Q3 2026 ClearPoint Neuro Inc Earnings Call

October 28, 2026

Operator: Greetings, and welcome to ClearPoint Neuro Q3 2026 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 conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of the securities laws.

Operator: Greetings, and welcome to ClearPoint Neuro Q3 2026 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 conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of the securities laws.

Speaker #1: Greetings and welcome to the ClearPoint Neuro third quarter 2026 financial results conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation.

Speaker #1: If anyone should require operator assistance during the conference, please press *0 on your telephone keypad. As a reminder, this conference call is being recorded.

Speaker #1: Comments made on this call may include statements that are forward-looking within the meeting of the securities laws. These forward-looking statements may include without limitation statements related to anticipated industry trends, the company's plans, prospects, and strategies, both preliminary and projected, the size of total addressable markets, or the market opportunity for the company's products and services, the company's expectation for future development, regulatory approval, timing commercialization, and the market for sale 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: These forward-looking statements may include, without limitation, statements related to anticipated industry trends, the company's plans, prospects, and strategies, both preliminary and projected, the size of total addressable markets, or the market opportunity for the company's products and services, the company's expectation for future development, regulatory approval, timing commercialization, and the market for cell and gene therapies, and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies, and management's expectations, beliefs, estimates, or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward-looking statements which speak only 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.

Speaker #1: 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.

Speaker #1: 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.

Operator: For more information about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8-K, Form 10-K, and Form 10-Q. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. I would now like to turn the conference over to your host, Mr. Joe Burnett, Chief Executive Officer. Thank you. You may begin.

Speaker #1: All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. I would now like to turn the conference over to your host, Mr. Joseph Burnett, Chief Executive Officer.

Speaker #1: Thank you. You may begin.

Joe Burnett: Thank you, Rob, and good evening to all the investors, analysts, and partners joining us for today's ClearPoint Neuro Q3 earnings call. Our company remains dedicated to developing therapies that can help restore function and improve outcomes for millions of patients worldwide living with serious neurological disorders. We are thrilled to have your continued interest and support as a part of this journey. In the Q3, we continued to make substantial progress with our neuro drug delivery strategy, focused on establishing ClearPoint as the gold standard for cell and gene therapy delivery. We have spent more than a decade building a leadership position in this market, and we are committed to maintaining and expanding that lead.

Speaker #2: Thank you, Rob. And good evening to all the investors, analysts, and partners joining us for today's ClearPoint Neuro third quarter earnings call. Our company remains dedicated to developing therapies that can help restore function and improve outcomes for millions of patients worldwide living with serious neurological disorders.

Speaker #2: We are thrilled to have your continued interest and support as part of this journey. In the third quarter, we continued to make substantial progress with our neurodrug delivery strategy, focused on establishing ClearPoint as the gold standard for cell and gene therapy delivery.

Speaker #2: We have spent more than a decade building a leadership position in this market, and we are committed to maintaining and expanding that lead. This strategic progress includes pipeline development for our comprehensive and uniquely positioned drug delivery ecosystem, including AI segmentation and modeling tools, periprocedural navigation software and frames, surgical robotics, laser therapy and access drills, cannulas and new routes of administration, focused ultrasound, and confirmatory drug infusion software.

Joe Burnett: This strategic progress includes pipeline development for our comprehensive and uniquely positioned drug delivery ecosystem, including AI segmentation and modeling tools, periprocedural navigation software and frames, surgical robotics, laser therapy and access drills, cannulas and new routes of administration, focused ultrasound, and confirmatory drug infusion software. In addition to our investment in this product portfolio, we continue to expand our ClearPoint Advanced Laboratories drug discovery facility in Torrey Pines, California, adding capacity, new capabilities, and services. We also stand ready to support our more than 60 active biopharma partners who continue to announce both data readouts and global clinical trial initiations, including multiple phase III studies that are either enrolling or expected to initiate in 2027.

Speaker #2: In addition to our investment in this product portfolio, we continue to expand our ClearPoint Advanced Laboratories drug discovery facility in Torrey Pines, California, adding capacity, new capabilities, and services.

Speaker #2: We also stand ready to support our more than 60 active biopharma partners, who continue to announce both data readouts and global clinical trial initiations, including multiple Phase 3 studies that are either enrolling or expected to initiate in 2027.

Joe Burnett: We look forward to the next regulatory milestones for our partner, uniQure's BLA submission to the FDA for AMT-130 to treat Huntington's disease during the weeks and months ahead, which could result in the very first FDA-approved gene therapy for this terrible disease. To complement the strategic progress, we have made financial progress as well in the quarter, growing overall revenue by 36% compared to operating expenses, which grew 23%, a result that reflects the scalability. This result was possible due to our continued integration activities post the IRRAS acquisition and the reorganization of our clinical field team to get ready for phase III trials and eventual drug delivery commercialization.

Speaker #2: We look forward to the next regulatory milestones for our partner UniQure's BLA submission to the FDA for AMT-130 to treat Huntington's disease during the weeks and months ahead.

Speaker #2: This could result in the very first FDA-approved gene therapy for this terrible disease. To complement our strategic progress, we have also made financial progress in the quarter.

Speaker #2: Growing overall revenue by 36% compared to operating expenses, which grew 23%, is a result that reflects scalability. This result was possible due to our continued integration activities following the ERIS acquisition and the reorganization of our clinical field team to get ready for phase three trials and eventual drug delivery commercialization.

Joe Burnett: In order to fund these hiring activities in support of our clinical field team expansion and the startup costs of our CAL expansion, we used our existing ATM facility for the first time, generating net proceeds of $22 million and ended the quarter with cash and cash equivalents of $46.2 million. This gives us the balance sheet flexibility to continue advancing our comprehensive drug delivery ecosystem, including robotics and focused ultrasound, and to prepare our field team for new commercial product launches that we expect in 2027. I will now turn the call over to Danilo D'Alessandro to discuss our financial results, after which I will provide a bit more detail on our four-pillared growth strategy. Danilo?

Speaker #2: In order to fund these hiring activities in support of our clinical field team expansion and the startup costs of our CAL expansion, we used our existing ATM facility for the first time, generating net proceeds of $22 million, and ended the quarter with cash and cash equivalents of $46.2 million.

Speaker #2: This gives us the balance sheet flexibility to continue advancing our comprehensive drug delivery ecosystem including robotics and focused ultrasound, and to prepare our field team for new commercial product launches that we expect in 2027.

Speaker #2: I will now turn the call over to Danilo D'Alessandro to discuss our financial results, after which I will provide a bit more detail on our four-pillar growth strategy.

Speaker #2: Danilo?

Danilo D'Alessandro: Thank you, Joe. Thank you all for joining us today. Looking at the 3Q 2026 results, total revenue was $12.1 million for the three months ended 30 September 2026, and $8.9 million for the three months ended 30 September 2025, which represents 36% growth versus the 3Q 2025. Our revenue is made up of three components: biologics and drug delivery, neurosurgery navigation and therapy, and capital equipment and software. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials. Biologics and drug delivery revenue increased 11% to $4.9 million in the 3Q, up from $4.4 million for the same period in 2025. This increase is primarily attributable to higher service revenue performed at ClearPoint Advanced Laboratories.

Speaker #3: Thank you, Joe. And thank you all for joining us today. Looking at the third quarter 2026 results, total revenue was $12.1 million for the three months ended September 30, 2026, and $8.9 million for the three months ended September 30, 2025, which represents 36% growth versus the third quarter of 2025.

Speaker #3: Our revenues made up of three components: biologics and drug delivery, neurosurgery navigation and therapy, and capital equipment and software. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials.

Speaker #3: Biologics and drug delivery revenue increased 11% to $4.9 million in the third quarter, up from $4.4 million for the same period in 2025. This increase is primarily attributable to higher service revenue performed at ClearPoint Advanced Laboratories.

Danilo D'Alessandro: Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system, the Prism Laser System, and IRRAflow. This revenue grew 59% to $5.4 million in the 3Q 2026 from $3.4 million for the same period in 2025, driven primarily by additional revenues due to sales of the IRRAflow product, which we acquired in connection with our acquisition of IRRAS in the 4Q 2025, in conjunction with growth of our legacy neurosurgery products. Capital equipment and software revenue, consisting of sales of our reusable hardware and software and of related services, increased 68% to $1.7 million in the quarter from $1 million for the same period in 2025, due to an increase in the placements of ClearPoint navigation systems, Prism laser units, and IRRAflow control units.

Speaker #3: Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system. The Prism laser system and Airflow. This revenue grew 59% to $5.4 million in the third quarter 2026, from $3.4 million for the same period in 2025.

