Q4 2025 ClearPoint Neuro Inc Earnings Call

March 17, 2026

Operator 3: Greetings, and welcome to the ClearPoint Neuro, Inc. Q4 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 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 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 expectations regarding the integration, performance, and anticipated benefits of its recent acquisition of IRRAS Holdings, Inc., including operational efficiencies and the impact of the company's financial condition and results of operations.

Speaker #3: Any questions or answers session will follow the formal presentation. If anyone should require operator assistance during the call, please press *0 on your telephone keypad.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: The company's expectations regarding the integration, performance, and anticipated benefits of its recent acquisition of Eros Holdings, Inc., including operational efficiencies, and the impact on the company's financial condition and results of operations; the company's expectations 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.

Operator 3: 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. 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 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.

Operator: 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. 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 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Operator 3: Now I'd like to turn the call over to Joe Burnett, Chief Executive Officer. Please go ahead, sir.

Operator: Now I'd like to turn the call over to Joe Burnett, Chief Executive Officer. Please go ahead, sir.

Speaker #3: Please go ahead, sir.

Speaker #2: 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 neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies, to the brain.

Joseph M. Burnett: 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 neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine, and we at ClearPoint believe 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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 about what is to come in 2026.

Speaker #2: 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.

Joseph M. Burnett: 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, an expanded manufacturing footprint, 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. Currently more than 10 of our biopharma partner programs have now been accepted to some form of FDA expedited review.

Speaker #2: This foundation is made up of four growing product categories: a vetted pipeline of new development programs, an expanded manufacturing footprint, a thoroughly audited quality system, a collection of global regulatory approvals, and expansive IP portfolio and installed base of more than 150 global centers and the cash position and investor base to execute on our strategy.

Speaker #2: 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.

Speaker #2: 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.

Joseph M. Burnett: 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 in 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.

Speaker #2: 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.

Speaker #2: 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 in new geographies, additional site activations, generation and publication of new clinical evidence, and the execution and launch of new products in our development pipeline.

Speaker #2: 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.

Joseph M. Burnett: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: While the only neurogene 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.

Joseph M. Burnett: 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 IRRAS 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.

Speaker #2: As we look ahead to the full year 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 ERIS just a few months ago.

Speaker #2: 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.

Speaker #2: 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.

Joseph M. Burnett: 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.

Speaker #2: Danilo?

Speaker #3: 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.

Danilo D'Alessandro: 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 IRRAS 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 IRRAS 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.

Speaker #3: 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.

Speaker #3: Our revenue is made up of three components: biologics and drug delivery, neurosurgery navigation and therapy, and capital equipment and software. We include the ERIFLO product line in our navigation and therapy segment.

Speaker #3: 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.

Danilo D'Alessandro: Biologic 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 disposable 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 IRRAflow 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.

Speaker #3: 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 disposable products and services related to the cases utilizing the ClearPoint system to deliver medical therapy to the intended target.

Speaker #3: This revenue segment grew to $14.8 million for the year 2025, including $1.2 million in ERIFLO 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.

Speaker #3: Capital equipment and software revenue consists of sales of ClearPoint reusable hardware and software and related services, with $3.1 million for the year 2025.

Danilo D'Alessandro: Capital equipment and software revenue consists of sales of ClearPoint reusable hardware and software and related services with $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 personnel cost, including share-based compensation expense of $0.2 million, and additional costs due to the consolidation of IRRAS.

Speaker #3: 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%.

Speaker #3: The increase was due to higher product and software development costs of $1.2 million, an increase in personal costs, including share-based compensation expense of 0.2 million, and additional costs due to the consolidation of ERIS.

Speaker #3: Sales and marketing expenses were $16.5 million for the year 2025 compared to $14.5 million for this period in 2024, an increase of $2 million or 14%.

Danilo D'Alessandro: 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 personnel 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 IRRAS, partially offset by decreased marketing cost of $0.2 million and decreased travel cost of $0.2 million. General and 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 30%.

