ClearPoint Neuro, Inc.CLPTNASDAQ
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Operator: [Audio Gap] 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 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 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 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'll now turn the call over to Joe Burnett, Chief Executive Officer.
Joseph Burnett: Thank you, Paul, and thank you to all of the investors, partners and analysts joining us on today's exciting call. 2025 continues to be a strategic transformation for ClearPoint Neuro. Over the past few years, we have built an incredibly strong foundation for this company through new product development, biopharma partner acquisition, modernization of our quality system and manufacturing, global regulatory approvals, expansion of our commercial reach and reliable funding from capital markets. We built this foundation from the ground up and expanded our strategy through our 4 pillars of growth: biologics and drug delivery, neurosurgery navigation, laser therapy and access and in achieving global scale. In 2025, we have now exited that funded and foundational phase, and we have entered 2 new chapters of ClearPoint, which will continue to be our guiding strategies over the next decade. The first strategy phase, which we refer to as fast forward, involves ClearPoint launching new, unique and disruptive products into 4 existing markets that total more than $1 billion in aggregate today. Here, we will continue to earn market share each year and offer a credible path to cash breakeven and meaningful profitability. The second strategy phase, which we call Essential Everywhere, involves ClearPoint building a new $10 billion-plus addressable market in the neuro drug delivery hand-in-hand with our pharma partners. Here, the complete ClearPoint ecosystem, including our team, will play an essential role for predictable quality drug delivery at high-volume specialized treatment centers around the world. These next 2 chapters, one where we penetrate an existing market and one where we build a new one, will take place in parallel, leveraging the same product portfolio, the same operational infrastructure and the same commercial channel to allow us to achieve global scale. I am therefore thrilled to announce the merger agreement that was just signed, whereby ClearPoint Neuro will acquire IRRAS with the target closing date in the coming weeks. This is an incredibly exciting merger of 2 like-minded companies who have been successful not only in product development and regulatory approvals, but also in completing some of the hardest work in medical technology, which is bringing cutting-edge products to market, establishing a sales channel, generating clinical evidence and building an installed base of early adopters. We both expect to be leaders in the neurosurgery market and have a very similar razor-razorblade business model. The IRRAS team should be congratulated on developing the IRRAflow platform and generating an estimated $9 million run rate with a September year-to-date growth rate of 83% and gross margins in the mid-50s today. We are in a very similar stage of growth and feel like the 2 teams have a lot in common. We plan to integrate swiftly, and we look forward to welcoming IRRAS to the team once the merger formally closes. There are 3 important strategic rationales that make the IRRAS team and portfolio a perfect fit for this next phase of ClearPoint Neuro. First, the IRRAflow catheter, a proprietary disposable dual lumen catheter, will immediately give ClearPoint access to a large existing market in the treatment of intracerebral hemorrhage, chronic subdural hematoma and other conditions requiring intracranial fluid management. It is estimated that these clinical presentations represent up to approximately 400,000 procedures annually in the United States alone and close to $0.5 billion existing market opportunity, which ClearPoint now gains access to. Second, the design of the indwelling and flexible IRRAflow catheter provides us with a launching point for the design of longer duration infusion cannulas that may open up additional biopharma partners, especially in the oncology space, who often require a device that allows multiple infusions over an extended duration, potentially in an outpatient setting. Our goal is to become a true one-stop shop for cell, gene and other therapy delivery that are directed by our same biopharma and neurosurgery call points. Third, the combined entity is expected to immediately gain operational scale with an expansive commercial team, including marketing, sales and clinical specialists that will now include more than 40 added professionals across the United States. This merger with IRRAS will deliver a new pillar of growth for the company and is expected to extend our lead in neuro drug delivery. I will now turn the call over to Danilo to discuss the Q3 financial update, after which I will spend time detailing the next steps of this 2-part ClearPoint strategy. Danilo?
