HeartBeam (BEAT) Q3 2026 Earnings Call Transcript

DATE

Thu, Nov. 12, 2026

CALL PARTICIPANTS

• Executive Chairman - Richard Ferrari
• Founder and President - Branislav Vajdic
• Chief Financial Officer - Timothy Cruickshank

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TAKEAWAYS

• Net Cash Used in Operating Activities -- $2.6 million, representing a 23% decrease compared to the second quarter of 2026 driven by cost efficiency measures and reduced noncore spending.
• Operating Expenses -- $3.5 million, reflecting a 35% decline versus the third quarter of 2025 due to the completion of primary development for the HeartBeam System.
• Full-Year Operating Cash Outflow Guidance -- $12 million to $12.5 million, representing a reduction from the company's previous forecast of staying below $14 million.
• Research and Development Spending -- $2.1 million, down from $3.3 million in the prior year period reflecting a $1.2 million reduction in related consulting and employee costs.
• Selling, General, and Administrative Expenses -- $1.3 million, compared to $2 million in the third quarter of 2025 due to a $400,000 decrease in noncash stock-based compensation.
• Pro Forma Cash Balance -- Approximately $10.1 million, consisting of $6.1 million in cash as of Sept. 30 and $4 million in net proceeds raised through an at-the-market facility post-quarter.
• ALIGN-ACS Diagnostic Performance -- 81.8% specificity and 60.2% sensitivity for the HeartBeam 3D ECG, compared to 71.4% and 63.0%, respectively, for a standard 12-lead ECG.
• STEMI Sensitivity -- 82.9% for the HeartBeam device versus 83.8% for a standard 12-lead ECG, indicating comparable performance for time-sensitive heart attacks.
• Reader Agreement -- 0.73 Fleiss' kappa score for HeartBeam recordings compared to 0.54 for standard ECGs, suggesting higher consistency among cardiologists using the 3D ECG signal.
• U.S. Pivotal Study Size -- Approximately 300 patients, according to a proposal submitted to the FDA that was developed using a Harvard University statistical model.
• HEADSTART-ACS Enrollment -- 486 patients in Indonesia, representing the largest heart attack assessment study to date for the company's technology.
• AI Sensitivity Delta -- 12 percentage points higher than physician interpretation in internal testing, with a 19 percentage point increase for non-ST elevation heart attacks.
• Atrial Flutter Algorithm Accuracy -- 97% accuracy in a study of 600 recordings compared to electrophysiology results, according to research presented at EHRA 2026.
• Total Nine-Month Net Loss -- $12.7 million, a reduction from a $15.7 million net loss during the same nine-month period in 2025.
• Pivotal Trial Enrollment Timeline -- Expected completion by mid-2027, assuming enrollment begins in either late 2026 or the first quarter of 2027.
• Study Site Capacity -- Eight to 10 cardiac centers, which management expects will enroll patients at a rate of 10 individuals per month each.
• Baseline Fourth Quarter Cash Outflow -- Target of less than $2.5 million, reflecting a strategy to maintain a low employee base and utilize variable consulting costs.
• Total Issued Patents -- 25 worldwide, protecting the company's proprietary 3D ECG signal capturing and interrogation technology.

SUMMARY

HeartBeam, Inc. (NASDAQ:BEAT) reported that heart attack detection is its primary strategic priority, supported by the confirmation of a 510(k) regulatory pathway with the FDA. The company stated that its Breakthrough Device Designation and enrollment in the TAP program have facilitated frequent communication with regulators and payers regarding pivotal study design and reimbursement pathways. Financial results showed a reduction in operating expenses following the completion of primary product development for the HeartBeam cardiac platform and the ALIGN-ACS pilot study. Management indicated that clinical data from the ALIGN-ACS study demonstrated that the handheld 3D ECG device has diagnostic accuracy comparable to a standard 12-lead ECG. The company is currently finalizing its U.S. pivotal study design and expects to commence patient enrollment by the first quarter of 2027.

• Richard Ferrari stated, "We have a 510(k) path. That's significant because it streamlines our time lines with respect to ultimately getting approval to launch our MI initiatives."
• Branislav Vajdic noted that the FDA's TAP program provides prioritized interaction, stating, "The level of engagement and availability are providing opportunities for us to iterate faster and provide us with an increased level of confidence."
• Timothy Cruickshank addressed the Dec. 28 NASDAQ compliance deadline, indicating, "we fully believe we're working towards organically rectifying this, and that's the approach the company's taking at this point."
• Richard Ferrari stated that patient delay in seeking care is a primary cause of death following symptom onset, noting that every 30-minute delay increases the risk of heart failure by 8.7%.
• Management stated that it is testing subscription models through concierge practices where providers supply the device to at-risk patients as part of a service fee.
• Richard Ferrari stated, "The beauty to what HeartBeam's technology is that, we can embed this technology in several different form factors," including credit-card-sized devices and wearable patches.