Speaker #3: 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 ERIS.

Speaker #3: Partial offset by decreased marketing costs of $0.2 million and decreased travel costs of $0.2 million. Generally, the 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%.

Speaker #3: 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 costs of $0.2 million related to the ERIS acquisition.

Danilo D'Alessandro: This increase was due primarily to severance expense of $1.4 million in connection with the IRRAS acquisition, increased professional service fees of $1 million, higher personnel costs, including share-based compensation of $0.9 million, higher information technology and software costs of $0.5 million, increased bad debt expense of $0.2 million, and additional costs of $0.2 million related to the IRRAS acquisition. Net interest expense for the year 2025 was $1.2 million. Interest expense for the year 2025 was $2.4 million, compared with $0.45 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 Q4 2025 results.

Speaker #3: Net interest expense for the year 2025 was $1.2 million. Interest expense for the year 2025 was $2.4 million, compared with $0.45 million for the year 2024.

Speaker #3: The increase was due to the issues of non-stability 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.

Danilo D'Alessandro: Total revenue was $10.4 million for the three months ended 31 December 2025, in comparison to $7.8 million for the three months ended 31 December 2024. Biological and drug delivery revenue increased 23% to $5.2 million in Q4 2025. This increase is attributable to $1.1 million of higher product revenue resulting from greater demand for disposables as multiple partners progressing their trials, partially offset by lower service revenue of $0.1 million. Neurosurgery navigation and therapy revenue was $4.7 million for Q4 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 IRRAS product line acquisition completed in November 2025.

Speaker #3: Biologics and drug delivery revenue increased 23% to $5.2 million in the fourth quarter of '25. This increase is attributable to $1.1 million of higher product revenue resulting from greater demand for disposables as multiple partners progressed in their trials.

Speaker #3: 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.

Speaker #3: The increase is driven by an increased customer base and additional revenues due to the ERIFLO product line acquisition completed in November 2025. Capital equipment product and related service revenue was $0.5 million for the fourth quarter of 2025, a slight decrease compared to $0.6 million in the same period of 2024.

Danilo D'Alessandro: Capital equipment product and related service revenue was $0.5 million for Q4 2025, a slight decrease compared to $0.6 million in the same period of 2024. Gross margin was 62% for Q4 2025, compared to a gross margin of 61% for the same period in 2024. Operating expenses for Q4 2025 were $13.4 million, compared to $10.4 million for Q4 2024. The increase was mainly driven by the acquisition and consolidation of IRRAS's financials and increased professional services fees.

Speaker #3: 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.

Speaker #3: The increase was mainly driven by the acquisition, installation of ERIS's financials, and increased professional services fees. A 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 non-stables and stock offering of $51.4 million, and cash acquired as part of the ERIS acquisition of $1.1 million.

Danilo D'Alessandro: At 31 December 2025, the company had cash and cash equivalents totaling $45.9 million as compared to $20.1 million at 31 December 2024, with the increase resulting from the net proceeds of the notes payables and stock offering of $51.4 million and cash acquired as part of the IRRAS acquisition of $1.1 million. Partially offset 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 31 December 2025 was $23.9 million, an increase of $15 million from the year ended 31 December 2024.

Speaker #3: Partially offset 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.

Speaker #3: Net cash flows used in operating activities for the year ended December 31, 2025, was $23.9 million, an increase of $15 million from the year ended December 31, 2024.

Speaker #3: This increase was primarily due to a higher net loss of $6.6 million and the paydown of accounts payable and accrued expenses of $10.6 million.

Danilo D'Alessandro: 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 IRRAS acquisition as part of the purchase price, and IRRAS acquisition-related transaction expenses. In addition, we had $1.1 million of operational post-acquisition IRRAS 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 IRRAS acquisition represents a non-recurring event. I'd like now to turn the call back to Joe.

