CLPT

Image source: The Motley Fool. Monday, Aug. 3, 2026 at 4:30 p.m. ET Chief Executive Officer - Joseph Burnett Executive Vice President and Chief Financial Officer - Danilo D’Alessandro Operator: 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, the company's plans, prospects and strategies and its beliefs, estimates or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they are made. Actual results or trends could differ materially. The company undertakes no obligation to revise forward-looking statements for the new information or future events except as required by law. For more information about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8-K, Form 10-K and Form 10-Q. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. And now I'll turn the call over to Joe Burnett, Chief Executive Officer. Thank you. You may begin. Joseph Burnett: Thank you. And as always, thank you to all the investors, analysts, and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine and we at ClearPoint believe that we can play an important, if not essential, role in this exciting future. The second quarter of 2026 in itself has been an exciting one and possibly one of the most important series of events in our history. While our long-term vision remains unchanged, anchored by our 4-pillar growth strategy, there has been substantial progress leading us to up-prioritize certain parts of the strategy and to take advantage of this new information from the last few months. So today, instead of looking to the horizon and reconfirming our long-term strategy, I will focus on these 3 most important and elevated priorities that are right in front of us. These 3 activities will represent the largest time and financial investment for the second half of this year. First, we have all seen regulatory updates from pharma partners demonstrating an accelerated pathway to Phase 3 trial enrollment and even commercial approval. This revised potential schedule is much faster than what we believed just 6 months ago and once again has highlighted the need to pursue commercial readiness activities in support of our partners' global launch plans. Second, as of July, we have now taken possession of the 30,000-square-foot CAL preclinical facility in Torrey Pines, California, which includes our analytical lab space. This milestone has enabled us to sign our very first statement of work for GLP services, which we expect to complete in the first half of 2027 when all of our equipment and procedures are in place. We believe that this asset will fuel growth in our preclinical services business, starting here in the second half of 2026, with continued growth in 2027 and beyond. And third, the announcement of our partnership in focused ultrasound, which when combined with our in-development robotic system and Harmony 1.0 control software, will be designed to assist our partners in the next phase of drug delivery growth after approval, which will be commercial expansion, scale and efficiency. These 3 foundational activities have become paramount over the last few months and warrant a greater demand of our focus and our attention. I will now hand the call over to Danilo D’Alessandro, our CFO, to review financials in the quarter, after which I will spend some time detailing the second half 2026 priorities. Danilo? Danilo D’Alessandro: Thank you, Joe, and thank you all for joining us today. Looking at the second quarter 2026 results. Total revenue was $10.9 million for the 3 months ended June 30, 2026, and $9.2 million for the 3 months ended June 30, 2025, which represents 18% growth versus the second quarter of 2025. Our revenue is made up of 3 components: biologics and drug delivery, neurosurgery navigation therapy and capital equipment and software. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products. Biologics and drug delivery revenue decreased 15% to $4 million in the second quarter, down from $4.7 million in 2025. This decrease was mainly due to a decrease in product revenue of $0.9 million due to a single customer order that occurred in the quarter of the prior year and did not recur in the current quarter. BDD service revenue increased $0.2 million from prior year. Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system, the PRISM laser system, and IRRAflow. This revenue grew to $5.6 million for the second quarter of 2026, driven primarily by additional revenues due to sales of the IRRAflow product as well as introduction of our 3.0 operating room navigation software, which has positively impacted procedural volumes in the operating room during the 3 months ended June 30, 2026, compared to the same period in 2025. Capital equipment and software revenue consisting of sales of our reusable hardware and software and of related services increased 24% to $1.3 million in the quarter from $1 million for the same period in 2025 due to an increase in the placement of ClearPoint navigation systems, PRISM laser units, and IRRAflow control units. Gross margin for the second quarter of 2026 was 62%, an increase of 2% compared to 60% in Q2 2025, mostly related to a decrease in excess and obsolete inventory. Research and development costs were $4.6 million for the 3 months ended June 30, 2026, compared to $3.8 million for the same period in 2025, an increase of $0.8 million or 21%. The increase was due primarily to higher personnel costs of $0.8 million. Sales and marketing expenses were $6.8 million for Q2, compared to $4 million for the same period in 2025, an increase of $2.7 million, or 68%. This increase was due primarily to additional personnel costs of $1.8 million and increases in travel costs of $0.3 million, resulting from the expansion of our clinical and sales teams. The increase was also driven by additional amortization expense of acquired intangible assets of $0.2 million and marketing material costs of $0.2 million. General and administrative expenses were $5.6 million for the second quarter, an increase of $2.2 million or 64%. This increase was due primarily to increases in occupancy costs of $0.7 million, professional service fees of $0.5 million, personnel costs of $0.3 million, general corporate costs of $0.3 million, and IT and software costs of $0.2 million. As of June 30, 2026, we had cash and cash equivalents totaling $29.4 million as compared to $45.9 million at December 31, 2025. The cash reduction was primarily due to the operational cash burn of $15 million through Q2 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We do expect the operational cash burn to decrease in the second half of the year as we benefit from the completion of the IRRAS integration. I'd like now to turn the call back to Joe. Joseph Burnett: Thank you, Danilo. As mentioned earlier on the call, our long-term 4-pillar growth strategy remains unchanged. However, there are a number of priority adjustments that we have made this year to be responsive to the best and latest information that we have in hand. As a smaller but agile company, we believe that this is one of our strengths and I want to spend some time walking through these priorities and the rationale and results that we plan to achieve for 2026. The first of these priorities is our clinical capacity. The most noteworthy change since our last call is that the FDA has seemingly reversed course on their regulatory approach surrounding some rare diseases. Therapies for these diseases can be very challenging to test clinically due to the speed of disease progression and challenges with patient enrollment. When we started this year, we believed that the additional requirement of multi-year sham studies in these difficult patient populations would be required for U.S. approval, pushing the potential timing of a gene therapy approval out years into the future. Recent news from key biopharma partners seems to indicate that the FDA is once again open to creative trial designs and strategies that could support BLA submissions in the second half of this year. For ClearPoint, we want to ensure that the access to our technology and the support of our clinical team are not bottlenecks to the success of these launches. As a result of this new information, we have once again reactivated our clinical support growth strategy to meet this need, as we believe it may become a necessity as early as 2027. We intend to invest in growing our clinical specialist team globally and to train them to support these Phase 3 and commercial drug delivery cases. To provide the level of expertise that our surgeons demand is not a small task. We believe we have about 12 to 15 months to really get ready, so the time to hire and begin training is now. It is important to note that this is not only a U.S. strategy, as our partners are pursuing therapy submissions beyond the United States as well. We have accelerated our investment into the global approvals for our products and drug delivery ecosystem and have once again started hiring clinical specialists around the world. As an example, we have recently hired clinical support teammates in the United States, European Union, Canada and Japan. This same expanded team will also be used to support multiple Phase III trials in the next 12 to 18 months, which often include patient populations up to 10x what a Phase I trial would require. In fact, we expect between 10 and 15 trials using ClearPoint technology to be enrolling patients in the next 18 months. So when combined with potential commercial drug approvals, we believe that the time is now to prioritize this investment. This is a very exciting role to recruit for as well, as we expect our team to be in the room for many first-of-their-kind gene and cell therapy cases in the years ahead, which is a pretty rare thing for a technical and clinical specialist and a chance to build an exciting and meaningful career. I made the statement earlier that the last few months were arguably one of the most important series of events in our history. This is because the news flow over the past few months really dominated and demonstrated the strength of our diversified biopharma partner strategy. Now, even if we did not look at our full list of 60-plus drug delivery partners and only looked at the subset that we have publicly mentioned that are under FDA expedited review, here are some of the newsworthy events from their public comments. uniQure reported that following a Type B meeting, FDA indicated the 3-year data from its Phase I/II program of AMT-130 in Huntington's disease can serve as the primary basis for a BLA under the accelerated approval pathway. uniQure is now working to align with FDA on a confirmatory study ahead of time of a submission that is targeted for the third quarter. Just last week, Aspen Neuroscience received RMAT designation in Parkinson's disease and completed dosing of cohorts 3 and 4 in its Phase I/IIa ASPIRO trial, bringing total patients dosed to 15. In July, Kenai Therapeutics completed enrollment of its Phase Ib/IIa REPLACE trial of RNDP-001 in idiopathic Parkinson's disease. Neurona Therapeutics presented updated Phase I/II data in drug-resistant mesial temporal lobe epilepsy at the AAN Annual Meeting and was acquired by UCB in a transaction that closed in June. Siren Biotechnology was awarded an $8 million non-dilutive grant from the California Institute for Regenerative Medicine, or CIRM, to support clinical development of SRN-101 in high-grade gliomas. And REGENXBIO announced alignment with FDA on a path forward for resubmission of its BLA for MPS II, or Hunter syndrome, stating that no additional studies are required and that it expects to resubmit in the third quarter. This is why I made the statement about the second quarter being one of the most important series of events in our history. Our #1 goal as a company is to become an essential part of neuro drug delivery, especially for cell and gene therapies. This is the way that we can uniquely help the most patients and at the same time return the most value to our shareholders. The most important thing we can do is to have our technology and our team participate across all of these different neurological indications. Well, over the past few months, we got closer in Huntington's, we got closer in Parkinson's, we got closer in epilepsy, we got closer in tumor, we got closer in rare disease, we got closer in stroke rehabilitation. Across the board, we got closer to our goal. While we do not expect any individual program's progress to move in a straight line, that is precisely why we built a portfolio this broad. With 60-plus partners across many indications, we expect news updates like this to continue across our partner base in the months and years ahead. Our second priority is the CAL. The ongoing construction of the ClearPoint Advanced Laboratories, or the CAL, has continued through Q2, and as of July, we are now in possession of the 30,000-square-foot facility in Torrey Pines, California, right down the street from multiple biopharma partners. Importantly, we have now signed our very first statement of work for GLP services at the CAL, which we expect to complete in the first half of 2027. Once fully operational, we expect that this GLP capability, along with offering numerous additional drug discovery services and added capacity, will allow us to add multiple revenue streams to our biologics and drug delivery preclinical business. While our revenue miss in the quarter versus our own internal plan was largely attributed to a delayed ramp of these preclinical CAL services, we expect a return to growth for our biologics and drug delivery business here in the second half of the year. And our third priority is supporting our partners with the technology that follows their expected approval. We announced a 10-year focused ultrasound drug delivery partnership with the SONOCARE Lab at Sungkyunkwan University in South Korea, supported by preclinical proof-of-concept results demonstrating successful delivery of tracers across the blood-brain barrier. This was performed in large subject preclinical studies using our prototype system. In parallel, our in-development ClearPoint Neuro robotic platform continued to advance and received valuable feedback from more than 50 neurosurgeons during the quarter. In addition, we continued to advance Harmony 1.0, our software designed to control the ClearPoint drug delivery ecosystem through a single workflow. We are developing each of these technologies to help our partners achieve commercial drug delivery scale by increasing the access and efficiency of robotic workflows or by enabling intravenously administered agents to cross the blood-brain barrier. Given this new and elevated priority, our investment is expected to deliver fully functioning devices to be used pre-clinically at the CAL facility and generate additional biologics and drug delivery service revenue in 2027. As we embrace this new and important market information, our revised 2026 priorities are designed to build capacity across the full development pathway, from preclinical studies at the CAL, through larger pivotal Phase III