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spk04: Greetings, and welcome to the HeartBeam second quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. This time, I will turn the call over to HeartBeam Chief Executive Officer, Branislav Zazdik. Please go ahead, sir.
spk02: Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to today's second quarter 2023 financial results conference call. On today's call, we will be relating some very important updates about our business and our products. Recently, we completed $26.5 million in funding, which will enable us to execute on upcoming... product development, clinical and regulatory milestones and extends our cash runway into late 2024. With this funding, we took the opportunity to adjust our strategic focus to enable timely delivery of our ambulatory vector electrocardiogram or VECG products, our key future value drivers. Our first step is to obtain an 510K FDA clearance for the hard beam AMI-GO VECG device. This application was submitted to the FDA in May, and we will be following this with a second FDA application on the system's ability to synthesize a 12 lead ECG. Given this strategic focus on our AMI-GO system, we withdrew the 510K application for our Amy product, which is a software applied to 12 lead ECG in the emergency department. This will allow us to devote all of our resources and energy to products that are being powered for our 12 lead ECG into the hands of patients and outside of a medical facility. We just announced the publication of our first peer-reviewed paper, a foundational study demonstrating the ability of our VECG platform to detect the presence of coronary artery blockages. The study comparing our 3D VECG approach to conventional standard 12 lead ECG appeared in Jack Advances, a journal of the American College of Cardiology. We also strengthened our board with the appointment of three respected industry executives, Dr. Michael Jaffe, Ken Nelson, and Mark Strom, bringing the number of HeartBeam board members to eight. We also are excited to report that we recently welcomed to our team Debbie Castillo, PhD, as Vice President of Regulatory Affairs. Debbie is an experienced biomedical engineer and brings more than 12 years experience in regulatory affairs and quality assurance for medical devices and diagnostics, both with the FDA and the private sector. Finally, we continued to solidify our intellectual property portfolio in the second quarter with a new patent issued by US Patent Office on automated cardiac detection with the HeartBeam Amigo system. We believe this patent underscores our leadership effort in the ambulatory VECT space. As previously reported, on May 3rd of this year, we closed a secondary offering of $25 million. followed by a registered direct offering of $1.5 million, for a total of $26.5 million. We worked with Public Ventures as our placement agent. They are wholly owned subsidiary of MDB Capital Holdings. MDB and Public Ventures have proven to be tremendous strategic partners for Heartbeat. Public Ventures is a member-driven investor community with the mission of backing visionary public companies that have potential to become market leaders in their technology category. We continue to work with them as we execute on our strategic plan. And in fact, our moment with PatentFest, also an MDB entity, is ongoing example of how we plan to continue to use their services. We believe that we are the leader in the mobile VECG space, and as we build on our global interactive property portfolio, our work with Patentvest is a tangible example of our commitment. Patentvest is a unified technology development and patent law firm focused on creating IP leadership for development state technology companies like HeartBeam, and we expect They will support our goal of creating clear leadership in the area of ambulatory BCG cardiac detection. I would like now to turn the call over to our President, Rob Eno, to further discuss our strategic focus and provide product updates. Rob?