Speaker #3: $8 million is related to liabilities assumed from the ERIS acquisition as part of the purchase price, and ERIS acquisition-related transaction expenses. In addition, we had $1.1 million of operational post-acquisition ERIS expenses in Q4.

Speaker #3: We do not expect to incur cash outflows for the payment of assumed liabilities of a similar magnitude in future periods. As a paydown of the liabilities assumed in connection with the ERIS acquisition represents a non-recurring event.

Speaker #3: I'd like now to turn the call back to Joe.

Speaker #1: Thank you, Danilo. As you can tell from our fourth quarter results, we ended 2025 on a strong note and with terrific momentum going into 2026.

Joseph M. Burnett: Thank you, Danilo. As you can tell from our Q4 results, we ended 2025 on a strong note and with terrific momentum going into 2026. Now, I will just spend a few minutes digging a bit deeper into our 4-pillared growth strategy. As a reminder, our 4 pillars consist of the following segments. 1, pre-commercial biologics and drug delivery products and services. 2, neurosurgery navigation and robotics. 3, laser therapy and access. 4, neurocritical management. These are the 4 markets that we participate actively in today, and pretty much 100% of our current revenue is coming from these 4 markets. In 2026, we expect all 4 of these segments to each grow in the double digits.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: In 2026, we expect all four of these segments to each grow in the double digits. In the future, we 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.

Joseph M. Burnett: In the future, we 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 and 56 million does not include any meaningful expected revenue from the commercial drug delivery. 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's start with pillar number 1, pre-commercial biologics and drug delivery. The team has made substantial progress building out the ClearPoint Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL.

Speaker #1: To be clear, our existing revenue forecast for 2026 of between $52 million and $56 million does not include any meaningful expected revenue from the 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.

Speaker #1: First, let's start with pillar number one: free commercial biologics and drug delivery. The team has made substantial progress building out the ClearPoint Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL.

Speaker #1: In the fourth quarter of 2025, we performed our very first preclinical study for a sponsor, and continue to execute additional studies already here in the first quarter of 2026.

Joseph M. Burnett: In Q4 2025, we performed our very first preclinical study for a sponsor and continue to execute additional studies already here in Q1 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: For some perspective, if we look at only the programs under expedited review, which span across eight different indications, there would be more than $2 million patients in the United States alone that have indications that are being considered for expedited designation pathways.

Joseph M. Burnett: For some perspective, if we look at only the programs under expedited review, which span across 8 different indications, there would be more than 2 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 million in annual revenue to ClearPoint. 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.

Speaker #1: Treating just 1% of those patients or about 20,000 patients a year could deliver approximately $300 million in annual revenue to ClearPoint. 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.

Speaker #1: 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 the last quarter of 2025, we had the highest volume of clinical trial cases supported by our Biologics and Drug Delivery team in our history.

Joseph M. Burnett: I can also share with you that in Q4 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 neurocapabilities, should position us to achieve 20% of the estimated $300 million 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.

Speaker #1: 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 neurocapabilities, should position us to achieve 20% of the estimated $300 million market for pre-commercial biologics and drug delivery products and services.

Speaker #1: 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.

Speaker #1: Moving on to pillar number two, which is neuronavigation 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 not only in the MRI, but also in the operating room using CT imaging.

Joseph M. Burnett: The launch of our 3.0 software platform has been very successful as we have added multiple new installations, especially in sites that are intent on using ClearPoint 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 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.

Speaker #1: 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 navigation procedures to be performed in the same room each day.

Speaker #1: 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.

Joseph M. Burnett: 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.

Speaker #1: 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.

Speaker #1: At the request of a number of pharma partners, we have now initiated the PNDA regulatory process in Japan and expect to perform our first cell therapy clinical trial cases sometime in the second half of this year.

Speaker #1: 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 robotic platform at the new CAL facility before the end of this year.

Joseph M. Burnett: Importantly, we plan to perform our very first pre-clinical studies using the ClearPoint 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 and 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-powered MRI scanners. This clearance gave us access to the other half of the US laser therapy market as previously we only had clearance for 3 Tesla strength magnets.

