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Greetings, and welcome to the ClearPoint Neuro, Inc. Fourth Quarter and Full Year 2025 Financial Results Conference Call. 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 operator assistance during the call, please press 0 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 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 the recent acquisition of Eris 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 or 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 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. I will now turn the call over to Joseph Burnett, Chief Executive Officer. Please go ahead, sir.

Thank you, Danilo. As you can tell from our fourth quarter results, we ended 2025 on a strong note, with terrific momentum going into 2026. Now I will just spend a few minutes digging a bit deeper into our four-pillar growth strategy. As a reminder, our four pillars consist of the following segments: number one, 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 management. 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 in the double digits. In the future, expect to add our fifth pillar of growth, which would be commercial cell and gene therapy delivery as our biopharma partners continue to progress through the various global regulatory processes. To be clear, our existing revenue forecast for 2026 of between $52,000,000 and $56,000,000 does not include any meaningful expected revenue from commercial drug delivery, so any change to the FDA treatment of rare diseases or approvals of these drugs outside of the United States would be upside to this forecast. First, let us start with pillar number one, pre-commercial biologics and drug delivery. The team has made substantial progress building out the ClearPoint Neuro, Inc. Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL. In 2025, we performed our very first preclinical study for a sponsor and continue to execute additional studies already here in 2026. While construction will not be complete until our scheduled grand opening in the second half of the year, we do have the capability now to do smaller studies, and we expect to add full GLP capability soon as well. We continue to support our talented biopharma partners as their cell and gene therapy treatments progress through the development, clinical, and regulatory process. We now have more than 60 active biopharma partners, we support more than 25 active clinical trials, and we have more than 10 partner programs that have been accepted to some form of FDA expedited review. For some perspective, if we look at only the programs under expedited review, which span across eight different indications, there would be more than two million patients in the United States alone that have indications that are being considered for expedited designation pathways. Treating just 1% of those patients, or about 20,000 patients a year, could deliver approximately $300,000,000 in annual revenue to ClearPoint Neuro, Inc. Keep in mind that modest assumption of procedure volume is not even high enough to treat the newly diagnosed patients each year, let alone provide care to the millions of patients already living with the disease. I can tell you from direct conversations with our partners that their ambition and expectations far exceed that number. I can also share with you that in 2025, we had the highest volume of clinical trial cases supported by our biologics and drug delivery team in our history. In the meantime, while we are waiting for these first-in-world treatments to successfully win approval, our existing and collaborative biopharma relationships combined with our unique neuro capabilities should position us to achieve 20% of the estimated $300,000,000 market for pre-commercial biologics and drug delivery products and services. To say it another way, we are participating in pre-commercial drug delivery today and plan to enter commercial drug delivery in the future, but we do not need these future drugs to be approved to generate meaningful revenue. Moving on to pillar number two, which is neuro navigation and robotics, we have made some tremendous progress recently. The launch of our 3.X software platform has been very successful, as we have added multiple new installations, especially in sites that are intent on using ClearPoint Neuro, Inc. not only in the MRI, but also in the operating room using CT imaging. The results from our limited market release were very positive, highlighting the advantages of our platform in accuracy, procedure time, radiation dose, and room turnover rate, which will enable multiple ClearPoint Neuro, Inc. navigation procedures to be performed in the same room each day. We expect the data from this early experience to be submitted for publication later this year. Our switch to a new European Notified Body has been successful, and the CE marking for the 3.X software represents a further step in establishing a successful certification track record under this new Notified Body. We expect that the 3.X software certification will go a long