INDUSTRY GLOSSARY

• Acute Coronary Syndrome (ACS): A range of conditions associated with sudden, reduced blood flow to the heart, such as a heart attack.
• STEMI (ST-Elevation Myocardial Infarction): A severe type of heart attack identified by specific changes on an electrocardiogram.
• AUC (Area Under the Curve): A statistical measure of a diagnostic test's overall accuracy in distinguishing between healthy and diseased states.
• Fleiss' kappa: A statistical metric used to measure the degree of agreement between multiple observers or raters.
• 510(k): An FDA regulatory submission used to demonstrate that a medical device is safe and effective by showing it is substantially equivalent to a legally marketed device.
• Breakthrough Device Designation: A status granted by the FDA to speed the review of medical devices that provide more effective treatment for life-threatening conditions.
• TAP (Total Product Life Cycle Advisory Program): An FDA program providing strategic engagement between the agency and manufacturers to accelerate patient access to medical devices.
• DRG Code (Diagnosis-Related Group): A classification system used for hospital inpatient reimbursement based on diagnoses and clinical factors.
• Category III CPT Code: A temporary code for emerging technology or services used for data collection and reimbursement assessment.

Full Conference Call Transcript

Operator: Greetings, and welcome to the HeartBeam Third Quarter 2026 Financial Results Conference Call. [Operator Instructions] 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 today and webcast may include predictions, estimates, and other information that may 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 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 of 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 hosts today, Richard Ferrari, Executive Chairman; Branislav Vajdic, Founder and President; and Tim Cruickshank, Chief Financial Officer, will present results of operations for the third quarter ended September 30, 2026. At this time, I would like to turn the conference over to Richard Ferrari.

Richard Ferrari: Thank you, and thanks to all of you that have dialed into the conference call. Let me just walk you through the agenda very briefly. We're going to give you the progress on our key strategic initiatives. We'll bring you updates regarding our cardiac platform and our heart attack detection, which is an incredible milestone that we've achieved this particular quarter. And then finally, we'll close out with the financials. Next slide. The progress on the key strategic priorities.

I think many of you that have been following the company will remember that in July of this year, we outlined our plan going forward, and we organized the focus on our core strategic priorities, which are shown on this particular slide. That was MI detection, working closely with the FDA, working on reimbursement, enhancing the long-term value of the company through AI and the other technological initiatives, and then on the financial side, cost efficiency and tight controls with respect to running the company.

Now, when you look at heart attack detection, I have to say that in the last 90 days, Q3 was a fabulous quarter for achievement, and I think that's a testament we have, and the shift to the priorities that I have already mentioned. When you look at those achievements, these milestones are, for a small company, quite significant. Getting Breakthrough Device Designation, something we were really going after, really wanted to count on. And just to give you sort of a reference point, the FDA, on an average over the last 5, 6, 7 years, only hands out about 164 of these designations.

So it's proof statement that the technology and the opportunity to enhance patients' lives is significant with respect to HeartBeam. That also enabled us to get enrolled, if you will, into their TAP program. Now, the TAP program is also quite significant because it enables us to have faster turnaround with our communications with the FDA. It also opens up CMS and payers so that we can have discussions with them regarding reimbursement and what are the needs that they need to see in our clinical trial to establish reimbursement.

And then I think many of you may know that we had our publication, our presentation at the TCT meeting at the end of October, which again, in our perspective, is the first study, it was 132 patients, first study to really look at, in an emergency room setting, a comparison between the gold standard of the last 50 years, 12-lead EKG, and our handheld device for MI detection. And those results, Branislav will touch on a little bit later in this presentation, which were significant. I don't know that we've said this before.

We did tell you that we were working hard with the FDA with respect to whether or not we would have a 510(k) or a De Novo path. We have a 510(k) path. That's significant because it streamlines our time lines with respect to ultimately getting approval to launch our MI initiatives. And then lastly, again, because of the path and the designation, Breakthrough Device Designation, we're in constant communications actually with the FDA on our pivotal study. We've had a number of interactions with them.

We are very confident in how we've structured that pivotal trial, and we're also very confident that we will getting approval with FDA very shortly on launching that trial and starting it, potentially this year, but certainly in Q1 of 2027. Now on the reimbursement path, we have a reimbursement consultant we're working with, and as I mentioned to you, we will be in discussions with CMS payers, seeing what it is that they need to have from us with respect to the clinical trial results or secondary endpoints that we might put in there that would enable them to go ahead and issue a DRG code for the HeartBeam technology. So we're pleased with the progress we're making there.