Speaker #1: 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.

Speaker #1: For pillar number three, laser and 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.

Speaker #1: 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.

Speaker #1: 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.

Joseph M. Burnett: 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 adeor, 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.

Speaker #1: 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.

Speaker #1: 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.

Joseph M. Burnett: These cell and gene therapy procedures often require multiple trajectories where we believe the Velocity Alpha 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 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's the need for periprocedural catheter adjustments, and there's the need to include small, minimally invasive access points. Every laser procedure a hospital does with ClearPoint today is getting their team more familiar with the drug delivery workflow of tomorrow.

Speaker #1: 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 is arguably the most similar workflow to these future cell and gene therapy cases.

Speaker #1: In both laser and drug delivery, there are multiple different trajectories. There is the delivery of a volumetric therapeutic dose, there's the need for periprocedural catheter adjustments, and there's the need to include small, minimally invasive access points.

Speaker #1: Every laser procedure a hospital does with ClearPoint 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.

Joseph M. Burnett: Practice makes perfect and permanent, and we continue to believe that achieving 20% of this total market is a reasonable near-term goal. Last but not least, pillar number 4, which is neurocritical management and is made up of the various IRRAflow assets included in the acquisition at the end of 2025. This is a new market for ClearPoint, but it is an important one as it fits our two-phase strategy perfectly. Number 1, it allows us to participate today in an existing $500 million market opportunity with a unique and differentiated product supported by growing clinical evidence. Number 2, it gives us another drug delivery option for the brain that fills a historic gap in our portfolio for a flexible indwelling option.

Speaker #1: And last but not least, pillar number four, which is neurocritical management and is made up of the various EriFlow assets included in the acquisition at the end of 2025.

Speaker #1: This is a new market for ClearPoint, 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 million market opportunity with a unique and differentiated product supported by growing clinical evidence.

Speaker #1: 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.

Speaker #1: The EriFlow 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.

Joseph M. Burnett: The IRRAflow 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 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 million 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 billion market opportunity, generate $200 million in annual revenue and get us comfortably to cash breakeven and profitability.

Speaker #1: The existing market for these intracranial procedures is arguably the largest that ClearPoint 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 million market opportunity.

Speaker #1: 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 billion market opportunity generates $200 million in annual revenue and gets us comfortably to cash breakeven and profitability.

Speaker #1: 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 have therapy candidates under FDA expedited review.

Joseph M. Burnett: 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 have therapy candidates under FDA expedited review. If we accomplish these two goals, we will have built a $500 million 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. With that, I will open up the call to any questions.

Speaker #1: If we accomplish these two goals, we will have built a $500 million annual revenue business and helped a lot of patients along the way.

Speaker #1: These are the two phases of our company, and we are just getting started. With that, I will open up the call to any questions.

Speaker #1: Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad, and a confirmation tone will indicate your line is in the question queue.

Operator 4: Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: Ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker #1: You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker #1: And the first question comes from the line of Frank Takkanen with Lake Street Capital Markets. Please proceed.

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

Speaker #2: Great. Thanks for taking the questions, and I appreciate the comprehensive update. I was hoping to start with a follow yeah, of course. I was hoping to start with a follow-up related to the 2026 guidance.

Frank Takkinen: Great. Thank you for taking the questions and appreciate the comprehensive update. Was hoping to start with a follow-

Frank Takkinen: Yeah, thanks, Frank.

Frank Takkinen: Yeah, of course. 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, and 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. Then as it relates to that, big picture, how should we think about organic growth versus growth? Obviously we can see growth with IRRAS in there, so maybe the right way is just how should we think about organic growth?

Speaker #2: I think you called out some of the most recent FDA communications around rare diseases, and then integration efforts and priorities, as a reason for tightening that guidance a little bit.

Speaker #2: 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. Then, as it relates to that, big picture, how should we think about organic growth versus growth?

