the second part of that question, maybe any risks associated with the product coming to the market. We've had -- we have a very talented contract manufacturing firm we're working with. And they're a large firm. They've done this before. Our product will be manufactured in a medical device manufacturing facility. And so, we feel pretty confident that we are developing the right processes to be able to manufacture the product in large quantities. We also have done a really great job in terms of sourcing the raw materials that we need. We have an incredibly seasoned VP of Operations who from day 1 was really focused on supply chain recognizing that ship to get in, challenges that persisted through the course of COVID. And we feel like we're in a really good place as it relates to all of the components. And so, as we continue to execute the way we have before and we've got a very seasoned team, I don't see at this moment anything that's going to cause us to have a problem as it relates to our ability to execute and get this product out in the summer.

Great. Thanks, John. We've got a couple more and I can probably take those at least from the webcast and then maybe operator we'll see if there's any more on the phones. One question is, what unit production capacity are we planning for the initial summer launch of the ring? As we have mentioned on numerous occasions, we're not going to provide financial guidance, but I think as you heard in John's comments just now and also how we were kind of characterizing this on the -- in the script for today, we're going to be well prepared in terms of parts and capabilities to deliver thousands and thousands of units initially. And we have plans for how we think that this is going to play out from an overall demand standpoint. So, we're getting positioned for that. We feel good about it. And we're looking forward to the launch obviously. And then another question about when we might be able to announce the partner's names for both studies, or I guess betas this questioner is referring to? We've announced the partners that we can thus far. Obviously, we'd like to be able to announce more partners as we move through time. And certainly, as soon as we're able to, we will keep you posted. As we have mentioned, we've been working with Stanford and their athletic department. We're working with Novant Health, who is an integrated health network down in the Southeast in the Carolinas and Georgia. They have 6 million annual patient visits a year. They generate $7 billion in revenue. And then, we're working with three global medical device companies, one major pharmaceutical company, one global athletic apparel retailer, which we announced today as well. And so that pretty much fills out the others that we are…

There are no more further questions at this time.

Okay. Well, I think that pretty much wraps it up for us for today. Thank you for your time, everyone. As a reminder, you can stay connected and up to date on Movano Health news and events by checking out our investor website at ir.movano.com.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.