Greetings, and welcome to the HeartBeam Second Quarter 2025 Financial Results Conference Call. As a reminder, this conference call is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our company's website, heartbeam.com. Your host today, Rob Eno, Chief Executive Officer; and Tim Cruickshank, Chief Financial Officer, will present results of operations for the second quarter ended June 30, 2025. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Mr. Rob Eno.

Thank you, operator. The topics we'll cover on today's call are listed on the slide. We'll provide a brief reminder of the HeartBeam system and its status, followed by our product vision. We'll discuss our progress to 2025 milestones and our commercial readiness efforts, followed by financial results before turning it over to Q&A. Before we dive into updates since our last call in May, I wanted to remind everyone about our initial product, the HeartBeam system and its regulatory status. HeartBeam is developing the first-ever portable cable-free ECG that can synthesize a 12-lead ECG. Our unique IP-protected approach captures the heart's electrical signals in three dimensions or three non-coplanar directions, side to side, top to bottom and into the body. The system is designed to be easy to carry and easy for patients to use at home or on the go at the time of symptom onset. In December 2024, we received our foundational FDA 510(k) clearance. This is for the system as a whole for arrhythmia assessment, the credit card signal collection device, the patient application, a physician portal and signal quality algorithms. This was a major milestone as it validated our unique approach. And in January, we submitted our second 510(k) application. This is for the software that synthesizes a 12-lead ECG from our 3D signals for arrhythmia assessment. This is important because it takes the high-resolution signals collected by the HeartBeam system and synthesizes them into a familiar 12-lead ECG. This application is currently being reviewed by the FDA. We continue to expect clearance for the software by the end of the year. This clearance will be a watershed event for HeartBeam, and these two clearances together will form the product with which we'll start our initial commercialization. Now I'd like to describe the ecosystem we're building around the HeartBeam system. This ecosystem dramatically increases the overall value of the system and will drive deeper adoption. Everything starts with the HeartBeam system, the first and only credit card-sized cable-free device that synthesizes a 12-lead ECG. Our extensive market research has demonstrated that the easy-to-use and always available HeartBeam system, combined with an on-demand U.S.-based board-certified cardiologist available to review ECG readings 24/7, is a valuable combination. The concept resonates strongly with both physicians and patients who have indicated a willingness to pay a premium for this functionality. And around this core, we're creating an ecosystem to unlock the unparalleled performance of our technology. Key components of our ecosystem include automated arrhythmia assessments through our integration with AccurKardia. We want to encourage our users to take readings to practice and to build up their data. When this functionality is cleared by the FDA, users will receive an automated arrhythmia assessment immediately after each of these routine recordings. Integration with wearables. Our system will prompt users to take a HeartBeam reading upon specific parameters from a wearable, whether that be an inconclusive reading with a 1-lead ECG or potentially worrisome parameters noted by the wearable. In addition, when a patient experiences symptoms and uses the HeartBeam device, we'll be able to present relevant contextual information from the wearable to the physician for richer context. Next, our AI team is developing AI wellness features to enhance the experience. We'll announce more details on these features, but one we're excited about is ECG-based cardiac age in which an AI model determines the user's cardiac age. Differences between this and the user's actual age can provide valuable insights. Also, we'll be creating community features with tailored educational content. This has been a top request from potential users and will allow them to connect more deeply with the platform. And finally, our system will allow long-term trending of the HeartBeam synthesized 12-lead ECGs, allowing the patient's physician to get insights, including the trending of specific parameters over time. For example, changes in ECG intervals can provide important information on cardiac health. Creating this ecosystem will add unique insights and actionable data for both patients and physicians that are unavailable elsewhere and add to the premium offering of HeartBeam. In the future, adding artificial intelligence to our high-resolution signals acquired by patients longitudinally over time can further enrich these insights and provide even greater value. Next, I'd like to take a moment to articulate HeartBeam's vision beyond arrhythmias and how we believe our technology will ultimately align with the significant shift that's occurring within health care. One of the most important trends in medicine today is the movement of medical-grade devices from the hospital and clinic to the patient. Accurate, connected medical-grade technologies have been shown to expand access, reduce health care costs, and enable personalized medicine. For example, this has been seen in the emergence of continuous glucose monitors, at-home blood pressure monitoring, and portable oxygen monitors. These technologies empower patients, they provide clinicians with richer information, and shift the balance toward proactive home-centered care. But within cardiac diseases, there's a major gap and a huge opportunity. Cardiac diseases are the leading cause of death worldwide and most cardiac events, whether arrhythmias or ischemia happen outside of the health care setting. Diagnosing these events is crucial to patients and for the health care system. And we believe as we implement our vision, our technology will be well positioned to accomplish this. An ECG is the most common cardiac test, and it's crucial to monitoring and early detection, but the most common at-home options have been limited to downgraded versions, unable to provide a 12-lead output that's standard in the hospital and clinic. The most common at-home ECGs have just a single lead, bringing a synthesized 12-lead ECG into the patient's pocket is a transformative step. Patients and physicians want a 12-lead ECG, not a 1-lead or a 6-lead for the peace of mind should they have symptoms, but also to track their cardiac health with best-in-class