way toward consolidating our entire installed base under one software version to simplify training and to ensure our worldwide customers all have access to our latest software features. At the request of a number of pharma partners, we have now initiated the PMDA regulatory process in Japan and expect to perform our first cell therapy clinical trial cases sometime in the second half of this year. Our recently announced robotic platform is also making development progress, and we expect multiple product usability showcases with customers this year. Importantly, we plan to perform our very first preclinical studies using the ClearPoint Neuro, Inc. robotic platform at the new CAL facility before the end of this year. Again, given our unique MRI capabilities, our fast, simple, and predictable operating room performance, our clear focus on cranial robotic development, and our deep relationships with biopharma, which will fuel future volume, we believe that achieving 20% of the cranial navigation market is a reasonable goal to achieve in the years ahead. For pillar number three, laser therapy and access, we have made progress as well. In 2025, the PRISM system received FDA clearance expanding compatibility of the system with 1.5 Tesla power MRI scanners. This clearance gave us access to the other half of the U.S. laser therapy market, as previously we only had clearance for 3.0 Tesla strength magnets. As we look to 2026, we have now installed our first 1.5 Tesla sites and have proposals in front of numerous interested centers. In 2026, we expect additional pipeline progress as we seek European approval for PRISM, submit our Harmony 1.0 software including numerous PRISM visualization features, and publish our first tumor clinical trial enabled by PRISM to help us bridge beyond functional neurosurgery and into neuro-oncology. On the access side of the business, our drill partner Adior just this week received FDA clearance for the Velocity Alpha MR Conditional Power Drill, which is designed to reduce procedure time compared to our currently available hand twist drill. We are just now starting our limited market release and prioritizing early drug delivery sites and cases. These cell and gene therapy procedures often require multiple trajectories where we believe the Velocity MR drill will provide meaningful advantages and simplify the overall procedure. We believe that our laser therapy and access portfolio will continue to grow in popularity not only because of the many unique and differentiated features, but for the simple fact that the laser ablation workflow with ClearPoint Neuro, Inc. is arguably the most similar workflow to these future cell and gene therapy cases. In both laser and drug delivery, there are multiple different trajectories, there is the delivery of a volumetric therapeutic dose, there is the need for periprocedural catheter adjustments, and there is the need to include small, minimally invasive access points. Every laser procedure a hospital does with ClearPoint Neuro, Inc. today is getting their team more familiar with the drug delivery workflow of tomorrow. Practice makes perfect and permanent, and we continue to believe that achieving 20% of this total market is a reasonable near-term goal. And last but not least, pillar number four, which is neurocritical management and is made up of the various EarFlo assets included in the acquisition at the end of 2025. This is a new market for ClearPoint Neuro, Inc., but it is an important one as it fits our two-phase strategy perfectly. Number one, it allows us to participate today in an existing $500,000,000 market opportunity with a unique and differentiated product supported by growing clinical evidence. And number two, it gives us another drug delivery option for the brain that fills a historic gap in our portfolio for a flexible indwelling option. The EarFlo catheter is now being offered as yet another tool in our ecosystem that our biopharma partners can consider and trial for themselves at the CAL facility. The existing market for these intracranial procedures is arguably the largest that ClearPoint Neuro, Inc. can participate in today, and our clinical expertise, global reach, commercial footprint, and investment pipeline can only improve our chances to earn 20% of this approximately $500,000,000 market opportunity. All in all, we believe we have an excellent vision and strategy for the future of our company: Phase One to earn 20% of a combined $1,000,000,000 market opportunity, generate $200,000,000 in annual revenue, and get us comfortably to cash breakeven and profitability; and Phase Two to provide unwavering support to our unique ecosystem of drug delivery tools to help our biopharma partners treat the very first 1% of patients living with severe neurological diseases that has therapy candidates under FDA expedited review. If we accomplish these two goals, we will have built a $500,000,000 annual revenue business and helped a lot of patients along the way. These are the two phases of our company, and we are just getting started. We will now open for questions.

