Greetings, and welcome to the ClearPoint Neuro, Inc. Third Quarter 2024 Financial Results Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of securities laws. These forward-looking statements may include, without limitation, statements related to anticipated industry trends, the company's plans, prospects and strategies, both preliminary and projected, the size of total addressable markets or the market opportunity for the company's products and services and management's expectations, beliefs, estimates or projections regarding future revenue, results of operations or the adequacy of cash and cash equivalent balances to support operations and meet future obligations. Actual results or trends could differ materially. The company undertakes no obligation to revise forward-looking statements for new information or future events. For more information, please refer to the company's annual report on Form 10-K for the year ended December 31, 2023, and the company's quarterly report on Form 10-Q for the three months ended June 30, 2024, both of which have been filed with the Securities and Exchange Commission, and the company's quarterly report on Form 10-Q for the three months ended September 30, 2024, which the company attempts to file with the Securities and Exchange Commission on or before November 14, 2024. All the company's filings may be obtained from the SEC or the company's website. And now, I would like to turn the call over to Joe Burnett, President and CEO. Please go ahead, sir.

Thank you. And thank you to all of the investors and analysts on today's call for being a part of the ClearPoint Neuro vision and journey. Our mission and our priority is to help restore quality of life to patients and their families who are suffering from some of the most debilitating neurological disorders imaginable. In the third quarter of 2024, the entire ClearPoint Neuro team contributed to a record revenue quarter of $8.1 million and, in our view, the strongest financial and strategic performance in our history. We made significant progress across all four of our growth pillars, including: number one, biologics and drug delivery; number two, neurosurgery navigation; number three, therapy and access products; and number four, in achieving global scale. As we commented on our last earnings call, we are beginning to see the return on the investments we made over the past three years in the form of growth across all four of our pillars and not only biologics and drug delivery. We are thrilled to report that all four of our growth pillars grew more than 20% in the third quarter, with each segment contributing to the overall top-line results, while at the same time achieving scale and continuing our reduction in operational cash burn. And as continued from the second quarter, we believe we have entered an exciting next phase at ClearPoint Neuro. We have gone beyond being just an MRI navigation-focused company. We have added operating room navigation with SmartFrame OR, we have added our own laser therapy solution with Prism, we have added significant preclinical services to support early partnership with biopharma, and we continue to see progress with our cell and gene therapy partners through the clinical and regulatory pathways to commercial approval on a global basis. The first of such gene therapy approvals has the potential of FDA clearance in the months ahead. We are very excited about how these new products and initiatives are performing in the field as well. I will now turn the call over to Danilo, our CFO, to review our financial performance in the quarter, after which, I will add some details to our four pillar growth strategy.

Thank you, Joe, and thank you, ladies and gentlemen, for joining us today. Looking at the third quarter 2024 results. Total revenue was $8.1 million for the three months ended September 30, 2024, in comparison to $5.8 million for the three months ended September 30, 2023, which represents an acceleration to 41% growth versus the third quarter of 2023 and the fourth quarter in a row of growth above 30%. As a reminder, our revenue is made up of three components: Biologics and Drug Delivery, Neurosurgery Navigation and Therapy, and Capital Equipment and Software. Biologics and Drug Delivery revenue includes the sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products. Biologics and Drug Delivery revenue grew 27% or $4.4 million in the third quarter, up from $3.5 million in 2023. This increase was fueled by a 353% increase in Biologics and Drug Delivery product revenue as our pharmaceutical customers progressed in their preclinical and clinical trials. The Biologics and Drug Delivery product growth was partially offset by a $0.7 million decrease in service revenue. Neurosurgery Navigation and Therapy revenue consists of commercial sales of disposable products related to ClearPoint Navigation System, our SmartFrame OR product, and PRISM Laser Therapy disposables. This revenue segment grew 49% to $2.9 million for the third quarter as we activated new accounts and expanded the introduction of SmartFrame OR and the PRISM Laser Therapy. Capital Equipment and Software revenue, consists of sales of ClearPoint Neuro Navigation hardware and software and the PRISM Laser System and of related services, increased 133% to $0.8 million in the third quarter from $0.4 million for the same period in 2023. Gross margin for the third quarter of 2024 was 60% as compared to gross margin of 57% for the third quarter of 2023. The increase in gross margin was primarily due to an increase in volume and lower costs related to the transition of our manufacturing facility in 2023. Research and development costs were $3.3 million for the three months ended September 30, 2024, compared to $2.4 million for the same period in 2023, an increase of $0.9 million or 36%. The increase was due primarily to an expansion of our research and development initiatives and investments in further innovation. Sales and marketing expenses were $3.5 million for the third quarter compared to $2.8 million for the same period in 2023, an increase of $0.7 million or 25%. This increase was mainly due to additional personnel costs as we expand our commercial reach to support and accelerate our product launches. General and administrative expenses were $3.2 million for the third quarter compared to $2.9 million for the same period in 2023, an increase of $0.3 million or 9%. This increase was mostly due to higher headcount costs. With respect to our cash position, as of September 30, 2024, we held cash and cash equivalents of $21.6 million compared to $32.8 million as of June 30, 2024. In August 2024, we proceeded with an early repayment of the entire principal and interest outstanding on our existing convertible loan for a total amount of $10.1 million. As of September 30, 2024, we have no outstanding debt. In line with the prior quarters, we continue to meaningfully reduce our operational cash burn. Our operational cash burn in Q3 was down to $1.2 million, a 33% reduction from the prior year’s third quarter. In the past trailing 12 months, our operational cash burn was $8.9 million. This represents a 43% reduction compared to the corresponding prior 12-month period, that is from October 2022 to September 2023.