technology. We believe this is also crucial for the health care system as a whole as care moves to the home. As discussed in our last earnings call, the main focus of the company for the remainder of 2025 is working with the FDA on the review of our 510(k) application and on our commercial readiness efforts as we prepare for commercialization, and we've made significant strides toward both of these goals. On the regulatory front, we continue to engage in positive and productive discussions with the FDA on the 12-lead synthesis software submission. The FDA review team is familiar with HeartBeam from our initial 510(k) clearance, and we have submitted the results of the VALID-ECG study in which we achieved our performance goals. As we're in active and ongoing discussions, we can't give specific details, but we continue to anticipate clearance by the end of the year. As we've discussed that clearance together with our existing clearance will form the basis of our commercial launch. In addition, we started our interactions with the FDA on expanding our indication to include ischemia or inadequate blood flow to the heart. ECGs can detect electrical changes that occur during ischemic events such as heart attacks. We're engaging with the FDA to discuss our rationale and clinical study plans. As discussed previously; in order to optimize time to commercialization, we've signed an agreement with AccurKardia to bring their automated arrhythmia assessment algorithm to the HeartBeam system. When our users take a recording, we'll provide them with an automated arrhythmia assessment powered by AccurKardia. We're currently working with the AccurKardia team to prepare an FDA submission for the application of their algorithm to the HeartBeam system. I'll go into more detail on our go-to-market and business development efforts in upcoming slides, but I'll quickly highlight that we continue to execute on commercial readiness plans such as finalizing a cardiology reader service and establishing the necessary infrastructure for commercial launch. Additionally, we're seeing a market increase in interest from industry partners as we get closer to our 12-lead synthesis clearance and commercialization. On other fronts, an abstract on our AI algorithm was accepted and will be presented during the HRX Live Conference in Atlanta in September, and we've had an additional patent issued, giving us a total of 21 patents worldwide. The team has done an exceptional job of achieving the milestones we said we were going to achieve, and we're on track for the remaining milestones in 2025. To reiterate the key points, our discussions with the FDA around the 12-lead synthesis software continue to be productive, and we believe the timeline for FDA clearance remains firmly on track for Q4. This clearance will be followed by our pilot commercial launch. The other two major milestones that we're expecting in Q4 are the FDA submission of the AccurKardia algorithm applied to the HeartBeam system and the start of enrollment in our MI pilot study that's part of our effort to expand our initial indication. In the past months, we're pleased to be honored with two additional industry recognitions. In July, we were awarded the Innovation in Remote Cardiac Diagnostics honor through the Medical Device Network Excellence Program. The MDN program analyzes over 1 billion data sets annually to recognize forward-thinking companies that drive positive change and set new standards for excellence across the global medical device sector. Additionally, HeartBeam is a finalist for the 2025 Octane High-Tech Awards, which recognizes top innovators, entrepreneurs, and technology leaders with a presence in Orange County. These latest awards add to the growing list of industry recognitions, and we're honored that the company and its groundbreaking ECG technology is being recognized as it validates the team's hard work and the substantial progress that we've made. On the commercial readiness front, the team continues to build and refine the systems needed for our commercial launch. These efforts include establishing the third-party cardiology reader service and setting up the customer service infrastructure, contract manufacturing, and logistics and fulfillment efforts. We're also finalizing the commercial software, which has been significantly enhanced by feedback we've received during our beta testing. On the hardware side, we've completed development of our next-generation hardware, which further enhances the quality of our system and will be the hardware version we launch with. Meanwhile, we're working to finalize our commercial offering and pricing model. We've selected our initial two geographies for pilot commercialization: Florida and Southern California. We've identified our initial target concierge practices in these areas, and we're engaging in discussions with them. The plan is to have signed letters of intent with these practices so that everything is in place to launch commercially after receiving FDA clearance on the 12-lead synthesis software. Our initial commercialization is focused on patients paying directly for the technology. We plan to reach these patients through concierge and preventive cardiology practices. We estimate there are 1.5 million patients with concierge medicine in the U.S., and assuming just 1/3 have elevated cardiac risk, a family history, or are interested in the latest cardiac monitoring technology, that's between $250 million and $500 million in annual recurring revenue as an initial segment. Proving the concept and demonstrating market acceptance through our targeted commercial launch will open up multiple avenues for scaling, including building a targeted sales force of our own, rolling out through major concierge and preventive cardiology practices, and leveraging our sales efforts with strategic partners. We're seeing a marked increase in interest from industry partners as we get closer to our 12-lead synthesis clearance and commercialization. We obviously can't talk about any ongoing discussions, but there's one common theme. These players understand that HeartBeam's technology is transformative and an ideal platform. There are multiple ways for partners to get involved in the HeartBeam ecosystem, including data and AI, companion products and services, and complementary diagnostics and treatments. To that end, we've added a recognized industry expert to help drive business development and partnership opportunities. This resource brings a wealth of knowledge and relationships in the space and is also an existing shareholder of HeartBeam. The additional capacity will help drive our efforts and keep up with the growing inbound demand. Now I'll turn it over to Tim to walk through the financials.