Danilo D’Alessandro: Thank you, Joe, and thank you all for joining us today. Let me start by giving some further details about the proposed merger and the key transaction terms. Upon closing, ClearPoint Neuro will deliver a closing consideration of $5 million in cash and 1,325,000 shares of ClearPoint Neuro's common stock, subject to customary working capital adjustments. The agreement also provides for ClearPoint Neuro to pay a revenue share on net sales of certain IRRAS products above defined annual thresholds for the year 2026 through 2028. The closing of the merger is subject to a number of conditions, including approval of the transaction by IRRAS shareholders, and the closing is expected to be completed in the fourth quarter of 2025. In parallel with the signing of the merger agreement, we entered into an agreement to access an additional $20 million in funding under our existing note financing arrangement with Oberland Capital, conditioned upon the closing of ClearPoint Neuro's transaction to acquire IRRAS Holdings, Inc. and other customary closing conditions. We expect to use the additional funding to support integration activities, enhance working capital and fund the new growth initiatives for our combined business operations. Now looking at the third quarter 2025 results. Total revenue was $8.9 million for the 3 months ended September 30, 2025, in comparison to $8.1 million for the 3 months ended September 30, 2024, which represents 9% growth versus the third quarter of 2024. As a reminder, our revenue is made up of 3 components: biologics and drug delivery, neurosurgery navigation and 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 stayed relatively consistent at $4.4 million in the third quarter. Service and other revenue increased $0.7 million due to new studies performed for our partners in the 3 months ended September 30, 2025, offset by a decrease in product revenue due to timing of the pharmaceutical partners' clinical and preclinical trials. Neurosurgery navigation therapy revenue consists of commercial sales of disposable products related to ClearPoint Navigation System, our SmartFrame OR product and PRISM Laser Therapy disposables. This revenue segment grew 20% to $3.4 million for the third quarter, driven by higher sales of PRISM Laser Therapy and the introduction of our 3.0 operating room navigation software. Capital equipment and software revenue, consisting of sales of ClearPoint navigation hardware and software in the PRISM Laser System and the related services increased 25% to $1 million in the third quarter from $0.8 million for the same period in 2024. Gross margin for the third quarter 2025 was 63% as compared to a gross margin of 60% for the third quarter of 2024. The increase in gross margin was primarily due to higher margins on service revenue and mix of products sold. Research and development costs were $3.5 million for the 3 months ended September 30, 2025, compared to $3.3 million for the same period in 2024, an increase of 4%. The increase was due primarily to higher product and software development costs. Sales and marketing expenses were $3.8 million for the third quarter compared to $3.5 million for the same period in 2024, an increase of $0.3 million or 8%. This increase was mainly due to additional personnel costs as we expand our commercial reach to support and accelerate our product launches. General and administrative expenses were $3.6 million for the third quarter compared to $3.1 million for the same period in 2024, an increase of $0.4 million or 14%. This increase was mostly due to higher headcount costs, professional fees and IT costs. With respect to our cash position, as of September 30, 2025, we held cash and cash equivalents of $38.2 million compared to $20.1 million as of December 31, 2024, with the increase resulting from the net proceeds of the note payable and stock offering of $32 million, partially offset by the use of $11.8 million in cash for operating activities. With that, I'd like to now turn the call back to Joe.
Joseph Burnett: Thank you, Danilo. Now one part of the commentary that I want to make sure is clear from the financials is the impact that the transition to our new ClearPoint controlled CRO facility in Torrey Pines had on the quarter. First, our overall revenue growth for the quarter was lower than in prior quarters, but the source of that reduced growth rate came from the fact that the same team that would normally be supporting biopharma studies and our partner drug pipeline was temporarily reprioritized to transition out of the prior facility and to open the new facility. This effort includes a onetime and significant coordination of moving people and equipment, setting up standard operating procedures and then obtaining all of the necessary certifications with appropriate federal and state agencies. The fact that our lease was signed in June of this year and in just 3 months, we were already certified and running preclinical studies for our partners is a huge testament to the capability, effort and focus of this team. We expect that the biologics and drug delivery pillar will return to double-digit growth here in the fourth quarter and accelerate further in 2026 and 2027 as we are already bidding on large partner studies for the coming years. Now let's dig into our 4-pillar growth strategy a bit further. And I will start with one important note for those of you who have been following our 4-pillar mantra since we started about 8 years ago. We will be adjusting the definitions a bit given the announced acquisition of IRRAS and our 2-part strategy that we have transitioned to here in 2025. Pillar #1, we now define a little differently, and we call it pre-commercial biologics and drug delivery. We have renamed this segment because we want to differentiate between the future commercial drug delivery market that is still in its infancy with the current and existing pre-commercial drug delivery market that ClearPoint Neuro has access to today. We estimate that this pre-commercial market is approximately $300 million annually across preclinical studies and services, co-development contracts and clinical trial products and support for our more than 60 biopharma partners. Today, we have less than 10% share of this existing market with plenty of room to grow. Pillar #2 is also defined a little differently as we now call it neurosurgery navigation and robotics. This is reflective of our recent announcement