ClearPoint Neuro Inc.

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 product 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 under-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 8K, Form 10K, and Form 10Q. All the company's filings may be obtained from the SEC or the company's website at www.sec.gov. clearpointneuro.com. I'll now turn the call over to Joe Burnett, Chief Executive Officer.

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 four 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 two 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 four 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 break-even 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 and 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 two 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 ERIS with a target closing date in the coming weeks. This is an incredibly exciting merger of two 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 razor blade business model. The ERIS team should be congratulated on developing the Aeroflow 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 two teams have a lot in common. We plan to integrate swiftly, and we look forward to welcoming ERIS to the team once the merger formally closes. There are three important strategic rationales that make the ERIS team and portfolio a perfect fit for this next phase of ClearPoint Neuro. First, the airflow 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 half a billion existing market opportunity, which ClearPoint now gains access to. Second, the design of the indwelling and flexible Aeroflow 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 IRIS 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 two-part ClearPoint strategy. Danilo? 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 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 ERAS 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 ERAS 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 arrangements with Oberlin Capital, conditioned upon the closing of ClearPoint Neuros transaction to acquire Eros 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 three months ended September 30th, 2025, in comparison to $8.1 million for the three months ended September 30th, 2024, which represents 9% growth versus the third quarter of 2024. As a reminder, our revenue is made up of three components, biologics and drug delivery, neurosurgery, navigation, and therapy, and capital equipment and software. Biologics and drug delivery revenue includes 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 $.7 million due to new studies performed for our partners in the three months ended September 30th, 2025, offset by 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 of resident 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 of 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 three 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 $.3 million or 8%. This increase would mainly be due to additional personal costs as we expand our commercial reach to support and accelerate our product launches. General administrative expenses were $3.6 million for the third quarter compared to $3.1 million for the same period in 2024, an increase of $.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 30th, 2025, we held cash and cash equivalents of $38.2 million compared to $20.1 million as of December 31st, 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. 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 one-time and significant coordination of moving people and equipment, setting up standard operating procedures, and 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 three 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 four-pillar growth strategy a bit further. And I will start with one important note for those of you who have been following our four-pillar mantra since we started about eight years ago. We will be adjusting the definitions a bit given the announced acquisition of ERIS and our two-part strategy that we have transitioned to here in 2025. Pillar number one, 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 number two 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 pre-planning and software workflow that could be deployed by surgeons using three 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's 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 pre-planning software and one step-by-step workflow to always be used, but the surgeon will still maintain choice across our three 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 robotic 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 number three 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 guessed it, we have less than 10% of the market today and plenty of room to grow. Finally, for our anticipated pillar number four, which we will begin with the planned closing of our acquisition of ERIS in the neurocritical care space. This pillar will be named cranial irrigation and aspiration. As detailed in today's press release, the ERAflow system is used today to treat patients with intercerebral hemorrhage, chronic subdural hypnotoma, and other conditions requiring intracranial fluid management. The Earflow 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 Eraflow 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 billion dollar 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 Cal 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 Eraflow system, now with a much larger ClearPoint sales organization, and we'll also add our cranial access vault, 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 ERIS acquisition. If we can grow our share of this combined and existing billion-dollar market by just a couple 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 two 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. Delivery.