Great. Thank you, Rob. A focus over the past quarter has been on capital efficiency. We're already a lean organization with under 20 employees. But as a pre-commercial company, we're also, of course, highly sensitive to cash burn and maximizing our resources. So to that end, we've been undergoing a continuous process of reviewing costs and ensuring they directly align with our company's critical objectives at hand. Those efforts resulted in net cash used in operating activities of $3.4 million for the quarter, a 23% decrease from the previous quarter. Inside that number is a baseline recurring expenditure of $3.1 million, which is 11% lower than the historic baseline I've talked about of $3.5 million per quarter. The additional $0.3 million we spent to go from $3.1 million to $3.4 million was related to investments in commercial readiness activities and manufacturing capabilities in preparation for the pilot launch and all of the activities that Rob walked you through on the previous slides. Additionally, following the end of Q2, the company has continued to take measures to extend our runway by further decreasing cash burn over the course of 2025. One example of those measures is a temporary reduction to Board fees and executive-based salaries with individuals taking a portion of compensation as shares in lieu of cash for a short period of time. Our dedicated Board and management team here is willing to show their belief in this mission and prepared to put the company in the best position for success. So you can expect to see those impacts of the reductions to operating cash flows as early as Q3, and we'd expect them to continue through Q4. These savings will give us more flexibility in timing the additional expenses required for our pilot commercial launch and could allow us the opportunity to pull some of those commercial expenditures forward as FDA clearance approaches. So for cash, we finished Q2 2025 with a cash balance of $5.1 million when cash, cash equivalents, and short-term investments are added together. With our continued strong financial discipline in place, we're focused on strategically financing the business as we continue to achieve milestones and derisk the business. We have the continued support of MDB Capital, and we'll be working with them and our other partners to ensure that the business is adequately capitalized. I'll remind you, unlike most pre-commercial microcap businesses, we've been able to secure financing and keep a clean cap table, all the while keeping a heavy focus on minimizing dilution for our shareholders, and our intent is to continue this discipline. Rob, with that, I'll hand it back over to you.