On the long-term value and the AI side, we're going to touch on this in a minute, the market opportunity here, which you'll hear me speak about more, is just gigantic actually. And the beauty to what HeartBeam's technology is that, we can embed this technology in several different form factors, which I'll also review. And the real benefit of HeartBeam is on its 3D technology. And you've heard me mention this before, that is the technology we have is simply the best signal capturing and interrogation product that exists. Now that's important because we're moving into utilizing AI to help further streamline the information to physicians, and the richer data one has, the more valuable the information is.

So we're really excited, and Branislav will touch on this, about our AI initiatives. And as Tim will touch on later as well, is what we've been doing in controlling the cost and managing our cash appropriately. Next slide. So I'm going to walk in -- walk us through the HeartBeam cardiac platform for you. So next slide. This slide really depicts, I think, the essence of what it is HeartBeam is dedicated to do.

Patient delay in terms of getting to the hospital from the time that they have the symptom is the #1 cause of death, and there is simply no device that a patient can have with them at their home, on vacation, traveling, that would enable them to determine whether or not they're having a heart attack. And if you look at the data on the left-hand side of that page, it's very, very revealing as to the damage that delay causes. Every 30-minute delay, 8.7% heart failure risk. This is a -- obviously, a big problem for the health care system.

People that have congestive heart failure, they are repeat flyers in and out of the hospital at huge costs in terms of care, and a 7.5% 1-year mortality. And again, at the bottom, very costly approach to delays. So we're very, very excited about, "our initial results," as you'll see from the ALIGN study and what that means, and the fact that we're really just improving how rapidly a patient has a symptom and can get to the hospital. And again, I'll just reinforce this. Currently, there is no home ECG tool that reliably detects heart attacks. So the importance of getting to the hospital is paramount. Next slide.

When you look at the core technology platform, I've said this a few times this morning, but I'll say it again, the size of the TAM, the cardiac platform opportunity that we have is simply one of the largest in the entire health care industry, a $40 billion opportunity affecting 50 million plus patients. And when you squeeze down on the specifics to heart attack detection, those patients that would be at risk, that's 20-plus million people.

So once again, you could see the importance of having a device that was with you at all times, specifically if you had already had balloon angioplasty, cardiac surgery, atrial fibrillation procedure, coronary stents, any predetermined risks related to your genetics in terms of heart health. So our goal is to close that gap between symptom onset and care by giving patients something that they can have with them and get an immediate response. It's a first-of-a-kind portable cable-free EKG device. And it provides a clinical-grade report to a bank of cardiologists that read that information and then provide notification to the patient. On top of that, we have 25 issued patents worldwide incorporating our proprietary technology.

And once again, the signal capturing and the ability to integrate the signal for us, the EKG signal, just opens up tremendous opportunities for us going forward to further and further enhance types of information we're providing to the physicians, the cardiologists, as well as to the patient themselves. Next slide. I think you've also heard us talk about the fact that the technology is already proven. We've already built this technology. We have utilized it in a number of clinical trials. There's nothing more for us to build with respect to the signal capturing and the hardware. All we're doing now is enhancing through AI initiatives.

And because of that, we're capable of taking that technology and putting it into different form factors depending upon the application. So in this particular slide, you see the HeartBeam card, and that will be an item that someone carries with them. As you know, it's just roughly the size of a credit card. It will allow them to determine whether or not they have AFib or whether or not they're having a heart attack. The patch is a different form factor and addresses a different aspect of the market. It's targeted more for the inpatient step-down units where the nurses are circulating and you may have an at-risk cardiac patient staying overnight or 2.

It'd be great if you had a patch on there where they said, "Gee, listen, why don't you put 2 fingers up and let's take a reading and see how you're doing?" But of course, when they're discharged, we want them to go away either with the card or the patch, again, depending upon the specifics of that particular patient.

And then we have what we call the HeartBeam remote unit, and this is, again, same technology, but it's something that we're looking at in terms of outside the United States in more remote locations where towns or villages or what have you, who don't have tremendous access to the new and greatest technology, would in fact be able to offer something to the people of that particular area that would provide, again, the type of information that's so critically important to their cardiac health. So next slide, please. So the heart attack detection and the milestones that we've achieved, now we've touched on this, but this is the road map going forward.

So when you think about HeartBeam, this is the way that you really should value the company, is these next series of steps. And we're really proud of the team that we've got because they execute flawlessly in Q3, and they will execute flawlessly, in my opinion, on these next series of milestones. So we already know positive pilot study data, and Branislav is going to touch on that. So we have agreement with the FDA on 510(k), and we indicated to you previously that we thought that's the way it would go. We are in constant communication with them regarding the pivotal study, mostly regarding the statistical model required, which drives the number of patients.