spk07: Thank you, Branslav, and thanks to everyone joining us today. We mentioned this last quarter, but I wanted to reiterate the key points. We've refined our strategic focus and are concentrating on our AmyGo platform, bringing the performance of a 12-lead ECG into patients' hands. We see this platform, which will enable physicians to remotely monitor patients and immediately interpret any concerning cardiac events as an important value creation path. In addition, we'll be undertaking clinical studies in 2023 and beyond to demonstrate the performance of the HeartBeam Amygo platform, which we believe is the most advanced ambulatory cardiac detection platform available. As Bratislav mentioned, the first peer-reviewed study related to our technology was recently published in Jack Advances. This publication highlighted the capabilities of the technology to detect the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12-lead ECG. It also demonstrated the advantages of including a baseline recording for comparison in the analysis. This is something that is integral to the HeartBeam technology, but today when 12-lead ECGs are analyzed, it's not common that a baseline ECG is used for comparison. The significance of this study is in demonstrating the potential to provide patients with an easy-to-use system to record a diagnostic quality ECG signal outside of a medical institution. which could improve heart attack detection, speed up access to care, and save lives. We'll be conducting additional studies focused on our 12-lead synthesis and on the performance of the system as a whole, and we believe these studies will be key to driving clinical and patient adoption. Our commercial launch activities will be for the second version of Heartbeat Mamico after we obtain FDA clearance for the algorithms that synthesize the 12-lead ECG. I'll describe this in more detail in just a minute. And this year, we're undertaking aggressive pre-commercial efforts, defining the initial market segments for HeartBeam AME Go and identifying potential business partners for HeartBeam AME Go and other technologies in our portfolio. And finally, as Breneslav mentioned, we'll continue to address the aggressive development of our intellectual property through our partnership with PatInvest. Turning to our product timelines and updates, we have two planned FDA 510K submissions. The first, which we call version one, is for the hardware. In other words, obtaining clearance as a three-lead ECG collection device. Next, version two builds upon version one and includes the algorithms that take the three-lead VECG signals and synthesize a 12-lead ECG for physician review. In May, we submitted our 510K application for version one. We've also started the process for version two. In June, we submitted a request for a pre-submission meeting to FDA. The pre-sub process is an excellent means to get feedback on key elements of the submission. That pre-sub meeting has been scheduled. It has been scheduled, and we look forward to working closely with FDA on both of these applications. The result of these two submissions, once cleared by FDA, will be a device carried by patients that can synthesize a 12-lead ECG for physician review. We'll focus then on a limited market release, which we estimate in the second half of 2024. With the appointment of Debbie Castillo as Vice President of Regulatory Affairs, we've strengthened our team. Debbie's an experienced biomedical engineer with extensive knowledge of the FDA. In addition to her private sector experience, Debbie held various roles at FDA, including acting branch chief, senior lead reviewer, and lead scientific reviewer. And finally, in an effort to focus on the HeartBeam AmyGo product, we withdrew our 510K application for HeartBeam Amy. HeartBeam Amy is focused on emergency room reuse, which is significantly smaller opportunity than the HeartBeam AmyGo ambulatory ECG market. This decision will allow the company to focus on the product development, clinical, regulatory, and market preparation efforts for HeartBeam AmyGo. I'll now turn the call over to Rick Bronstein, Chief Financial Officer, to discuss operational updates in financial.
spk09: Thank you, Rob. Turning to our financials, I'll now give a brief review of our financial results. A full breakdown is available in our regulatory filings. We just filed the 10-Q and in the press release that crossed the wire after the close of business today. General administrative expenses for the second quarter of 2023 were $1.8 million compared to $1.8 million for the second quarter last year. Although overall G&A expenses flat, spending is actually down in 2023 compared to 2022. In 2022, we were invested in the commercial team, and due to our change in near-term focus in early 2023, we are not currently emphasizing commercial activities. The reduced sales and marketing expense was offset by increased non-cash stock-based compensation of about $0.4 million, resulting primarily from the issuance of employee stock options following the May 2023 financings. Research and development expenses for the second quarter of 2023 were $1.5 million compared to $1.7 million for the second quarter of 2022. Our focus on R&D differed in 2022 compared to this quarter. While both consisted largely of product development and regulatory costs, in 2022 our focus was on the development of our platform for our products, working with an outside development organization, Libmore, and preparing for our first FDA submission. This quarter, our U.S. development team are employees hired from Libmore, and the focus is wholly on Heartbeam Amigo. We submitted version one for FDA clearance in May, and at the same time, we continue to use our professional services agreement with Triple Ring. Triple Ring represents over 20% of our investment in R&D this quarter ended June 30th, 2023. So we are investing in a device cost reduction program. As of June 30th, 2023, we have a remaining commitment with them for this project of 0.8 million. In both periods, we also invested in research costs in support of future product pipeline coming from our patented ZECG platform technology, which is the basis for our patent portfolio of 10 issued patents. With the current interest rates in short-term markets around 5%, we earned $158,000 in interest income in the second quarter of 2023, and this only for two months as we closed the financing in early May. This compared to $10,000 in the second quarter of 2022. The net loss for the second quarter of 2023 was $3.2 million compared to a net loss of $3.5 million for the second quarter of 2022. We ended the second quarter of 2023 with $21.3 million in cash, cash equivalents, and short-term investments compared to $3.6 million as of December 31st. As mentioned, in May, we closed the common stock financings with net proceeds of approximately $24.3 million. The use of the proceeds is planned to last into late 2024, time to when we expect to have received clearance for our commercial product. We are confident we remain on track. With regard to our short-term investments, we take a risk-averse approach, only investing in short-term government-backed money market funds that we are holding to maturity. The approximate $4 million in short-term investments at June 30, 2023, represents such securities with a four- to six-month term. Also of importance in the recent financing is the fact that the 17.7 million shares offered did not include any warrants And our balance sheet as a result has a very simple and straightforward capital structure. Approximately 26 million shares now outstanding. Finally, I'd like to share the results of our recent annual meeting of shareholders. At the event, all proposals passed, which included adding 4 million authorized shares to the 2022 Equity Incentive Plan, reflecting the overall dilute effect of the S-1 financing.