Speaker #3: Driven primarily by additional revenues due to sales of the Airflow product, which we acquired in connection with our acquisition of ERIS in the fourth quarter of 2025, and in conjunction with growth of our legacy neurosurgery products.

Speaker #3: Capital equipment and software revenue, consisting of sales of our reusable hardware and software and related services, increased 68% to $1.7 million in the quarter, from $1 million for the same period in 2025, due to an increase in the placements of ClearPoint Navigation Systems, Prism laser units, and Airflow control units.

Danilo D'Alessandro: Gross margin for the 3Q 2026 was 58%, a decrease of five percentage points compared to 63% in Q3 2025, primarily due to overhead costs at the new CAL facility and additional amortization expense of acquired intangible assets, partially offset by a decrease in other cost of revenue. Research and development costs were $4 million for the three months ended 30 September 2026, compared to $3.5 million for the same period in 2025, an increase of $0.6 million, or 16%. The increase was due primarily to higher personnel cost of $0.6 million. Sales and marketing expenses were $5.5 million for Q3, compared to $3.8 million for the same period in 2025, an increase of $1.7 million, or 44%.

Speaker #3: Gross margin for the third quarter 2026 was 58%, a decrease of 5 percentage points compared to 63% in Q3 2025, primarily due to overhead costs at the new Cal facility and additional amortization expense of acquired intangible assets, partially offset by a decrease in other cost of revenue.

Speaker #3: Research and development costs were $4 million for the three months ended September 30, 2026, compared to $3.5 million for the same period in 2025, an increase of $0.6 million, or 16%.

Speaker #3: The increase was due primarily to higher personnel cost of 0.6 million. Sales and marketing expenses were $5.5 million for Q3, compared to $3.8 million for the same period in 2025, an increase of 1.7 million or 44%.

Danilo D'Alessandro: This increase was due primarily to additional personnel cost of $1.2 million, an increase in travel cost of $0.2 million resulting from the expansion of our clinical and sales team, and additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $3.8 million for the 3Q, an increase of $0.3 million, or 7%. This increase was due primarily to increases in occupancy cost of $0.5 million, information technology and software cost of $0.2 million, and general corporate cost of $0.1 million. These were partially offset by a decrease in bad debt expense of $0.6 million. In the aggregate, our operating expenses in Q3 were $13.4 million, a meaningful decrease from the nearly $17 million in OpEx last quarter. As of 30 September 2026, we had cash and cash equivalents totaling $46.2 million, as compared to $45.9 million at 31 December 2025.

Speaker #3: This increase was due primarily to additional personnel cost of $1.2 million and increase in travel cost of 0.2 million resulting from the expansion of our clinical and sales team and additional amortization expense of acquired intangible assets of 0.2 million.

Speaker #3: General and administrative expenses were $3.8 million for the third quarter, an increase of $0.3 million, or 7%. This increase was due primarily to increases in occupancy costs of $0.5 million, information technology and software costs of $0.2 million, and general corporate costs of $0.1 million.

Speaker #3: These were partially offset by decrease in batch expense of 0.6 million. In the aggregate, our operating expenses in Q3 were $13.4 million. A meaningful decrease from the nearly $17 million in OPEX last quarter.

Speaker #3: As of September 30, 2026, we had cash and cash equivalents totaling $46.2 million, compared to $45.9 million at December 31, 2025. The increase in cash was primarily due to net proceeds of $22.0 million from the aftermarket equity offering program, partially offset by operational cash burn of $20.1 million through Q3 2026.

Danilo D'Alessandro: The cash increase was primarily due to the net proceeds of $22 million from the at-the-market equity offering program, partially offset by the operational cash burn of $20.1 million through Q3 2026. I would like now to turn the call back to Joe.

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

Joe Burnett: Thank you, Danilo. I will now provide some further details organized by our continued four pillar growth strategy. Starting with pillar number one, biologics and drug delivery. The most noteworthy headline has been the BLA regulatory submission by one of our partners, uniQure, for their AMT-130 program to treat Huntington's disease. We continue to support uniQure on the device-related aspects of the submission, and our device documentation is now on file with the agency. Subject to the FDA's review, we expect the next two regulatory steps would be, first, that the FDA would formally accept the AMT-130 submission for review, and second, that ClearPoint would submit a companion 510(k) for our product to address its specific use with AMT-130. This is the same pathway we pursued for Kebilidi, the only other neuro gene therapy that has received FDA approval for administration directly to the brain.

Speaker #2: Thank you, Danilo. I will now provide some further details, organized by our continued four-pillar growth strategy. Starting with pillar number one: biologics and drug delivery, the most noteworthy headline has been the BLA regulatory submission by one of our partners, Unicare, for their AMT130 program to treat Huntington’s disease.

Speaker #2: We continue to support UniCare on the device-related aspects of the submission, and our device documentation is now on file with the agency. Subject to the FDA's review, we expect the next two regulatory steps would be, first, that the FDA would formally accept the AMT-130 submission for review; and, second, that ClearPoint would submit a companion 510(k) for our product to address its specific use with AMT-130.

Speaker #2: This is the same pathway we pursued for Kability, the only other neurogene therapy that has received FDA approval for administration directly to the brain.

Joe Burnett: The duration of these two regulatory pathways would likely take place in parallel with the goal of a simultaneous approval of both the drug and for our device that enables the delivery of the drug. In addition, we expect continued enrollment as well as the initiation of multiple phase III partner trials in the next year. As a reminder, phase III and confirmatory trials are often substantially larger from a site initiation and patient enrollment perspective. While phase I studies may take place in under 15 patients and only at a handful of sites, these larger randomized trials may include up to 200 patients and around 20 sites. As previously mentioned, we have reorganized and invested in a strong clinical support commercial organization, which we are training to be ready for this increase in cell and gene therapy patients.

Speaker #2: The duration of these two regulatory pathways would likely take place in parallel, with the goal of a simultaneous approval of both the drug and our device that enables the delivery of the drug.

Speaker #2: In addition, we expect continued enrollment as well as the initiation of multiple phase three partner trials in the next year. As a reminder, phase three and confirmatory trials are often substantially larger from a site initiation and patient enrollment perspective.

Speaker #2: While phase one studies may take place in under 15 patients and only at a handful of sites, these larger randomized trials may include up to 200 patients and around 20 sites.

Speaker #2: As previously mentioned, we have reorganized and invested in a strong clinical support commercial organization, which we are training to be ready for this increase in cell and gene therapy patients.

Joe Burnett: As I will mention later, demand for our ClearPoint navigation systems and capital equipment increased during the quarter, reflecting the growing recognition among neurosurgery departments that ClearPoint is a critical enabling technology for participation in the rapidly expanding cell and gene therapy clinical trial market. Revenue and services directly performed at the CAL facility continued to expand, launching new capabilities through both equipment and the hiring of talent, including PET and SPECT tracers, as well as radiopharmaceuticals. We will continue adding equipment and capabilities this year and next as we build a boutique yet comprehensive neuro-focused drug delivery program, which also includes potential BCI partners that we have worked with in prior years. Our goal is to offer a set of neuro-focused services that is differentiated in North America once the build-out is complete. For pillar number two, neurosurgery navigation, we saw our largest capital sales quarter in our history.

Speaker #2: As I will mention later, demand for our navigation systems and capital equipment increased during the quarter, reflecting the growing recognition among neurosurgery departments that ClearPoint is a critical enabling technology for participation in the rapidly expanding cell and gene therapy clinical trial market.

Speaker #2: Revenue and services directly performed at the Cal facility continue to expand, launching new capabilities through both equipment and the hiring of talent, including PET and SPECT tracers, as well as radio pharmaceuticals.

Speaker #2: We will continue adding equipment and capabilities this year and next as we build a boutique, yet comprehensive, neuro-focused drug delivery program. This also includes potential BCI partners that we have worked with in prior years.

Speaker #2: Our goal is to offer a set of neurofocused services that is differentiated in North America once the build-out is complete. For pillar number two, neurosurgery navigation, we saw our largest capital sales quarter in our history.

Joe Burnett: We believe this highlights both the demand by large academic centers to get access to ClearPoint in preparation of drug delivery trials and commercialization, as well as interest in our iCT operating room solution that is more practical for routine DBS and biopsy cases. Early experience with our iCT solution was recently published in the Journal of Stereotactic and Functional Neurosurgery and demonstrated both procedural efficiency and targeting accuracy. These findings suggest that with ClearPoint in the operating room, physicians do not need to trade one objective for the other. You can have both speed and accuracy, particularly in bilateral procedures including DBS and drug delivery.

Speaker #2: We believe this highlights both the demand by large academic centers to get access to ClearPoint in preparation of drug delivery trials and commercialization, as well as interest in our ICT operating room solution that is more practical for routine DBS and biopsy cases.