trials, to commercial scale around the world, all hallmarks of the leading neuro drug delivery company. As a result of these new priorities and investments, we are adjusting our 2026 revenue guidance to between $48 million and $52 million, as our investment will be less focused on traditional sales expansion than previously planned and more focused on clinical case support for commercial drug delivery, global regulatory product expansion, capital equipment purchases at the CAL and development of our focused ultrasound robotics and Harmony software solutions. We believe these decisions are the best way to extend our lead as the premier drug delivery partner, be true to our strategy and prepare ourselves for an exciting future. With that, I would like to welcome any questions from investors or analysts on the call. Operator: [Operator Instructions] And your first question comes from Frank Takkinen with Lake Street Capital Markets. Please state your question. Frank Takkinen: I wanted to follow up with a question on the strategic focus or change in strategic focus a little bit closer. Maybe walk us through in a little more granular detail, the reorganization, is this a matter of reps moving into the clinical support area? Is this a matter of investing in and building up the infrastructure more -- say more capital reps rather than reps pursuing recurring revenues? And then probably a challenging question to triangulate to, but it would be nice to understand kind of how this can impact growth for 2027. It feels like obviously 2026 is really a big investment year. And what can this mean for growth in 2027 as these different items converge? Joseph Burnett: Yes, thanks for the question, Frank. So I'll start with the organization and structural design, which, it's not a massive change to what we had originally planned, but it is a reflection on what does the company and the commercial team need to look like 2, 3 years out in the future? The reality is that our company and our business model is very different than a traditional device company. And the most glaring difference between the 2 is the partnerships that we do have with biopharma. So to kind of think of it this way, if in fact not only these Phase III trials continue to progress where a typical Phase III trial could be anywhere from 80 to 120 patients, and we start stacking those on top of each other. In the event that 1, 2, 3, 5 of these cell or gene therapies start to get approved, what's different about our model is that in many cases, we are going to be selling our products directly to a pharma company and the pharma company could be providing it as a kit with their drug to the hospital. So that in itself is a very, very different model. And you can imagine 5 years from now, it's possible that half of our revenue is coming through this sort of B2B model as opposed to a traditional sales model. So from our standpoint, that sort of derives the need for a slightly different salesperson who's very, very in tune with the clinical support, making sure these potentially million-dollar procedures go incredibly well and that needs to be the primary focus. So, rather than hiring a bunch of more traditional sales folks to fill these particular roles, it puts us in a position where we can hire more of the clinical support mechanism and sort of survive with a limited group of these more traditional sales folks. I would say this -- it's a similar situation when you think about the competitive environment for our products. Right now we're competing for navigation, we're competing for laser, we're competing in the EVD space with the IRRAflow product. This new position we have when our products are actually approved as combination devices with the drug itself, it doesn't have that same competitive support. And again, it's leading us to focus a little bit more on sort of, again, on just providing the best white-glove clinical support service that we can. So I think that's hopefully the answer to the first question. And Frank, what was the second question that you had there? Frank Takkinen: Just thoughts on 2027 growth. Joseph Burnett: Oh, yes. Yes, so 2027, I mean, that's more timing. I mean, where I think could be drivers that would accelerate the growth versus in this year. And based on the midpoint of the guidance we provided of saying $50 million, that I think equates to -- if you can count all the IRRAflow new revenue into that, it's above 30% growth. But next year, we will have a true apples-to-apples comparison for the full year. And we still expect it to be kind of high double digits, let's call it, or high teens, I would say if not 20% growth is kind of the range of what we're thinking about for total growth for 2027. But then there's a couple levers that could accelerate beyond that. So for example, nearest term with the CAL facility, if we in fact now have possession of the full 30,000-square-foot facility, if we equip it with all the analytic equipment that we need to do histology and other analytic testing here in the second half of the year, if our permanent installation of our MRI magnets and SPECT machines take place in the first quarter of next year as are currently planned, that could be a meaningful growth driver for next year that would get us above and beyond that high teen sort of growth rates. Similarly, in the event that one of these cell or gene therapy partners, their BLA submission is not only accepted, but it's actually approved in 2027, it's possible that we would not only be selling into this totally new space of commercial drug delivery that we haven't really done in the past, but it's also possible that some of these companies are interested in purchasing stocking orders of some of these products. So, we might actually get paid, deliver product, recognize revenue at a sort of accelerated rate versus what the patients actually experience because we can -- a pharma partner could de-risk their launch by having 3, 6, 9, even 12 months of ClearPoint inventory in their own inventory locations to supply as part of the product launch. So where I'd say we can kind of count on that high teens growth for 2027, you get to the point where accelerated adoption of GLP studies at the CAL could go faster than that, and any sort of commercial approval could go faster than that as well. Frank Takkinen: Got it. That's very helpful. And then on the GLP statement of work, would you quantify how large that could be? Joseph Burnett: Yes, I don't want to give away too much confidential information, but I would say this first version is split into a few different statements of work, and the total is in the multi-million dollar range. So we don't expect to recognize much of the revenue this year. We recognize revenue as the stage of the study is complete, but by the end of the first half of next year, we currently expect for the full amount to be recognized by then. Frank Takkinen: Okay, that's great. And just one last follow-up. I appreciate all the color. Can you break out organic growth versus IRRAflow revenue in Q2? Joseph Burnett: I don't know, Danilo, do you have that number handy? Danilo D’Alessandro: Yes. So in the second quarter, IRRAflow was $2.1 million disposables in the neurosurgery navigation therapy line and about $350,000 in the capital equipment and software. Operator: And our next question comes from Thomas Stephan with Stifel. Thomas Stephan: Great. I guess first one on kind of the pivot. I think the reprioritization makes a lot of sense, notably given the FDA developments over the last couple of 3 to 5 months. But Joe, can you talk about, I guess, your level of confidence that ClearPoint will be able to scale in time to sort of ensure that the company is not any sort of bottleneck? And what are the key milestones in getting there? Joseph Burnett: Yes, thanks for the question, Tom. Yes, I'm very, very confident that would not be an issue. I mean, even if you looked at our clinical support team that we have in place today, I mean, we have more than 30, maybe even 40, trained clinical specialists at ClearPoint that are capable of doing sort of what I would call the basic navigation cases, sort of the starting point of what a clinical specialist learns at ClearPoint. We've got, I'm staring at 4 in the office that have recently been hired and going through training right now. So, we already have a considerable infrastructure that's in place to be able to cover these cases. And I mean even if each one of these folks is covering 2 to 3 cases a week, let's say, of these complicated procedures, I mean, we're still talking about in the thousands. I think the question for us has been we want to be thoughtful on our cash expenditure. And given that these things -- these investments we talked about between global regulatory approvals, clinical specialist hiring, investment in robotics and focused ultrasound to help scale in the future, those things don't come for free, and we recognize we need to make a couple of choices along the way. And I think the decision we're making is to not hire kind of that traditional sales role as aggressively as we have in the past. And in fact, we eliminated a few of those positions in the second quarter as well. So it's really that choice that we've made. In the event that we got a pre-order of products or we got a new partner starting Phase III trials or continued progress and positive news relative to the FDA or other global approvals of these drugs, any one of those things can continue to help inform our decisions. And maybe we do hire a little bit quicker. I think on the IRRAflow side, there's the opportunity to flip a switch and hire faster. There's quite a bit of potential positive clinical trial evidence surrounding the use of the IRRAflow device that's in a number of clinical trials currently. If those trials turned out to be positive and there's more clinical and guideline-type demand for what we do, that's something that it's not a difficult role to hire for as well. So we're just -- it's really a reflection of us trying to be thoughtful with our cash burn, provided we are purchasing capital equipment for the CAL right now and make sure we show a meaningful reduction in operational cash expense in the second half of this year. Thomas Stephan: Got it. Super helpful. And then sort of a follow-up. As we think about uniQure specifically, I think a lot of investors are sharpening their pencils more there when they're thinking about the ClearPoint story. So, Joe, sticking with kind of the theme of capacity, upon launch of AMT-130, I mean, what type of capacity do you want ClearPoint to be at in terms of the level of demand it can support, kind of max capacity, if you will, from a patient standpoint? And then as a follow-up to that, any help on just how to quantify or think about quantifying the revenue opportunity with AMT-130 for ClearPoint maybe in the first 1 to 3 years? Joseph Burnett: Yes. I mean I want to start, we try to be the best partner we can for all of our biopharma partners. So I definitely don't want to say anything that contradicts what uniQure might predict relative to their product launch pipeline and their scale. What I can tell you is I don't think ClearPoint technology or our ability to support a procedure would be a bottleneck. I think it's -- the other part of the capacity is the hospital scaling as well and how quickly they can be ready to do these types of procedures. And one of the things that we initiated in the second quarter is something we call the CLEAR trial program. So think of it as a site readiness gap assessment for hospitals to be able to fill out, I think it's 119, 120 questions. It's an interview that we do with the site to go ahead and give the hospital some insights to say, hey, here's what you need to be able to do these types of procedures and here's your current status and these are the gaps you need to fill prior to a commercial launch. And I think the good news is, I think we already have 15 centers just in the first couple months that have filled out and sort of qualified by saying, yes, not only do we have the materials, the patient recruitment, the cooperation with pharmacy to thaw out the drugs, all those types of things, but they've also pretty much raised their hand and say, yes, we could be ready to do 1, if not 2 of these procedures a week. So, if we can get to 20 or 30 of these centers that are each willing to commit 1 to 2 cases a week, which is 50 to 100 cases a week, you can imagine getting to a ramped-up procedure type pretty quickly here. Oh, and the second part of your question there, Tom, as well, is, if you think about the revenue that we generate from a typical uniQure procedure based on navigation sales as well as cannula sales, it's in that anywhere from $15,000 to $25,000 per procedure. So it's one of the more complicated procedures so a lot of our equipment and cannulas are used. So that's kind of on the higher end of a typical one. But generally, when we do our own modeling internally across the board of all of our pharma partners, we sort of think in that $12,000 to $15,000 range per patient, of which uniQure is at the higher end of that for sure. Operator: Your next question comes from Mathew Blackman with TD Cowen. Mathew Blackman: Good afternoon, Joe and Danilo. Can you hear me okay? Joseph Burnett: Yes, got you, Matt. Mathew Blackman: Great. Just got a couple of questions. I think folks have tackled sort of the investment reprioritization side of things. I was curious, as it relates to the CAL facility, can you just frame how much incremental business you could do now for your partners that you couldn't do before? I appreciate you having to get that business, but what sort of incremental capacity do you have now, both from a breadth and depth of services offered that you didn't have before the facility was up and running? And then just one follow-up. Joseph Burnett: Yes, I'd say there's, as far as the type of services, and what the facility is capable of, there's really 3 different vectors of growth versus what we were able to do a year ago. So the first one is just basic capacity. We have a lot more space. We've got a lot more people that are built into that cost structure to do more of these studies. So simple things about being able to do larger studies or more studies is one of those vectors of growth. The second one is what we talked about a little bit before, which is GLP capability. Kind of as a reminder, everything we've had to do in the past has always been pilot studies, benchtop studies, very simple, more fact finding and optimization missions and a lot less of the data collection and analysis that would be rigorous enough for an FDA submission. So the fact that we are now advertising our ability to do GLP, the fact that we've now signed an agreement to provide these services to at least one customer, we've got a number of other proposals that are out there, it puts us in a situation to say that, yes, we have this new technical capability, which often comes with larger commitments and higher margin studies as well because