ClearPoint Neuro Inc【CLPT】株式ニュース

ClearPoint Neuro Reports First Quarter 2026 ResultsMay 13, 2026 4:05 PM
ACCESS NewswireRecord Revenue Achieved Including 25% Organic Growth in Devices and 43% Overall GrowthSOLANA BEACH, CA / ACCESS Newswire / May 13, 2026 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its first quarter ended March 31, 2026.First Quarter 2026 HighlightsReported first quarter revenue of $12.1 million, including $2.3 million of IRRAflow revenue, representing 43% overall growth and 16% year-over-year total organic growth compared with the first quarter of 2025;The activated installed base across all ClearPoint technology including IRRAflow systems now includes over 175 global centers;Achievement of measurable revenue and cost synergies through the continuing integration of the IRRAflow product portfolio and team;Continued clinical trial and regulatory progress across more than 60 active biopharma partners;FDA clearance and successful completion of the first clinical procedure utilizing the Velocity Alpha MR High Speed Surgical Drill System;Received Medical Device License (MDL) from Health Canada for the ClearPoint Neuro Navigation System, covering both MRI-guidance and iCT guidance workflows with first cases now scheduled;Completion of the first commercial drug delivery case utilizing ClearPoint technology in the Asia-Pacific region;Gross margin expanded to 64%; andReported cash and cash equivalents totaling $35.6 million as of March 31, 2026."Our team is off to a strong start in 2026 with forward progress across our entire four-pillar growth strategy," commented Joe Burnett, President and CEO at ClearPoint Neuro. "While record revenue achievement and 25% organic devices growth made the headline, there is no shortage of meaningful strategic progress across the entire organization. This includes highlights from each pillar: multiple new drug routes-of-administration tested for the first time at the ClearPoint Advanced Laboratories, expansion of our navigation installed base globally, FDA clearance of the Velocity Alpha MR conditional drill that has now been used clinically for the first time, and the integration of the entire IRRAflow portfolio into the ClearPoint Neuro commercial and operations teams which will lead to meaningful revenue and cost synergies in the second half of 2026. We continue to believe that these four pillars will each contribute double digit growth in 2026, and represent a solid foundation on which to build our commercial cell and gene therapy delivery business in the future. Individual drug development programs of course come with inherent risk, however if you look across our entire portfolio of more than 60 partners and programs, every quarter we see partners getting funded or acquired, we see INDs being approved, we see more patients being recruited and enrolled in regulatory trials, and we see our partners getting closer and closer to pivotal data readouts. With more than 60 shots on goal across this portfolio, and having worked closely with the amazing teams doing this drug development, we feel more than ever that global approvals are not a matter of if, but when."Business OutlookThe Company estimates revenue in 2026 to be between $52.0 million and $56.0 million.Financial Results - Quarter Ended March 31, 2026Total revenue was $12.1 million for the three months ended March 31, 2026, and $8.5 million for the three months ended March 31, 2025, which represents an increase of $3.6 million, or 43%.Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased slightly to $4.8 million for the three months ended March 31, 2026 from $4.7 million for the three months ended March 31, 2025.Of note the construction of the new CAL facility (ClearPoint Advanced Laboratories) is continuing, which is designed to the bring the CAL's capacity to the level expected in the years ahead.Neurosurgery navigation, therapy and access revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint and IRRAflow systems, increased 80% to $5.9 million for the three months ended March 31, 2026, from $3.3 million for the same period in 2025. The increase is driven by additional revenues from sales of the IRRAflow product of as well as the introduction of our 3.0 operating room navigation software, which has positively impacted procedural volumes in the operating room during the three months ended March 31, 2026, compared to the same period in 2025.Capital equipment and software revenue, consisting of sales of ClearPoint and IRRAflow reusable hardware and software and related services, increased 177% to $1.4 million for the three months ended March 31, 2026, from $0.5 million for the same period in 2025 due to an increase in placements of ClearPoint navigation capital and software, IRRAflow control units, and Prism laser units.The Company achieved a gross margin of 64% on its sales for the three months ended March 31, 2026, and a gross margin of 60% in the same period in 2025. The increase in gross margin is primarily due to lower excess and obsolete inventory for the three months ended March 31, 2026, as compared to the same period in 2025.Operating expenses were $16.2 million for the three months ended March 31, 2026, compared with $11.3 million for the same period in 2025, an increase of 44%. The increase was mainly driven by higher personnel costs as a result of the expanded team due to the acquisition of IRRAS which occurred in November 2025, as well as increased occupancy costs and travel costs.At March 31, 2026, the Company had cash and cash equivalents totaling $35.6 million as compared to $45.9 million at December 31, 2025, with the decrease resulting from the use of $8.0 million in cash for operating activities and $2.0 million in cash paid for taxes related to the net share settlement of equity awards. The Company expects cost synergies resulting from the acquisition of IRRAS to contribute to a reduction in cash burn in the second half of 2026 and believes that the asset integration could potentially be cash neutral for the full year 2027.Teleconference InformationInvestors and analysts are invited to listen to a live broadcast review of the Company's first quarter 2026 results on Wednesday, May 13, 2026 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=IjzOoM7l. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until June 12, 2026, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/.About ClearPoint NeuroClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.Forward-Looking StatementsStatements in this press release and in the teleconference referenced above concerning the Company's plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the market opportunity and rate of sales and revenue growth for the Company's products and services, including for the Company's preclinical CRO facility and its products and services, the Company's neuronavigational products, the IRRAflow Active Fluid Exchange System, and the PRISM Laser Therapy System; the Company's expectations for achieving key growth drivers for its sales including its ability to expand its commercial organization, receive regulatory approval for its products in new geographies, activate additional customer sites, generate clinical and economic data to support and expand the adoption rate for its products, and its development of new products; the Company's ability to successfully develop new products for gene and cell therapy delivery; the adoption of the Company's products and services for use in the delivery of gene and cell therapies; the regulatory approval and commercialization of cell and gene therapies being developed by the Company's biotech Partners; the Company's expectations regarding its four-pillar growth strategy, including its belief that each pillar will contribute double-digit growth in 2026; the Company's expectations regarding future revenue and cost synergies from the integration of the IRRAflow product portfolio and team, including the expectation that IRRAS integration could be cash neutral for the full year 2027; the Company's expectations for the ClearPoint Advanced Laboratories (CAL) facility, including anticipated future study capacity; the Company's expectations regarding international regulatory approvals, including the Medical Device License from Health Canada and the scheduling of future cases; the Company's expectations regarding the Velocity Alpha MR High Speed Surgical Drill System and the PRISM Laser Therapy System, including their clinical adoption and commercial potential; the Company's expectations that global regulatory approvals of cell and gene therapies by its biotech Partners are a matter of timing rather than outcome; and the Company's expectations for revenues, operating expenses, and management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company's biotech Partners' risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech Partners' therapies; the limitation or modification of the FDA's eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the Company's biotech Partner's continued use of the Company's products and services in their delivery of gene and cell therapies; the Company's ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company's ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; risks inherent in the research, development, and regulatory approval of the Company's new products; the future market for preclinical services and products and the investment and timeline required to expand such services, which could divert resources from the Company's other business operations; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company's failure to integrate IRRAS into its business in accordance with expectations; deviations from the expected market potential of the IRRAS products; diversion of management's attention on the integration of IRRAS into its business; the risk that the Company's four-pillar growth strategy may not achieve double-digit growth across each pillar as anticipated due to market, competitive, or operational factors; the risk that expected revenue and cost synergies from the IRRAS integration, including the expectation of cash neutrality for the full year 2027, may not be achieved on the anticipated timeline or at all; risks related to the construction, completion, and operational ramp up of the CAL facility, including the possibility that study capacity may not scale as expected; risks related to obtaining and maintaining international regulatory approvals, including approvals from Health Canada, and the Company's ability to successfully commercialize its products in new geographies; risks related to the clinical adoption and commercial success of the Velocity Alpha MR High Speed Surgical Drill System and other newly cleared products; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as instability, protectionism and economic nationalism; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's business activity, including its research and development programs and the expansion of its commercial organization; the ability of the Company to manage the growth of its business; and the Company's ability to attract and retain its key employees. For a detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Contact:Investor Relations:
Danilo D'Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.comCLEARPOINT NEURO, INC.