Speaker #2: Early experience with our ICT solution was recently published in the Journal of Stereotactic and Functional Neurosurgery, and demonstrated both procedural efficiency and targeting accuracy.

Speaker #2: These findings suggest that, with ClearPoint in the operating room, physicians do not need to trade one objective for the other. You can have both speed and accuracy, particularly in bilateral procedures, including DBS and drug delivery.

Joe Burnett: We also continued development of our robotic platform and are increasingly confident in the need for a company like ClearPoint to deliver a dedicated cranial robot where both hardware and software decisions are driven by the requirements of cranial neurosurgical procedures rather than broader surgical applications. We will continue to work closely with both neurosurgeon teams and our biopharma partners to build a system with all the functionality required for fast, accurate, multi-trajectory cases. This also includes unique disposable accessories like bolts and Z-axis adjusters that are specifically designed for the required flexibility during the infusion itself. For pillar number 3, laser therapy and access, I will focus on one exciting milestone, which we just announced in our press release earlier today. ClearPoint is an industry partner in a five-year competitively awarded NCI R01 grant led by Dartmouth Health to advance MR-guided laser therapy for spinal metastasis.

Speaker #2: We also continued development of our robotic platform and our increasingly confident in the need for a company like ClearPoint to deliver a dedicated cranial robot where both hardware and software decisions are driven by the requirements of cranial neurosurgical procedures, rather than broader surgical applications.

Speaker #2: We will continue to work closely with both neurosurgeon teams and our biopharma partners to build a system with all the functionality required for fast, accurate, multi-trajectory cases.

Speaker #2: This also includes unique disposable accessories like bolts and Z-axis adjusters that are specifically designed for the required flexibility during the infusion itself. For pillar number three, laser therapy and access, I will focus on one exciting milestone, which we just announced in our press release earlier today.

Speaker #2: ClearPoint is an industry partner in a five-year, competitively awarded NCI R01 grant led by Dartmouth Health to advance MR-guided laser therapy for spinal metastasis.

Joe Burnett: This program runs from benchtop through large preclinical subject validation and into a clinical trial using the ClearPoint Prism system. ClearPoint contributes technical, software development, and procedural expertise to the program. This is early-stage research that supports our spine laser therapy roadmap. We believe spine LITT could represent a meaningful new opportunity for ClearPoint, potentially addressing more than 10,000 patients globally who today may require highly invasive open surgery before radiation. The standard of care open procedure can involve substantial blood loss, reconstruction, and a prolonged recovery that may delay systemic cancer therapy. A minimally invasive MR-guided approach could significantly reduce that procedural burden. Prism, while not currently available for spinal use, may be particularly well suited for this application with longer 15 and 25 millimeter ablation windows, a non-cooled platform that simplifies workflow, and rapid imaging updates for real-time monitoring and control near this very critical anatomy.

Speaker #2: This program runs from benchtop, through pre-large preclinical subject validation, and into a clinical trial using the ClearPoint Prism system. ClearPoint contributes technical, software development, and procedural expertise to the program.

Speaker #2: This is early-stage research that supports our spine laser therapy roadmap. We believe Spine-Lit could represent a meaningful new opportunity for ClearPoint, potentially addressing more than 10,000 patients globally who today may require highly invasive open surgery before radiation.

Speaker #2: The standard-of-care open procedure can involve substantial blood loss, reconstruction, and a prolonged recovery that may delay systemic cancer therapy. A minimally invasive, MR-guided approach could significantly reduce that procedural burden.

Speaker #2: Prism, while not currently available for spinal use, may be particularly well-suited for this application, with longer 15- and 25-millimeter ablation windows, a non-cooled platform that simplifies workflow, and rapid imaging updates for real-time monitoring and control near this very critical anatomy.

Joe Burnett: While our Prism laser therapy system is third to market for cranial applications, spine could be a very different story where we may have first-mover advantage. If successful, we believe our unique product features will provide a compelling competitive advantage, enabling us to capture a leadership position in this emerging spinal tumor market. We believe the spinal LITT market represents a substantial long-term opportunity and over time could rival the size of cranial tumor and epilepsy markets for our Prism platform. Finally, pillar number 4, our intracranial fluid management. We are now more confident than ever that the IRRAflow product is well positioned to become an important advancement in neurocritical care. We are targeting five key product and clinical milestones in 2027.

Speaker #2: While our Prism laser therapy system is third to market for cranial applications, spine could be a very different story, where we may have first-mover advantage.

Speaker #2: If successful, we believe our unique product features will provide a compelling competitive advantage enabling us to capture a leadership position in this emerging spinal tumor market.

Speaker #2: We believe the spinal-lit market represents a substantial long-term opportunity and, over time, could rival the size of the cranial tumor and epilepsy markets for our Prism platform.

Speaker #2: Finally, pillar number four—our intracranial fluid management—we are now more confident than ever that the Eraflow product is well positioned to become an important advancement in neurocritical care.

Speaker #2: We are targeting five key product and clinical milestones in 2027. These include launching our Shoreline software, our DART catheter, and our next-generation forward tunneling catheter, as well as presenting results from the randomized ARCH trial and pursuing a specific on-label FDA indication for subdural hematoma, one of the largest potential indications for the Eraflow product.

Joe Burnett: These include launching our Shoreline software, our DART catheter, and our next generation forward tunneling catheter, as well as presenting results from the randomized ARCH trial and pursuing a specific on-label FDA indication for subdural hematoma, one of the largest potential indications for the IRRAflow product. We believe this broader portfolio and supporting evidence will justify the continued measured expansion of our clinical account manager and specialist teams so that these company representatives will be ready and productive by the time these new products and data are released. In addition to the positive direction of our four pillar growth strategy overall, the company made financial progress compared to the Q2 growth as well. Revenue grew 36% year-over-year compared to the operating expense growth of 23%, which reflects progress towards our additional scale.

Speaker #2: We believe this broader portfolio and supporting evidence will justify the continued measured expansion of our clinical account manager and specialist teams so that these company representatives will be ready and productive by the time these new products and data are released.

Speaker #2: In addition to the positive direction of our four-pillar growth strategy overall, the company made financial progress compared to the second quarter growth as well.

Speaker #2: Revenue grew 36% year-over-year, compared to operating expense growth of 23%, which reflects progress towards our additional scale. The primary drivers of this improvement versus last quarter are: number one, the results of the commercial reorganization, which now prioritizes clinical case support and is reflected in a more than 15% reduction in sales and marketing expenses compared to the second quarter.

Joe Burnett: The primary drivers of this improvement versus last quarter are, number 1, the results of the commercial reorganization, which now prioritizes clinical case support and is reflected in a more than 15% reduction in sales and marketing expenses compared to the Q2. And number 2, the continued integration of the IRRAflow product and team as the synergies start to materialize into our P&L. As Danilo mentioned, we accessed our existing ATM facility for the first time in Q3, and we ended the quarter with $46.2 million in cash and cash equivalents. We believe the time was appropriate to use our ATM for a few reasons. First, the startup cost to get the CAL facility operational requires some front-loaded investment in construction, equipment, and hiring. These investments will start to recover once we launch our full scope of services in the months ahead.

Speaker #2: And number two, the continued integration of the ERAflow product and team as the synergies start to materialize into our P&L. As Danilo mentioned, we accessed our existing ATM facility for the first time in Q3, and we ended the quarter with $46.2 million in cash and cash equivalents.

Speaker #2: We believe the timing was appropriate to use our ATM for a few reasons. First, the startup costs to get the CAL facility operational require some front-loaded investment in construction, equipment, and hiring.

Speaker #2: These investments will start to recover once we launch our full scope of services in the months ahead. Second, the continued integration and expansion investment of the EraFlow product portfolio, including the five new product and clinical milestones that we now expect to deliver in 2027, will unlock significant value.

Joe Burnett: Second, the continued integration and expansion investment of the IRRAflow product portfolio, including the 5 new product and clinical milestones that we now expect to deliver in 2027, which will unlock significant value. The time to bring these programs to completion was in parallel, not in series, so we wanted to make the investment now to fuel this portfolio growth in 2027 and beyond. And third, the potential of both our robotic and focused ultrasound systems, which this new capital will allow us to invest simultaneously and not have to choose one over the other. As we have said previously, our priority is to maintain our leadership position in neuro drug delivery, which is unwavering. And multiple market factors and opportunities require this investment now.

Speaker #2: The time to bring these programs to completion was in parallel, not in series, so we wanted to make the investment now to fuel this portfolio growth in 2027 and beyond.

Speaker #2: And third, the potential of both our robotic and focused ultrasound systems, which this new capital will allow us to invest in simultaneously and not have to choose one over the other.