it's more of a more involved sort of analysis and documentation that's required for GLP. So that's the second vector. And then the third vector is just brand-new services that we never provided in the past and we would have to outsource to someone else. So for example, being able to do histology. That's something where we've never done it ourselves. We were never able to actually charge for that before. Part of our capital investment is to have histology equipment at the CAL, where our partners can do studies and move samples right down the hallway to be able to complete sort of all of the testing that would be required again under these GLP conditions. So it's really 3 different avenues. I think about a year ago, we sort of peaked out and we mentioned our preclinical capacity, it's probably being $8 million a year or something like that is what we could have done in the past at our prior subleased facility. We believe internally that this new facility with GLP, with all these additional services could surpass $60 million or so at this facility. So that's the level of scale. And again, it only takes 1 or 2 of these larger GLP studies to accelerate that growth. So the numbers I was mentioning before, I think were somewhat conservative relative to how quickly we would scale. I think we had hoped that we could have done it a little bit faster here in Q2. I made the comment about how our revenue performance in the quarter was a bit lower than our internal projection. And that was simply a reality of that, even though we were ready and sort of hungry to do some of these studies, the pharma partner would have to be comfortable doing these studies in a live construction zone. And the reality is that some people wanted the facility to be kind of totally turned over and that's the problem. That's the milestone we hit here in July is that we are now in possession of the facility. Mathew Blackman: Great. That's really helpful. Appreciate that. And then I'm trying to better understand the role the robotic platform could have for ClearPoint in coming years. I'm trying to figure out, are there specific use cases or indications for the robot, or does the system evolve over time into the primary delivery mechanism for partners? I guess that's the first question. And do the economics change for you at all by offering a robotic delivery option, even if it's clinical versus commercial? I'm just curious how this platform could impact your business model going forward. Joseph Burnett: Yes. I think the robotic platform is similar to how we're describing focused ultrasound and how we've described our navigation platform in the past is that in many situations that are out there, there's a lot less of a cranial focus in what's done in neurosurgery and more of a spine or outside the brain focus. There's plenty of robotics out there, but if you look at them step by step and what they're capable of doing, 95% of the features are designed for these very lucrative spine procedures, which make up a significant amount of a hospital budget versus maybe less than ideal cranial features, which is the only thing that we focus on, right? We're not really focused on spine for robotics at this point. So, this is some of the feedback that I mentioned in my prepared remarks where we met with 50 different surgeons over the course of the past 3 or 4 months across, I think there were 7 or 8 different trade shows and other programs that gave us audiences to be able to have some of these feedback sessions and across the board, the surgeons were able to say, yes, this is different. This is designed for that cranial procedure. And our approach to the market is to say, look, we are going to find a room in your hospital that is so busy between DBS and laser and commercial drug delivery and clinical trials that we are going to keep a cranial robotic system in use all the time. So you might as well have the best, most feature-specific, purpose-built version of that. You're still going to do tons of spine procedures, but as a hospital, you don't need to be focused on saying, well, I want a robot that does spine and cranial and all these other things because that room in your hospital can be dedicated to cranial and we want to be the vendor of choice in that situation. And if some of our pharma partners get behind us and start recommending our robotic system as the one that they would like to see their procedures delivered with, that gives us a pretty unique sort of commercial strategy and even pricing strategy in some ways, which was your second part of the question, which, robotically, how do these things take place? There's a lot of different ways that we could deploy this robotic platform, anything from the typical way of practice today where you purchase a bunch of capital equipment upfront and a service contract that exists year over year. That service contract comes with clinical support of our team to help with the navigation. And then there's some modest disposables that are used in each procedure. That's how we see it most commonly done in spine today, compared to a totally alternative approach where you just pay for the service at the hospital and it's like a per procedure navigation fee to get the support of our clinical team and to unlock certain algorithms for different trajectories on drug delivery. So, it remains to be seen exactly which approach that we rally behind. But I expect there to be a big change in per procedure revenue to ClearPoint. It just might show up in a slightly different fashion. Operator: Your next question comes from Anderson Schock with B. Reilly Securities. Anderson Schock: So first, with multiple partners approaching BLA submissions and potential commercializations, have you begun commercial ASP negotiations on the cannula and/or the navigation frames? And how should we think about the commercial premium over the clinical trial ASP benchmark? And then is there any clarity you can provide on whether the BLA submissions or approval will include just the cannula or both the cannula and the navigation co-labeled? Joseph Burnett: Yes, sure. Thanks, Anderson. So the first question I would say is, yes, we are actively in negotiations with numerous partners around commercial pricing and supply agreements. We need to remember that in many cases, the cannula and possibly, in some cases, the navigation could be co-labeled devices. So as a result, pharma partners understand that, hey, they want to be working with ClearPoint for, if not years, then decades. And there's certain parts of the supply that they want to make sure that they have control over. So one example or request that we get all the time is to say, well, there's tariff risk, there's supply risk. If an earthquake hits San Diego, California, how do we make sure that ClearPoint's ability to supply cannulas or navigation is not impacting our own launch? So in situations like that, we welcome the idea of saying, hey, if you want to put some investment into ClearPoint, we can build a European facility or a Japanese facility that makes this particular product to create some redundancy, right? Another common request we get is, well, what if one of our competitors acquires ClearPoint? How do I make sure that I still have access to the technology? And the way we handle that in many cases is that we're willing to take our IP or manufacturing know-how, our systems and processes, put them into escrow at Iron Mountain. And in the event that ClearPoint would be acquired, then that company wouldn't lose control. They could have a second supply manufacturer, and then they would just pay a royalty back to the acquiring company of ClearPoint. So there's a lot of different things that our business model of being a co-labeled product sort of creates for us. And as a result of us being super willing to support our pharma partners however we can, we do believe that there's some extra value there. So there are situations where we have earned what we describe as commercial pricing agreements, where we might charge for the cannulas or navigation a certain ASP during the bench testing, then maybe a higher ASP during the clinical trial, and it can culminate with an even higher ASP during the commercial launch, provided we're providing these extra protections in unison with them. In some cases, we've been able to win royalty on the drug itself. However, the commercial pricing agreement at a higher ASP is something that we found is a little bit easier to negotiate with pharma than a direct royalty on the drug. Yes. So I think that's really the primary difference. And to answer your question, yes, we are negotiating those as we speak. Anderson Schock: Okay, got it. Thank you. That's very helpful. And then on the CAL, could you provide an update on capacity and on the individual studies you've cited that are in the $5 million to $10 million-plus range? Can these be signed and begin today, or will they be limited after the GLP capability in the first half of next year? Joseph Burnett: Yes, I mean, I would say we are taking orders to secure time slots for these particular studies for either the space or the equipment or our lab technicians' time, that type of thing. So, in the guidance that we've provided of the $48 million to $52 million, which is pretty much 30-plus percent growth in the second half of this year, that does not include the execution of any of these large studies. So the way we're thinking about it is that in the second half of this year, in 2026, we are showcasing the facility. We're bringing biopharma partners through, we're emphasizing our capabilities, we're introducing them to the team. A lot of the equipment will be delivered by the end of this year, if not the beginning of next year, but probably in the second half of next year is when we would expect some of the larger studies to start running through. Operator: And we have now reached the end of the question-and-answer session. I'll hand the floor back to Joe Burnett for closing remarks. Joseph Burnett: Well, thank you again for being a part of this ClearPoint vision that we've spoken about today. We take great pride in supporting our partners, hospitals, and investors as best as we can by being responsive to the current needs while still preparing for our exciting future. We look forward to updating you on this progress, both internal ClearPoint milestones as well as the regulatory and clinical data readouts from our partners, which we expect on almost a monthly basis moving forward. Good night, everyone. Operator: This concludes today's conference and you may disconnect your lines at this time. Thank you all for your participation. Before you buy stock in ClearPoint Neuro, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and ClearPoint Neuro wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $399,832!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,374,595!* Now, it’s worth noting Stock Advisor’s total average return is 968% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 10, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends ClearPoint Neuro. The Motley Fool has a disclosure policy. ClearPoint Neuro (CLPT) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is re-prioritizing clinical capacity and commercial readiness due to an unexpected acceleration in FDA regulatory pathways for rare disease gene therapies. The company has taken possession of its 30,000-square-foot ClearPoint Advanced Laboratories (CAL) facility, enabling a transition from pilot studies to high-margin GLP services. Performance in Q2 was impacted by a $0.9 million non-recurring order from the prior year and a slower-than-planned ramp in preclinical services due to facility construction timelines. Strategic investments are shifting away from traditional sales expansion toward specialized clinical support for complex, high-stakes cell and gene therapy procedures. The focused ultrasound partnership and robotic platform development are designed to address future commercial scale and efficiency needs for biopharma partners. Management attributes the quarter's strategic importance to positive clinical and regulatory progress across a diversified portfolio including Huntington's, Parkinson's, and epilepsy programs. Revenue guidance for 2026 was adjusted to $48 million to $52 million to reflect a focus on clinical support and global regulatory expansion over traditional sales growth. Management expects between 10 and 15 trials using ClearPoint technology to be enrolling patients over the next 18 months, necessitating immediate hiring of clinical specialists. Operational cash burn is projected to decrease in the second half of 2026 as the company realizes benefits from the completed IRRAS integration. The CAL facility is expected to reach full operational capacity for GLP services in the first half of 2027, potentially surpassing $60 million in annual service capacity. Growth in 2027 is projected in the high teens to 20% range, with potential acceleration from commercial drug approvals or accelerated GLP study adoption. The company eliminated several traditional sales positions in Q2 to reallocate capital toward clinical support specialists required for Phase 3 and commercial launches. A $15 million operational cash burn through the first half of 2026 was driven by facility investments and personnel expansion in R&D and sales. Management noted that while they are ready for preclinical studies, some partners delayed projects until the CAL facility was fully turned over from construction. The company is actively negotiating commercial supply agreements that include protections like IP escrow and manufacturing redundancy to mitigate supply chain risks for pharma partners. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained the shift toward a B2B model where products may be sold directly to pharma companies as part of a drug kit rather than traditional hospital sales. 2027 growth is anchored in high teens, but could be accelerated by 'stocking orders' from pharma partners ahead of commercial launches. The company is hiring clinical specialists globally (US, EU, Canada, Japan) to ensure they are not a bottleneck for million-dollar gene therapy procedures. ClearPoint estimates revenue of $15,000 to $25,000 per procedure for the uniQure program, which is at the higher end of their typical $12,000 to $15,000 range. Management is confident in their capacity to support thousands of cases, noting that hospital site readiness is the more likely bottleneck. A new 'CLEAR trial program' has already identified 15 centers capable of performing 1 to 2 of these complex procedures per week. The new facility adds three growth vectors: increased volume capacity, new GLP data collection for FDA submissions, and in-house services like histology. Management confirmed the first signed GLP statement of work is in the 'multi-million dollar range,' with most revenue recognition expected in the first half of 2027. The facility is designed to support larger, more rigorous studies that were previously impossible in their prior subleased space.