Consolidated Statements of Operations
(in thousands, except for share and per share data) For the Three Months Ended March 31, 2026 2025 Revenue: Product revenue $8,802 $5,291 Service and other revenue 3,326 3,194 Total revenue 12,128 8,485 Cost of revenue 4,372 3,353 Gross profit 7,756 5,132 Research and development costs 4,522 3,379 Sales and marketing expenses 6,715 3,834 General and administrative expenses 4,997 4,082 Operating loss (8,478) (6,163)Other income (expense): Other (expense) income, net (35) 4 Interest income 351 151 Interest expense (1,382) - Net loss before income taxes (9,544) (6,008)Income tax expense 8 18 Net loss $(9,552) $(6,026)Net loss per share attributable to common stockholders: Basic and diluted $(0.32) $(0.22)Weighted average shares outstanding: Basic and diluted 29,546,889 27,718,918 CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(in thousands, except for share and per share data) March 31, 2026 December 31, (Unaudited) 2025 ASSETS Current assets: Cash and cash equivalents $35,593 $45,923 Accounts receivable, net 8,662 6,549 Inventory, net 8,573 8,359 Prepaid expenses and other current assets 2,049 2,769 Total current assets 54,877 63,600 Property and equipment, net 2,914 2,621 Operating lease, right-of-use assets 13,088 8,430 Goodwill 7,472 7,472 Intangible assets, net 13,419 13,922 Other assets 1,646 1,702 Total assets $93,416 $97,747 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $2,330 $1,256 Accrued compensation 2,977 4,360 Other accrued liabilities 2,125 2,786 Operating lease liabilities, current portion 234 694 Contract liabilities, current portion 1,814 1,669 Total current liabilities 9,480 10,765 Operating lease liabilities, net of current portion 13,710 8,461 Contract liabilities, net of current portion 608 581 Long-term notes payable, net 49,644 49,077 Deferred tax liabilities, net 354 354 Other long-term liabilities 779 489 Total liabilities 74,575 69,727 Commitments and contingencies Stockholders' equity: Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at March 31, 2026 and December 31, 2025 - - Common stock, $0.01 par value; 90,000,000 shares authorized at March 31, 2026 and December 31, 2025; 29,986,639 and 29,368,760 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively 300 294 Additional paid-in capital 239,468 238,995 Shares to be issued 5,535 5,641 Accumulated deficit (226,462) (216,910)Total stockholders' equity 18,841 28,020 Total liabilities and stockholders' equity $93,416 $97,747 CLEARPOINT NEURO, INC.