Speaker #2: As we have said previously, our priority is to maintain our leadership position in neurodrug delivery, which is unwavering. Multiple market factors and opportunities required this investment now.

Joe Burnett: The cell and gene therapy market has become exceptionally dynamic with new BLA submissions, confirmatory and phase III clinical trials, significant program consolidation, and continued acquisitions by large, well-capitalized partners, and has created a timely opportunity to strengthen our advantage. I will now open the call to any questions from our analyst team.

Speaker #2: The cell and gene therapy market has become exceptionally dynamic, with new BLA submissions, confirmatory Phase 3 clinical trials, significant program consolidation, and continued acquisitions by large, well-capitalized partners, creating a timely opportunity to strengthen our advantage.

Speaker #2: I will now open the call to any questions from our analyst team.

Operator: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. 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. One moment, please, while we poll for questions. Our first question comes from Frank Takkinen with Lake Street Capital Markets. Your line is now live.

Speaker #1: At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad.

Speaker #1: A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue.

Speaker #1: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions.

Speaker #1: Our first question comes from Frank Taken with Lake Street Capital Market. Your line is now live.

Frank Takkinen: Great. Thank you for taking the questions. I have two. I am going to ask them both up front and then hop in queue as I am on a few calls. Joe, maybe on the first one, obviously, you have a lot of partners with different assets and development on different timelines. I was hoping maybe you could help us kind of stack and rank some of those upcoming catalysts. I am sure it is a conversation for a longer call, but maybe thinking through H1 2027, H2 2027, what are the important milestones that we should be watching for from your partners to better track the biologic and drug delivery opportunity?

Speaker #3: Great, thank you for taking the questions. I've got two; I'm going to ask them both up front and then hop in the queue, as I'm on a few calls.

Speaker #3: Joe, maybe on the first one. Obviously, you've got a lot of partners with different assets and development on different timelines. I was hoping maybe you could help us kind of stack and rank some of those upcoming catalysts.

Speaker #3: I'm sure it's a conversation for a longer call, but maybe thinking through kind of like first half '27, second half '27, what are the important milestones that were that we should be watching for from your partners to better track the biologic and drug delivery opportunity?

Speaker #3: And then as my second question, you've talked about in the past, kind of some front-loaded investment expected from the field in anticipation of some of these drugs getting to market.

Frank Takkinen: Can you maybe talk through if any of that has started to materialize, or if you are starting to hear anything in the market about some of those investments? Thanks again for taking the questions.

Speaker #3: Can you maybe talk through if any of that has started to materialize or if you're starting to hear anything in the market about some of those investments and thanks again for taking the questions.

Joe Burnett: Absolutely, Frank. Thanks for the question as well. I will start with the first one. I do want to provide an important caveat here is that, ClearPoint, the way that we work with our partners, we take our confidential information very seriously as well. So, we really do not want to be the primary resource for folks to get an understanding of where our partners happen to be in their regulatory process or their development process. It puts us in a position where we are then tracking 60 different companies and have to figure out, private, public, disclosed, undisclosed, what information that we want to share.

Speaker #2: Yeah, absolutely, Frank. Thanks for thanks for the question as well. So I'll start with the first one. You know, I do want to provide an important caveat here is that, you know, you know, ClearPoint, the way that we work with our partners, we take our confidential information very, very seriously as well.

Speaker #2: So we really don't want to be the primary resource for folks to get an understanding of where our partners happen to be in their regulatory process or their development process.

Speaker #2: You know, it puts us in a position where we are then tracking 60 different companies and have to figure out, you know, you know, private, public, disclosed, undisclosed, you know, what information that we want to share.

Joe Burnett: Our primary reference is always going to be pointing just right to our partner to simply say, "Hey," whether it's on their website or if the information is in some sort of public document or a press release, that's always going to be the go-to for us. What I would tell you, to your question about what's happening in the near term and what we sort of are expecting here, there's 2 buckets I'd say that really materialize the most. The first one is, again, the uniQure BLA submission, which took place almost 2 months ago at this point. And there have been a number of clinical updates that have taken place since then.

Speaker #2: So our primary reference is always going to be pointing just right to our partner, to simply say, hey, whether it's on the law and on their website or if the information is in some sort of public document or a press release, that that's always going to be the go-to for us.

Speaker #2: What I would tell you, you know, that to your question about what's happening in the near term and what we sort of are expecting here, you know, there's two that really two buckets, I'd say, that really materialize the most.

Speaker #2: You know, the first one is, again, the UniQure BLA submission, which took place almost two months ago at this point. And there have been a number of clinical updates that have taken place since then.

Joe Burnett: We do still expect a decision to be made by the FDA at some point here in the next month or so, where they would either formally accept or reject or in some fashion delay that BLA submission. If, in a best case scenario, the BLA would be accepted, as we mentioned, at that point, we would submit our companion 510(k). And if you look to the limited experience we have with the FDA and these neuro gene therapies, the expectation would be a final formal decision sometime 6 to 8 months after the acceptance of that BLA. Again, if everything went perfectly. So that would put a potential approval for the very first neuro gene therapy to treat Huntington's disease sometime middle to H2 of next year. Again, if everything went according to plan.

Speaker #2: You know, we do still expect a decision to be made by the FDA at some point, you know, here in the next month or so, where they would either formally accept or reject or in some fashion delay that BLA submission.

Speaker #2: In an IBETH case scenario, the BLA would be accepted. As we mentioned, at that point, we would submit our companion 510(k). And if you look to the limited experience we have with the FDA and these neurogene therapies, the expectation would be a final formal decision sometime six to eight months after the acceptance of that BLA.

Speaker #2: Again, if everything went perfectly, that would put a potential approval for the very first neurogene therapy to treat Huntington's disease sometime in the middle to second half of next year.

Speaker #2: Again, if— you know, if everything went according to plan, that would obviously be an incredible milestone, I think, for the entire gene therapy space, the Huntington's community, certainly for UniQure, and certainly for ClearPoint as well.

Joe Burnett: That would obviously be an incredible milestone, I think, for the entire gene therapy space, the Huntington's community, certainly for uniQure, certainly for ClearPoint as well. As we mentioned, we have resources that we are hiring and training now to prepare for such an event. Whether the product is commercially approved next year and we're supporting those cases, or if there's some delay to that timeline, as I mentioned there, putting us in a position where that same clinical team is supporting potentially a uniQure parallel confirmatory study, which they've announced could be up to 200 patients, all the way to supporting all of the other phase III trials that are either enrolling today or we're expecting to enroll in the future.

Speaker #2: And as we mentioned, you know, we have resources that we are hiring and training now to prepare for such an event. Whether the product is commercially approved next year, and we're supporting those cases, or if there's some delay to that timeline, as I mentioned there, you know, putting us in a position where that same clinical team is supporting potentially a Unicure parallel confirmatory study, which they've announced could be up to 200 patients.

Speaker #2: All the way to supporting all of the other phase three trials that are either enrolling today or we're expecting to enroll in the future.

Joe Burnett: That's really the second bucket I would consider, Frank, is that independent of a commercial drug delivery of a large population gene therapy like AMT-130, there's also numerous partners that have either started or will start initiating their phase III trials in the next 12 to 15 months. What's important about a phase III trial is, again, you're going from maybe 3 to 5 sites, up to 15 to 20 sites. And it's interesting, we have a number of different partners. I'll use Parkinson's as an indication. I think epilepsy would be another one, where that's a very, very large underserved patient community that's looking for a better treatment than is what is available today. If you're a hospital, a leading clinical trialist center, you can't accept clinical trials for 5 or 10 different Parkinson's studies.

Speaker #2: So that's really the second bucket I would consider, Frank. Independent of a commercial drug delivery for a large population gene therapy like ANT130, there are also numerous partners that have either started or will start initiating their Phase 3 trials in the next 12 to 15 months.

Speaker #2: What's important about a phase three trial is, again, you're going from maybe three to five sites. Up to 15 to 20 sites. And it's interesting, we have a number of different partners.

Speaker #2: I'll use Parkinson's as an indication. I think epilepsy would be another one, where you know, that's a very, very large underserved patient community that's looking for a better treatment than is what is available today.

Speaker #2: If you're a hospital, you know, a leading clinical trialist center, you can't accept clinical trials for five or ten different Parkinson's studies. It puts you in a situation where now, any Parkinson's patient that comes in, as a hospital, you have to start playing favorites as to which one of these trials you're going to enroll them in.

Joe Burnett: It puts you in a situation where now any Parkinson's patient that comes in, as a hospital, you have to start playing favorites as to which one of these trials you are going to enroll them in. Some of our partners are now looking for many new sites from which to install ClearPoint, get access to the technology, and use that new site as an enrolling center for their phase III trial. That is one of the things that we have very clear examples in our capital sales results in Q3, as well as our capital sales funnel that we expect in Q4 and for the duration of 2027, where it is these new sites that have realized, "Hey, I probably need ClearPoint to participate in some of these existing studies." It is no longer just the functional neurosurgeon reaching out to ClearPoint.