Speaker #2: Obviously, we can see growth with Iris in there, so maybe the right way is just, how should we think about organic growth?

Speaker #3: Yes. No, thanks for the question, Frank. So, starting with the first question, which has to do with what's kind of included in the guidance and where we could kind of go from there.

Joseph M. Burnett: Yes. No, thanks for the question, Frank. You know, starting with the first question, which has to do with, you know, what's kind of included in the guidance and, you know, where we could kinda go from there. You know, there are two things that I cited in my prepared remarks. One was sort of the FDA's current condition around rare diseases, and the second one is, you know, really digging deeper into the IRRAS acquisition and figuring out, you know, if the key prior priorities are the same as the current ClearPoint one.

Speaker #3: There are two things that I cited in my prepared marks: one was sort of the FDA current condition around rare diseases, and the second one is really digging deeper into the iris acquisition and figuring out if the prior priorities are the same as the current ClearPoint one.

Speaker #3: 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 3 studies.

Joseph M. Burnett: 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 three studies. You know, based on that information and how it would impact our two biopharma partners, we have effectively taken out any and all revenue associated with the commercial launch of those particular products. 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.

Speaker #3: 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 if and when the FDA were to change course there.

Speaker #3: So, in the event that some good news is created—in the case of UniQure or the case of REGENXBIO—it's possible we would revisit that guidance.

Joseph M. Burnett: In the event that some good news is created, you know, in the case of uniQure or the case of REGENXBIO, you know, it's possible we would revisit that guidance. 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. That's 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 were working with on more established and larger markets, sort of less rare diseases and more, you know, large volume patient populations, the majority of those patients were already planning to do that same phase three sham study.

Speaker #3: 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.

Speaker #3: So that’s 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 were working with on more established and larger markets—sort of less rare diseases and more large-volume patient populations—the majority of those patients were already planning to do that same Phase 3 sham study.

Speaker #3: So, this newest FDA guidance—we don't believe it carries over to timelines relative to these larger populations, because the expedited review process always included doing a Phase 3 study. What they were often allowed to do was skip Phase 2 and go directly to Phase 3, but that large, multi-center or geographically expansive sham study was always in the mix.

Joseph M. Burnett: You know, this newest FDA guidance, we don't believe it carries over to timelines relative to these larger populations because the expedited review process always included doing a phase 3 study. What they were often allowed to do was skip phase 2 and go directly to phase 3, but that large multicenter geographically expansive sham study was always in the mix. That's one half of the equation. The other one has to do with IRRAS itself. You know, the biggest thing I can point to then there, again, it's a very exciting product. We're learning a lot every single day, meeting customers. You know, as I mentioned, they had an existing revenue base last year in that $8 to 9 million range, give or take.

Speaker #3: So that's one half of the equation. The other one has to do with Iris itself, and the biggest thing I can point to there—again, it's a very exciting product.

Speaker #3: We're learning a lot every single day, meeting customers. As I mentioned, they had an existing revenue base last year in that $8 to $9 million range, give or take.

Speaker #3: I'd say the biggest change that we've made is really in our European strategy, where we've kind of hit the reset button as we think about European expansion.

Joseph M. Burnett: I'd say the biggest change that we've made is really in our European strategy, where we've kinda 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'd like a fresh start with at this point. If anything, we maybe took a little bit out of our European revenue piece just based on this latest information. Again, if something happens on the positive side, we always reserve the right to revisit that guidance in the second half of the year. That's kind of what's embedded in the guidance itself. Then Frank, what was the second question that you had there?

Speaker #3: And very specifically, which distributors we want to continue working with versus which ones we'd 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.

Speaker #3: So that's kind of what's embedded in the guidance itself. And then, Frank, what was the second question that you had there?

Speaker #2: No, underlying core growth, organic growth.

Frank Takkinen: Underlying core growth, organic growth.

Speaker #3: Yeah, I'd 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.