Interested in ClearPoint Neuro, Inc.? Here are five stocks we like better. Q2 revenue increased 18% to $10.9 million, driven by neurosurgery navigation, therapy products and capital equipment, while Biologics and Drug Delivery revenue fell 15% due to a prior-year one-time order. ClearPoint revised 2026 revenue guidance to $48 million–$52 million. ClearPoint is shifting investment toward clinical support and commercial-readiness for partner-led gene and cell therapy trials, expecting 10–15 trials using its technology to enroll patients over the next 18 months. The new 30,000-square-foot CAL facility has begun its first GLP project and could eventually increase preclinical capacity from about $8 million to more than $60 million annually. Management expects limited 2026 revenue from CAL but is targeting high-teens to roughly 20% growth in 2027. ClearPoint Neuro (NASDAQ:CLPT) reported second-quarter 2026 revenue growth while outlining a shift in investment priorities toward clinical capacity, preclinical laboratory services and technologies intended to support commercial-scale neuro drug delivery. Total revenue for the three months ended June 30 was $10.9 million, up 18% from $9.2 million in the prior-year period, CFO Danilo D'Alessandro said. The company adjusted its full-year 2026 revenue guidance to a range of $48 million to $52 million as it directs more resources toward readiness for partner-led clinical trials and potential commercial launches. → Lost in Space: Why Aerospace Valuations Are Plummeting Right Now Neurosurgery Navigation and Therapy revenue rose to $5.6 million in the quarter, driven primarily by IRRAflow product sales and the introduction of the company's 3.0 operating-room navigation software, D'Alessandro said. Capital Equipment and Software revenue increased 24% to $1.3 million, reflecting additional placements of ClearPoint navigation systems, Prism laser units and IRRAflow control units. Biologics and Drug Delivery revenue declined 15% to $4 million from $4.7 million a year earlier. D'Alessandro said the decrease primarily reflected a $0.9 million product order from a single customer in the prior-year quarter that did not recur. Service revenue in the category increased by $0.2 million. Gross margin rose to 62% from 60%, primarily because of lower excess and obsolete inventory. Research and development expense increased 21% to $4.6 million, mainly due to higher personnel costs. Sales and marketing expense increased 68% to $6.8 million, reflecting expanded clinical and sales teams, travel, marketing materials and amortization expense. General and administrative expense increased 64% to $5.6 million, driven by occupancy, professional services, personnel, corporate and IT costs. → MarketBeat Week in Review – 07/27- 07/31 ClearPoint ended the quarter with $29.4 million in cash and cash equivalents, compared with $45.9 million at the end of 2025. The reduction included $15 million of operational cash burn through the first half and $2 million of tax payments related to net share settlement of equity awards. D'Alessandro said the company expects operational cash burn to decline in the second half as the IRRAS integration is completed. Joe Burnett said recent regulatory developments involving the company's biopharma partners have accelerated ClearPoint's planning for potential Phase III trials and commercial gene and cell therapy launches. The company is increasing investment in global clinical specialists and regulatory approvals for its drug-delivery ecosystem, rather than emphasizing traditional sales expansion to the same extent as previously planned. → GE HealthCare Stock Climbs on Vital Diagnostics Demand Burnett said ClearPoint has hired clinical support personnel in the U.S., European Union, Canada and Japan. The expanded team is intended to support larger late-stage trials and potential commercial procedures. The company expects between 10 and 15 trials using ClearPoint technology to enroll patients over the next 18 months. “We believe we have about 12 to 15 months to really get ready, so the time to hire and begin training is now,” Burnett said. During the call, Burnett cited partner developments including uniQure's discussions with the FDA regarding a potential accelerated-approval submission for AMT-130 in Huntington's disease; Aspen Neuroscience's RMAT designation in Parkinson's disease; Kenai Therapeutics' completion of enrollment in its REPLACE study; and REGENXBIO's stated plan to resubmit its BLA for MPS II in the third quarter. Burnett said ClearPoint's broad partner base, comprising more than 60 drug-delivery partners, is intended to reduce reliance on the progress of any one program. He also said the company has begun a “Clear Trial Program,” a site-readiness assessment for hospitals that could eventually conduct commercial procedures. According to Burnett, 15 centers have completed the assessment and indicated they could potentially be ready for one or two procedures per week. ClearPoint took possession in July of its 30,000-square-foot ClearPoint Advanced Laboratories, or CAL, facility in Torrey Pines, California. The site includes analytical laboratory space and is located near multiple biopharma partners, according to management. The company has signed its first statement of work for good laboratory practice, or GLP, services at the facility. Burnett said the work is expected to be completed during the first half of 2027 and is expected to generate revenue in the multimillion-dollar range, though little revenue is expected to be recognized in 2026. Management said the CAL facility expands ClearPoint's capacity to perform more and larger studies, adds GLP capabilities, and enables services such as histology that the company previously outsourced. Burnett said the prior preclinical operation had annual capacity of approximately $8 million, while the new facility could ultimately surpass $60 million in capacity. Larger studies are expected to begin running through the facility primarily in the second half of 2027. Burnett said the company's second-quarter revenue was below its internal plan largely because preclinical CAL services ramped more slowly than expected while the facility was still under construction. He said management expects Biologics and Drug Delivery revenue to return to growth in the second half of 2026. ClearPoint also announced a 10-year focused-ultrasound drug-delivery partnership with the SONOCARE Lab at Sungkyunkwan University in South Korea. The partnership is supported by preclinical proof-of-concept work involving delivery of tracers across the blood-brain barrier using the company's prototype system, Burnett said. The company is also advancing its ClearPoint Neuro robotic platform and Harmony 1.0 software, which is intended to control the company's drug-delivery ecosystem through a single workflow. Burnett said ClearPoint received feedback from more than 50 neurosurgeons on the robotic platform during the quarter. Management expects the technologies to be used preclinically at CAL and to contribute additional biologics and drug-delivery service revenue in 2027. Burnett said the company is targeting high-teens growth, or potentially about 20%, in 2027, with potential upside from faster-than-expected adoption of CAL GLP studies or commercial approvals from cell and gene therapy partners. ClearPoint's revised 2026 strategy prioritizes building capacity from preclinical studies through pivotal trials and commercial launch support, Burnett said. The company said these investments will include clinical case support, global regulatory expansion, capital equipment for CAL, and development of focused ultrasound, robotics and Harmony software solutions. ClearPoint Neuro, Inc is a medical technology company specializing in the development and commercialization of an MRI-guided therapy platform for minimally invasive neurosurgical procedures. Headquartered in Cambridge, Massachusetts, the company's flagship ClearPoint® SmartFrame™ system enables surgeons to perform accurate and efficient intracranial interventions by providing real-time magnetic resonance imaging feedback. This technology is designed to improve patient safety and outcomes in treatments ranging from deep brain stimulation electrode placement to laser ablation of epileptic foci and brain tumors. The ClearPoint System integrates hardware, software and imaging capabilities to guide instruments through the brain with submillimeter precision. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "ClearPoint Neuro Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Positive BioPharma Partner Regulatory Progress and Early Success in Focused Ultrasound Technology Platform Expansion SOLANA BEACH, CA / ACCESS Newswire / August 3, 2026 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its second quarter ended June 30, 2026. Second Quarter 2026 Highlights Reported second quarter revenue of $10.9 million, representing 18% overall growth, including the recently acquired IRRAflow Portfolio; Biologics and Drug Delivery Revenue declined 15% in the quarter, primarily due to a decrease in products shipped to biopharma customers supporting new trial initiations compared to the second quarter a year ago. This decline was partially offset by growth in preclinical service revenue in the quarter. As of July 2026, the ClearPoint Advanced Laboratories (CAL) facility is now in the Company's possession and new services revenue is expected to return the Biologics and Drug Delivery segment to growth in the third quarter; Multiple biopharma partners recently received positive feedback from the FDA on their potential BLA submissions, as well as other global regulatory progress, leading us to believe that additional cell and gene therapies could become available commercially by the end of 2027; The Company expects 10-15 clinical trials using ClearPoint Neuro technology to be enrolling patients in the next 18 months, along with approximately 10 partner clinical trial data readouts; The Company has entered into multiple statements of work for preclinical services at CAL, including our first statement of work involving GLP services, which we expect to complete in the first half of 2027; Both our in-development Robotic platform and Harmony 1.0 software were showcased at multiple neurosurgery trade shows in the second quarter; feedback from more than 50 surgeons reinforced our strategy and provided essential user input; Announced plans to enter the focused ultrasound market via a partnership with the SONOCARE Lab at Sungkyunkwan University, South Korea, alongside the successful intravenous delivery of tracers across the blood-brain barrier in a preclinical model using the ClearPoint Neuro prototype system; and Positive regulatory news has re-activated the need for commercial drug delivery readiness in 2027 leading to a reorganization of the Company's commercial structure which began in Q2 with an emphasis on installed base expansion and clinical case support. "Establishing ClearPoint Neuro as the leading neuro cell and gene therapy delivery company has been our number one priority for the last 10 years. Over that time, we have pivoted the company vision, invested more than $200 million, built our unique ecosystem, and earned more than 60 active biopharma partners, many of whom have programs which are now under FDA expedited review," commented Joe Burnett, President and CEO at ClearPoint Neuro. "Exciting news over the past few months from our partners, global regulatory bodies, and our own product development teams have only furthered that conviction." "First, the FDA recently reversed their guidance on a number of rare disease decisions, once again opening the door for potential partner BLA submissions later this year. This timing could yield commercial approvals as early as 2027, and as a key product and service provider to our partners, we need to ensure that we are ready. This regulatory news, combined with the planned initiation of larger phase III trials, has elevated the priority to invest in building our clinical capacity so that the ClearPoint installed base and our clinical support team are not a bottleneck. We believe the next 18 months will only increase the need for capable sites as we expect between 10 and 15 clinical trials to be enrolling, and approximately 10 data readouts to be presented, creating informative news flow on almost a monthly basis. It is important to note that progress toward commercial cell and gene therapy delivery is not just a U.S. phenomenon, and expanding our global footprint is included in these activities." "Second, we are now in possession of the ClearPoint Advanced Laboratories, or the ‘CAL', our preclinical lab facility in Torrey Pines. Importantly we have now signed our very first statement of work for an IND enabling study involving GLP services at the CAL and we expect it to be performed in the first half of 2027." "Third, we announced a 10-year focused ultrasound drug delivery partnership with the SONOCARE Lab at Sungkyunkwan University in South Korea, supported by preclinical proof-of-concept results demonstrating successful delivery of tracers across the blood-brain barrier. In parallel, our in-development ClearPoint Neuro robotic platform continued to advance and received valuable feedback from neurosurgeons during the quarter. Our Harmony 1.0 software, designed to control the ClearPoint drug delivery ecosystem through a single workflow, was further refined. These in-development technologies are all designed to help our partners reach the phase that will inevitably follow regulatory approval which is achieving global scale." "As we embrace this new and important market information, our revised 2026 priorities are designed to build capacity across the full development pathway, from preclinical studies at the CAL, through larger, pivotal phase III trials, to commercial scale around the world, all hallmarks of the leading neuro drug delivery company," continued Burnett. "As a result of these new priorities and investments, we are adjusting our 2026 revenue guidance to between $48.0 - $52.0 million as our investment will be less focused on traditional sales expansion than previously planned, and more focused on clinical case support for commercial drug delivery, global regulatory product expansion, capital equipment purchases at the CAL facility, and development of our focused ultrasound, robotics and harmony software solutions. We believe these decisions are the best way to extend our lead as the premier neuro drug delivery partner, be true to our strategy, and prepare ourselves for an exciting future." Business Outlook The Company estimates revenue in 2026 to be between $48.0 million and $52.0 million. Financial Results - Quarter Ended June 30, 2026 Total revenue was $10.9 million for the three months ended June 30, 2026, and $9.2 million for the three months ended June 30, 2025, which represents an increase of $1.7 million, or 18%. Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, decreased to $4.0 million for the three months ended June 30, 2026 from $4.7 million for the three months ended June 30, 2025. This decrease is attributable to lower product revenue due to a single customer order that occurred in the quarter of the prior year and did not recur in the current quarter. Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint and IRRAflow systems, increased 62% to $5.6 million for the three months ended June 30, 2026, from $3.4 million for the same period in 2025. The increase is driven by additional revenues from sales of the IRRAflow product as well as the introduction of our 3.0 operating room navigation software, which has positively impacted procedural volumes in the operating room during the three months ended June 30, 2026, compared to the same period in 2025. Capital equipment and software revenue, consisting of sales of ClearPoint and IRRAflow reusable hardware and software and related services, increased 24% to $1.3 million for the three months ended June 30, 2026, from $1.0 million for the same period in 2025 due to an increase in placements of ClearPoint navigation capital and software, IRRAflow control units, and Prism laser units. The Company achieved a gross margin of 62% on its sales for the three months ended June 30, 2026, and a gross margin of 60% in the same period in 2025. The increase in gross margin is primarily due to lower excess and obsolete inventory for the three months ended June 30, 2026, as compared to the same period in 2025. Operating expenses were $17.0 million for the three months ended June 30, 2026, compared with $11.2 million for the same period in 2025, an increase of 51%. The increase was mainly driven by the IRRAS acquisition in November 2025, primarily through higher personnel costs resulting from the expansion of our clinical and sales teams, as well as increased occupancy costs, and travel costs. At June 30, 2026, the Company had cash and cash equivalents totaling $29.4 million as compared to $45.9 million at December 31, 2025, with the decrease resulting from the use of $15.0 million in cash for operating activities and $2.0 million in cash paid for taxes related to the net share settlement of equity awards. We expect our operational cash burn to decrease in the second half of the year. Teleconference Information Investors and analysts are invited to listen to a live broadcast review of the Company's second quarter 2026 results on Monday, August 3, 2026 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=FFVNbjau. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada. For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until September 2, 2026, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/. About ClearPoint Neuro ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com. Forward-Looking Statements Statements in this press release and in the teleconference referenced above concerning the Company's plans, growth and strategies may include forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include, among others, statements regarding: the Company's financial guidance and its expectations for revenue, operating expenses, cash and cash equivalents, operational cash burn, capital expenditures, liquidity and future capital requirements; the market opportunity for, and the expected adoption, growth and commercialization of, the Company's products and services, including its neuronavigational products, the IRRAflow Active Fluid Exchange System, the PRISM Laser Therapy System, and the preclinical services offered through its CRO facility (CAL); the continued development and commercialization of the Company's focused ultrasound system, robotic system and Harmony 1.0 software; the anticipated timing, scope, performance and results of preclinical services under executed statements of work; the expected number, timing, enrollment and results of the clinical trials of the Company's biotech Partners and the timing and outcome of their regulatory submissions and any resulting commercialization; the expected benefits of the Company's commercial reorganization, its 2026 priorities and related investments, and its acquisition of IRRAS; and other statements of management's expectations, beliefs, plans, estimates or projections relating to the future. Words such as "anticipate," "believe," "expect," "intend," "plan," "may," "will," "should," "could" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Specific risks which may cause the Company's actual results to differ from those expressed in or implied by forward-looking statements include: risks relating to the clinical and regulatory programs of the Company's biotech Partners, including that their trials may not commence, enroll patients or generate data readouts when expected or at all, and that the number of trials enrolling or data readouts presented may be lower than anticipated, that anticipated phase III studies may not begin on the expected timeline or at the expected scale, that positive or encouraging feedback from regulatory authorities may not be indicative of the ultimate outcome and does not ensure that any application will be submitted, accepted for review or approved, and that additional patient data may support a different interpretation than data previously released, all of which are largely outside the Company's control; risks relating to changes in the guidance, policies, leadership, staffing, funding or priorities of the FDA and other regulatory authorities, including that recent changes in FDA guidance or policy applicable to rare disease programs may be further modified, reversed, delayed or applied inconsistently; risks relating to the Company's planned entry into the focused ultrasound market, including through its arrangement with the SONOCARE Lab at Sungkyunkwan University, which may be modified or terminated or may not proceed on the expected timeline or at all, and to the development and commercialization of the Company's focused ultrasound system, robotic system and Harmony 1.0 software; risks relating to the Company's collaborations with academic and other third-party institutions, including with respect to the ownership, allocation and licensing of intellectual property developed under those arrangements; the risk that results observed in preclinical models, including the delivery of tracers across the blood-brain barrier using the Company's prototype system, are not replicated in future studies or in humans and are not predictive of clinical or commercial success; risks relating to the Company's investments in clinical capacity, including expansion of its installed base and clinical support team, which may not be completed when expected or at all and may not be sufficient to prevent capacity from becoming a limiting factor for partner trial enrollment or commercial launches; risks relating to the execution of the Company's commercial reorganization and its revised 2026 priorities and related investments, which may be disruptive, may not be implemented as planned, or may not deliver the anticipated benefits when expected or at all; risks relating to the Company's preclinical services business, including that executed statements of work may be delayed, rescheduled, reduced in scope or terminated and that the CAL facility may not achieve or maintain GLP compliance or generate revenue on the anticipated timeline; risks relating to the Company's liquidity and capital resources, including that the Company may fail to meet its publicly announced financial guidance and its ability to fund operations and capital expenditures for the period anticipated, to raise additional capital on acceptable terms, and to satisfy the covenants under its existing indebtedness; and risks relating to the integration of IRRAS, the clearance and commercialization of the Company's own products in the United States and internationally, the Company's ability to attract and retain key personnel, and macroeconomic, geopolitical and policy conditions. For a more detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contact: Investor Relations:Danilo D'Alessandro, Chief Financial Officer(888) 287-9109 ext. [email protected]   CLEARPOINT NEURO, INC.Consolidated Statements of Operations(in thousands, except for share and per share data) CLEARPOINT NEURO, INC.Consolidated Balance Sheets(in thousands, except for par value and share data)   CLEARPOINT NEURO, INC.Consolidated Statements of Cash Flows(in thousands) SOURCE: ClearPoint Neuro, Inc. View the original press release on ACCESS Newswire

Wall Street expects a year-over-year decline in earnings on higher revenues when Orthofix (OFIX) reports results for the quarter ended June 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on August 5, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This medical device maker is expected to post quarterly loss of $0.03 per share in its upcoming report, which represents a year-over-year change of -123.1%. Revenues are expected to be $209.51 million, up 3.2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 5.41% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Orthofix, the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination makes it difficult to conclusively predict that Orthofix will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Orthofix would post a loss of$0.29 per share when it actually produced a loss of -$0.12, delivering a surprise of +58.62%. Over the last four quarters, the company has beaten consensus EPS estimates three times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Orthofix doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. ClearPoint Neuro, Inc. (CLPT), another stock in the Zacks Medical - Instruments industry, is expected to report loss per share of $0.29 for the quarter ended June 2026. This estimate points to a year-over-year change of -38.1%. Revenues for the quarter are expected to be $13 million, up 41% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for ClearPoint Neuro has remained unchanged. Nevertheless, the company now has an Earnings ESP of -15.12%, reflecting a lower Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #3 (Hold), makes it difficult to conclusively predict that ClearPoint Neuro will beat the consensus EPS estimate. The company could not beat consensus EPS estimates in any of the last four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ORTHOFIX MEDICAL INC. (OFIX) : Free Stock Analysis Report ClearPoint Neuro, Inc. (CLPT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

SOLANA BEACH, CA / ACCESS Newswire / July 21, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that it will release financial results for its 2026 second quarter on Monday, August 3rd, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2026 second quarter on Monday, August 3rd at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada. For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until September 2, 2026, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com About ClearPoint Neuro ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct Central Nervous System delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com. Forward-Looking Statements Statements in this press release and in the teleconference referenced above concerning the Company's plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, the size of total addressable markets or the market opportunity for the Company's products and services, timelines for regulatory approval and commercialization of its biotech partners' gene and cell therapies, the Company's expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company's ability to market, commercialize and achieve broader market acceptance for the products and services offered by the Company; the regulatory requirements for approval and pace of market adoption of the gene and cell therapies under development by the Company's biotech partners; the Company's biotech partner's continued use of the Company's products and services in their delivery of gene and cell therapies; the Company's ability to maintain its current relationships with its biotech partners or enter into relationships with new partners; the Company's ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; the future market for the Company's preclinical services; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company's failure to integrate IRRAS into its business in accordance with expectations; and deviations from the expected market potential of the IRRAS products. For a detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contact: Investor Relations Danilo D'Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 [email protected] SOURCE: ClearPoint Neuro, Inc. View the original press release on ACCESS Newswire

This article first appeared on GuruFocus. Total Revenue: $12.1 million for Q1 2026, a 43% increase from $8.5 million in Q1 2025. Organic Growth: 16% organic growth in revenue. Biologics and Drug Delivery Revenue: Increased 2% to $4.8 million from $4.7 million in Q1 2025. Neurosurgery Navigation Revenue: Grew to $5.9 million, including $2.1 million from IRRAflow disposables. Capital Equipment and Software Revenue: Increased 177% to $1.4 million from $0.5 million in Q1 2025. Gross Margin: 64%, up from 60% in Q1 2025. Research and Development Costs: $4.5 million, a 34% increase from $3.4 million in Q1 2025. Sales and Marketing Expenses: $6.7 million, a 75% increase from $3.8 million in Q1 2025. General and Administrative Expenses: $5 million, a 22% increase from Q1 2025. Cash and Cash Equivalents: $35.6 million as of March 31, 2026, down from $45.9 million at December 31, 2025. Warning! GuruFocus has detected 7 Warning Signs with CLPT. Is CLPT fairly valued? Test your thesis with our free DCF calculator. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ClearPoint Neuro Inc (NASDAQ:CLPT) achieved record revenue of $12.1 million for Q1 2026, marking a 43% growth compared to Q1 2025. The company's acquisition of IRRAS Holdings Inc contributed significantly to inorganic device growth, enhancing overall growth rate. ClearPoint Neuro Inc (NASDAQ:CLPT) has over 60 active biopharma partners and more than 25 clinical trials across 15 disease indications, indicating strong industry collaboration. The company reported a gross margin increase to 64% in Q1 2026, up from 60% in Q1 2025, due to decreased inventory reserves. ClearPoint Neuro Inc (NASDAQ:CLPT) is expanding its global presence, with more than 175 active sites using its technology, expected to surpass 200 by the end of 2026. Research and development costs increased by 34% to $4.5 million in Q1 2026, primarily due to higher personnel and development costs. Sales and marketing expenses rose by 75% to $6.7 million in Q1 2026, driven by additional personnel costs and increased travel expenses. General and administrative expenses increased by 22% to $5 million, mainly due to higher occupancy and personnel costs. The company experienced a cash reduction, with cash and cash equivalents totaling $35.6 million as of March 31, 2026, down from $45.9 million at the end of 2025. Operational cash burn was $8 million in Q1 2026, with expectations for a decrease in the coming quarters as the IRRAS integration completes. Q: Can you provide an update on the current state of affairs at the FDA and how leadership changes might impact your interactions? Additionally, how does the acquisition of one of your partners by UCB affect your activities? A: Joseph Burnett, CEO: On the devices side, we've seen little change and have had positive cooperation with the FDA. However, on the biologics side, there has been confusion due to leadership changes, and we're awaiting final decisions. Regarding the UCB acquisition of Neurona, it's positive as both teams are working together, and we continue to support Neurona's asset in their Phase 3 trial. Q: What are the key variables that might push you towards the low or high end of your revenue guidance? A: Joseph Burnett, CEO: The largest factor is the continued investment and preparation of preclinical services at our new CAL facility. We are currently under capacity, and as we expand our facility, the timing of when studies get booked will drive the range in guidance. Q: Can you discuss the revenue cadence for the year and the impact of IRRAflow synergies? A: Danilo D Alessandro, CFO: We expect sequential growth quarter-over-quarter for the remainder of the year. IRRAflow is expected to account for 20% to 25% of our total business. We've made changes in our European strategy, which may cause a lag in growth outside the US. Q: Is the mid-60% gross margin sustainable, and what are the expected OpEx run rates moving forward? A: Joseph Burnett, CEO: Gross margin can fluctuate, but we are subscale in many areas, including IRRAflow. We've moved operations to our Carlsbad facility, which should help with cost synergies. OpEx includes some one-time costs, and we expect to see improvements as we integrate operations. Q: Do you have all the key pieces in place to achieve your $500 million revenue target, or are there assets you need to acquire? A: Joseph Burnett, CEO: We have control of our portfolio and are focused on execution. Our robotic platform is in preclinical use, and we are confident in its development. We are not dependent on inorganic growth to reach our target, as we focus on advancing therapies and educating the market. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

ClearPoint Neuro (NASDAQ:CLPT) held its first-quarter earnings conference call on Wednesday. Below is the complete transcript from the call. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. View the webcast at https://event.choruscall.com/mediaframe/webcast.html?webcastid=IjzOoM7l ClearPoint Neuro reported record revenue of $12.1 million for Q1 2026, with a 43% growth rate driven by organic and inorganic device growth, particularly due to the acquisition of the EraFlow product line. The company outlined progress in its four strategic growth pillars: biologics and drug delivery, neurosurgery navigation and robotics, laser therapy and access, and neurocritical care and active CSF exchange, expecting all to grow double digits in 2026. ClearPoint Neuro maintained a gross margin of 64% for Q1 2026, and while operational cash burn was $8 million, it is anticipated to decrease in future quarters following the ERAS integration. The company has 60 active biopharma partners and is involved in over 25 clinical trials across 15 disease indications, with more than 10 partner programs under FDA expedited review. Future revenue guidance for 2026 is projected between $52 to $56 million, with strategic focus on expanding its CAL facility and integrating EraFlow assets into its portfolio. OPERATOR Greetings and welcome to the ClearPoint Neuro, Inc. First quarter 2026 financial results at this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operating assistance, please press Star zero on your telephone keypad. 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 the Company's expectations regarding the integration, performance and anticipated benefits of its recent acquisition of Eras Holdings, Inc. Including operational efficiencies and the impact on the Company's financial condition and results of operations the Company's expectation for future development, regulatory approval, timing, commercialization and the market for cell and gene therapies and the anticipated adoption of the Company's products and services for use in the delivery of gene and cell therapies and management's expectations, beliefs, estimates or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward looking statements which speak only as of the date on which they were made. 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 about the Company's risks and uncertainties, please refer to the Company's filings with the SEC, including the company's recent filings on Form 8K, Form 10K and Form 10Q. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. at this time I would like to turn the call over to Joe Burnett, Chief Executive Officer. Joe Burnett (Chief Executive Officer) Please go ahead. Thank you Shamali and as always, thank you to all of the investors, analysts and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine and we at ClearPoint believe we can play a crucial, if not essential, role in this exciting future. Our company has started 2026 on a strong note by achieving record revenue of 12.1 million for the quarter driven primarily by organic devices growth of 25% which includes our historical drug delivery, cannulas, navigation, disposables, laser ablation applicators, capital systems and software. This revenue was complemented by inorganic device growth from our acquisition of the new EraFlow product line which pushed our overall growth rate to 43% company wide. We continued to realize meaningful revenue and cost synergies as a result of our new completed acquisition of Eras with the majority of post merger integration costs now behind us and taking place in Q1. Importantly, we made progress across all four of our growth pillars that are designed to make our unique drug delivery ecosystem more refined and more accessible to biopharma partners, surgeons and to patients globally. We believe that we are truly a unique hybrid device biotech enabling company that not only has an existing revenue plan of more than $50 million today, but a completely untapped and expansive opportunity in commercial cell and gene therapy delivery built for tomorrow. Our strategy now includes more than 60 active biopharma partners, more than 25 existing clinical trials across more than 15 different disease indications and more than 10 partner programs that are already under some form of of FDA expedited review. That is a significant head start and through both our team and our investment into this portfolio we intend to extend our lead. With that I will turn the call over to Danilo d', Alessandro, our CFO who will walk through the financial detail after which I will give a more strategic update on our progress. Danilo thank you Joe and thank you Danilo d'Alessandro (Chief Financial Officer) all for joining us today. Looking at the first quarter 2026 results, total revenue was $12.1 million for the three months ended March 31, 2026 and $8.5 million for the three months ended March 31, 2025, which represents 43% growth versus the first quarter of 2025 and 16% organic growth. 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 include sales of disposable products and services related to customer sponsored preclinical and clinical trials utilizing our products. Biologics and drug Delivery revenue increased 2% to $4.8 million in the first quarter, up from $4.7 million in 2025. This increase was mainly due to an increase in Product revenue of $0.1 million. BND Service Revenue was in line with prior year neurosurgery navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the clearpoint system, the Prism Laser System and AEraFlow. This revenue segment grew to $5.9 million for the first quarter of 2026, including $2.1 million in AEraFlow disposable revenue. The growth in this segment was primarily due to our increased installation base and the full market release of our Prism Laser System and ICT solution, capital equipment and software. Revenue consisting of sales of our reusable hardware and software and related services increased 177% to $1.4 million in the quarter from $0.5 million for the same period in 2025 due to an increase in the placements of Clearpoint Navigation System, Prism Laser units and AEraFlow control units. Gross margin for the first quarter 2026 was 64%, an increase of 4% compared to 60% in Q1 2025, mostly related to a decrease in excess and inventory reserves. Research and development costs were $4.5 million for the three months ended March 31, 2026 compared to $3.4 million for the same period in 2025, an increase of $1.1 million or 34%. The increase was due primarily to higher personal cost of $0.6 million and higher product and software development cost of $0.3 million. Sales and marketing expenses were $6.7 million for Q1 compared to $3.8 million for the same period in 2025, an increase of $2.9 million or 75%. This increase was due primarily to additional personal cost of $1.9 million and increase in travel cost of $0.5 million resulting from the expansion of our clinical and sales teams due to the ERAS integration as well as additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $5 million for the first quarter, an increase of $0.9 million or 22%. This increase was due primarily to higher occupancy costs of $0.7 million and higher personal costs of $0.2 million As of March 31, 2026, we held cash and cash equivalents totaling $35.6 million as compared to $45.9 million at December 31, 2025. The cash reduction was primarily due to the operational cash burn of $8 million in Q1 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We expect the operational cash burn to decrease in the coming quarters as we complete the ERIS integration. I'd like now to turn the call back to Joe. Joe Burnett (Chief Executive Officer) Thank you Danilo. We look to build upon a successful first quarter and continue to expect 2026 revenue to be in the range of 52 to 56 million. We are also pleased to report that our first quarter burn came in on budget from what we were expecting. As a reminder, the first quarter each year has historiCALly been our highest burn quarter of one time events related to post merger integration costs after the acquisition of the Eras assets. Additionally, Gross margin expanded 64%. Now, although gross margin can fluctuate from quarter to quarter, it is encouraging that our first full quarter with the Eras technology came in slightly ahead of of our pre integration projections. As always, let's now turn to our four pillar growth strategy for a bit more detail. As a quick reminder, our four pillars consist of the following segments Number 1 Pre Commercial Biologics and Drug Delivery Products and services Number two Neurosurgery, Navigation and Robotics Number three Laser Therapy and Access and number four NeurocritiCAL Care and Active CSF Exchange. These are the four markets that we participate actively in today and pretty much 100% of our current revenue is coming from these four markets. In 2026, we expect all four of these segments to each grow double digits. For clarity's sake, this does not include any revenue from the commercial launch of cell and gene therapies, which we expect to start in the years ahead upon appropriate global drug approvals. First, let's start with pillar number one Pre Commercial Biologics and drug delivery. The team has made substantial progress building out the clearpoi Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL. This new facility will become a common starting point for our relationship with biopharma partners to perform benchtop and precliniCAL studies as well as troubleshoot workflows to build custom devices and software that are drug and target specific. Despite the fact that the facility was significantly limited for most of the month of March for planned construction projects, we were still able to perform numerous studies in the first quarter which included multiple new routes of administration which were tested for the very first time by the Clearpoint team. This demonstrates not only our ability to co develop new products with partners, but also shows how we expect our drug delivery portfolio will continue to grow in the future, while often with new techniques and new intellectual property that we are building alongside of our partners. Additional progress was made globally evidenced by a record number of cliniCAL trial Our biopharma partners need to know that their therapies can reach patients anywhere in the world and our commitment to global availability of our ecosystem delivers on exactly that. It's a costly investment, but also a key competitive advantage that reinforces the significant head start we've built in this space. And as planned, we have begun to integrate the IroFlow product line into our portfolio. The Iroflo Dual Lumen Catheter is a flexible, multi day placement catheter that we expect to address. We had multiple meetings with interested researchers and plan to provide updates later this year on this new option for our partners. Moving on to pillar number two, which is Neuro, Navigation and Robotics, where we have made some tremendous progress recently as well as our successful launch of the 3X platform continues in the United Parties and our first cliniCAL cases ever performed in Canada are expected here in the near future. Numerous demonstrations of our prototype clearpoint robotic platform which prioritizes cranial procedures have been extremely well received and have repeatedly highlighted our unique understanding of the cranial drug delivery space. It is important to remember that we are leveraging more than 15 years of software development focused on the brain. This historiCAL investment into our best in class cranial segmentation and navigation workflow allows us to jump out of the starting gate, especially when paired with an established robotic arm provider using the Kuka LDR Med robotic arm. One highlight to share is that we recently performed our first ever precliniCAL drug delivery case at our CAL facility using this robotic platform and the results were better than expected. We plan to offer this system for use in precliniCAL biopharma studies at the CAL facility to our more than 60 active partners for pillar number three laser therapy and access. Our biggest highlight of the quarter was the FDA clearance of the velocity alpha Mr. High Speed SurgiCAL Drill system manufactured by our partner Addior MediCAL ag. We believe this drill will be an attractive solution for surgeons. Compared to our historiCAL and hand operated twist drill, this device operates at more than 75,000rpm and when using our custom drill bits we expect to meaningfully reduce procedure times. These efficiency gains were already evident during the very first ever cliniCAL procedure performed with the drill just a couple of weeks ago for one of our partners Cell Therapy cliniCAL trial. Additionally, we were pleased to announce