Speaker #2: So some of our partners are now looking for many new sites from which to install ClearPoint, get access to the technology, and use that new site as an enrolling center for their Phase 3 trial.

Speaker #2: So that's one of the things that, you know, we have very clear examples in our you know, our capital sales results in the third quarter, as well as our capital sales funnel that we expect in Q4 and for the duration of 2027, where it is these new sites that have realized, hey, I probably need ClearPoint to participate in some of these existing studies.

Speaker #2: And, you know, it's no longer just the functional neurosurgeon reaching out to ClearPoint. It could be the chair of neurosurgery in some in some cases, it could even be the C-suite that's helping to move the process along.

Joe Burnett: It could be the chair of neurosurgery. In some cases, it could even be the C-suite that is helping to move the process along. Big picture for us is, we never want to be the bottleneck with the advancement of this technology. We are hiring, we are investing now so that our installed base grows. We have a great clinical specialist support team out there that is trained, not just in navigation, but also in drug delivery broadly, so that in any circumstance that the site needs ClearPoint's help, we can support not just the partner, but the hospital itself. Sort of long answer for the first question, but I will move on to the second one, which is some of the investments that we are seeing.

Speaker #2: So, you know, the big picture for us is, you know, we never want to be the bottleneck with the advancement of this technology.

Speaker #2: So we're hiring, we're investing now so that our installed base grows and we have a great clinical specialist support team out there that's trained not just in navigation, but also in drug delivery broadly.

Speaker #2: So that, you know, in any circumstance that, you know, the site needs ClearPoint's help, we can support not just not just the partner, but the hospital itself.

Speaker #2: So, sort of a long answer for the first question, but I'll move on to the second one, which is about some of the investments that we're seeing.

Joe Burnett: Part of it is really tied to I will give one example anyway that is tied to what I was just discussing in drug delivery, and that has to do with robotics. If you go to a hospital today, it is very common you would walk through the hallway and you might see two or three different neurosurgery robotics that are there that are used possibly for different indications or at different times, or sometimes, and many times, just very underutilized today. If we were just developing another neurosurgical robot, we would not be as excited as we are for the ClearPoint version that we are in development right now. The reason for that is a couple different points.

Speaker #2: And part of it is really tied to—I'll give one example anyway that's tied to what I was just discussing in drug delivery—and that has to do with robotics.

Speaker #2: You know, if you if you go to a hospital today, it's very common you would walk through the hallway and you might see two or three different neurosurgery robotics that are there.

Speaker #2: They are used possibly for different indications or at different times, or sometimes—and many times—just very underutilized today. You know, if we were just developing another neurosurgical robot, we wouldn't be as excited as we are for the ClearPoint version that we're in development right now.

Speaker #2: And the reason for that is, you know, a couple of different points. The first one is that we are focused pretty much 100% on cranial workflows.

Joe Burnett: The first one is that we are focused pretty much 100% on cranial workflows, meaning things that are done in the skull itself, versus many of what I would say our future competitors' focus seems to be on, is spinal applications. There are absolutely concrete decisions you would make if you are building a cranial robot versus a do-it-all neurosurgery robot, including spine. Because spine historically has been the largest part of a neurosurgery budget, it is natural that some of these large robotics companies would maybe do a new software release that is 90% improvements for spine and 10% improvements for cranial.

Speaker #2: Meaning things that are done in the skull itself. Versus many of what I would say are future competitors focus seems to be on is spinal applications.

Speaker #2: So there are absolutely concrete decisions you would make if you're building a cranial robot versus a do-it-all neurosurgery robot, including spine. And because spine historically has been the largest part of a neurosurgery budget, it's natural that, you know, some of these large robotics companies would, you know, maybe do a new software release that's 90% improvements for spine and 10% improvements for cranial.

Joe Burnett: We've sort of flipped the script there, where we are making all of our design decisions on exactly what our pharma partners would need to do to speed up these multi-trajectory cases, preload them with trajectories that are specific to some of our workflows, complement them with multiple accessories. As I mentioned, Z-axis adjusters, different bolts to provide flexibility during the infusion, so that we would actually have a unique solution that is available when these new drugs start to come to commercialization and are looking for a way to scale beyond just the MRI suite that most of our procedures are done in today. That's one example where we're making the investment because we feel we have a true right to win in this space, not just to make another me-too product.

Speaker #2: We've sort of flipped the script there, where we are making all of our design decisions based on exactly what our pharma partners would need to do to speed up these multi-trajectory cases. We preload them with trajectories that are specific to some of our workflows, and complement them with multiple accessories—as I mentioned, Z-axis adjusters and different bolts—to provide flexibility during the infusion.

Speaker #2: So that we would actually have a unique solution that is available when these new drugs start to come to commercialization and are looking for a way to scale beyond just the MRI suite that most of our procedures are done in today.

Speaker #2: All right, so that's one example where, you know, an investment we're making the investment because we feel we have a true right to win in this space, not just to make another me too product.

Joe Burnett: The second one I would point to is on focused ultrasound, which is a combination with our robotic platform. Our goal here is to move drug delivery for using focused ultrasound and blood-brain barrier disruption out of the MRI suite entirely and into the operating room and to infusion clinics. To do that, we need to manipulate our transducer in a way that's very different than other focused ultrasound systems that are available today. Our robotics platform is the mechanism for software navigation, targeted movement, anything you need to operate within the CT space. This one investment, we believe, is not only going to unlock faster, simpler, scalable procedures for drug delivery, but it's also going to unlock focused ultrasound for us, which these things we can in fact start to monetize pre-clinically at the CAL well before we ever get FDA clearance for these things.

Speaker #2: The second one I would point to is on focused ultrasound, which is a combination with our robotic platform. Our goal here is to move drug delivery for using focused ultrasound and blood-brain barrier disruption out of the MRI suite entirely and into the operating room and to an infusion clinics.

Speaker #2: To do that, we need to manipulate our transducer in a way that's very different than, you know, other focused ultrasound systems that are available today.

Speaker #2: And our robotic platform is the mechanism for software navigation targeted movement, you know, anything you need to operate within the CT space. So you know, this one investment we believe is not only going to unlock faster simpler scalable procedures for drug delivery, but it's also going to unlock focused ultrasound for us, which, you know, these things we can in fact start to monetize preclinically at the CAL well before we ever get FDA clearance for these things.

Joe Burnett: If you think about pre-loading investment, that's an example of one I can at least share with you today, Frank.

Speaker #2: So if you think about preloading investment, that's an example of one I can at least share with you today, Frank.

Frank Takkinen: Okay. That's great. Thanks, guys.

Speaker #1: Okay, that's great. Thanks, guys.

Joe Burnett: Sure thing.

Speaker #2: Sure thing.

Operator: Our next question comes from Matthew Blackman with TD Cowen. Your line is now live.

Operator: Our next question comes from Mathew Blackman with TD Cowen. Your line is now live.

Speaker #3: Our next question comes from Matthew Blackman with TD Cowen. Your line is now live.

Mathew Blackman: Good afternoon, everybody. Can you hear me okay?

Speaker #4: Oh, good afternoon, everybody. Can you hear me okay?

Joe Burnett: Yeah, I got you, Matthew.

Joe Burnett: Yeah, I got you, Mathew.

Speaker #2: Yeah, I got you, Matthew.

Mathew Blackman: Great. Hey, Joe. Hey, Danilo. I will start with a question for Danilo. Just want to put a little bit finer point to the extent you are able to share. Obviously, healthier balance sheet. You have a lot of stuff to invest in. Can you just give us a sense of how we should, in at least general terms, think about the burn trajectory over the next 12 months? Even if not an absolute number, maybe just relative to what your traditional burn has been. Then I have one follow-up question for Joe.

Speaker #4: Great. Hey Joe, hey Danilo. Let me start with a question for Danilo and put a little bit finer point on it, to the extent you're able to share.

Speaker #4: Obviously, with a healthier balance sheet, you've got a lot of stuff to invest in. Can you just give us a sense of how we should, at least in general terms, think about the burn trajectory over the next 12 months?

Speaker #4: Even if not an absolute number, maybe just sort of relative to what your traditional burn has been? And then I've got one follow-up question for Joe.