Joseph M. Burnett: Yeah. I'd say we expect it to be pretty balanced between the two. You know, I think I did make that comment that we expect all four of our segments, and if you wanna 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 noise here and there, but you know, I think the development pipeline, the fact that our commercial organization today is significantly larger than it was a year ago, I think the fact that new clinical evidence is coming out in each one of those four categories, and I think we're getting familiar with the ClearPoint and IRRAS team starting to work together.

Speaker #3: 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 is coming out in each one of those four categories.

Speaker #3: And I think we're getting familiar with the ClearPoint and IRIS team starting to work together. We think both organic and inorganic growth coming from IRIS could be relatively balanced, but all in that double-digit range.

Joseph M. Burnett: You know, we think both organic and inorganic growth coming from IRRAS could be relatively balanced, but all in that double-digit range.

Speaker #2: Got it. That's helpful. And then I was hoping to ask a little bit more about the core billion-dollar market and the pathway to $200 million. If you envision yourself on the other side of the integration of IRIS and you're back to a point where the business is all integrated, how should we think about the durable growth rate? What I'm trying to get at is that pathway from today, around that $50 to $60 million revenue range, to $200 million.

Frank Takkinen: Got it. That's helpful. Was hoping to ask a little bit more about the core billion-dollar market and pathway to $200 million. If you envision yourself on the other side of the integration of IRRAS and you're back to a point where the business is all integrated, how should we think about the durable growth rate? What I'm trying to get at is that pathway from today around that $50 to 60 million revenue range to $200 million. How long could that take and what kind of growth rates should we expect to see over time?

Speaker #2: How long could that take and what kind of growth rates should we expect to see over time?

Speaker #3: Yeah, I mean, I think if we generally can grow in that 15 to 20 percent, maybe even north of 20 percent range for the foreseeable future, that assumes that we're taking one and a half to 2 percent share pretty much each year across all four of those.

Joseph M. Burnett: Yeah, I mean, I think if we generally can grow in that 15% to 20%, maybe even north of 20% range for the, you know, foreseeable future, that assumes that we're, you know, taking 1.5% to 2% share pretty much each year across all four of those. 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, you know, a single study could be in that $15 to 20 million range, right?

Speaker #3: And again, there could be differences that take place in each one of those markets. 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 to 20 million dollar range, right?

Speaker #3: 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.

Joseph M. Burnett: We could see a large bump in any given year based on, you know, our capability being ready and then a biopharma company hiring us to do that work for them. We could have a leap one year to the next in the biologics and drug delivery side. You know, similarly on the IRRAflow technology, there's a lot of clinical evidence being supported. There's a randomized clinical trial actually supported by IRRAS, called the ARCH trial, where we expect a data readout at some point later this year.

Speaker #3: So we could have a leap one year to the next in the biologics and drug delivery side. Similarly, on the iris flow technology, there's a lot of clinical evidence being supported; there's a randomized clinical trial actually supported by iris called the ARCH trial, where we expect a data readout at some point later this year.

Joseph M. Burnett: You know, that is a very, very large market where IRRAflow is a relatively new technology, where if we had clinical evidence that showed not only, you know, 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, you know, those are things that could really swing market share pretty quickly because, you know, this is not a high intensive training product. This is one where, you know, 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, right?

Speaker #3: So that is a very, very large market where iris flow 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.

Speaker #3: 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, right?

Speaker #3: So where we can't 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 percent, maybe even 20 percent from an organic standpoint until we get to that 200 million dollar number.

Joseph M. Burnett: It's where we can't 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. You know, we do feel comfortable in that 15%, certainly 15%, maybe even 20% from an organic standpoint, until we get to that $200 million number.

Speaker #2: Helpful. And then last one, Joe, we get a lot of questions on just the attachment to Unicare and obviously the volatility around FDA's communication there.

Operator 2: Helpful. 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've 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 kinda de-emphasizing the attachment on just one singular asset and what the model looks like over time.