just today that the drill has now received CE marking in Europe as well as which expands the system's availability beyond the United States and provides a sCALable pathway to support neurosurgiCAL procedures and therapy adoption globally, including across our European partnered biologic programs. Our PRISM Laser therapy system continues to be a highly competitive solution in the market with multiple installs, evaluations and purchases completed in the first quarter. As a quick reminder, our newly expanded labeling now includes both 3.0 and 1.5 Tesla scanners, which has significantly expanded our potential customer base compared to where we were a year ago. And last but not least, pillar number four, which is NeurocritiCAL Care and Active CSF Exchange, is made up of the various era flow assets included in the acquisition of the eras at the end of 2025. This is a completely new market for Clearpoint, but an important one as it fits into our two phase strategy perfectly. Number one, it adds a flexible indwelling catheter to our biologics and drug delivery portfolio, a capability we've historiCALly lacked, opening up a new potential pathway for drug delivery to the brain. In the first quarter, we have successfully merged our commercial teams together, including initial cross training on the devices. With the sales integration now behind us, we expect to continue to grow this business in 2026 and in the years ahead. Having mapped out multiple revenue and cost synergies, we believe that the addition of the Iroflow assets could potentially be cash neutral for Clearpoint as early as 2027 or next year. Globally, we now have more than 175 active sites using some form of Clearpoint technology and expect that number to surpass 200 by the end of 2026. This site expansion not only allows Clearpoint technology to be available to more hospitals and patients worldwide, but it also enables the sCALing of our business model, including the expert cliniCAL support for which we are very well respected in the neurosurgiCAL community. With that, I would like to open up the CALl to any questions. Thank you. OPERATOR We will now be conducting A question And Answer session,. If you would like to Ask A question, please press Star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary be necessary to pick up the handset before pressing the star keys. One moment, please. While we poll for questions, Frank Tackinen (Equity Analyst) our first question comes from the line of Frank Tackinen with Lake Street Capital Market. Please proceed with your question. Great. Thank you for taking the questions. I was hoping to start with one in pillar one and kind of a two part, question and a little unrelated. So sorry if it's a little lengthy but part, one would be related to can you just give us an update from clearpoint standpoint the current state of affairs or clinical backdrop at the FDA? Obviously there's been some headlines around some leadership changes and I'm just curious how this has impacted some of your interactions. Do you foresee maybe some of those conversations becoming a little bit more efficient in the future with different leadership and anything else that's important there, that's part, one and then part, two. One of your part,ners was acquired by UCB or pending acquisition. Just curious if you could provide any updates related to your part,ner activities ongoing there that you're able to discuss. Thanks and sorry again for the lengthy question. Joe Burnett (Chief Executive Officer) Frank, I expect nothing less than multi part questions for you, so thanks for asking. So the first one, relative to the fda, you know, there's two different groups of the FDA that we generally work with which you know, part on the devices side and then part on the combination devices side, which definitely has a component of biologics to it. On the devices side we've seen very little change. We've seen incredible cooperation. We've hosted multiple pre submission meetings with a team that's been pretty well intact. So we haven't seen anything negative at all on that side. It's been very positive for really years now at this point and that includes conversations we've had with the newly acquired Eras assets as well. So if you think about the traditional device part of the business, we have not seen very much difference. If anything, I think it's going smooth on the biologic side. We're not always privy to each and every one of these questions, but obviously you can't read a headline today without understanding that there's been incredible confusion at the fda. Confusion on some of the feedback that had been provided across multiple clearpoint partners and I'm sure likely others as well. And I think everyone is looking for really that confusion, I think to halt more than anything else as the first step and my understanding is where we are with the new lease selection or for both the head of CBER as well as the head of the FDA itself. We're still a little bit in a waiting mode here to see what that final decision is. Now certainly any appointment to either one of those roles from someone who is not only incredibly competent in the device, I'm sorry, the biologic space, statistical clinical trial design, et cetera, that would be very, very welcome. And then of course, anyone who's gone through the gauntlet of how difficult it is to enroll these incredibly complex clinical trials, I think would also be viewed as a positive, not just by clearpoint, but the entire community as well. So we're anxiously awaiting as well to see what those final decisions look like and sort of the ability to get started on the second question relative To I believe you're talking about the Neurona acquisition by ucb. Again, that was, I think, a very, very positive. The Neurona team is still very much intact, very much working alongside us. And from our standpoint, we've had a wonderful relationship with UCB for many years now as well. So it's kind of two of our partners sort of coming together and getting the benefits of both teams at that time. So we expect to continue to support the Neurona asset as it moves into their phase three pivotal trial as we speak. Just one quick thing I would bring up, Frank, because it's a really important question too. It's kind of getting back to the FDA side of things. We need to remember that not to bucket everything together. There's sort of the rare disease side of things, which are things like Huntington's disease and a number of these very, very rare conditions that sit on sort of one side. And then there's the much higher volume, higher prevalence diseases like epilepsy, Parkinson's, et cetera. So when the FDA had given guidance in the past to provide expedited review for these programs to try to accelerate their pathway to market, the larger market opportunities were always in a position where they were going to be doing some form of a pivotal phase three study. So when this sort of confusion arose to some extent, where it was argued that some of the decisions had been changed or some of the guidance had been changed, I don't personally believe that that's impacted disorders like Parkinson's or epilepsy or Alzheimer's disease or dementias or things like that, because the plan was always to do that pivotal trial. I think the bigger question was on the other side with these rare dise, where it's just incredibly difficult to do one of these randomized sham studies because surgeons are not necessarily comfortable enrolling patients. And patients themselves might feel like they're missing a chance to experiment with other studies if they're waiting for one in a situation where they don't even get the experimental drug, they were just given a placebo. So just the practicality of some of these rare disease studies is really the thing that was the biggest question that we had seen. Got it. Frank Tackinen (Equity Analyst) Very helpful. And then maybe for my second one, just help us through kind of low end versus high end of guidance. What are some of the key variables you're tracking that might push you towards one of those two ends? Joe Burnett (Chief Executive Officer) Yeah, I mean, I would say the largest factor there is really the continued investment and preparation of the preclinical services that we're providing at the new CAL, facility. You know, as you've seen throughout our history, there's always choppiness from quarter to quarter. But the thing I would point out there is that we're still very much not fully operational yet and under capacity. And I view that as kind of a positive. And Danilo's comments, he mentioned that our pre clinical services, our biologics and drug delivery services were flat year over year. What I would point out is sort of twofold. If you think about our new facility, think of it this way. This is not troll of one of them. And these are all three revenue generating floors for benchtop testing, for analytics, for histology, you know, you name it. So even start the quarter we only had 1/3 of that revenue generating space, if you will. And then even if you look at the 1/3 we had, there was an entire month of March where we weren't doing studies because we were finishing completion of some of the construction there as to. So if you think about estimating capacity of what that facility could do for us, you know, we still came in, you know, in the millions of dollars, but we, you could argue we were like 2/9 or 20% of, you know, what the, what our actual capacity is. So we're significantly subscale on that as well. And you know, we expect, if you think by the end of Q2, early Q3, we should be getting close to taking the first floor over the second or the second floor, if you think of it in my analogy. And then by Q1 of 2027, we have the full facility completed. So it's going to be this kind of sort of stable, but increase over the next year or so, maybe in the next 18 months. And you know, to answer your question, when those facilities and studies get booked is really the biggest driver of that range and guidance. Frank Tackinen (Equity Analyst) Got it. Okay, very helpful. Thank you. Tom Steffen (Equity Analyst) Thank you. Our next question comes from the line of Tom Steffen with Stifel. Please proceed with your question. Great. Hey guys, thanks for taking the questions. Maybe as a follow up to Frank's prior question, Danilo, maybe for you, can you talk a bit about revenue cadence for the year as we think about the guide and notably as we how much of the mix is kind of base business versus versus IroFlow and Danilo d'Alessandro (Chief Financial Officer) then I'll have a follow up. Yeah, the way I would think about it is with sequential growth, potentially quarter over quarter for the coming for the remainder of the year. So it will be gradual, but we expect it to be somewhat consistent over the next three quarters with Regard to the, the Eras, the ERA flow side of things, we expect it to grow and it still accounts for that 20 to 20 in that 20 to 25% of our total business. That's what we expect between now and the end of the year. Joe Burnett (Chief Executive Officer) Got it. That's great, Tom. The only thing maybe I'd add there as well is that, you know, as we mentioned at the beginning in the first half of the year, our European and OUS strategy for ERAflow has changed a little bit. Where we've moved on from certain distributors and we're going direct in different markets as well. So that sort of paused our European growth to some extent while the US continues to kind of fire here in the first half. So there could be a little bit of a lag there relative to when sort of outside of the US EraFlow kicks in because of some of these changes. But again it's, I wouldn't say it's just noise, I mean I think it's real, but it's not something that's going to change the map of our revenue for the year. Got it. Tom Steffen (Equity Analyst) That's great, Appreciate that. And then I guess moving down the P and L if you will, specifically around Euroflow and I know you mentioned it can fluctuate, but is this mid 60% range potentially sustainable moving forward? And then sort of similarly on opex, Joe, you mentioned some one timers. How much were those and what's kind of the right OPEX run rate moving forward for 26? Joe Burnett (Chief Executive Officer) Thanks. Yeah, in a quarter to quarter there's definitely going to be some fluctuation. So I mean it could be down next quarter and then up the one after that. It's nice to get a good one under our belt for the first quarter. But we are still very much subscale in just about everything that we do, including Iroflow. So if you think about what took place in Q1, we shut down the Eraflow factory that was in San Diego and we moved all of their operations and employees over to our Carlsbad facility. So if you think of it something that showed up on the gna, for example, as an increase, you know, we have an empty building right now that we're in the process of subleasing to go ahead and you know, to, to over. That's one of those very obvious cost synergies that we've already done all the work to move everything over and now it's just finding a tenant to take over the lease. So those are the types of things you do, you know, multiply that times 10 or 15 different opportunities with redundant vendors with the ability to have some sort of negotiating power with our vendors of just raw materials, putting more and more products through our factory. And then even on the sales and marketing side to be able to have our clinicals travel less because the volume has increased across our portfolio in different cities. You know, with gas prices where they are and travel expenses where they are, that's a very, very meaningful part of the strategy too. That doesn't hit our gross margin, but it helps. It's definitely going to help us on the sell X, side of things. Got it. Tom Steffen (Equity Analyst) Thanks guys. Thank you. Thank you. Matthew Blackman (Equity Analyst) Our next question comes from the line of Matthew Blackman with TD Cowan. Please proceed with your question. Hey Joe, Danil, thanks for taking my questions. Can you hear me okay? Yes, loud and clear. Great. Well, good to hear your voices clearly. A lot has happened since I last had the opportunity to be on a clear point call and so on that theme, sort of a big picture question. You're now more evolved. 