Danilo D'Alessandro: Yeah, no, I think, Matt, we obviously have some of these investments that Joe laid out. There is going to be, in the coming 12 months, more related to something that we did not have in the past, which was a little bit tied to CapEx. So there will be some capital expenditures related to the CAL that we expect in the coming 12 months, and that will land. In terms of the operational burn, like Joe also mentioned earlier, we are targeting now to continue on the path of operating leverage, where we see that the revenue outstrips the growth of the OpEx, so that we can continue to gradually reduce the burn in the coming quarter over quarter, in the coming four to six quarters.

Danilo D'Alessandro: Yeah, no, I think, Mat, we obviously have some of these investments that Joe laid out. There is going to be, in the coming 12 months, more related to something that we did not have in the past, which was a little bit tied to CapEx. So there will be some capital expenditures related to the CAL that we expect in the coming 12 months, and that will land. In terms of the operational burn, like Joe also mentioned earlier, we are targeting now to continue on the path of operating leverage, where we see that the revenue outstrips the growth of the OpEx, so that we can continue to gradually reduce the burn in the coming quarter over quarter, in the coming four to six quarters.

Speaker #2: Yeah, no, I think, Matt, so we obviously have some of these investments that Joe laid out. There is going to be in the coming 12 months more related to some something that we didn't have in the past, which was a little bit tied to CAPEX.

Speaker #2: So there will be some capital expenditures related to the CAL. That we expect in the coming in the coming 12 months. And that will that will land.

Speaker #2: In terms of the operational burn, like also Joe mentioned earlier, we're targeting now to continue on the path of operating leverages operating leverage where we see that the revenue outstrips the growth of the opex.

Speaker #2: So that we can continue to gradually reduce the burn in the coming quarter over quarter in the coming in the coming four to six to six quarters.

Danilo D'Alessandro: I would say when you look at, in particular, the H1 of this year, it was a little heavier than usual, just given the activities related to the IRRAS integration, which were, in many cases, one-offs that we had to take. Imagine contracts that were non-cancellable and all of those kind of things where we were just working to get the synergies in place. Already in the Q3, we see that our OpEx has been reducing meaningfully compared to the OpEx in Q1 and Q2 of 2026.

Speaker #2: I'd say when you look at in particular the first half of this year, it was a little heavier than usual just given the activities related to the ERIS integration, which were in many cases one-offs that we had to take imagine contracts that were non-cancellable and all of those kind of things where we were just working to get the synergies in place and already in the third quarter we see that our opex has been reducing meaningfully compared to the opex in Q1 and Q2 of 2026.

Mathew Blackman: Okay. So, and these are my words, I am hearing maybe a little bit more burn, than what you have done historically over the next 12 months, but certainly nothing of significant magnitude. You are not going out like drunken sailors is kind of the message I am hearing.

Speaker #4: Okay, so and these are my words, I'm hearing, you know, maybe a little bit more burn than what you've done historically over the last the next 12 months.

Speaker #4: But certainly nothing of significant magnitude. You're not you're not going out like drunken sailors is kind of the message I'm hearing.

Danilo D'Alessandro: Yes. Yeah, we do not drink.

Speaker #2: Yes, yeah, we don't drink.

Mathew Blackman: Good. Then Joe, I was intrigued by the spine LITT update. I was hoping maybe just, 10,000 cases worldwide. Can you just remind us of what the revenue per case as we think about, however far down the road this may be, what the revenue opportunity for ClearPoint could be? On the regulatory side, to get a label, I would assume you would need a label to commercialize. Can you use any of the data from the NCI study to support a label? Is that something you would have to do independently? Just any sort of help on the pathway to get a label for spine LITT. Thank you. For spine tumors.

Speaker #4: Good. And then Joe, I was intrigued by the spine lit update. I was hoping maybe just, you know, 10,000 cases worldwide. Can you just remind us of what the revenue per case as we think about however far down the road this may be, what the revenue opportunity for ClearPoint could be?

Speaker #4: And then on the regulatory side, to get a label, I would assume you would need a label to commercialize. Can you use any of the data from the NCI study to support a label?

Speaker #4: Is that something you'd have to do independently? Just any sort of help on the pathway to get a label for spine metastases.

Speaker #4: Thank you for spine tumors.

Joe Burnett: Yeah, sure thing. Just to highlight what makes the procedure challenging today is, remember, if you are doing a cranial laser procedure inside the brain, what you are using is you are superheating the tip of the catheter or the cannula where the laser energy is being delivered. Then you are interpreting that heat transfer using MRI thermometry, which tells you importantly how hot the tissue has gotten. Have you ablated and destroyed the tissue that you want to? Then similarly, are you making sure you are in a safety zone for the other ones and you are not burning in a spot that you do not want to? In cranial procedures, that is relatively simple because there is no motion whatsoever, right? The skull is actually pinned. The brain is not really vibrating, outside of a little bit of heartbeat phenomenon, that kind of thing. But it is something that is a lot more predictable.

Speaker #2: Yeah, sure thing. You know, just to highlight, you know, what makes the procedure challenging today is, you know, remember if you're doing a cranial laser procedure inside the brain, what you're using is your superheating the tip of the catheter, the cannula, where the laser energy is being delivered.

Speaker #2: And then you're interpreting that heat transfer using MRI thermometry, which tells you, importantly, how hot the tissue has gotten. You know, have you inflated and destroyed the tissue that you want to?

Speaker #2: And then similarly, are you making sure you're in a safety zone for the other ones and, you know, you're not burning in a spot that you don't want to.

Joe Burnett: In cranial procedures, that is relatively simple because there is no motion whatsoever, right? The skull is actually pinned. The brain is not really vibrating, outside of a little bit of heartbeat phenomenon, that kind of thing. But it is something that is a lot more predictable.

Speaker #2: In cranial procedures, that's relatively simple because there's no motion whatsoever. Right, the skull is actually pinned, the brain is not really vibrating, you know, outside of, you know, a little bit of, you know, heartbeat phenomenon, that kind of thing.

Speaker #2: But it's something that's a lot more predictable. When you're doing that same type of procedure in the spine, you're dealing with the patient breathing.

Joe Burnett: When you are doing that same type of procedure in the spine, you are dealing with the patient breathing. So up and down, up and down, up and down, which throws thermometry off significantly. What makes our system pretty unique for this procedure is that you can in fact do a very large and necessary ablation very quickly because it is not cooled. All of the energy is delivered directly to the tumor itself. If you were to hold the breath of the patient for maybe 60 seconds, you could get a pretty clear example. That is what we have seen in the existing preclinical data that was submitted as a part of this grant itself.

Speaker #2: So up and down, up and down, up and down, which throws thermometry off significantly. What makes our system pretty unique for this procedure is that you can in fact do a very, very large and necessary ablation very quickly because it's not cooled.

Speaker #2: All of the energy is delivered directly to the tumor itself. And if the patient, you know, if you were to hold the breath of the patient for maybe 60 seconds or go, you could get a pretty clear pretty clear example.

Speaker #2: And that's what we've seen in the existing preclinical data that was submitted as a part of this grant itself. So again, you know, if you compare this type of product to the other ones that are available today on the market, there are some very substantial and meaningful differentiators on why, you know, making this investment—both on our own and now with the government's help—to go ahead and see this take place all the way to market.

Joe Burnett: So again, if you compare this type of product to the other ones that are available today on the market, there are some very substantial and meaningful differentiators on why making this investment, both on our own and now with the government's help to go ahead and see this take place all the way to market. I don't see any reason that this data would not be used for future clinical evidence, and it kind of remains to be seen exactly what the label would say itself. I say that because if you read our current label for our device, it's designed for all neurosurgery procedures, which spine is one of them. So whereas we are going to do software development of new products, we might have a few accessories that we develop as part of this development process that could highlight new specific indications for this tumor.

Speaker #2: I don't see any reason that this data would not be used for future clinical evidence. And it kind of remains to be seen exactly what the label would say itself.

Speaker #2: And I say that because, if you read our current label for our device, it's designed for all neurosurgery procedures, with spine being one of them.

Speaker #2: So, whereas we are going to do software development of new products, we might have a few accessories that we develop as part of this development process, which could highlight new specific indications for this tumor.

Joe Burnett: We're not quite sure at this point exactly what the regulatory pathway would be. We are still focused primarily on making sure it works for these preclinical subjects and then the first patients in the clinical trial itself.

Speaker #2: It kind of we're not quite sure at this point exactly what the regulatory pathway would be. We are still focused primarily on making sure it works for these preclinical subjects and then the first patients in the clinical trial itself.

Mathew Blackman: Great. Any color on revenue per procedure? I just forget.

Speaker #4: Great. And then, any color on review for procedure? I just forget—would it just be yes, no? It was a lot of questions.

Joe Burnett: Oh, sorry, yeah.

Mathew Blackman: Would it just be. No, it was a long question.