Frank Takkinen: Helpful. 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've 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 kinda de-emphasizing the attachment on just one singular asset and what the model looks like over time.

Speaker #2: The question I wanted to ask was really focusing on the diversified offering. You've got BlueRock and Nirana's assets coming as the next most likely near-term, big market opportunities that should really exemplify the value of a diversified offering.

Speaker #2: 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 and expedited review.

Speaker #2: And kind of de-emphasizing the attachment on just one singular asset and what the model looks like over time.

Speaker #3: Yeah, so Frank, I don't want to comment on the timing of our partner programs; they give their updates when they prefer to. So I'm just going to stick to what they've said.

Joseph M. Burnett: Yeah. Frank, I don't wanna comment on the timing of our partner programs. You know, they give their updates when they prefer to, so I'm just gonna stick to what they've said. You know, if you go to the websites of BlueRock, Neurona, some of these other companies as well, you know, they 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're in.

Speaker #3: And if you go to the websites of BlueRock, Nirana, 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're in.

Joseph M. Burnett: 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, you know, the scale of how many programs that we're in and then how many are in phase, you know, preclinical versus phase I/II versus phase III and even in the case of PTC, one that's commercialized. I'd encourage you to kinda take a look through that, and I think it'll 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.

Speaker #3: 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're in, and then how many are in phase preclinical versus phase one, two versus phase three, and even, in the case of PTC, one that's commercialized.

Speaker #3: So I'd encourage you to kind of take a look through that, and I think it'll provide some feedback there as to where we are.

Speaker #3: The other thing I would bring up, however, is that even these phase three trials can provide meaningful revenue to ClearPoint. So a typical phase three study that we're seeing or we're participating in could be anywhere from 60 to 120 patients.

Joseph M. Burnett: You know, a typical phase III study that, you know, we're seeing or we're participating could be anywhere from 60 to 120 patients that are studied, sometimes randomized 2 to 1 in the test arm versus the control arm. You know, 120 patients times, you know, 5, 10, 15 studies that could be going on at the same time could again be a very meaningful volume, maybe even 1,000 patients a year that would just be still in this clinical trial phase. Again, we don't count that in that phase II opportunity of commercial drug delivery, but it is supporting the growth in addition to the CAL of that, you know, pre-commercial biologics line.

Speaker #3: That are studied sometimes randomized two to one in the test arm versus the control arm. 120 patients times 5, 10, 15 studies that could be going on at the same time, could again be a very meaningful volume, maybe even 1,000 patients a year, that would just be still in this clinical trial phase.

Speaker #3: So again, we don't 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.

Joseph M. Burnett: I think you know, I mentioned in the remarks, Q4 was the largest volume we ever saw of drug delivery. Patients are raising their hand and enrolling in these trials, and we expect many more to start here in 2026.

Speaker #3: 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.

Speaker #2: Very helpful. Thank you. The next question comes from the line of Anderson Shock with B. Reilly Securities. Please proceed.

Frank Takkinen: Very helpful. Thank you.

Joseph M. Burnett: Sure thing.

Operator 4: The next question comes from the line of Anderson Schock with B. Riley Securities. Please proceed.

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

Anderson Schock: Hey, thank you for taking the questions. 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?

Speaker #4: Hey, thank you for taking the questions. 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.

Speaker #4: Could you provide any more color on the indication and population size for this new partner or partners?

Speaker #3: Yeah, in some cases, it's been a new indication. In some cases, it's 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, MTLE.

Joseph M. Burnett: Yeah. In some cases, it's been a new indication. In some cases, it's relevant in an existing indication. You know, the two largest ones that are under expedited review today would be Parkinson's disease and drug-resistant epilepsy, you know, MTLE. 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. I think there's eight total indications and maybe 13 partners that are under FDA expedited review. Again, we have a little bit of overlap. I think there's four or five in Parkinson's alone, for example.

Speaker #3: So those are the two that I think the largest existing populations. The ones in addition to that are anything from glioma to Friedrich's ataxia to Huntington's disease with Unicare as mentioned before.