Thanks, Danilo. As mentioned previously, 2024 continues to be a great year of execution with a 38% year-over-year increase in revenue, a 39% reduction in operational cash burn, multiple new product launches, additional long-term pharma partnerships, global expansion of our portfolio, and a strong cash position with a debt-free balance sheet. As always, let's break that progress down into our four growth pillars. Starting with pillar number one, Biologics and Drug Delivery. We had a terrific quarter on numerous fronts. Let's talk about four recent key milestones in our gene and cell therapy business. First, as Danilo mentioned, we saw a significant increase in actual product sales to pharma partners. This is very important as it shows the progression of our partners who are advancing along the regulatory pathway. Our early engagement with pharma is normally heavily weighted towards service revenue. We begin with strategy discussions, discovery consultancy, pilot studies, and benchtop testing, which generally have limited product sales and higher service sales. Later in the engagement, we generally move into supporting non-clinical studies, clinical trials, post-procedural data analysis, and eventually commercialization where the partners or the hospital is purchasing actual navigation and infusion products. This is where we see product sales to biopharma generally outpace service sales and demonstrates that continued progression of our partners through this regulatory process. Second, we have now seen multiple partners selected for various accelerated FDA pathways designed to speed the clinical trial execution and eventual regulatory approval of these new-to-world cell and gene therapies, often referred to as regenerative therapies. We now have seven partnered programs that have been designated as either Fast Track, Priority Review, or RMAT, which highlights the importance that the FDA has placed on the entire cell and gene therapy market and the recognition of the life-altering impact that these drugs may have to patients. While there's never a guarantee of timeline or approval, it is very reassuring and exciting that the FDA has created these accelerated pathways and that many of our partners have demonstrated significant enough progress and clinical results to be eligible for these programs in the first place. In total, if we added together all of the indications that are now included in these expedited programs alone, the total patient prevalence is measured in the millions of patients globally. Third, we continue to make progress expanding our preclinical services and capacity with the next-stage goal to be GLP-ready and to commence with our initial ClearPoint-driven GLP studies later in 2025. Our team continues to feel confident in the demand for our products and services as well as our unique expertise. We believe in our ability to execute larger studies under GLP-compliant procedures and facilities in the very near future. This further evolution of our drug delivery business will continue to expand not just in the value that we provide but also in the potential to build even stronger and earlier long-term structured relationships with the pharmaceutical industry through the continuum of services. And fourth, speaking of those relationships with pharma, we are excited to share that we have now executed strategic agreements across all of our desired frameworks, proving that we do in fact provide unique capabilities that are valued by the cell and gene therapy community. These frameworks also demonstrate our creativity and our flexibility on how we can collaborate based on the needs of each individual biopharma partner. We obviously cannot provide specific individual pricing or confidential strategic information, but what I can share is that we have now successfully signed agreements representing four different revenue structures and sometimes a combination of all four. These can be, number one, co-development, where partner pays a development fee and development milestones to ClearPoint for the custom development of a delivery device or software that will be used in their preclinical and clinical trials. Number two, commercial pricing, where a partner intends to provide their drug once FDA approved in a kit with the ClearPoint Neuro technology to simplify the commercial delivery of the product and purchase the devices directly from ClearPoint instead of ClearPoint Neuro selling the product to hospitals. The commercial pricing is at a premium compared to non-clinical and clinical trial device pricing. Number three, clinical milestones whereby ClearPoint Neuro receives cash payments upon progression of a therapy through its regulatory pathway. For example, approval of an IDE or IND study granted by the FDA or the first patient enrolled in a trial. Importantly, these milestones can happen during the drug discovery and regulatory process and do not have to take place at the very end with a commercial approval. And finally, a royalty payment to ClearPoint Neuro on the drug itself based on commercial sales of the gene or cell therapy, which is delivered using ClearPoint delivery devices. As a reminder, while not assured, we believe it is likely that these new-to-world drugs will be approved as combination devices with the ClearPoint Neuro cannulas and catheters, as we have seen in the European Union for the very first neuro gene therapy approved. Our company therefore becomes an essential supplier to our pharma partners. As a result, our partners are looking for very long-term agreements, assurances of supply, access to ClearPoint Neuro's unique