We're, again, very confident in getting that approval with a study design and a number of patients that we can manage exceedingly well. I mentioned that, and I don't want to be overly optimistic, but it's possible we may enroll the first patient before year-end. But if not, we're very confident in Q1 2027. And again, based on the conversations we're having and the size of the trial that I think we'll be doing, we would expect the pivotal trial to likely be finished mid-2027. And then after that, it's just simply compiling the data and providing that information to the FDA for clearance.

And I can't give too much more information on the time line-related to clearance because a lot of that is dependent upon, "the start of the trial and the number of patients." But when you look at this, the singular word that should come to your mind is execution. We know how to execute, and we know what's exactly required to deliver a green check in every single one of those boxes. And we have a great relationship with the FDA. The Breakthrough Device Designation and the TAP have really enhanced our ability to move through in a really expeditious manner. Next slide, and I'm going to turn it over to Branislav.

Branislav Vajdic: Thank you, Rich. Actually, I would like to emphasize 2 points. The first one is on the alignment with the FDA on our 510(k) pathway, which is a super important step. It clarifies the regulatory path for heart attack assessment, and we believe it shortens that path as well. Secondly, Breakthrough Device Designation and the TAP give us a prioritized interaction and dedicated FDA advisors as we finalize the pivotal study design. We expect to complete pivotal study design in the fourth quarter of this year. So far, the interaction with the FDA, and I have been part of all these interactions, through the Breakthrough and TAP programs have been outstanding.

The level of engagement and availability are providing opportunities for us to iterate faster and provide us with an increased level of confidence. Now, let me walk you through the data behind this progress. Next slide, please. Earlier this month, at TCT 2026 in San Diego, Dr. Graham Nichol of the University of Washington presented the results of our ALIGN-ACS pivotal study. The study enrolled 132 adults at the emergency department of 2 major cardiology centers in Belgrade, Serbia. It evaluated the diagnostic accuracy of the HeartBeam System compared with a standard 12-lead ECG in assessing acute coronary syndrome, which includes heart attack as well.

Eight cardiologists, blinded to each patient's diagnosis, independently interpreted both HeartBeam and standard 12-lead ECG recordings, with HeartBeam recordings read with the support of a clinical decision support system. Their interpretations were compared with each patient's final diagnosis for gold standard. At the top level, we can say that the results showed that the patient-recorded HeartBeam 3D ECG was as accurate as the standard 12-lead ECG. HeartBeam showed higher specificity at 81.8% compared with 71.4% for the standard 12-lead ECG, with comparable sensitivity of 60.2% compared with 63.0%. Very similar, which points to its potential as a rule-in diagnostic aid.

On the right-hand side, I would like to draw your attention to additional results of this study that are very encouraging indeed. The area under curve, so-called AUC, is a measure of overall diagnostic accuracy. Actually, you can view it as a measure of information content found in our 3D 3-lead and standard 12-lead signal as well. The 3D 3-lead and the 12-lead showed the same area under curve, same AUC. This is a super important finding, and we'll be using it in finalizing our U.S. pivotal study design. Also, every patient in the study was able to successfully obtain HeartBeam recording, which is a very encouraging sign for ease of use.

For STEMI heart attack, the most time-sensitive for all heart attacks, sensitivity was 82.9% for HeartBeam compared with 83.8% for standard 12-lead ECG. Again, very similar indeed. The cardiologists also agreed with one another more often when reading the HeartBeam recordings, with a reader agreement score known as Fleiss' kappa of 0.73 compared with 0.54 for the standard 12-lead ECG. As Rich mentioned, the results of this pivotal study will inform the design of our U.S. pivotal study, which is planned to commence in the first quarter of 2027, or possibly a little bit earlier, if everything gets accelerated. As Dr.

Nichol noted, these early findings demonstrate the potential of this technology to help shorten time to care for patients experiencing a heart attack. We want to say thank you to Dr. Nichol, all of our investigators, the patients, and all of the individuals that helped support this important study. Next slide, please. ALIGN-ACS is one of our growing body of clinical evidence. In October, we completed enrollment ahead of schedule in our HEADSTART-ACS, the largest heart attack assessment study to date using HeartBeam technology. The study was conducted in Indonesia, a country of 288 million people, spread across thousands of inhabited islands, where many patients are unable to readily access a 12-lead ECG when symptoms occur.