of plans to enter into the cranial robotic space and to become the only company that would offer one preplanning and software workflow that could be deployed by surgeons using 3 different techniques: one, single-use frames in the MRI; two, single-use frames in the operating room with CT; and three, multi-use robotic systems that guide other ClearPoint products to target. This strategy is important for both our biopharma partners and neurosurgery customers. For biopharma, we plan to solve a commercial problem. Pharma companies prefer not to be overly prescriptive in the way that our cannula is navigated to the target and want to provide some level of flexibility to surgeons, so they can use a technique they are familiar with. However, pharma also realizes that this crucial surgical technique will never become fast, efficient and predictable if they allow hundreds of different navigation options without some level of consistency. Think of a lean manufacturing line with pods all around the world. There is a huge benefit to each one of those pods doing the same procedure with the same technique and the same equipment. Our navigation strategy will enable one preplanning software and one step-by-step workflow to always be used, but the surgeon will still maintain choice across our 3 hardware solutions, finding a balance between control and flexibility. For surgeons and hospitals, we plan to solve a slightly different problem, which is that of time and training. There are many different ways to perform both cranial and spinal navigation surgery, and the market is incredibly fragmented across multiple companies and products. For a hospital to invest not only their capital, but also their training time of their staff, they need to make sure that the technology is versatile and can be applied widely. Again, enter ClearPoint, where we plan to have the best cranial navigation platform uniquely positioned to support biopharma, but also capable of standard minimally invasive cranial procedures like deep brain stimulation, lead placement, biopsy sampling, laser ablation therapy and stereotactic EEG. The hospital team will be able to learn a single software interface and deploy that across pretty much all cranial procedures, including the new cell and gene therapy procedures that are coming. We believe this is an efficient and productive investment of their time. Our goal is that every hospital can choose their favorite corporate partner for spine procedures, but that they will prefer the unique ClearPoint solution for their cranial procedures. In fact, our vision is that one day to have a dedicated ClearPoint room for those cranial patients. We believe that the Neurosurgery Navigation and Robotics segment represents an existing market worth more than $125 million. And again, ClearPoint has less than 10% share today and plenty of room to grow. Pillar #3 remains unchanged and focuses on laser ablation therapy and access products, including OR and MRI Power Drill components for cranial procedures, applicator introducers and cranial access bolts. We estimate this total existing market to be in excess of $75 million, and you guess it, we have less than 10% of the market today and plenty of room to grow. Finally, for our anticipated Pillar #4, which we will begin with the planned closing of our acquisition of IRRAS in the neurocritical care space. This pillar will be named cranial irrigation and aspiration. As detailed in today's press release, the IRRAflow system is used today to treat patients with intracerebral hemorrhage, chronic subdural hematoma and other conditions requiring intracranial fluid management. The IRRAflow platform is unique and potentially disruptive today in that it enables both irrigation and aspiration of these fluids in a controlled systematic way. This technology has been evaluated in multiple peer-reviewed articles, highlighting the device's clinical advantages, including reduction in catheter occlusions, the potential to reduce infection rates and shorter treatment times, which may equate to lower hospital costs as well. Today, we estimate the existing market for this intracranial fluid management space to be in excess of $500 million, and we estimate that the IRRAflow system currently has less than 5% market share today and plenty of room to grow. I think you can sense a theme building for this initial fast-forward strategy. We are talking about an expected aggregate $1 billion-plus existing market where we currently have less than 5% total market share, and we have plenty of room to grow into it. It is important to note that we believe the portfolio we have available today and the pipeline of products we plan to launch in the next few years are capable of increasing our share and delivering that growth. In pre-commercial biologics and drug delivery, we expect to participate in numerous new and larger clinical trials alongside our biopharma partners as well as increase our preclinical capacity, begin doing higher-value GLP studies and provide additional services at the cow to serve our pharma partners more comprehensively. In neurosurgery navigation and robotics, we will continue the full market release of our 3.0 software into the operating room. And we anticipate the launches of our next-generation DUET Frame, our 4.0 Harmony software and our robotic platform, all against the backdrop of a much larger sales organization and global regulatory approvals. In laser therapy and access, we will continue the full market release of the PRISM system, which now includes 1.5 Tesla labeling, and we'll plan for the releases of the 4.0 Harmony software, compatibility with our robotic system, CE mark expansion and an MRI conditional velocity drill to speed up procedures inside the MRI suite. In our anticipated fourth pillar, cranial irrigation and aspiration, we will continue to leverage the peer-reviewed clinical data that highlights the use of the IRRAflow system now with a much larger ClearPoint sales organization, and we'll also add our cranial access bolt, a more intelligent system control software and a forward tunneling device in the next couple of years. And we were able to do all of this using our much larger combined sales organization of more than 50 commercial team members and an existing installed base of more than 150 combined customers after the anticipated closing of the IRRAS acquisition. If we can grow our share of this combined and existing $1 billion market