Consolidated Statements of Cash Flows
(in thousands) Three Months Ended March 31, 2026 2025 Cash flows from operating activities: Net loss $(9,552) $(6,026)Adjustments to reconcile net loss to net cash flows from operating activities: Allowance for credit losses (recoveries) (95) 217 Depreciation and amortization 86 103 Amortization of intangible assets 504 - Share-based compensation 2,218 1,908 Payment-in-kind interest 525 - Amortization of debt issuance costs and original issue discounts 42 - Amortization of lease right of use assets, net of accretion in lease liabilities 523 231 Increase (decrease) in cash resulting from changes in: Accounts receivable (2,019) 846 Inventory, net (125) 78 Prepaid expenses and other current assets 653 168 Other assets (71) - Accounts payable and accrued expenses (437) (2,882)Lease liabilities (391) (234)Contract liabilities 172 (581)Net cash flows from operating activities (7,967) (6,172)Cash flows from investing activities: Purchases of property and equipment (645) (183)Net cash flows from investing activities (645) (183)Cash flows from financing activities: Payment of At-The-Market offering costs - (78)Proceeds from stock option exercises 148 21 Payments for taxes related to net share settlement of equity awards (1,993) (1,305)Net cash flows from financing activities (1,845) (1,362)Net change in cash, cash equivalents and restricted cash (10,457) (7,717)Cash, cash equivalents and restricted cash, beginning of period 46,973 20,104 Cash, cash equivalents and restricted cash, end of period $36,516 $12,387 Cash and cash equivalents 35,593 12,387 Restricted cash included in other current assets and other assets, non-current 923 - Total cash, cash equivalents and restricted cash $36,516 $12,387 SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for: Income taxes $- $- Interest $525 $- SOURCE: ClearPoint Neuro, Inc.View the original press release on ACCESS NewswireOriginal: ClearPoint Neuro Reports First Quarter 2026 Results

ClearPoint Neuro Reports Fourth Quarter and Full Year 2025 ResultsMarch 17, 2026 4:05 PM
ACCESS NewswireRecord Revenue and IRRAS Holdings Acquisition Highlight the Company's 'Fast. Forward.' StrategySOLANA BEACH, CA / ACCESS Newswire / March 17, 2026 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its fourth quarter and full year ended December 31, 2025.2025 Full Year and Fourth Quarter HighlightsReported fourth quarter revenue of $10.4 million, including $1.2 million of IRRAflow revenue, representing 34% overall growth and 19% year-over-year organic growth compared with the fourth quarter of 2024;Reported revenue of $37.0 million for the full year 2025, an overall increase of 18% and 14% increase in organic growth over 2024 and signifying the eleventh consecutive year of growth;Completed the acquisition of IRRAS Holdings, Inc., in November 2025 expanding the Company's portfolio into neurocritical care, and allowing an expanded set of solutions spanning functional neurosurgery, neurocritical care, and intracranial drug delivery;In conjunction with the IRRAS acquisition, entered into an agreement to access an additional $20.0 million in funding under the existing note financing arrangement with Oberland Capital;Received EU MDR Certification for ClearPoint Navigation Software Version 3.0.2, expanding the Company's latest operating room navigation platform to EU customers;Completed initial development and showcased a prototype of the Company's proprietary robotic neuro-navigation system at the 75th Annual Congress of Neurological Surgeons in Los Angeles in October 2025; andReported cash and cash equivalents totaling $45.9 million as of December 31, 2025."Our Company ended 2025 on a high note with the strongest financial quarter of the year, a newly acquired and commercialized neurocritical care product line, and a genuine excitement regarding our 2026 opportunities," commented Joe Burnett, President and CEO at ClearPoint Neuro. "We have invested more than $100 million over the past five years to build a strong foundation, made up of four growing product categories, a vetted pipeline of new development programs, an expanded manufacturing footprint, a thoroughly audited quality system, a collection of global regulatory approvals, an expansive IP portfolio, an installed base of more than 150 global centers, and the cash position and investor base to execute on our strategy. Most importantly, through our unique biologics and drug delivery ecosystem, we have attracted more than 60 active biopharma partners, we are currently supporting more than 25 global clinical trials, and more than 10 of our biopharma partner programs have now been accepted to some form of FDA expedited regulatory review. Our Company has never been in a stronger position than we are right now.""As we look ahead, we have now entered the next two phases of our growth strategy:""The first phase, which we call "Fast. Forward." is to penetrate an existing $1 billion market opportunity made up of four distinct product segments: 1) pre-commercial drug delivery products and services, 2) neurosurgery navigation and robotics, 3) laser therapy and access, and 4) neurocritical fluid management. We expect all four of these product lines to grow double digits in 2026 through the expansion of our commercial organization, approval of products in new geographies, additional site activations, generation of clinical data, and the execution and launch of new products in our development pipeline.""The second phase, which we call "Essential. Everywhere." is to build