The study enrolled 486 patients presenting to the emergency department with chest pain at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia. The data analysis is underway, and we anticipate presenting the results at the cardiology conference in 2027. Together with ALIGN-ACS, we now have clinical experience with more than 600 patients in heart attack assessment. Next in line is our U.S. pivotal study planned, again, for beginning of 2027. It will support our FDA submission for the heart attack assessment. In October, we also joined the EU, actually, co-funded EXIT-CVD Research Consortium as a contributing partner alongside Philips, Medtronic, GE HealthCare, and other global health care organizations.

HeartBeam will lead the HEART-CHECK study, one of the project's 22 clinical studies examining high-risk patients. These studies are expanding our body of clinical evidence in heart attack assessment and are integral part, actually, of our heart attack detection commercialization plan. Next slide, please. Alongside the clinical and regulatory work, we are building the path to payment for our heart assessment product. It will highlight 3 areas. First, our acceptance into the FDA TAP program provides us with early connection with CMS, payers, patients, and provider organizations as we build real-world evidence and assess coding, coverage, and payment pathways. Breakthrough Device Designation is also a prerequisite for certain expedited Medicare coverage pathways.

Under the proposed RAPID pathway, CMS would issue a proposed national coverage determination on the same day an eligible Breakthrough Device receives FDA clearance. RAPID is proposed and not final yet, and we are actively evaluating how it may apply to HeartBeam. Second, the new CPT codes are emerging, including a recent Category III CPT code for algorithm-assisted ECG analysis to identify heart attack. This is an encouraging development, and of course, the coverage and payment decisions by CMS and payers are separate and still ahead. Third, we are building supporting evidence of our impact on reducing the time from symptoms onset to first medical contact.

We are working to determine endpoints related to reimbursement for a heart attack assessment study, informed by our early engagement with CMS and payer through TAP program. Next slide, please. I will finish with our AI program update, which builds on the same 3D ECG platform. Our data set includes more than 168 ECGs for heart attack training and more than 2,100 HeartBeam device recordings for testing. We finished development of our arrhythmia AI model, and our full attention and focus are now on heart attack assessment AI model. In early internal analysis of HeartBeam recordings, the AI identified more heart attacks than physicians reading the same recordings.

Sensitivity for our AI was about 12 percentage points higher across all heart attacks and 19 percentage points higher for non-ST elevation heart attacks, at actually similar specificity. These results are very encouraging, yet they are early, they are internal and not yet peer-reviewed, and HeartBeam AI remains investigational and is not FDA cleared at this time. Our initial atrial flutter algorithm, developed in collaboration with University Hospital Basel, Switzerland, showed 97% accuracy compared with electrophysiology study in 600 recordings using standard 12-lead ECGs. That work was presented as an abstract at EHRA 2026 European Conference and published in Europace, and the full manuscript has been accepted by Canadian Journal of Cardiology.

We are also collaborating on AI applications with Mount Sinai Hospital in New York and University Hospital Basel, Switzerland. Let me conclude by emphasizing our overarching goal: to shorten the time between the first symptoms and the decision to seek medical care. We aim to achieve this by providing patients and their physicians with clinical-grade cardiac information when every minute matters. We believe HeartBeam can help close the gap to the millions of people at risk. With that, I would like to hand it back to Rich.

Richard Ferrari: Yes. Thank you, Branislav. So, in fact, the next slide actually tees up Tim on the financials.

Timothy Cruickshank: Great. Thank you, Rich. Thanks, Branislav. Those were great updates. Taking a look at the Q3 2026 financials, and we'll focus in on cash flow first. Net cash used in operating activities were $2.6 million in the quarter. That's a 23% decrease in operating cash outflow compared to the second quarter of 2026, and an 18% decrease compared to the same quarter in the prior year. Last quarter on this call, we walked you through the step-down in cash flows that we expected to see, focused on getting baseline Q4 2026 operating cash flow to below $2.5 million.

We're happy to report that's tracking as planned, and in fact, ahead of schedule a bit, and I'll have some more on that in a moment. Total operating expenses, $3.5 million, down 32% compared to Q2, and down 35% compared to the third quarter of last year. Two drivers were, with R&D, we're down $1.2 million from last year's third quarter. $0.8 million of that came from the completion of product development and the related consulting costs for the HeartBeam System and the prototype patch, as Rich has called out earlier. But the development is broadly complete, so we're seeing a decrease across the board there.

Another $0.3 million from completing the ALIGN-ACS pilot study, and a further $0.1 million from lower employee costs. For the SG&A portion, that's down $0.7 million, driven by $0.4 million of noncash stock-based compensation decreases, and then $0.3 million from lower employee costs. The takeaway here on cash flow, the focus on our heart attack detection programs providing an opportunity for enhanced capital efficiency. I've talked a lot in the past about the variable nature of our cost basis, how it provides us a lot of flexibility in decision-making. We keep a very low employee base, and we rely heavily on seasoned consultants focused on specific projects and objectives.