Speaker #3: 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.

Speaker #3: So again, we have a little bit of overlap. I think there's four or five in Parkinson's alone, for example. So it's nice because it gives us much higher confidence if 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.

Joseph M. Burnett: It's nice because it gives us, you know, much higher confidence if you look at a disease state like Parkinson's with over 1 million, you know, patients in the United States that are really waiting for a superior treatment. You know, we have five, maybe six partners that are already under expedited review, and, you know, maybe that treatment isn't that far away. But just as importantly, we've got four, five, maybe six of these shots on goal that are under expedited review. Again, maybe every one of them doesn't make it all the way through the regulatory gauntlet, but, you know, if one, two, three of them get approved, we could be very successful there.

Speaker #3: We have five, maybe six, partners that are already under expedited review. And maybe that treatment isn't that far away, but just as importantly, we've got four or five, maybe six of these shots on goal that are under expedited review.

Speaker #3: So again, maybe every one of them doesn't make it all the way through the regulatory gauntlet, but if one, two, or three of them get approved, we could be very successful there.

Speaker #4: Okay, got it. Thank you. And then you mentioned the first tumor clinical data for PRISM publishing this year, potentially expanding beyond functional neurosurgery in a neuro-oncology.

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

Speaker #4: How should we think of the timeline for this expansion in the TAM and neuro-oncology versus PRISM's current addressable market?

Speaker #3: Yeah, I'd say it's really just a strength of our commercial team, and how we're growing and evolving as well. If you think about the laser therapy market, it's historically been split between epilepsy and tumor.

Joseph M. Burnett: Yeah, I'd say it's really just a, you know, a strength of our commercial team and how we're growing and evolving as well. If you think about the laser therapy market, it's 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, you know, we've always been a little bit heavily weighted towards functional neurosurgery and movement disorders.

Speaker #3: 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've always been a little bit heavily weighted towards functional neurosurgery and movement disorders.

Speaker #3: So having a publication that's looking directly at our laser performance in a group of very sick tumor patients, I think, puts us in a situation that we can look customers in the eye and say, 'Yes, we're taking this very, very seriously, and we're going to be participating in multiple clinical trials moving forward.' Even if it's a customer base that we haven't had quite the same experience as we have with functional.

Joseph M. Burnett: Having a publication that's looking directly at our laser performance in a group of, you know, very sick tumor patients, I think, you know, puts us in a situation that we can, you know, look customers in the eye and say, "Yes, we're taking this very, very seriously, and we're gonna be participating in multiple clinical trials moving forward," even if it's a customer base that we haven't had quite the same experience as we have with functional.

Speaker #4: Okay, got it. Thank you for taking our questions.

Anderson Schock: Okay, got it. Thank you for taking our questions.

Speaker #3: Yeah, thanks, Andrew.

Joseph M. Burnett: Yeah. Thanks, Andrew.

Speaker #2: Thank you. This concludes the question-and-answer session. I’d like to turn the call back over to Joe Burnett for closing remarks.

Operator 4: Thank you. This concludes the question and answer session. I'd like to turn the call back over to Joe Burnett for closing remarks.

Operator: Thank you. This concludes the question and answer session. I'd like to turn the call back over to Joe Burnett for closing remarks.

Speaker #1: Well, thanks again for joining our call today. Our team feels like we have built an incredible foundation which will now serve as the launchpad for our two parallel strategies.

Joseph M. Burnett: Well, thanks again for joining our call today. Our team feels like we have built an incredible foundation, which will now serve as the launchpad 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. We are thrilled to have you on our team supporting this vision and supporting us on the road ahead. Good night.

Speaker #1: 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.

Speaker #1: We are thrilled to have you on our team supporting this vision and supporting us on the road ahead. Good night.

Operator 4: Thank you. This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.

Operator: Thank you. This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.

Q4 2025 ClearPoint Neuro Inc Earnings Call

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