Thanks, Tim. In summary, the team remains focused on securing FDA clearance for the 12-lead synthesis software, which remains on track for Q4. This will be the culmination of tremendous efforts from the team and will be followed by commercialization. We continue to make solid progress in multiple commercial readiness areas, advancing the software and hardware for the commercial system and putting the infrastructure in place from customer service to logistics to the cardiology reader service. We've signed the agreement with AccurKardia to leverage their arrhythmia assessment algorithm. We have strong interest from concierge and preventive cardiology practices, and we're now engaging in outreach to target practices to further validate our pricing model. As we're approaching FDA clearance and commercialization, discussions with strategic partners are accelerating as these partners recognize that our platform is the best technology for providing high-quality ECGs. Additionally, we've heightened our capital efficiency efforts and have reduced our cash burn to minimize dilution to shareholders. I'm more optimistic about the potential for this business than ever before. Once we receive clearance, we have a strong plan in place for launch, and we have extensive feedback from physicians and patients that the system delivers the data that they need, and they see great value in HeartBeam's unprecedented technology. Soon after our launch with a small and growing community of users, we believe that we'll demonstrate a path toward profitability. We further believe that with just a small fraction of adoption compared to other popular devices, we'll create a valuable platform, and our share value should reflect this. HeartBeam has developed the only personal cable-free ECG device capable of producing a synthesized 12-lead ECG. There's a clear trend of moving medical-grade technologies to the home. And as we implement our vision, HeartBeam will be well positioned to bring the latest and most sophisticated ECG technology to the patient at home. We thank all of you for attending, and now we'd like to open it up to Q&A.

The first question comes from Bill Sutherland with The Benchmark Company.

I apologize, Rob, I missed your opening comments, but I did want to see if you could provide an update on your commercial strategy, particularly regarding your progress on early access and any relevant numbers.

Yes, Bill, great to hear you. Yes. So we can certainly talk in more detail offline. The early access program that we've had, the beta program is primarily focused on us learning the end-to-end system, training patients and practices. And it's going well. We're making a lot of progress. We have, as I mentioned, we actually made some iterations to further enhance the software based on the feedback that we've got. So that's going well. And the other part that I mentioned is we've identified for our commercial launch, our pilot commercial launch, we've identified the two geographic areas that will be the focus. That's Southern California and Florida, and we're starting to do outreach to the key practices in those areas to do things like further validate the pricing and the business model as we make progress within that area. So I hope that answers your question, Bill. We can talk more offline if you want.

No, no, no, that's great. And then you are in the search for a Chief Commercial Officer, has that been updated?

Yes. Great question. We do have a candidate actually lined up, and we're just really trying to figure out as a company with that candidate when the right time is to start kind of balancing the real focus on cash burn and dilution together with when we want to start things. We've got an internal team and some consultants that we've been able to make great progress in finalizing the commercial offering and outreach to initial sites. And so we still plan to bring on that person. We're just kind of waiting to finalize the timing a little closer to the actual launch.

Yes, that makes sense. I need to ask about the OBBB Act. Are there any impacts on your plans and direction?

No. So Tim, feel free to add on. From my perspective, no change to our plans from anything related to government policy now from tariffs, from the bill, from anything else. We're obviously monitoring the statements coming out that are very positive in terms of the desire to push for wearable and other technology with patients, and we see that as obviously incredibly positive for this industry as a whole. But I haven't seen anything from my perspective that we see as a negative coming out of any policy measures.

Excellent. I'm curious about the potential strategic partners who have started reaching out to you. Can you give us an idea of some of the types of strategic partners that might be a good fit?

Yes, I can't provide specific details on that. We are interested in exploring ways to expand or scale more quickly, particularly through areas where patients are clustered, such as networks of practices or companies targeting the same call points. We are open to any opportunities that can assist our core team as we initiate pilot commercialization, and those represent potential pathways for growth. Additionally, we are interested in companies that are connected to our platform in terms of data and artificial intelligence. There are also opportunities related to companion products and services, as well as complementary diagnostics and treatments. I won't delve too deeply into that, but there are various avenues that could help us scale and enhance the ecosystem I mentioned earlier.