And so, when we determined it was time to go all in on accelerating our efforts towards heart attack detection, we're able to, not only quickly shift our capital allocation, but also reduce our overall spending significantly. And we're seeing evidence of that almost a quarter ahead of schedule. On the balance sheet, cash and cash equivalents totaled $6.1 million at September 30, 2026. That compares to $4.4 million at the end of last year. Since quarter end, we raised approximately $4 million of net proceeds through prudent use of our at-the-market facility. So in total, that gives us a pro forma cash balance of approximately $10.1 million.

As we look ahead, as we outlined in the previous quarter, we expect that baseline fourth quarter operating cash outflow to be below $2.5 million on pace for that. That pro forma cash that I mentioned, along with our continued efforts to reduce our noncore spending, is extending our cash runway further into 2027, and it's aligned with achieving a number of key upcoming milestones. Accelerated timing of the U.S. pivotal study, if we would potentially add to the $2.5 million cash outflows that we estimate for Q4, but that would be a welcomed expenditure if we're able to continue to accelerate that program.

And for the full year 2026, we now expect net operating cash outflow between $12 million and $12.5 million, which is a further reduction from prior guidance earlier in the year of staying below $14 million. So pleased with the results there and seeing the cash numbers come in as planned. As we go to the next slide. Turning to the income statement, SG&A, $1.3 million compared to $2 million in the third quarter of last year, and $2.8 million in Q2. R&D was $2.1 million compared to $3.3 million last year, and $2.3 million in Q2. Total operating expenses, $3.5 million compared to $5.3 million last year, and $5.1 million in Q2.

And net loss for the quarter, $3 million compared to the $5.3 million in the prior third quarter of 2025, and then $5 million in Q2. So across the board, SG&A, R&D, you're seeing evidence of the measures we put in place to enhance our capital efficiency, both in cash flow, but ongoing in the P&L as well. While we've been working at it consistently over the past year, we really accelerated our efforts over the past quarter, and you get a good visual of the magnitude of that outcome of our cost containment when you compare Q3 2026 to Q3 2025 there on the screen.

So for the 9 months of the year, operating expenses coming in at $13.3 million versus $15.8 million. That's a 16% decrease in the 9-month period. Net loss, $12.7 million versus $15.7 million in the prior 9 months, and cash used in operating activities, $9.5 million versus $11.1 million, a decrease of 14%. So as we look at that 9-month number of $9.5 million in net cash used in operating activities, you can quickly see the range of $12 million to $12.5 million for the full year and how that comes about with our anticipated spend of $2.5 million, and we've just buffered that for any acceleration we see in the pivotal study.

In summary, the purposefully variable nature of our cost base really allowed us to pivot quickly. We're laser-focused on accelerating the path to FDA clearance for heart attack assessment, and you're also seeing evidence of those efforts in our milestones, but amazingly in our cash reductions as well as we stay laser-focused. We're managing dilution to shareholders in one of the most controllable ways. We're reducing our noncore spend and really limiting our cash outflows. This capital efficiency is extending our runway and also aligning our spend with the achievement of our key upcoming milestones. So with that, Rich, I'll turn it back to you.

Richard Ferrari: Yes. Thank you. Our last slide is the summary and the key takeaways. We hope that you feel the slides that we presented today were clear, and there shouldn't be any question about the fact that heart attack detection is our top strategic priority going forward. We also hope that you can appreciate the significance of the HeartBeam technology and the significant market opportunity that lies in front of us. The team that we have is just really exceptional, and I think it's a credit to the leadership on a number of fronts by Branislav and our internal team.

When I think about this going forward, when I think about what HeartBeam is doing, when I think about the importance of the technology in saving millions and millions of lives, and I think many of you have heard me say this before, we have a clear path over the next 12 months. We know exactly what needs to be done. We have great communications with the FDA. We're working on the really critical, important elements to really drive shareholder value. And between now and the end of 2027, I would tell you very little risk in our path going forward.

It is pure execution, and I hope that all of you can appreciate that we said that 90 days ago, and we've delivered on exactly every single element of execution that we had laid out, and we're extremely confident in the next series of execution milestones. So I'll stop there, and I think we're going to be going into questions, and we'll be happy to answer as many of those as we can.

Operator: [Operator Instructions] Our first question is from Jeremy Pearlman with Maxim Group.

Jeremy Pearlman: Firstly, you mentioned that you're finalizing the U.S. pivotal study design, probably hopefully within this quarter. Is there any information you could share, maybe more details regarding what that study size might look like? What are some of the primary, secondary endpoints, and the expected enrollment duration?