by just a couple of percentage points each year, then we can achieve 20% overall share, a $200 million revenue run rate at 70% gross margins and a meaningfully profitable business. And remember, this does not include arguably the largest opportunity that we have in front of us, which is the commercial cell and gene therapy delivery. This is part 2 of our strategy, which we call Essential Everywhere and involves building a new multibillion-dollar market around our ClearPoint drug delivery ecosystem, which is commonly referred to as the gold standard in this space. We have worked very hard over the last decade and have built a significant head start. When these cell and gene therapies are launched, we expect to offer not just a single product, but rather a complete drug infusion ecosystem, including co-labeled cannulas and routes of administration that are written into the label of the drug itself, flexible navigation platforms that include MRI guidance, CT guidance and robotic guidance, AI predictive modeling and monitoring software to ensure efficient high-quality infusions, and in delivery. We did the same way across these specialized treatment centers, so we increase quality, lower costs and make these procedures more predictable. When these cell and gene therapy programs achieve FDA clearance and CE mark approval, our team will have already been working with these partners for years in advance. We will no longer be viewed as only an extension of their development team, but as an extension of their commercial team as well. In some cases, our products will be sold directly to hospitals, but in other cases, we believe our products may be sold directly to our pharma partners and then provided as a kit to the hospital alongside the drug. This way, the pharma partners can ensure supply and consistency of these essential products and can even maintain an inventory of their own to further derisk their drug delivery supply chain. Many of our existing partners, including uniQure, Blackrock, AskBio and Aona have all updated patients and investors on their progress over the past few months. We obviously must let our partners take the lead for any updates on the status of their programs. However, we continue to work side-by-side with them as we navigate the clinical regulatory pathways and prepare for eventual commercialization. Now let me provide a bit of perspective on this market. We are effectively pre-revenue in this phase as there is only one available neuro gene therapy that is approved in the United States and the European Union. The drug is, in fact, co-labeled with the ClearPoint SmartFlow cannula and is designed to treat a very rare childhood disease called AADC deficiency syndrome. Nonetheless, this is a very important strategic proof point of our capability even if this rare disorder is a smaller revenue opportunity and is just getting started. As you are aware, we are now supporting more than 20 different clinical indications across our entire portfolio, which include more than 30 million existing patients in the United States alone. That is often too large a number to make meaningful, so let's get a little bit more specific. Let's forget about the 60-plus partners that we have today, and let's focus only on the 9 that are now working with the FDA through the expedited review process. Also, let's forget about the 20-plus total indications, and let's focus only on the 7 indications that are currently accepted under FDA expedited review, meaning they are the furthest along in the neuro regulatory pathway. These indications under expedited review include AADC deficiency, Hunter Syndrome, Huntington's disease, drug-resistant epilepsy, Parkinson's disease, frontotemporal lobe dementia and Friedreich's Ataxia. They have a total patient population of approximately 2.1 million patients diagnosed and symptomatic here in the United States alone, where our commercial infrastructure is the strongest. Now if we only looked at a fraction of our partners and only looked at a fraction of our partner indications that are under FDA expedited review and only looked at the United States where our commercial team is the strongest, and then we only treated 1% of the patients that could potentially benefit from these therapies each year, we anticipate that this would amount to approximately 20,000 annual procedures or about the same number of DBS, laser ablation and stereotactic procedures performed annually. At current ASPs used in the clinical trials, this would equate to approximately $300 million of additional annual revenue if you believe those assumptions. While the drug development and regulatory process have proven to be inherently hard to predict, our strategy is built for this uncertainty as number one, we do not have the same binary risk as pharma because we have a portfolio of multiple partners, multiple indications and often redundancy with multiple partners that are pursuing the same indication. Number two, while we might not have the largest per patient revenue upside as the cell or gene therapy drug itself, we also do not have the high cost of executing the clinical trial for the therapy. In fact, we are able to sell investigational products and generate revenue during the preclinical and clinical trials themselves. And number three, we have the benefit of a parallel device strategy that is generating revenue today and as discussed earlier, has a credible path to profitability. Our long-term vision is to have these 2 strategies merge together into a company generating $500 million a year in revenue with a single commercial and operational infrastructure generating scale. This is the path that we are on, and we have an incredible team here at ClearPoint that plans to see it through. Now instead of looking to the horizon, let's quickly look at the steps directly in front of us. Although there are still many moving parts, including the CAL expansion status and the completion of the IRRAS merger and planned integration this year, we are narrowing our full year 2025 revenue forecast to between $36 million and $38 million, which is still within our prior guidance. We also currently expect total revenue of the merged companies in 2026 to be between $54 million and $60 million, but we will provide an additional update in mid-January after we have closed the IRRAS transaction and integrated the 2 commercial teams together. With that, I would now like to open up the call to any questions.