spk08: I will now turn it to call back over to Branislav for his closing thoughts.
spk02: Thank you, Rick. We remain incredibly optimistic for the future of HeartBeam. I would like to summarize the recent efforts in the following categories, financial, strategic focus, and progress, and validation. Following our $26.5 million investment, dollar capital raise, we have a strong cash position, providing a runway to late 2024. We have adjusted our strategic focus to enable timely delivery of HeartBeam's breakthrough ambulatory VECG products, the company's key future value driver, and we are highly focused on executing on our product development, clinical, and regulatory milestones. The key element of this focus is the HeartBeam AmyGo credit card size VECG device. In May, we submitted a 510K FDA application on version one of our system. And in June, we have submitted a pre-sub request for version two of the system. We are excited about the addition of Debbie Castillo, our new vice president of regulatory, as we work with the FDA on these submissions. Finally, we have several recent milestones that add to the validation of the technology and the company. Our foundational clinical study was recently published in Jack Advances. We added three strong members to the board of directors, in addition to Debbie Castillo joining our management team. And we had an additional patent granted on our automated cardiac detection with HeartBeam Amigo system. I look forward to providing our shareholders with further updates in the near term. I thank you all for attending today, and now the HeartBeam team would like to answer your questions.
spk06: Operator.
spk03: Thank you.
spk04: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. Our first question comes from Ben Hainar with Alliance Global Partners. Please proceed with your question.
spk05: Thank you, gentlemen. Thanks for taking the questions and congrats on the progress. First off for me, just, you know, I know it's early days, but wondering if you've gotten any reaction to the JAK publication, and then maybe you could talk about, you know, obviously the performance was solid. You know, any surprises, positive or negative, you know, with regard to the device and or, you know, kind of the human reading that came out in the study?
spk02: Yes, Ben, thank you for your question. Yes, we were actually very fortunate that our publication caused an editorial as well. This is a sign of a well-received publication, a publication that's very impactful. And indeed, all our associated medical team members, as well as some of our potential business partners, have noticed this as a very significant event for our future acceptance. The study shows that we have a technology that puts the power of a 12-lead ECG, the standard of care, in patients' pockets. It's always with a patient. and that is a huge value for those high-risk patients. So all in all, this is our first publication, extremely well received, and it's only the first one. We have a few of the follow-on publications in the works, and we will continue on that treadmill of publications showing the efficacy of our technology.
spk05: And can you discuss, well, first off, I guess maybe, any surprises there and then any on the publications that you have in the works, you know, can you share anything about, you know, how they might be similar or different to the current study or the just published study?
spk02: Yes, the future studies will take a bit different angle at our technology and I cannot really, you know, discuss it in many details, but I can tell you that You know, every one of these studies will be like a brick in the wall, so to speak. And at this point, we have a number of patents and a number of publications that we are working on. And again, that cadence coming out of HeartBeam will continue both on the publication front and the IP front.
spk07: Brent Brunislaw, maybe I'll just add briefly, if you don't mind. Completely agree with all that. And the question of surprises, I don't think there's any surprises. But I think one thing which comes out in the paper which maybe is less obvious is the importance of a baseline. So in both the VECG and the 12 lead, the results were a lot better when the baseline was used to compare with the reading. And what's interesting about that is that's an integral part of our process. We have a baseline when the patient enrolls and we compare that by definition. And when you think about how 12 leads are analyzed today, they're often analyzed in isolation without a baseline. So the top line of the paper is that the VECG performed equal to a 12 lead in both comparison or one at a time. We're always going to have that baseline, and sometimes the 12 leads are analyzed in a vacuum. So I think that's a kind of subtle but important point in the study.