Richard Ferrari: Yes, this is Rich. I'll give you some points to that, and Branislav, maybe you want to end with a couple of points. But I can tell you that we haven't arrived yet with agreement on the size of the trial, but we've had very, very good conversations with the FDA, and we have a proposal to the FDA based on a statistical model from Harvard University. And I would again give you the range that we think is most likely, probably in around 300 patient size for the trial. So when you think about that, we'll have approximately 8 centers, possibly 10 centers enrolling.

If you took a very, very conservative approach to enrollment, now remember, these are the top cardiac centers in the country, but let's just use a conservative number that they enroll 10 patients a month. If it were 8 centers, let's just use 10 centers and make it a lot easier, that would be 100 patients enrolled in the trial every single month. Three months, you'd be at 300 patients. So that's a rough estimate. Now, it may take us 4 months to enroll, or what have you, but the fact of the matter is, every other trial that we have, in fact, started, enrolled faster than what we thought. So we do have, I think, a high confidence level.

Our centers are excited. As Branislav had mentioned, the ALIGN-ACS basically is the proxy, if you will, for the pivotal trial. So we're quite confident that we will get approval from the FDA. And like I said, it's a question of whether or not that happens before year-end or at the very beginning of 2027.

Branislav Vajdic: Yes, I would like to just supplement this. We have a proposal to the FDA now through this Breakthrough program that is going to result in a quite timely feedback. And it is, at this point, a very solid proposal. We believe it addresses all the concerns. But at this point, we cannot be sure really what the FDA reaction will be, inasmuch as we feel very good about what we are proposing to the FDA. So things may change a bit from what Rich has described, but we are very confident of the material that we are submitting.

Richard Ferrari: Yes. You had also asked about the secondary endpoints, and I don't know that we've completely defined those yet as we're having these conversations, but we will in the final package.

Jeremy Pearlman: Right. No, I understand. I understand it's still early, it hasn't been finalized, but I appreciate all that extra information. Maybe just segueing from that, the FDA regulatory pathway, what -- again, this also might be a little too early, but what clinical evidence and performance thresholds do you think would be required from the FDA to get clearance, that 510(k) clearance?

Richard Ferrari: Branislav, go ahead and touch on that.

Branislav Vajdic: Yes. ALIGN-ACS study that we just presented at TCT conference is sort of mirroring the endpoints that we propose now to the FDA, right? And I described our results, and really those results that you have seen in my slide there, there will be endpoints that we propose. And again, performance that we have seen in this pilot study is very encouraging indeed. And the pivotal study, it could be viewed as an enlarged same design that we have tested now already in this pilot study called ALIGN-ACS.

Jeremy Pearlman: Okay. Understood. And then this may be the last question from me. Are there -- I know you do have existing FDA clearance for arrhythmia detection. Are there any -- and I know it's clear that the focus is on heart attack detection, and I understand that, but are there any opportunities to maybe monetize that already clearance, maybe through licensing, a strategic partnership where you wouldn't have to put in a lot of capital or resources behind it, but still be able to monetize it in some way?

Richard Ferrari: Well, I think it's a great question. Our focus, as you've heard us say before, with the arrhythmia detection right now, monetizing it in a large way is -- just simply isn't the focus. But we are, quite frankly, again, working with, as we mentioned before, a number of powerful concierge practices. They are putting units into the hands of patients. It's just not a significant event at the moment, or as a learning and understanding of the use parameters.

Now we've also had, as you might imagine, since the ALIGN-ACS data, we have had a number of folks who are interested in what it is we're doing, and the technology may be able to be utilized in something they may be doing. But it's really too early to say. We're clearly open to those kinds of discussions. But at the moment, I think revenue generated from commercialization is just being modest, and we're testing the market and trying to understand reimbursement and trying to understand the use parameters and understanding how physicians will, let's call it, prescribe our product to their patients.

Operator: Our next question is from Yi Chen with H.C. Wainwright.

Ahmed Mahmoud: This is Ahmed on for Yi. So for suspected heart attacks, what response time would the reader service need to deliver? And who would be responsible for urgent escalation? And how would you handle a patient with ongoing symptoms whose tracing is negative or inconclusive?

Richard Ferrari: Yes, I'm going to let Branislav answer.

Branislav Vajdic: Sure. Absolutely. Our current, I would say, conversations with our reader service indicate that they would be quite comfortable with 30-minute commitment. Perhaps we will end up with 15-minute reaction time commitment. We are in the middle of those negotiations with them. And that will be a 24/7 indeed. And it is all about accelerating time to intervention, which is, again, critical parameter basically determining the outcome for that patient. As far as those patients that appear to be normal in terms of there is no ECG change and the symptoms may not be suggesting a heart attack, we are fully aware that without blood draw and troponin level, we cannot rule out, nobody can rule out a heart attack.