Operator: [Operator Instructions] Our first question is from Frank Takkinen with Lake Street Capital Markets.
Frank Takkinen: Congrats on the agreement in the quarter. It sounds like a lot of exciting developments. I was hoping to start with one on market sizing around the neurocritical care market. I heard the comments around $500 million market, 400,000 procedures. Maybe just bring us a little bit deeper into that, if there's any subsegments you can talk to, where you think you can focus, how much of that market you can penetrate over time? And then it would be interesting to also hear about competitive landscape, what you're going up against and how you feel the device will fare in the marketplace?
Joseph Burnett: Yes, absolutely. Thanks for the question, Frank. Yes. So when we think about the U.S. market for this neurocritical care, we're talking more specifically about where these external ventricular drains or EVDs would be located. It's a market that's pretty much looks like it did 20, 30, 40, 50 years ago with a very underserved population and a very simple solution today, which is effectively a gravity drainage system to pull excess blood and clot out of the brain. And in many cases, surgeons will inject a bolus of some kind of antibiotics or anticoagulant drug like TPA to go ahead and break up the clot and facilitate the drainage a little bit more. Despite all this time passing, there really hasn't been that much innovation in that sector. And IRRAS is a company that has really decided to focus and provide a truly next-generation and disruptive solution there. So what the IRRAS system can do is not only drain the system actively or drain this excess fluid out of the brain actively, but it also aspirates by providing a continuous flow into the brain that would allow the surgeon to administer saline to break up the clot or to administer any of those other drugs that I mentioned. So I think about 75% of estimated use cases involves the delivery of some type of drugs into the brain as well. So the early peer-reviewed data and registry data that's been performed seems to show that by doing this type of active irrigation and aspiration, that facilitates the early release of patients by a significant margin. It seems to reduce the amount of clogging, which is one of the most annoying things neurosurgeons have to deal with when an EVD clogs in the middle of the night and they're the ones that are on call that has to deal with it. It seems to trend towards fewer shunt placements. And there's a meta-analysis going on right now of all of the published data, which I think will provide some very, very interesting insights on the technology. So when we think about anything an EVD might be worked for, this is where we're going to start operating. And we estimate there's probably around 400,000 or so EVD type procedures that are here in the United States and obviously, more globally. Now this is a premium product, so the ASP is higher than a typical EVD system would be. So you could argue the market should be higher than maybe that $500 million number here in the U.S., but we're really just getting started, and we haven't begun the integration yet. So we're trying to err on the conservative side.
Frank Takkinen: Got it. Very helpful. And then I was hoping to ask one about the pro forma business that you laid out $54 million to $60 million revenue guidance for next year. Maybe help us understand kind of what portion of that is related to ClearPoint versus IRRAS here for 2026? And then as a second part to that, how should we think about gross margin profile and burn profile?