Joe Burnett: Yeah. If you think about our current revenue, which I would expect, it is somewhere between $13,000 and $20,000 per procedure, is what I would expect, both from the laser and some of the accessories and the software that might be used during the procedure.

Speaker #2: Yeah, you know, if you think about our current, you know, our current revenue, which I would expect, you know, it's somewhere between 13 and 20,000 per procedure is what I would expect both from the laser and some of the accessories and software that might be used during the procedure.

Mathew Blackman: Got it. Thanks, guys. Really appreciate it.

Speaker #4: Got it. Thanks, guys.

Joe Burnett: Yeah. If I am modeling it, I think probably $15,000 would be a non-noisy assumption.

Speaker #2: Yeah, if I'm modeling it, I think of it probably as 15,000 would be a, you know, a non-noisy assumption.

Mathew Blackman: All right. Even I could do that math. All right. Appreciate it.

Speaker #4: Yeah, even I could do that math. All right, appreciate it.

Joe Burnett: Yeah, Matt, just to build on your question for Danilo as well, just a couple other thoughts. We have a mix of some sort of established technology, growing technology, and startup technology within the ClearPoint portfolio. If you think about using MRI navigation for deep brain stimulation, that is a pretty mature market that we do not really expect to grow that much, right? So that is probably a profitable business if you looked at it that way. We are not spending a ton on the development of those frames. That is something that is more in a harvest stage. It is definitely the smallest opportunity that we have, but it is also one that is not demanding a lot of investment at this point.

Joe Burnett: Yeah, Mat, just to build on your question for Danilo as well, just a couple other thoughts. We have a mix of some sort of established technology, growing technology, and startup technology within the ClearPoint portfolio. If you think about using MRI navigation for deep brain stimulation, that is a pretty mature market that we do not really expect to grow that much, right? So that is probably a profitable business if you looked at it that way. We are not spending a ton on the development of those frames. That is something that is more in a harvest stage. It is definitely the smallest opportunity that we have, but it is also one that is not demanding a lot of investment at this point.

Speaker #2: Yeah, man, and just to build on your question for Danilo as well, just, you know, a couple of the thoughts, you know, we have a mix of some sort of established technology growing technology and startup technology within the ClearPoint portfolio.

Speaker #2: You know, so if you think about using MRI navigation for deep brain stimulation, that is a pretty mature market that we don't really expect to grow that much, right?

Speaker #2: So that's probably a profitable business if you looked at it that way. We're not spending a ton on the development of those frames, you know, that's something that's more in a harvest stage.

Speaker #2: It's definitely the large, I'm sorry, the smallest opportunity that we have, but it's also one that's, you know, not demanding a lot of investment at this point.

Joe Burnett: You look at Prism for cranial, you look at IRRAflow and all of the different applications that it is currently indicated for today, those are growth technologies where we can absolutely grow with our existing portfolio. We can open new sites, we can take share, we can transition people away from older technology to new technology. Then you have got these startup investments like spine, like we were just talking about for laser tumors, like the CAL facility, like a subdural hematoma indication for IRRAflow, like commercial drug delivery, where we have not even gotten started yet. Those are the ones that are demanding a little front-loaded investment before we catch up. When we think about cash burn, it is hard to think about it just in the totality. We are thinking about it opportunity by opportunity.

Speaker #2: You look at Prism for cranial; Prism for—you know—Prism for cranial. You look at Airflow and all of the different applications that it's currently indicated for today.

Speaker #2: You know, those are growth technologies where we can absolutely grow with our existing portfolio. We can open new sites, we can take share, and we can transition people away from older technology to new technology.

Speaker #2: And then you've got these startup investments like spine, like we were just talking about for laser tumors, like the CAL facility, you know, like subdural hematoma indication for Airflow, like commercial drug delivery where, you know, we haven't even gotten started yet.

Speaker #2: You know, those are the ones that are demanding a little front-loaded investment before we catch up. And when we think about cash burn, we it's hard to think about it just in the totality.

Speaker #2: We're thinking about it opportunity by opportunity. And, you know, in this particular quarter, we had two or three of these opportunities screaming at us and saying, "Hey, you got to go faster, you got to make this happen."

Joe Burnett: In this particular quarter, we had two or three of these opportunities screaming at us and saying, "Hey, you have got to go faster. You have got to make this happen," which really led us to raise a little bit more capital. A concrete example of what we are talking about as it relates to the CAL, is that one of the technologies that we want to have access to deliver as a service to our partners is histology. There is a ton of benefits to be able to do the preclinical studies and the histology at the same site, to not have to store the tissue, to not have to transport it, you name it.

Speaker #2: Which really led us to, you know, to raise a little bit more capital. You know, a concrete example, you know, of what we're talking about as it relates to the CAL is that one of the technologies that we want to have access to to deliver as a service to our partners is histology, right?

Speaker #2: There's a ton of benefits to be able to do the preclinical studies and the histology at the same site to not have to store the tissue, to not have to transport it, you know, you name it.

Joe Burnett: To enable histology, there is equipment that you need to buy, there are technicians that you need to hire, and you need to do all of that 3 to 6 months before you could ever do your first study. You think of the CAL as a series of those investments that have to take place. We are not going to get any histology revenue in the next 6 months, but we are building that capability so that we offer it as a service and we win that business down the road. It is really just, the magic is finding this balance between which investments we are making in our growth campaigns and which ones are true new to ClearPoint technologies or new to world technologies that we have to invest in that we might not recoup for 6 plus months. Hopefully that gives a little more context.

Speaker #2: To enable histology, there's equipment that you need to buy, there's technicians that you need to hire, and you need to do all of that three to six months before you could ever do your first study.

Speaker #2: So you think of the CAL as a series of those investments that have to take place you know, we're not going to get any histology revenue in the next six months, but we're building that capability so that we offer it as a service and we win that business down the road.

Speaker #2: So it's really just, you know, the magic is finding this balance between which investments we're making in our growth campaigns and which ones are true new to ClearPoint technologies or new to world technologies that we have to invest in that, you know, we might not recoup for six plus months.

Speaker #2: So hopefully, hopefully that gives a little more context.

Mathew Blackman: Yeah, no, really appreciate it. Thanks, guys.

Speaker #4: Yeah, no, really appreciate it. Thanks, guys.

Joe Burnett: Sure.

Speaker #2: Sure.

Operator: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. One moment, please, while we poll for questions. Our next question comes from Tom Stephan with Stifel. Your line is now live.

Speaker #1: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. One moment, please, while we poll for questions.

Speaker #1: Our next question comes from Tom Stefan. With Stiefel, your line is now live.

Tom Stephan: Great. Hey, guys. Thanks for taking the questions. A couple on revenue, and I will start near term, with the 2026 revenue guidance. For Q4, Joe, maybe for you, pretty decent step-up, I believe, versus Q3, in the implied guide, relative to typical Q4 seasonality, I think when I look at that $49 million midpoint. Joe, can you talk a bit to the drivers of that uptick and, more importantly, just your level of confidence that $49 million midpoint is achievable or hopefully conservative? Then I have a follow-up.

Speaker #5: Great. Hey guys, thanks for taking the questions. A couple on revenue and I'll start near term. With the 2026 revenue guidance, for 4Q, Joe, maybe for you, you know, I'm pretty decent step up, I believe, versus 3Q in the implied guide, you know, relative to typical 4Q seasonality.

Speaker #5: I think, when I look at that $49 million midpoint—so Joe, can you talk a bit about the drivers of that uptick and, more importantly, just your level of confidence that the $49 million midpoint is achievable or hopefully conservative?

Speaker #5: And then I have a follow-up.

Joe Burnett: Yeah. To put things in context, we think that the three buckets of revenue that Danilo reports on could all be contributing to that growth. It is not that there is one of those buckets that by itself would be responsible for that million-dollar plus step-up that you just described. I think they can all contribute. Capital equipment, we mentioned we just had a record quarter in capital sales. But the reality is that our funnel is larger than it has ever been as well, particularly when you start to add in IRRAflow pumps, new Prism potential customers, the demand for our navigation system for drug delivery trials, and the demand for our iCT navigation system for more practical, faster, simpler procedures in the operating room. We have four different capital contributors there, each of which has, I would say, the healthiest funnel that we have ever had.

Speaker #2: Yeah, yeah. So I mean, so to put things in context, you know, we think that the three buckets of revenue that Danilo reports on could all be contributing to that growth.

Speaker #2: So it's not that there's one of those buckets that by itself would be responsible for that million dollar plus step up that you just described.

Speaker #2: You know, I think they can all contribute. Capital equipment, we mentioned we just had a record quarter in capital sales. But the reality is, is that our funnel is larger than it's ever been as well, particularly when you start to add in Airflow pumps, new Prism potential customers, the demand for our navigation system for drug delivery trials and the demand for our ICT navigation system, for, you know, more practical, faster, simpler procedures in the operating room.