The first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed.

Great. Thanks for taking the questions and appreciate the comprehensive update. I was hoping to start with a follow-up related to the 2026 guidance. I think you called out some of the most recent FDA communications around rare diseases, then integration efforts and priorities as a reason for tightening that guidance a little bit. Maybe talk a little bit more about each of those elements, what you may have previously incorporated into guidance and now what current assumptions incorporate into guidance. And then as it relates to that, big picture, how should we think about organic growth versus growth? Obviously, I can see growth with Eris in there, so maybe the right way is just how should we think about organic growth?

Yes. Thanks for the question, Frank. So starting with the first question, which has to do with what is kind of included in the guidance and where we could kind of go from there. There are two things that I cited in my prepared remarks. One was sort of the FDA current condition around rare diseases. And the second one is really digging deeper into the Eris acquisition and figuring out if the prior priorities are the same as the current ClearPoint Neuro, Inc. ones. So on the rare disease side of things, I think as many of our investors are aware, the current positioning that the FDA has communicated to at least two of our partners this year has been that sort of a more rigorous clinical trial strategy, which historically has been incredibly difficult to do for rare diseases to execute these traditional Phase III studies. So based on that information and how it would impact our two companies, or two biopharma partners, we have effectively taken out any and all revenue associated with the commercial launch of those particular products, and also just the understanding that it might take a while to really get to the bottom, you know, if and when the FDA were to change course there. So in the event that some good news is created, in the case of uniQure or the case of REGENXBIO, it is possible we would revisit that guidance. But for now, we think the most appropriate thing to do is base our guidance on the information that we have in hand, which is the latest information that those two biopharma partners have presented publicly. So that is really where we are on the rare disease side of things. I think it is important to note, however, that the vast majority of the biopharma partners we are working with are on more established and larger markets, sort of less rare diseases and more large volume patient populations. The majority of those partners were already planning to do that same Phase III sham study. So this newest FDA guidance, we do not believe it carries over to timelines relative to these larger populations because the expedited review process always included doing a Phase III study. What they were often allowed to do is skip Phase II and go directly to Phase III, but that large multicenter, geographically expansive sham study was always in the mix. So that is one half of the equation. The other one has to do with Eris itself, and, you know, the biggest thing I can point to there—again, it is a very exciting product. We are learning a lot every single day, meeting customers. As I mentioned, they had an existing revenue base last year in that $8,000,000 to $9,000,000 range, give or take. What I would say the biggest change that we have made is really in our Europe strategy, where we have kind of hit the reset button as we think about European expansion and, very specifically, which distributors we want to continue working with versus which ones we would like a fresh start with at this point. So, if anything, we maybe took a little bit out of our European revenue piece, just based on this latest information. But again, if something happens on the positive side, we always reserve the right to revisit that guidance in the second half of the year. But that is kind of what is embedded in the guidance itself. Then, Frank, what was the second question that you had there?

Underlying core growth. Organic growth.

Yes, I would say we expect it to be pretty balanced between the two. I think I did make that comment that we expect all four of our segments—and if you want to add capital equipment as a fifth segment, I think all five of those—we plan to grow double digits in the year. Now, quarter to quarter, there might be a little bit of noise here and there, but I think the development pipeline, the fact that our commercial organization today is significantly larger than it was a year ago, I think that new clinical evidence coming out in each one of those four categories, and we are getting familiar with the ClearPoint Neuro, Inc. and Eris team starting to work together. We think both organic and inorganic growth coming from Eris could be relatively balanced, but all in that double-digit range.

Got it. That is helpful. And then I was hoping to ask a little bit more about the core billion-dollar market and path to $200,000,000. If you envision yourself on the other side of the integration of Eris and you are back to a point where the business is all integrated, how should we think about the durable growth rate? And what I am trying to get at is that pathway from today around that $50,000,000 to $60,000,000 revenue range to $200,000,000. How long could that take and what kind of growth rates should we expect to see over time?

Yes. I mean, I think if we generally can grow in that 15% to 20%, maybe even north of 20% range for the foreseeable future, that assumes that we are taking 1.5% to 2% share pretty much each year across all four of those. And again, there could be differences that take place in each one of those markets. You know, for example, when we get our GLP capability for the CAL facility, and we earn our very first large GLP study on behalf of one of our biopharma partners, a single study could be in that $15,000,000 to $20,000,000 range. So we could see a large bump in any given year based on our capability being ready and then a biopharma company hiring us to do that work for them. So we could have a leap one year to the next in the biologics and drug delivery side. You know, similarly, on the EarFlo technology, there is a lot of clinical evidence being supported. There is a randomized clinical trial actually supported by Eris called the ARCH trial where we expect the data readout at some point later this year. So that is a very, very large market where EarFlo is a relatively new technology, where if we had clinical evidence that showed not only patient improvement but also some economic benefits for a hospital where a patient leaves the hospital sooner or has less complications during the procedure itself, those are things that could really swing market share pretty quickly because this is not a high intensive training product. This is one where we can ship a pump into that hospital the next day and we can be training residents 24 hours a day to get them familiar with the technology. So, where we cannot get to the point where we can outline exactly which one of those will be the primary driver any given year—other than this year, them all growing double digits—we do feel comfortable on that 15%, certainly 15%, maybe even 20% from an organic standpoint, until we get to that $200,000,000 number.

Helpful. And then last one, Joe, we get a lot of questions on just the attachment to uniQure and obviously the volatility around FDA's communication there. The question I wanted to ask was really focusing on the diversified offering. You have got BlueRock and Neurona's assets coming as the next most likely near-term, big market opportunities that should really exemplify the value of a diversified offering. Maybe just talk a little bit more about those assets, when they could be on the market, and then coming back to just the value of having so many partners in expedited review and kind of deemphasizing the attachment on just one singular asset and what the model looks like over time.