Joseph Burnett: Sure. Yes. I think our -- I think we mentioned in the commentary that the IRRAS gross -- I'll start with gross margin. The IRRAS gross margin is closer to that mid-50s range. And as you heard from Danilo's comments, the ClearPoint gross margin in the quarter is around 63% Obviously, both companies are still subscale. We've got a lot of additional product we could put through our factory today. And I think the eventual consolidation, given that IRRAS is based here in San Diego, and we would plan to bring the facilities together would actually immediately increase margin just on the simplest form. But at scale, there's no reason to believe that IRRAS would be any sort of drain on our current gross margin trajectory. And we feel, given those assumptions I mentioned in that sort of pro forma estimate of gaining 2% share each year kind of thing, we could -- we believe that we have a clear path to 70% plus gross margins across both sides of the portfolio. And the IRRAS system itself, as I mentioned, it is a razor-razorblade system. So there is a capital component. However, more than 90% of the revenue from IRRAS at least today is on the disposable side. So we imagine that the capital component is probably going to be trending down from 10% to 9% to 8% to 7% over the years as well.
Frank Takkinen: Okay. And then...
Joseph Burnett: What was the first part of that question? Yes.
Frank Takkinen: Just any thoughts around kind of burn profile and then of that $54 million to $60 million break out ClearPoint versus IRRAS?
Joseph Burnett: Yes. Danilo, do you want to cover the kind of the cash burn side?
Danilo D’Alessandro: Yes. So Frank, we were going to have obviously some integration costs in the first quarter. We estimate the burn to be in the single digits, mid- to high single digits in the first year. And obviously, as we grow and combine the entities, we expect to reduce that burn meaningfully and significantly over time. So we may have just some additional integration and transaction costs here in Q4 and Q1. But other than that, we should work swiftly to reduce the burn of the combined entity.
Frank Takkinen: Okay.
Joseph Burnett: And Frank, one way to think about the commercial side of things is that we were going to have to expand our commercial footprint to prepare for not just our own sort of device growth, but also prepare for these larger clinical trials and eventual commercialization of cell and gene therapy. So we were going to continue to do some of the hiring into that commercial organization. Now it's as if we get a huge bolus of that personnel all at once, along with another product that helps support the cost of that personnel. So I think our individual hiring plans will actually flatten out compared to the growth that we would expect in the future. So it's almost like we're getting some of these people a couple of years early. So that's where a lot of the burn will come from.
Frank Takkinen: Got it. That's helpful. And then if I just have one more on the current quarter. Congrats on getting the CRO site set up and launched. Maybe talk through potential orders in that space. It sounds like you're already having some of those conversations now, but magnitude, how large could those orders be and when could they come?
Joseph Burnett: Yes. So there's sort of 3 vectors of growth that we expect to get out of the new facility. One is a simple one, which is just excess capacity. We were only able to do smaller studies at our prior facility because we were effectively leasing space inside of another CRO that was dedicated to the neuro work that we were doing. We currently -- in the new facility, we estimate that we could do studies that are 4 to 5x the size of the largest study we did in the past. So if we were doing work in the past, maybe our largest pilot studies would be 1.5. I don't know that we did any individual ones more than $2 million at the old facility. Here, we are bidding on projects that are $5 million, $10 million, even $10-plus million for a single study. And that's a combination of the study being larger as well as our plans to be performing GLP studies. We believe we've got a lot of the kind of the paperwork and standard operating procedures in place, and we should be fully functional and able to execute our own higher-margin GLP studies next year, which is kind of like a more -- think of it as a more rigorous testing protocol that's used for FDA and CE mark submissions. So those are 2 -- 2 of those vectors of growth. Again, one is higher capacity; two is higher value GLP studies. The third one is with the excess space that we've got as well, we're going to continue to add additional sort of services to handle our pharma partners a little bit more comprehensively. So these could be imaging technologies. These could be hostology (sic) [ histology ] technologies. We've got a few additional ones that we're looking at as well. So we're not ready to unmask the entire plan at this point. But certainly, by early in Q1, I think the vast majority of our pharma business are going to be able to sort of appreciate everything that we can bring with the touch of it all being neuro focused with ClearPoint expertise.
Operator: Thank you. There are no further questions at this time. I'd like to hand the floor back over to Joe Burnett for any closing comments.
Joseph Burnett: Well, thanks again, everyone, for joining today's call. This is an incredibly exciting time for our company. We have a clear vision, a comprehensive strategy, a competitive portfolio and the right team in place to not only win in all 4 markets that we play in today, but to also prepare to become essential and everywhere as we get ready for the commercialization of neuro cell and gene therapies in the coming years. Thank you, and good night.
Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.