ClearPoint Neuro, Inc. (CLPT) Q2 2026 Earnings Report, Transcript and Summary

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.

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.

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 Instructions] And your first question comes from Frank Takkinen with Lake Street Capital Markets. Please state your question.

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?

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?

Just thoughts on 2027 growth.

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.

Got it. That's very helpful. And then on the GLP statement of work, would you quantify how large that could be?

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.

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?

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.

And our next question comes from Thomas Stephan with Stifel.

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?

Yes, thanks for the question, Tom. Yes, I'm very, very confident that 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.

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?

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.

Your next question comes from Mathew Blackman with TD Cowen.

Good afternoon, Joe and Danilo. Can you hear me okay?

Yes, got you, Matt.

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.

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.

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.

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.

Your next question comes from Anderson Schock with B. Reilly Securities.

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?

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.

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?

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.

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.

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.

This concludes today's conference and you may disconnect your lines at this time. Thank you all for your participation.