As we have no further audio questions, I would now like to hand the call over to Ian Scargill for any web questions.

Thank you, operator. Our first webcast question will be surrounding, can you provide more details on the productive discussions that you've had with the FDA? And secondarily, can you state what specific timeline there is for the clearance?

I'll take that. I guess I'd just say because there are ongoing discussions with the FDA, I can't provide more detail than what I presented. I'll just reiterate they're positive and productive discussions. The FDA team is familiar with our technology because it's the same team that was involved in our initial 510(k) clearance. And one of the key parts of this submission, as we've talked about on previous calls, is the VALID-ECG study. That's what compared the output of our 12-lead synthesis software to a simultaneously gathered standard 12-lead in patients in arrhythmia clinics. That one met the performance goals we had set out, and that's been submitted. So I can't give any more details beyond that characterization and that we continue to believe we're on track for clearance in Q4.

Perfect. Our next question from the webcast line. What are the plans for future funding? And how will you manage dilution associated with potentially that?

Sure. I'm happy to take that one, Rob. Yes. We remain acutely focused on managing dilution. I think in my comments, I brought that up, and it's a major focus area for the company. We're very proud of the fundraisings we've done in the past and keeping our cap table clean and managing dilution through that as well. When you look at our cash, $5.1 million in the bank, we spent $3.4 million last quarter. We're continuing to refine our expenditure and make sure we give ourselves maximum flexibility in terms of what the future timing of a raise could look like. And so that's the name of the game for us is really just creating flexibility, hitting our milestones, executing. And while doing that, we believe we'll come up with a structure to manage dilution effectively. We're more optimistic about the potential for this business than ever before. The inbound interest as well as the early access program and the insights we're getting give us a lot of confidence that following FDA clearance and launch with a small and growing community, as Rob talked about, of users, we believe we'll be able to then demonstrate a path to profitability, and we're heavily focused on that.

Thank you, Tim. Our next question is, when will an anticipated unit price for the device and subscription for the data cost be determined?

Yes. I'll start on that, and Tim, feel free to add on after this. As I mentioned in my remarks, we've got some really extensive market research, including talking to high net worth individuals and getting feedback on pricing. And we're now working with target practices to basically further validate that information. And it's both the pricing level that you asked about, but also the elements of our system. So we know it will be a subscription model. One of the questions we're working through is the device separate with a subscription or does it all bundle together? Do we have multiple options? So we're working through things like that, a few other parameters that we're trying to finalize. So the real matrix of things, our goal is to simplify the offering, so this is very straightforward to physicians and patients. We've talked about for a while, and it's in the numbers that I gave of we would expect kind of all in the annual revenue per unit is somewhere between $50 and $100 per month or $500 and $1,000 per year. We'll be dialing in that a little bit more. So the specific question is over the next 3 months as we're getting closer to the launch, we'll dial in both the price and the business model and the specific offering in more detail. Tim, anything to add on that?

That was really well spoken. We're focusing on the $500 to $1,000 range as we continue to validate our approach. When considering the business's cost structure, we currently maintain a margin of around 50% in the early stages. This includes expenses related to the device, onboarding, training, and related activities. We see a payback period of approximately 3 to 5 months from a cash flow perspective to cover these costs. After this period, we anticipate margins exceeding 70% for recurring revenue, based on our modeling. We will keep refining our approach as we interact with accounts, learn more, and observe this in action. We have a strong recurring revenue business model with high margins, and the ecosystem Rob described earlier in the call is essential for reducing customer churn and maintaining long-term engagement, which allows us to achieve those higher margins over time while retaining customers.

Great. So our next question from the webcast touches a little bit on the industry. How are you guys viewing other players like iRhythm and the opportunity for market share that HeartBeam can capture with these other established technologies?

