ClearPoint Neuro Inc.

Greetings, and welcome to the ClearPoint Neuro, Inc. fourth quarter and full year 2025 Financial Results Conference call. At this time, all participants are on 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 star zero on your telephone keypad. As a reminder, this conference is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of securities laws. These full-looking statements may include, without limitation, statements related to anticipated industry trends, the company's plans, prospects, and strategies, both preliminary and projected, besides the total adjustable markets or the market opportunity for the company's products and services. the company's expectations regarding the integration, performance, and anticipated benefits of its recent acquisition of Eris Holdings Inc., including operational efficiencies and the impact of 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 new information or future events. For more information about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8K, Form 10K, and Form 10Q. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. And now, I'd like to turn the call over to Joe Burnett. Chief Executive Officer. Please go ahead, sir.

Thank you, Joe. And as always, thank you to all of the investors, analysts, and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuroecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine, and we at ClearPoint believe we can play a crucial role in this exciting future. Our company ended 2025 on a high note with the strongest financial quarter of the year, a newly acquired and commercialized neurocritical care product line, and genuine excitement of what is to come in 2026. Over the past five years, we have invested more than $100 million and built a strong foundation to support our team and our goals moving forward. This foundation is made up of four growing product categories, a vetted pipeline of new development programs and expanded manufacturing footprints, a thoroughly audited quality system, a collection of global regulatory approvals, an expansive IT portfolio, an installed base of more than 150 global centers, and the cash position and investor base to execute on our strategy. Most importantly, through our unique biologics and drug delivery ecosystem, we have attracted more than 60 active biopharma partners, we are participating in more than 25 active clinical trials, We are exploring therapies for more than 15 different indications, and currently more than 10 of our biopharma partner programs have now been accepted to some form of FDA expedited review. Our foundation is set, and our company has never been in a stronger position than we are right now. As we look ahead, we have now entered the next two phases of our growth strategy. The first phase, which we call Fast Forward, is to penetrate an existing $1 billion market opportunity made up of four distinct product segments. Number one, pre-commercial drug delivery products and services. Number two, neurosurgery navigation and robotics. Number three, laser therapy and access. And number four, neurocritical management. We expect all four of these product lines to grow double digits in 2026 through the expansion of our commercial organization, approval of products and new geographies, additional site activations, generation and publication of new clinical evidence, and the execution and launch of new products in our development pipeline. The second phase, which we are entering in parallel, is called Essential Everywhere. This phase is different as it requires us not to grow share in an existing market, but to build a completely new market that does not yet exist for commercial cell and gene therapy delivery. This is a market in which we believe that the unique ClearPoint Neuro ecosystem will play an essential role. This ecosystem will include brain segmentation tools, predictive drug delivery modeling, pre-planning and navigation software, frame and robotics delivery options, drug loading and mechanized infusion technologies, an array of cell and gene therapy routes of administration, and post-procedure quality confirmation software to meticulously track proper delivery. All of these workflow steps will be supported by our talented team of clinical specialists and scientists who will be there in the room assisting our partners when these new-to-world therapies are finally commercialized. While the only neuro gene therapy approved today for direct delivery to the brain is for a very rare disease, it is important to remember that this drug is in fact co-labeled with ClearPoint technology, a trend we expect to continue in the future. As we look ahead to the full year of 2026, we now expect revenues to be in the range of 52 to 56 million, which now takes into account a couple of factors, including the latest FDA communications regarding the potential approval and treatment of rare diseases, as well as the integration efforts and priorities surrounding our recent acquisition of IRIS just a few months ago. I invite anyone listening to visit the ClearPoint Neuro website where you can download a new version of our investor deck that should better communicate the vision and scale of our strategy. I will now turn the call over to our CFO, Danilo D'Alessandro, to walk through the prior year financial data, after which I will provide a bit more commentary on the road ahead. Danilo?