intellectual property, redundancy of manufacturing and even more. It is this long-term need and partnership that puts us in a unique position to earn increased future revenues for our products and services beyond simply the price of a single disposable device. Moving on to pillar number two, which is Neurosurgery Navigation, we saw continued and accelerated customer site activations and product sales in the quarter, fueled by both placements of our traditional MRI-guided navigation system, as well as the continuation of the full market release of our SmartFrame OR, or operating room system designed for use with CT scanners in the operating room. We have also seen two very exciting developments in the DBS space that took place in the third quarter. First, Medtronic got approval or approved labeling for a sleep DBS procedure based on the wealth of compelling clinical evidence that excellent outcomes are achieved when the patient is comfortably asleep versus awake for these DBS procedures. This new labeling will allow a large company like Medtronic to begin educating patients on the technique which was not possible without this new FDA labeling historically. Second, Abbott has announced the TRANSCEND study, which is designed to study the use of DBS to treat severe depression. While it will likely take years before this new indication is achieved, the TRANSCEND study itself will enroll 100 patients, and many of the participating centers have communicated to us that they plan to use ClearPoint technology as their preferred navigation system. This will allow ClearPoint to participate in these trial patients and also be involved from the very beginning of this new indication. As a reminder, we have historically activated approximately six to eight new customers each year. With the five that we added here in the third quarter, that brings our total up to 19 for this year and actually more than 20 at the time of this earnings call. These accelerated placements have helped fuel not only our disposable product sales, which we will talk about in a second, but also capital, rental, and service sales, which more than doubled versus a year ago. We had communicated an earlier goal of achieving 100 global activated sites by the end of 2025, but given this new pace of placements, we believe we will achieve 100 by the first half of 2025, if not sooner. Next, let's move on to pillar number three, which is the therapy and access products. In the second quarter, we obtained FDA clearance for the PRISM anchor bolt accessory, which has opened the door for the use of the PRISM laser system with some existing robotic systems at sites that prefer to use robotic navigation in place of our ClearPoint Navigation. Here in the third quarter, we released new product packaging and compatibility with third-party anchoring mechanisms that can help us to get access to hospitals quicker by not needing to put additional new ancillary devices through the hospital's back approval process. These new releases may seem simple, but they are important steps to adoption and they show our customers that we are listening to their feedback, iterating quickly and doing everything we can to make adoption of PRISM fit comfortably into their existing hospital workflow with as few changes as possible. While we do remain somewhat limited to about half of the laser market today as our system is currently only approved for three Tesla scanners, there are plenty of target hospitals to keep us busy while we develop the regulatory pathway for 1.5 Tesla scanner approval, which we do anticipate becoming available in 2025. We are also making significant progress toward being able to commercialize an MRI conditional power drill, which we believe will be a powerful complement to our therapy and access products. This tool, developed by our partner adeor medical, is designed to provide significantly faster access for surgeons than our current hand drills and has the potential to meaningfully reduce procedure times. Once development is finalized and the drill is ready for commercialization, ClearPoint Neuro will be the exclusive worldwide distributor for this new product. Now, when we report numbers for Neurosurgery Navigation and Therapy, we bucket them together into medical device disposables. As Danilo mentioned, this segment grew 49% in the quarter and is again driven by three disposable revenue sources: MRI navigation, operating room navigation, and laser therapy. Overall, our product sales once again more than doubled versus a year ago, which has a positive impact on gross margin due to the increased throughput at our factory. Finally, let's talk about pillar number four, which is in achieving global scale and profitability. This was another disciplined quarter from a spending standpoint that saw 41% revenue growth while reducing operational cash burn down to only $1.2 million, which represents a 33% reduction versus the third quarter of 2023. We continue to believe that a cash flow breakeven quarter by the end of 2025 is possible, and we feel that our strong cash position today with over $21.6 million in cash and cash equivalents and no debt on our balance sheet. By retiring our only outstanding debt in the quarter, we have significant optionality to service any future capital needs and we'll review our capital planning in the context of driving profitable growth. We continue to believe our revenue for the full year will fall between our previous guidance of $30 million to $33 million, representing growth of between 25% and 38% for the full year. With that, I will now open up the call to any questions.