Speaker #2: So, you know, we have four different capital contributors there, each of which have, I would say, the healthiest funnel that we've ever had. So, you can never guarantee exactly when these deals close.

Joe Burnett: You can never guarantee exactly when these deals close. Again, we recognize revenue when we deliver the equipment, install and put it into use, if you will. If that happens 31 December or 1 January, it can be these choppy swings. But if you think about the next six to nine months and the totality of that capital opportunity, it is pretty significant and like I said, healthier than it has ever been for the company. That is one thing to think about. The second thing to think about has to do with the disposables themselves, which is the neurosurgery navigation, which again, with IRRAflow already grew 50 plus, 59%, I think, in the quarter. The underlying organic disposables also grew in the quarter too. It is not even chicken or egg, it is follow the leader, I guess is the right way to say.

Speaker #2: Again, we recognize revenue when we deliver the equipment, you know, install and put it into use, if you will. So, you know, if that happens December 31st or January 1st, it can be these choppy swings.

Speaker #2: But, you know, if you think about the next six to nine months and the totality of that capital opportunity, you know, it's pretty significant.

Speaker #2: And like I said, healthier than it's ever been for the company. So that's one thing to think about. The second thing to think about has to do with the disposables themselves, which is the neurosurgery navigation, which again, with Airflow, already grew 50 plus, 59 percent, I think, in the quarter.

Speaker #2: The underlying organic disposables also grew in the quarter, too. You know, it's not even chicken or egg—it's follow the leader, I guess, is the right way to say it.

Joe Burnett: There is no reason to believe that all of these capital units and new customers that we opened up and placed in Q3 are not going to turn into disposable users in Q4 and beyond. There is no way someone would spend, I think the $1.7, $1.8 million that we were talking about in the quarter on new equipment just to use it as a paperweight and not put it into use right afterwards. At the very least, even if our current business is not growing, and that is not even true because we certainly expect it to grow, these new placements should contribute to meaningful disposable growth, including new orders, new users, et cetera. That is another combination I would add on there.

Speaker #2: You know, there's no reason to believe that all of these capital units and new customers that we opened up and placed in Q3 are not going to turn into disposable users in Q4 and beyond.

Speaker #2: So, you know, there's no way someone would, you know, spend, I think the 1.7, 1.8 million that we were talking about in the quarter on new equipment just to use it as a paper weight and not put it into use right afterwards.

Speaker #2: So, you know, at the very least, even if our current business is not growing and that's not even true because we certainly expect it to grow, these new placements should contribute to meaningful disposable growth, including new orders, new users, et cetera, right?

Speaker #2: So that's another, sort of another combination I would add on there. And that's highlighted also globally because, as we mentioned earlier, especially with Airflow, we canceled a lot of the traditional—or legacy is a better word—legacy distributor contracts.

Joe Burnett: That is highlighted also globally, because as we mentioned earlier, especially with IRRAflow, we canceled a lot of the traditional, or legacy is a better word, legacy distributor contracts. In some places, we are going direct. In some cases, we have started to burn through the old inventory that was on the shelf and expect new orders, new purchases to take place through our direct channel there. That is the second bucket, I would say. Then the third one is the CAL itself. If you think behind the scenes, we have had three quarters in a row where revenue at the CAL has grown sequentially, one after the other. Based on the studies that we are already performing in the first month of October, we think that growth will continue here in Q4 as well.

Speaker #2: And in some places, we're going direct. So in some cases, you know, we've started to burn through the old inventory that was on the shelves and expect new orders, new purchases to take place through our direct channel there.

Speaker #2: So, you know, so that's kind of the second bucket, I would say. And then the third one is the CAL itself. You know, if you think behind the scenes, we've had three quarters in a row where revenue at the CAL has grown sequentially one after the other.

Speaker #2: You know, based on the studies that were already performed in the first month of October, we think that growth will continue here in Q4 as well.

Speaker #2: So, you know, capital disposables and CAL services, you know, all three of those things, I think, could be contributing here and sort of spread the, spread the responsibility of that step up.

Joe Burnett: Capital, disposables, and CAL services, all three of those things I think could be contributing here and sort of spread the responsibility of that step-up.

Tom Stephan: Got it. That is great. Really helpful, Joe. I think a good segue from that kind of Q4 momentum commentary into my second question on 2027. Apologies in advance if any of this has been asked or addressed, hopping between calls. Joe, would love, I guess, any early view on base business growth next year. Previously, I think you guys have talked about growth in the teens, maybe the high teens. I look at Street consensus is at around low to mid-teens year-over-year revenue growth, although not sure how much is base business versus other. Any comment, early look on 2027 revenue growth, particularly given the commercial organization changes, the changing priorities, and obviously how growth is trending in the back half of this year? Would be great to rightsize our models as we exit this year and enter next year. Thanks again, guys.

Speaker #5: Got it. That's great. Really helpful, Joe. And, you know, I think a good segue from that kind of Q4 momentum commentary into my second question on 27.

Speaker #5: And apologies, in advance, if any of this has been asked or addressed, topping between calls. But yeah, Joe, would love, I guess, any early view on base business growth next year.

Speaker #5: You know, previously, I think you guys have talked about growth in the teens, maybe the high teens, I look at street, consensus is at around low to mid teens.

Speaker #5: Year-over-year revenue growth, although I'm not sure how much is base business versus other. But, yeah, any comment—an early look on 2027 revenue growth, particularly given the commercial organization changes, the changing priorities, and obviously how growth is trending in the back half of this year.

Speaker #5: Would be great to, you know, kind of right size our models as we exit this year and enter next year. Thanks again, guys.

Joe Burnett: Yeah, sure thing, Tom. I think we still feel good from a base standpoint about that mid-teens growth for 2027. We have not given official guidance, I would say. The reason for that is that I think we are going to learn quite a bit here in the next couple months, both from the initiation of some of these phase III trials, the progress of AMT-130, and how the FDA responds to the BLA submission that is currently underway. Similarly, in our own portfolio, the speed of installation of some of our equipment at the CAL and the regulatory progress of those five IRRAflow programs that I mentioned earlier on the call as well. So, I think a safe place for us to be right now is in that mid-teens.

Speaker #2: Yeah, sure thing, Tom. Yeah, I mean, I think we still feel good from a base standpoint about that kind of mid teens growth for 2027.

Speaker #2: You know, we haven't given official guidance, I would say, and the reason for that is that I think we're going to learn quite a bit here in the next couple of months.

Speaker #2: Both from the initiation of some of these phase three trials, the progress of AMT 130 and, you know, how the FDA responds to the BLA submission that's currently underway.

Speaker #2: And then similarly, in our own portfolio, the speed of installation of some of our equipment at the CAL and the regulatory progress of those five Airflow programs that I mentioned earlier on the call as well.

Speaker #2: So, you know, where I think a safe place for us to be right now is in that mean teens. You know, mid teens, I think, I think we're going to learn a lot in the next two months.

Joe Burnett: I think we are going to learn a lot in the next 2 months and likely be in a position come second week of January, as we typically do, to give some further insight, an early announcement of revenue as well as some glimpse into our guidance for 2027.

Speaker #2: And likely be in a position come second week of January, as we typically do, to give some further insight, you know, an early announcement of revenue, as well as, you know, some glimpse into our guidance for 2027.

Tom Stephan: Super helpful. Thanks again, Joe.

Speaker #5: Super helpful. Thanks again, Joe.

Joe Burnett: Yeah, sure thing, Tom.

Speaker #2: Yeah, sure thing, Tom.

Operator: We have reached the end of the question and answer session. I'd like to turn the call back over to your host, Mr. Joe Burnett, for closing remarks.

Speaker #1: We have reached the end of the question and answer session. I'd like to turn the call back over to your host, Mr. Joe Burnett.

Speaker #1: For closing remarks.

Joe Burnett: Well, thanks again for joining our call today. Our team is confident that we have built an incredible foundation across our four pillars today to support the future of global commercial drug delivery. Our goal is to make advanced neurological therapies available to as many patients as possible, who suffer from serious and debilitating neurological diseases, to improve their quality of life. We are thrilled to have you alongside as we execute on this vision and continue building for the future. Thank you for your support and good night, everyone.

Speaker #2: Well, thanks again for joining our call today. Our team is confident that we have built an incredible foundation across our four pillars today to support the future of global commercial drug delivery.

Speaker #2: Our goal is to make advanced neurological therapies available to as many patients as possible who suffer from serious and debilitating neurological diseases to improve their quality of life.

Speaker #2: We are thrilled to have you alongside as we execute on this vision and continue building for the future. Thank you for your support, and good night, everyone.

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