Thank you, Joe, and thank you all for joining us today. Let me start by looking at the full year 2025 results. ClearPoint Neuro total revenues were $37 million for the year ended December 31, 2025, compared to $31.4 million in the year 2024. Our total 2025 revenue of $37 million includes $1.2 million of revenue from the acquisition of Eris Holdings Inc., which we completed on November 20, 2025. Our revenue is made up of three components, biologics and drug delivery, neurosurgery, navigation and therapy, and capital equipment and software. We include the Eraflow product line in our navigation and therapy segment. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials. Biologics and drug delivery revenue increased 10% to $19 million in 2025, up from $17.3 million in 2024. This increase was primarily due to an increase in our product sales as our pharmaceutical partners advanced their development programs. Neurosurgery navigation revenue consists of commercial sales of disposal products and services related to the cases utilizing the ClearPoint system to deliver medical therapy to the intended target. This revenue segment grew to $14.8 million for the year 2025, including $1.2 million in Aeroflow revenue. The growth in this segment was mainly due to our increased installation base and the full market release of our PRISM laser system and ICT solution. Capital equipment and software revenue consisting of sales of ClearPoint reusable hardware and software and related services was $3.1 million for the year 2025. Gross margin for the full year 2025 was 61%, in line with the year 2024. Research and development costs were $13.9 million for the year 2025, compared to $12.4 million in 2024, an increase of $1.5 million, or 12%. The increase was due to higher product and software development costs of $1.2 million, an increase in personal cost, including share-based compensation expense of $0.2 million, and additional costs due to the consolidation of ERIS. Sales and marketing expenses were $16.5 million for the year 2025, compared to $14.5 million for the same period in 2024, an increase of $2 million, or 14%. This increase was due to higher personal costs, including share-based compensation expense of $1.4 million, resulting from increases in headcount in our clinical team, as well as increased costs of $0.9 million due to the consolidation of ERAS, partial offset by decreased marketing costs of $0.2 million and decreased travel costs of $0.2 million. Generally, administrative expenses were $16.5 million for the year 2025 compared to $12 million for the same period in 2024, an increase of $4.5 million or 38%. This increase was due primarily to severance expense of $1.4 million in connection with the ERIS acquisition, increased professional service fees of $1 million, higher personal costs including share-based compensation of $0.9 million, higher information technology and software costs of $0.5 million, increased bed debt expense of 0.2 million and additional cost of 0.2 million related to the ERAS acquisition. Net interest expense for the year 2025 was $1.2 million. Interest expense for the year 2025 was 2.4 million compared with 0.5 million for the year 2024. The increase was due to the issuance of notes payable in May and November 2025. I will now turn to the fourth quarter 2025 results. Total revenue was $10.4 million for the three months ended December 31, 2025, in comparison to $7.8 million for the three months ended December 31, 2024. Biological and drug delivery revenue increased 23% to $5.2 million in the fourth quarter of 2025. This increase is attributable to $1.1 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials, partially offset by lower service revenue of $0.1 million. Neurosurgery navigation and therapy revenue was $4.7 million for the fourth quarter of 2025 from $2.9 million for the same period in 2024. The increase is driven by an increased customer base and additional revenues due to the AeroPro product line acquisition completed in November 2025. Capital equipment product and relief service revenue was $0.5 million for the fourth quarter of 2025, a slight decrease compared to $0.6 million in the same period in 2024. Gross margin was 62% for the fourth quarter of 2025 compared to a gross margin of 61% for the same period in 2024. Operating expenses for the fourth quarter of 2025 were $13.4 million compared to $10.4 million for the fourth quarter of 2024. The increase was mainly driven by the acquisition and installation of ERIS's financials and increased professional services fees. At December 31, 2025, the company had cash and cash equivalents totaling $45.9 million as compared to $20.1 million at December 31, 2024, with the increase resulting from the net proceeds of the NOS payables and stock offering of $51.4 million and cash acquired as part of the ERIS acquisition of $1.1 million. Partial set by the use of $23.9 million in cash for operating activities and $1.9 million in cash paid for taxes related to the net share settlement of equity awards. Net cash flows used in operating activities for the year ended December 31, 2025 was $23.9 million, an increase of $50 million from the year ended December 31, 2024. This increase was primarily due to a higher net loss of $6.6 million and the pay down of accounts payable and accrued expenses of $10.6 million. $8 million is related to liabilities assumed from the ERAS acquisition as part of the purchase price and ERAS acquisition related transaction expenses. In addition, we had $1.1 million of operational post acquisition ERAS expenses in Q4. We do not expect to incur cash outflows for the payment of assumed liabilities of a similar magnitude in future periods. as a pay down of the liabilities assumed in connection with the ERIS acquisition represents a non-recurring event. I'd like now to turn the call back to Joe.