Your first question comes from Matt Blackman with Stifel. You may begin.

Hi, this is Emily on for Matt. Congrats on a great quarter again.

Thanks, Emily.

Just looking to 2025, and I understand there's no guidance today, but can you just call out some of the general headwinds/tailwinds that should be on our radar? Maybe any inflection points with the GLP or what have you?

We are not quite ready to discuss 2025 in detail, but there are definitely factors that make us optimistic about our growth prospects. Practically speaking, we don't anticipate any obstacles related to market development or the growth of the underlying surgeries. In fact, we expect an increase in surgeries next year due to the ongoing use of deep brain stimulation. Medtronic has now received clearance to promote sleep DBS, which addresses a major concern for patients who might otherwise avoid the procedure due to the fear of being awake during it. This new indication allows companies like Medtronic and surgeons to educate patients about alternative options, likely encouraging more patients to proceed with the procedure. Additionally, there are several new indications for DBS related to epilepsy, OCD, and new studies aimed at severe depression that we believe will expand these markets. We've also seen positive demand for laser therapy, particularly for tumors, as hospitals recognize the efficiency of outpatient procedures, enabling faster patient turnover. Thus, we expect continued growth in this area. Furthermore, progress with our cell and gene therapy partners, even if no commercial approvals have been granted yet, is promising. Advancing from initial safety studies to larger Phase 2 or Phase 3 trials can also generate significant revenue for us. For context, clinical trial phases for conditions like Parkinson's disease typically involve 180 to 220 patients; multiple studies could parallel our total procedures for 2023. Therefore, there remains considerable opportunity that we view as supportive for growth, not to mention the new technologies we are developing. Lastly, it’s worth mentioning that this past year, we narrowly missed the cutoff for the Russell 2000 Index, which caused index fund holders to sell our stock, becoming a significant headwind. Given our current market cap, we are in a much better position to qualify for the Russell next year. Assuming no major changes, the headwinds we faced in 2024 could turn into a tailwind for our stock in 2025, and we need to focus on executing well in the meantime.

Okay, great. And just a follow-up, if I could. Up to 20 new placements today year-to-date, is that a new normal? I mean, it has been six, eight, 10 maybe, but should we be thinking more in 2025 going forward?

I would expect that our new normal is certainly in the double digits. I don't foresee us returning to a range of six to eight. We are currently engaged in advanced discussions with at least 50 additional hospitals and have initial conversations with over 100 more. This presents significant growth opportunities, especially as we increase our activities in the operating room. One of the main obstacles we faced in the past was that many hospitals wanted to collaborate with ClearPoint but lacked access to an MRI magnet; it might have been owned by radiology, or specific certifications prevented surgical procedures from occurring in the MRI. We were effectively excluded from those hospitals. However, that's no longer an issue now that we can deploy our technology in standard operating rooms equipped with tools like CT scanners and interoperative CTs that are widely available to those facilities.