4 Phase 5 Growth Pillar Strategy I think with a combined $500 million long term revenue target. Here's another multi part question for you. Question 1. Do you have all the key pieces in place today to hit that $500 million number some time in the future or are there still platforms or services you need to roll in to make that number achievable? Is, is there a way to get to that 500 million dollar target faster inorganically? Are there assets out there that have technology and revenue bases that could help accelerate, accelerate your pathway? How do you evaluate that pathway versus getting there organically? And then I do have one follow up question. Joe Burnett (Chief Executive Officer) Yeah, so the first question was around do we have all the parts to build this, build a spaceship and get to our destination here? And I think the answer is yes. I would say it in the way that there's still refinements in our portfolio, but we have control of the portfolio. So I'll give you a perfect example of that. Is our robotics platform. We do not have an FDA cleared robot today. We have one that we are doing preclinical cases with for pharma partners. So it's functional in the pre clinical setting. We have every confidence in this program because of the development that Kuka has put into the robotic arm development in parallel to what we have done over 15 years for our software development. So it's not that we're dependent on something inorganic or dependent on something that requires invention or luck. You know, these are things that I think are execution. But once we have A robotic platform and arguably become the only company where you have one software that can be done in the MRI using the same frame in ICT and then also with a robot as well. You know, I think that's something that, especially if our pharma partners support it as their robot of choice, I think that's going to differentiate us and give us a right to win. If you think about other things that are out there inorganically, you know, it's interesting. If we're not going to cross into neurovascular and we're not going to go out of the brain or implant something into the brain, which dramatically increased sort of complexity and costs and patient outreach and neurology call points and things like that, there aren't that many assets that are out there. And it's interesting because the reason for that is so few patients go through with surgery compared to the sheer number of patients that are out there that need help. And that's really the promise of improvements with dbs. Improvements to laser systems and awareness and access, improvements to reimbursement and arguably most importantly, improvements availability, you know, final commercial availability of cell and gene therapies and other drugs that can be restorative and not ablative or not be an implant, which I think patients are very likely from what we understand to pursue first. So you keep patients that they're available, which is something that I think will scale us quite a bit. So that's why I'm saying I don't think we're dependent on something inorganic to get there. Matthew Blackman (Equity Analyst) Got it. That really helpful. And then the follow up for you as well, Joe, some of the iroflow catheter. Look, I appreciate it's still early days, but feeling any interest from current or even potentially new biofilma partners in using the indwelling delivery option and maybe Danilo, if you could just. How would the aeroflow catheter, even if just in the roughest terms, differ from a business model or economic standpoint, if it in the future was co labeled with a drug versus what you have in place with the smart flow cannula. Any help there? Thanks guys. Joe Burnett (Chief Executive Officer) Yeah, I think I'd say yes. We've absolutely had discussions with partners and research centers. We host a meeting called Ignite every year and we had a number of different research ideas that came out of that. Where the researcher themselves was already planning to execute a study using an off the shelf device called an EVD or an external ventricular drain, which is a very, very common procedure. Eerily drained instead of just draining and doing a sort of a bolus shot into there. So, you know, the product, arguably for these in path, very simple EVD studies is kind of an obvious choice to switch to this as quickly as possible. So it's really an education standpoint. And as you pointed out, luckily Clearpoint has spent the last 10 plus years building relationships not just with researchers, but the biopharma companies that are interested in either funding their own study or licensing these ideas and these technologies out of universities and academic centers. So, you know, there is a product out there today that could absolutely, in our current EraFlow product line that could absolutely become an immediate substitute in some of these studies. And I think that's, that's a very likely case. Great, thank you. And Danilo d'Alessandro (Chief Financial Officer) And on the economics and on the economic side, we expect ERA flow margins to still be very healthy. Like Joe mentioned earlier, we're still pretty subscale. As it grows, we think the margins will keep, will keep expanding in that product portfolio. I think there already are. If you look at even 2026, just given the fact that we've consolidated facilities from a Bismol perspective. We're going to, you know, work with our partners. It's still very, very, very early, but we'd like to, of course, pursue similar ways of working that we've had with our. We will rate, test and explore with our existing, existing partners. Matthew Blackman (Equity Analyst) Got it. Thank you, guys. Appreciate it. Joe Burnett (Chief Executive Officer) Thank you. OPERATOR And we have reached the end of the question and answer session and therefore I would like to turn the floor back over to CEO Joe Burnett for closing remarks. Joe Burnett (Chief Executive Officer) Thanks again for joining our call today. Our team feels like we have built an incredible foundation on these four pillars today which will support an exciting future of global commercial drug delivery, which our 60/BioPharma partners are making progress towards each and every day. We are on a path to helping treat tens of thousands of patients a year who suffer from many of the most frightening neurological diseases imaginable. We are thrilled to have you on our team supporting this vision and supporting us on the road ahead. Good night, everyone. Thank you. OPERATOR And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga: CLEARPOINT NEURO (CLPT): Free Stock Analysis Report This article ClearPoint Neuro Q1 2026 Earnings Call Transcript originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Interested in ClearPoint Neuro, Inc.? Here are five stocks we like better. ClearPoint Neuro reported record first-quarter 2026 revenue of $12.1 million, up 43% year over year, and reaffirmed its full-year revenue outlook of $52 million to $56 million. Gross margin also improved to 64% from 60% despite higher operating expenses. Growth was driven by both the legacy business and the newly acquired IRRAflow assets, with management saying IRRAflow should make up about 20% to 25% of total business by year-end. The company also expects sequential revenue growth over the rest of 2026. Management highlighted progress across its four growth pillars, including expanding neurosurgery navigation, laser therapy, biologics and drug delivery, and neurocritical care, while also aiming for over 200 active sites by the end of 2026. ClearPoint said integration of IRRAS is advancing and could make the IRRAflow assets cash neutral as early as 2027. ClearPoint Neuro (NASDAQ:CLPT) reported record first-quarter 2026 revenue and reaffirmed its full-year outlook, as management highlighted growth in its legacy neurosurgical device business and early contributions from the recently acquired IRRAflow product line. Chief Executive Officer Joe Burnett said the company generated $12.1 million in revenue for the quarter, driven by what he described as 25% organic devices growth across drug delivery cannulas, navigation disposables, laser ablation applicators, capital systems and software. Including the IRRAflow assets acquired from IRRAS Holdings, Burnett said companywide growth reached 43%. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Burnett said ClearPoint remains focused on building “a complete neuro ecosystem” for minimally invasive treatments, including cell and gene therapies delivered to the brain. He said the company now works with more than 60 active biopharma partners, supports more than 25 clinical trials across more than 15 disease indications, and has more than 10 partner programs under some form of FDA expedited review. Chief Financial Officer Danilo D'Alessandro said total revenue rose to $12.1 million for the three months ended March 31, 2026, from $8.5 million in the prior-year period. He said that represented 43% year-over-year growth and 16% organic growth. → MP Materials Is Quietly Building a Rare Earth Powerhouse D'Alessandro said Neurosurgery Navigation revenue increased to $5.9 million in the quarter, including $2.1 million in IRRAflow disposable revenue. He attributed growth in the segment to a larger installed base and the full market release of the Prism laser system and the company’s ICT solution. Capital equipment and software revenue rose 177% to $1.4 million from $0.5 million a year earlier, reflecting increased placements of ClearPoint navigation systems, Prism laser units and IRRAflow control units. D'Alessandro said Biologics and Drug Delivery service revenue was in line with the prior year, while product revenue increased by $0.1 million. → MercadoLibre Boldly Invests in Growth: Discount Deepens Gross margin improved to 64% from 60% in the year-earlier quarter, primarily because of a decrease in excess and obsolete inventory reserves, according to D'Alessandro. Operating expenses also increased. Research and development costs rose to $4.5 million from $3.4 million. Sales and marketing expenses increased 75% to $6.7 million, primarily due to higher personnel costs, travel expenses tied to the IRRAS integration and additional amortization of acquired intangible assets. General and administrative expenses increased 22% to $5 million, largely because of higher occupancy and personnel costs. ClearPoint ended the quarter with $35.6 million in cash and cash equivalents, down from $45.9 million at Dec. 31, 2025. D'Alessandro said the decline reflected $8 million of operating cash burn and $2 million of tax payments related to net share settlement of equity awards. He said the company expects operating cash burn to decrease in coming quarters as it completes the IRRAS integration. Burnett said ClearPoint continues to expect 2026 revenue of $52 million to $56 million. He said first-quarter cash burn was in line with company expectations and noted that the first quarter has historically been ClearPoint’s highest burn quarter because of annual employee bonuses, FICA taxes, additional withholdings and other annual expenses. This year’s first quarter also included one-time integration costs related to the IRRAS asset acquisition. During the question-and-answer session, D'Alessandro said management expects sequential revenue growth over the remaining three quarters of the year. He said IRRAflow is expected to account for roughly 20% to 25% of ClearPoint’s total business between now and year-end. Asked what could determine whether results land at the low or high end of guidance, Burnett pointed to the pace of activity at the ClearPoint Advanced Laboratories facility in Torrey Pines, California. He said the facility is not yet fully operational and that revenue from preclinical services will depend in part on when studies are booked as additional space comes online. Burnett outlined the company’s four growth pillars: pre-commercial Biologics and Drug Delivery, Neurosurgery Navigation and robotics, laser therapy and access, and neurocritical care and active CSF exchange. He said ClearPoint expects all four segments to grow by double digits in 2026, excluding any revenue from the future commercial launch of cell and gene therapies. In Biologics and Drug Delivery, Burnett said the company made progress building out the ClearPoint Advanced Laboratories facility, despite construction limiting operations for much of March. He said the company performed multiple studies in the first quarter, including testing new routes of administration for the first time. He also said ClearPoint completed its first commercial drug delivery procedure using its technology in the Asia-Pacific region. In Neurosurgery Navigation and robotics, Burnett said the company’s 3.x platform launch is continuing in the U.S. and expanded to Europe with the first 3.x case there during the quarter. He also said Canada approval has generated interest, with initial Canadian clinical cases expected in the near future. Burnett said ClearPoint recently performed its first preclinical drug delivery case at its CAL facility using its prototype robotic platform. In laser therapy and access, Burnett highlighted FDA clearance of the Velocity Alpha MR high-speed surgical drill system, manufactured by partner adeor medical AG. He said the drill has also received CE marking in Europe. Burnett said the Prism laser therapy system saw multiple installations, evaluations and purchases during the first quarter. The fourth pillar, neurocritical care and active CSF exchange, consists of the IRRAflow assets acquired from IRRAS. Burnett said the dual-lumen IRRAflow catheter could address a gap in ClearPoint’s drug delivery offerings by enabling extended access to the brain. He said ClearPoint has already held multiple meetings with interested researchers and expects to provide updates later this year. Burnett said ClearPoint has merged its commercial teams and completed initial cross-training on IRRAflow devices. He said the company has identified revenue and cost synergies and believes the IRRAflow assets could potentially be cash neutral for ClearPoint as early as 2027. Asked about the regulatory environment, Burnett said the company has seen “very little change” and “incredible cooperation” on the FDA device side, including pre-submission meetings. On the biologics side, he said the broader industry has faced confusion, particularly around rare disease studies and the practicality of randomized sham-controlled trials. Burnett also addressed UCB’s pending acquisition of Neurona Therapeutics, a ClearPoint partner. He called the development positive and said the Neurona team remains intact and continues to work with ClearPoint as the program moves toward a pivotal Phase III trial. Globally, Burnett said more than 175 active sites now use some form of ClearPoint technology, and the company expects that number to exceed 200 by the end of 2026. ClearPoint Neuro, Inc is a medical technology company specializing in the development and commercialization of an MRI-guided therapy platform for minimally invasive neurosurgical procedures. Headquartered in Cambridge, Massachusetts, the company's flagship ClearPoint® SmartFrame™ system enables surgeons to perform accurate and efficient intracranial interventions by providing real-time magnetic resonance imaging feedback. This technology is designed to improve patient safety and outcomes in treatments ranging from deep brain stimulation electrode placement to laser ablation of epileptic foci and brain tumors. The ClearPoint System integrates hardware, software and imaging capabilities to guide instruments through the brain with submillimeter precision. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "ClearPoint Neuro Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.