So, those patients will be told the truth, which is, "We don't have enough information to tell you anything about your condition, right?" And if you feel this is a life-threatening situation, call 911, right? So, that's the standard of care right now, right? So if we don't have enough information, we don't have blood draw, then we're going to just tell them the standard of care applies.

Ahmed Mahmoud: I guess, one quick question on strategy for the launch. So, from the initial arrhythmia launch, anything that you learned about the patient willingness to adopt the device or -- and their willingness to pay? And how -- I guess, where do you interpret those lessons to adjust your commercial approach for heart attack assessment?

Richard Ferrari: Well, remember, the first step into that understanding is working with the concierge practices, right? Those practices that have a good body of patients that would be considered at-risk cardiac patients. So, that particular model that we have been exploring was where the service themselves would acquire the product from us and provide it then to those patients as part of "the concierge fee." And we're -- and they have been doing that. And we -- I can't say that we've 100% have solidified exactly how that model long-term will work. But for right now, that's what they are doing.

So, the concierge service buys from us, then they provide that to those patients that they think would benefit from it. And it's, again, I think a win-win. From the patient's point of view, obviously, they're quite ecstatic to have a device that would enable them to, in a sense, get comfort from the fact that it may be 2:00 in the morning, it may be some other hour of the day in which they're feeling something strange, that they have an ability to actually take a reading and understand whether or not they should do something more.

Now long-term, once we get -- for the MI detection done, I think that whole approach is going to take on a completely different look. Because now you've got a device that would, in fact, notify someone if they're having a heart attack. And for those patients that falls into that category, which, as you know, is some 20 million of kind of what we would call acute and severe cardiac concern, we're testing how much they would pay for a subscription as we're working with our reimbursement people and what CMS and/or payers would pay.

But the significance of having a device, the first handheld device to be able to determine whether or not you're having an MI or not, has been received in every situation that we've ever presented it in, to every single physician that we've ever presented it to, with an overwhelming response to, "I got to have this. When are you guys going to have the full approval?" So, we're confident that between now and, let's call it this time next year, we'll have that very, very well mapped out and understood.

Unknown Executive: Our first webcast question asks, "With the December 28th NASDAQ minimum bid compliance deadline approaching, can management provide an update on the strategy to regain compliance? And is the company considering or requesting an extension or evaluating alternative measures to maintain its NASDAQ listing? Or will there be any catalyst events within the next 7 months?

Richard Ferrari: Yes. Tim?

Timothy Cruickshank: Yes. Great. Thank you. Yes, we're in communication with NASDAQ and in good standing. So at this point, we're fully expecting an extension, which would be another 180 days. And if you look at what was presented today in terms of things we know about with the clinical study, enrollment times, and some heart attack detection catalysts, in addition to potential partnerships or other things that are working behind the scenes, we fully believe we're working towards organically rectifying this, and that's the approach the company's taking at this point. So we remain very confident in our ability to regain compliance organically.

And we'll obviously need to take all considerations should the time come, but we're not expecting it at this point.

Unknown Executive: Our next and last webcast question asks, "Have there been any ongoing discussions in the matter of partnerships?" Realizing that Singapore seems to be one potential partner, I think they may mean Indonesia.

Richard Ferrari: Once again, there hasn't been "formal discussions." There have been some inputs. And regarding Indonesia, we're going to wait and see what comes from the full data set when it's fully analyzed. We do know that they have a very high interest in what HeartBeam has offered. I can't say that's going to lead to any licensing or investment at this time, but what I can tell you is, they enrolled these patients in record time. It's actually quite important to their health care system, and we have very high-level connections with the Ministry of Health there. Regarding at least 2 other companies where one might consider, could there be a partnership of some sort?

Too early in the conversations to be able to make any real predictive statement about.

Operator: We have reached the end of our question-and-answer session. I would like to turn the call over back to Mr. Ferrari for closing remarks.

Richard Ferrari: Well, again, thank you for those questions. I know those are the important pieces of information to understanding HeartBeam. But again, I just reemphasize that if you look at the size of the market that we have available to us, the sheer importance of our technology, which has already been proven, the impact that we believe it's going to make, not only to the health care system, but clearly to many, many patients' lives, the fact that we view this as extremely low risk and pure execution on our part, we're very, very confident in what we're doing moving forward.

And I think our next quarter, when we have this particular call, you're going to see further evidence of all of those statements that I just made. We'll have further clarity from the FDA, and on the other initiatives that we're working on. But again, this is just pure execution from the HeartBeam team, and we're grateful to be in that position, actually. So thank you again for all of your interest, and we appreciate the time today.

Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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