All right. Great. Okay. Thank you very much.

Yeah. Thanks, Emily.

Your next question comes from Frank Takkinen with Lake Street Capital. Your line is open.

Thank you for answering the questions and congratulations on your progress. I would like to follow up on the recent discussion regarding new system activations. Could you clarify how many of those activations year-to-date are specifically from SmartFrame OR, and how much they have contributed to the overall new activations? Also, where do you see the potential for that disposable revenue?

Yeah, happy to give you a couple of examples there. So, I would say, I have to think of the exact number, it might be a little off, but the magnitude will be there. I believe of those 19 activations this year, I think only two or three of those we would count as new activations from SmartFrame OR. And it doesn't mean that we're only using the OR product at three centers. What it means is that we do not count a new activation if they were already using ClearPoint in the MRI and then they also added SmartFrame OR; we don't count that as a new activation. That's an existing customer that we're going deeper into that customer because we have additional complimentary technology. So, to directly answer your question, Frank, of those 19, I think it's three that the operating room enabled for us. So, it shows you we really have quite a long way to go. We're absolutely just getting started, but I think that's also the nature of a limited market release. You generally go to customers that are familiar with ClearPoint first to make sure that the product is doing exactly what it's supposed to before you go into sites that have had no experience if you will.

Got it. That's helpful. And then maybe one follow-up directly on that again. How many SmartFrame OR activations do you have today?

I would estimate there are around six or seven in that range, along with another 10 or so accounts where we are currently engaged in advanced discussions with the Value Analysis Committee. For those unfamiliar, the Value Analysis Committee is a standard procedure at any hospital. When introducing a new technology, it's crucial to establish pricing and demonstrate its benefits to the hospital, the surgeon, and the patient. This review process varies; sometimes the committee meets weekly, and other times it meets every three months. As a result, it's important to get in line and on their schedule, but we currently have at least 10 of those committee meetings happening right now.

Got it. And then last one for me. Gross margins have trended favorably. How should we think about where gross margins can go with some of the new products in the bay?

From a disposable standpoint, if we get to any meaningful scale at our Carlsbad facility, there's no reason we can't be at 70% gross margin on the disposable side. And that includes cannulas as well for drug delivery trials. That certainly involves cannulas where they're not using our navigation at all. In some cases, there might be one pharma customer that doesn't want to use our navigation, but they're going to use five or six of our cannulas. That's a very profitable procedure for us because the cannulas are easier to make than the navigation frames. The drag that sometimes we get quarter to quarter on the margin standpoint is really if we have a really good capital quarter, for example. Our capital margins of selling the head frames, some components, for example, we don't make any money on; they're just a necessary piece of equipment that the hospital needs to do the procedure from another vendor. So, our margins are in that 35% to 45% range there. So, it's not a bad deal for us. We actually still make money on that transaction. However, if you happen to have one quarter where we sell three or four systems like we did in the first quarter of this year, I think our overall capital revenues are around $1.3 million or $1.4 million, that can actually drag the total margin down a little bit just from a mix standpoint. But when we get to scale—and you can imagine us doing $50 million, $60 million, $70 million of disposable revenue each year and capital revenue kind of staying flat—our margin should be comfortably in the 70%s at that point.

Got it. That's helpful. Thank you.

All right. Thanks, Frank.

There are no further questions at this time. I'd like to turn the call back to Joe Burnett, President and CEO of ClearPoint Neuro, for any closing remarks.

Once again, thank you to everyone interested in being a part of this team's journey here at ClearPoint. This is an exciting time as we plan for new product and service launches across all four of our growth pillars. We have worked hard to get to this spot and we are incredibly excited for our team, but also for the patients that we hope to treat with these new devices and therapies in the near future. The patient and their family is why we are here and ultimately who we are working for. Thank you, and please have a good night.

This concludes the ClearPoint Neuro third quarter 2024 financial results conference call. Thank you for attending, and have a wonderful rest of your day.