spk06: Yeah, thank you, Rob.
spk05: I guess maybe a couple, mainly for Rick. On the GNA, it sounded like there was maybe $400,000 that was kind of non-recurring in the quarter. Is that a fair assessment, or what should we kind of think about going forward on the GNA line?
spk09: Okay. I would say reoccurring but non-cash. Right. And indeed, as we've now up to 26, 27 million shares, you'll see, I think, a growing non-cash stock expense. But if you go back to 2022, yes, there was 400,000, I would say, of non-recurring SG&A expense that we won't see again for probably until we start getting commercialization late you know, 2024 or so.
spk05: Okay. So, so there wasn't any, I may have misheard it. I thought that you said 400,000 related to stock based comp related to the financing.
spk09: No, as a result of the financing, we granted more stock options to people who, you know, now had a much slower share in the company. Okay. Okay.
spk05: So, and there wasn't any kind of one time issue. uh gna expenses associated with the deal no not in the corner i mean anything anything that was associated with the financing is all just you know ran through stockholders equity didn't go to the p l okay got it and and then on the uh cost reduction program which we're doing how's that progressing you know any more color there that you can provide and that's it for me uh uh thanks for taking the questions gentlemen
spk06: Okay, Branislav, do you want to handle that one or? Go ahead, buddy.
spk09: Yeah, okay. So, Ben, the, I mean, it's probably going to be most of the year. We're doing, you know, we're doing things to take a, basically a prototype level device that is, you know, costs over $1,000. and reducing something that when we start to get in volumes will be, you know, a couple hundred dollars, right? So there's various pieces that are going on. It's ongoing. You know, we're looking at the PCB board. We're looking at, you know, some molds that we'll buy and some other things. But it's a dedicated approach now that we look forward to commercialization to be able to produce, say, if you would, the credit card at a reasonable price. Okay, great.
spk06: Thanks for the color and thanks for taking the questions. Thank you, Ben.
spk03: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. At this time, we will now take questions from our webcast.
spk06: The first question asks, you mentioned that you have withdrawn Amy. Can you tell me more about that decision? Let me handle that question.
spk02: Our strategic focus is on ambulatory devices. You know, any application by valuable has a very different market and distribution strategy. As we have seen, the opportunity with our Amigo ambulatory VCG device. And as we make progress and get closer to its market availability, it is important for us to totally focus and take advantage of that huge opportunity. This market is much larger market, probably 20X or more than that of the emergency room market. The great need and the key opportunity is to bring the 12-lead VECG to the patients outside of the healthcare institution. Actually, the algorithm that we developed for Amy, which basically takes the 12-lead ECG and converts it to the VECG, and runs analysis on the VECG is planned to be included in the future generations of Amigo as well. So in that sense, we expect to see this technology appear in Amigo down the line.
spk01: Our second and final webcast question is, you are providing only high-level details on the timings of the future FDA submissions and clearances, rather than a detailed timeline. You say you're expecting a limited market release in the second half of 2024. Can you provide more context?
spk06: Yeah, Rob, would you please go ahead?
spk07: Sure. Yeah, the one thing that's clear about regulatory filings and the whole regulatory process is the timing is uncertain and to a large extent it's outside of our control when dealing with regulatory agencies. So we're going to continue to update on our progress toward our milestones. things that we've achieved as we did today, talking both about the version one and version two products. But rather than give estimates on the timing of some of these upcoming intermediate steps, we decided to focus on the key milestone, which is this limited market release of Amygo, which happens after the clearance of version two in the second half of 2024. and we'll continue to do that going forward, is focus on that ultimate state of market release, but also keep providing updates on the progress and the milestones that we've achieved.
spk03: I would now like to turn the floor back over to Dr. Dvazic for his closing comments.
spk02: Thank you, operator. I would like to thank each of you for joining our earnings conference call today. and look forward to continuing to update you on our ongoing progress and growth. If you were unable to answer any of your questions, please reach out to IR firm, MZ Group, who would be more than happy to assist.
spk06: Thank you again.
spk04: This concludes today's conference. You may disconnect your lines at this time.
spk03: Thank you for your participation.
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