Yes. So, Frank, I do not want to comment on the timing of our partner programs. They give their updates when they prefer to. So I am just going to stick to what they have said. If you go to the websites of BlueRock, Neurona, some of these other companies as well, I think they shy away from giving actual timing updates and rather simply provide the status of the current program and what phase of clinical trial they are in. As I mentioned a second ago, we have a new investor deck that is just going live today, which I think puts some of that diversity and some of that staging into language that I think our biotech investors will better understand to show the scale of how many programs that we are in and then how many are in preclinical versus Phase I/II versus Phase III and even in the case of PTC when that is commercialized. So I would encourage you to take a look through that, and I think it will provide some feedback there as to where we are. The other thing I would bring up, however, is that even these Phase III trials can provide meaningful revenue to ClearPoint Neuro, Inc. So a typical Phase III study that we are seeing or we are participating in could be anywhere from 60 to 120 patients that are studied, sometimes randomized two-to-one in the test arm versus the control arm. A 120 patients times five, 10, 15 studies that could be going on at the same time could again be a very meaningful volume, maybe even a thousand patients a year, that would just be still in this clinical trial phase. So again, we do not count that in that Phase Two opportunity of commercial drug delivery, but it is supporting the growth, in addition to the CAL, of that pre-commercial biologics line. And I think as I mentioned in the remarks, Q4 was the largest volume we ever saw of drug delivery. So patients are raising their hand and enrolling in these trials, and we expect many more to start here in 2026.

Very helpful. Thank you.

The next question comes from the line of Anderson Schock with B. Riley Securities. Please proceed.

So first, you called out more than 10 partners in expedited review pathways now, so implying at least one new partner in these pathways since the last call. Could you provide any more color on the indication and population size for this new partner or partners?

Yes. In some cases, it has been a new indication. In some cases, it is redundant in an existing indication. So the two largest ones that are under expedited review today would be Parkinson's disease and drug-resistant epilepsy, the MTLE. So those are the two that are, I think, the largest existing populations. The ones in addition to that are anything from glioma to Friedreich's ataxia to Huntington's disease with uniQure, as mentioned before, to a couple other rare genetic disorders as well. So I think there are eight total indications and maybe 13 partners that are under FDA expedited review. So, again, we have a little bit of overlap—I think it is four or five in Parkinson's alone, for example. So it is nice because it gives us much higher confidence when you look at a disease state like Parkinson's with over a million patients in the United States that are really waiting for a superior treatment. We have five, maybe six partners that are already under expedited review. And maybe that treatment is not that far away, but just as importantly, we have got four, five, maybe six of these shots on goal that are under expedited review. Again, maybe every one of them does not make it all the way through the regulatory gauntlet, but if one, two, three of them get approved, we could be very successful there.

Okay. Got it. Thank you. And then you mentioned the first tumor clinical data for PRISM publishing this year, potentially expanding beyond functional neurosurgery and into neuro-oncology. How should we think of the timeline for this expansion in the TAM in neuro-oncology versus PRISM's current addressable market?

Yes. I would say it is really just a strength of our commercial team and how we are growing and evolving as well. If you think about the laser therapy market, it has historically been split between epilepsy and tumor, with functional neurosurgeons maybe doing the epilepsy procedures and neuro-oncologists doing the tumor procedures. Now, we are participating in tumor procedures today, but because of our navigation history, because of our biopharma partnerships, we have always been a little bit heavily weighted towards functional neurosurgery and movement disorders. So having a publication that is looking directly at our laser performance in a group of very sick tumor patients, I think, puts us in a situation where we can look customers in the eye and say yes, we are taking this very, very seriously, and we are going to be participating in multiple clinical trials moving forward, even if it is a customer base that we have not had quite the same experience as we have with functional.

Okay, got it. Thank you for taking our questions.

Yes. Thanks, Anderson.

Thank you. This concludes the question-and-answer session. I would like to turn the call back over to Joseph Burnett for closing remarks.

Well, thanks again for joining our call today. Our team feels like we have built an incredible foundation which will now serve as the launch pads for our two parallel strategies. We are on the path to helping treat tens of thousands of patients a year who suffer from many of the most frightening neurological diseases imaginable. Supporting this vision and supporting us on the road ahead.