Yes, I'll take that one. It's a really interesting question. So I can talk for hours on this, but iRhythm is an incredible company with incredible technology. We don't believe that we're competing directly against them. So the iRhythm market is prescribed to patients to wear a patch for, the general is 14 days, collects all of the beats during that, goes to physician and gives a snapshot of what's happening is really valuable in diagnosing arrhythmias. Our device is meant to be with the patient, carried with them for a lot longer period of time. Obviously, not a continuous wearable, but something that people carry with them, establish a baseline, do routine recordings, and then have for the peace of mind when they have symptoms. So we think it's in a different place in the market than iRhythm and various wearable patches. One thing we have talked about earlier is we have IP on taking our unique approach to create a synthesized 12-lead through this 3-dimensional approach; we can apply that to patches such as what iRhythm and their competitors have. And that's something that we're certainly thinking about going forward, not as the first product, but because we think that is a very interesting market. So short answer is that we think that we're complementary to that and in a different use case to iRhythm. So we don't see it as necessarily competing or stealing share from them. We see that existing alongside in a different part of the ecosystem.

Perfect. Thanks, Rob. Our next webcast question talks a little bit about the HeartBeam device, which seems like an intuitive device to use. Is HeartBeam planning to ensure doctors and hospitals are getting training, question-answering time to ensure that market failures that occurred with perhaps the Butterfly device will not take place?

Yes, that's a great question. With my extensive experience in medical devices, I can say that usability is crucial. We aim to design an easy-to-use device, but it also depends on how both patients and physicians are trained. This is part of our rollout strategy and the reason for our early access program; we want to learn and optimize during a controlled pilot commercialization in select regions. Our plan includes having a salesperson and a clinical application specialist in each region. The specialist will be an expert on the product and will initially train the patients before transitioning to a train-the-trainer model, as Tim mentioned. It's essential that our physicians understand their part of the portal and that all patients receive proper training. Our customer service will focus on troubleshooting and answering questions, and we are also establishing a cardiology reader service to interpret ECGs. This service will involve thorough discussions and training to ensure they understand how our technology works with traditional 12-lead outputs. We recognize the significance of training for everyone involved with the product, and we will ensure the necessary resources are in place for comprehensive training. This is vital for the success of a new technology like this.

Great. And our last webcast question of the day, which comes in three parts. You've described this larger ecosystem. Is this going to be part of your initial commercial launch? What do the pilot program timelines look like? And when would they begin? And lastly, can you talk a little bit more about wearable integration to conclude today's call?

Sure. Let me address those points. I'll start with the pilot timeline. We have an early access program, essentially a beta program, where we are gathering feedback on the product. Our plan is to initiate our commercial launch, which we refer to as a pilot commercial launch, immediately after the second FDA clearance in Q4. That’s why we are reaching out to initial practices. The commercial pilot program will commence shortly following the FDA clearance. Regarding the ecosystem, we expect it to evolve over time. Our market research indicates that the highest value, and what potential users are most enthusiastic about, is the ECG that produces a synthesized 12-lead, along with 24/7 access to an on-demand cardiologist to interpret the ECG. This will be the core offering at launch. We’ve mentioned AccurKardia as an essential part of the ecosystem; however, it involves a separate FDA filing that will occur later this year. Our initial commercial launch won't depend on the AccurKardia algorithm, meaning we will proceed regardless. If that functionality isn't available at launch, it will be introduced shortly thereafter. Additionally, wearable integration and other features I previously mentioned are planned to be available in the months following the initial product rollout. We're currently developing those elements. I'm particularly excited about this subscription service for our users, as they will pay a subscription fee, and we will gradually introduce new features that will enhance the overall ecosystem included in that subscription.

Great. Thanks, Rob. So with this, we formally conclude our webcast Q&A. For any additional questions, please feel free to reach out to the email listed on the slide as shown. I'll now turn the call back over to the operator before some final remarks from Rob.

This concludes our question-and-answer session. I would like to turn the conference back over to Rob Eno for any closing remarks.

Thank you, operator. I just want to thank everybody for joining today. We look forward to continuing to update you on our ongoing progress and growth. And if we're not able to answer any of your questions today, please reach out to our IR firm, and they'll be more than happy to assist you. Thanks again.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.