a new market that does not yet exist for commercial cell and gene therapy delivery. This is a market in which we believe that the unique ClearPoint Neuro ecosystem will play an essential role. This ecosystem will include brain segmentation tools, predictive drug-delivery modeling, pre-planning and navigation software, frame and robotic delivery options, drug loading and mechanized infusion technologies, an array of cell and gene therapy routes-of-administration, and post procedure quality confirmation software to meticulously track proper delivery. All of these workflow steps will be supported by our talented team of clinical specialists and scientists who will be there in the room, assisting our partners when these new-to-world therapies are first commercialized.""For 2026, we now expect revenues to be in the range of $52.0 - $56.0 million. In parallel, we will continue to support our biopharma partners through the global regulatory process, which will generate additive revenue in the years ahead, as we enter the "Essential. Everywhere." phase."Business OutlookThe Company estimates revenue in 2026 to be between $52.0 million and $56.0 million.Financial Results - Year Ended December 31, 2025Total revenue was $37.0 million and $31.4 million for the years ended December 31, 2025 and 2024, respectively.Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 10% to $19.0 million for the year ended December 31, 2025, from $17.3 million for the same period in 2024. This increase is attributable to a $1.7 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials.Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 44% to $14.8 million during the year ended December 31, 2025, from $10.3 million for the same period in 2024. The increase is driven by an increased customer base, additional revenues due to the IRRAflow product line acquisition completed in November 2025, and higher sales for new offerings of SmartFrame OR, Prism Laser Therapy, and introduction of our 3.0 operating room software, during the year ended December 31, 2025, compared to the same period in 2024.Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 18% to $3.1 million for the year ended December 31, 2025, from $3.8 million for the same period in 2024, due to a decrease in the placements of ClearPoint navigation capital and software and Prism laser units.The Company achieved a gross margin of 61% on its sales for 2025, and is broadly in line with gross margin of 61% in the same period in 2024.Operating expenses were $46.9 million for the full year 2025, compared with $38.9 million for 2024, an increase of 21%. The increase was mainly driven by the integration of IRRAS, higher product and software development costs, acquisition-related expenses, professional services fees, and personnel-related expenses, including share-based compensation, as we increased headcount due to the IRRAS acquisition and to fuel the expansion of the research and development, clinical, and support organizations.Financial Results - Quarter Ended December 31, 2025Total revenue was $10.4 million for the three months ended December 31, 2025, in comparison to $7.8 million for the three months ended December 31, 2024.Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 23% to $5.2 million for the three months ended December 31, 2025, from $4.2 million for the same period in 2024. This increase is attributable to $1.1 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials, partially offset by lower service revenue of $0.1 million.Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 61% to $4.7 million for the three months ended December 31, 2025, from $2.9 million for the same period in 2024. The increase is driven by an increased customer base and additional revenues due to the IRRAflow product line acquisition completed in November 2025, during the three months ended December 31, 2025, compared to the same period in 2024.Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 18% to $0.5 million for the three months ended December 31, 2025, from $0.6 million for the same period in 2024.The Company achieved a gross margin of 62% on its sales for the three months ended December 31, 2025, and is broadly in line with gross margin of 61% in the same period in 2024.Operating expenses were $13.4 million for the three months ended December 31, 2025, compared with $10.4 million for the same period in 2024, an increase of 30%. The increase was mainly driven by the acquisition of IRRAS and increased professional services fees.At December 31, 2025, the Company had cash and cash equivalents totaling $45.9 million as compared to $20.1 million at December 31, 2024, with the increase resulting from the net proceeds of the notes payable and stock offering of $51.4 million, and cash acquired as part of the IRRAS acquisition of $1.1 million, partially offset by the use of $23.9 million in cash for operating activities and $1.9 million in cash paid for taxes related to the net share settlement of equity awards.Teleconference InformationInvestors and analysts are invited to listen to a live broadcast review of the Company's 2025 fourth quarter and full year results on Tuesday, March 17, 2026 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=XzyAJzOm. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until April 16, 2026, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/.About ClearPoint NeuroClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.Forward-Looking StatementsStatements in this press release and in the teleconference referenced above concerning the Company's plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the market opportunity and rate of sales and revenue growth for the Company's products and services, including for the Company's preclinical CRO facility and its products and services, the Company's neuronavigational products, the IRRAflow Active Fluid Exchange System, and the PRISM Laser Therapy System; the Company's expectations for achieving key growth drivers for its sales including its ability to expand its commercial organization, receive regulatory approval for its products in new geographies, activate additional customer sites, generate clinical and economic data to support and expand the adoption rate for its products, and its development of new products; the Company's ability to successfully develop new products for gene and cell therapy delivery, including brain segmentation tools, predictive drug-delivery modeling, new pre-planning and navigation software, frame and robotic delivery options, drug loading and mechanized infusion technologies, cell and gene therapy routes-of-administration, and post procedure quality confirmation software; the adoption of the Company's products and services for use in the delivery of gene and cell therapies; the regulatory approval and commercialization of cell and gene therapies being developed by the Company's biotech Partners; and the Company's expectations for revenues, operating expenses, and management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company's biotech Partners' risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech Partners' therapies; the limitation or modification of the FDA's eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the Company's biotech Partner's continued use of the Company's products and services in their delivery of gene and cell therapies; the Company's ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company's ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; risks inherent in the research, development, and regulatory approval of the Company's new products; the future market for preclinical services and products and the investment required to expand such services, which could divert resources from the Company's other business operations; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company's failure to integrate IRRAS into its business in accordance with expectations; deviations from the expected market potential of the IRRAS products; diversion of management's attention on the integration of IRRAS into its business; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as instability, protectionism and economic nationalism; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's research and development programs and the expansion of its commercial organization; the ability of the Company to manage the growth of its business; and the Company's ability to attract and retain its key employees. For a detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Contact:Investor Relations:
Danilo D'Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.comCLEARPOINT NEURO, INC.
Consolidated Statements of Operations
(in thousands, except for share and per share data) Year Ended December 31, 2025 2024 Revenue: Product revenue $23,859 $18,626 Service and other revenue 13,112 12,764 Total revenue 36,971 31,390 Cost of revenue 14,279 12,268 Gross profit 22,692 19,122 Research and development costs 13,897 12,392 Sales and marketing expenses 16,461 14,478 General and administrative expenses 16,498 11,986 Operating loss (24,164) (19,734)Other income (expense): Other expense, net (146) (40)Interest income 1,213 1,390 Interest expense (2,388) (518)Net loss before income taxes (25,485) (18,902)Income tax expense 55 12 Net loss $(25,540) $(18,914)Net loss per share attributable to common stockholders: Basic and diluted $(0.90) $(0.70)Weighted average shares outstanding: Basic and diluted 28,315,254 27,027,692 CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(in thousands, except for share and per share data) December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $45,923 $20,104 Accounts receivable, net 6,549 4,713 Inventory, net 8,359 6,863 Prepaid expenses and other current assets 2,769 1,683 Total current assets 63,600 33,363 Property and equipment, net 2,621 2,005 Operating lease, right-of-use assets 8,430 3,086 Goodwill 7,472 - Intangible assets, net 13,922 - Other assets 1,702 735 Total assets $97,747 $39,189 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $1,256 $1,340 Accrued compensation 4,360 4,885 Other accrued liabilities 2,786 1,450 Operating lease liabilities, current portion 694 557 Contract liabilities, current portion 1,669 2,121 Total current liabilities 10,765 10,353 Operating lease liabilities, net of current portion 8,461 3,011 Contract liabilities, net of current portion 581 436 Long-term notes payable, net 49,077 - Deferred tax liabilities, net 354 - Other long-term liabilities 489 - Total liabilities 69,727 13,800 Commitments and contingencies Stockholders' equity: Preferred stock, $0.01 par value; 25,000,000 shares authorized at December 31, 2025 and 2024; none issued and outstanding at December 31, 2025 and 2024 - - Common stock, $0.01 par value; 90,000,000 shares authorized at December 31, 2025 and 2024; 29,368,760 and 27,617,415 shares issued and outstanding at December 31, 2025 and 2024, respectively 294 276 Additional paid-in capital 238,995 216,483 Shares to be issued 5,641 - Accumulated deficit (216,910) (191,370)Total stockholders' equity 28,020 25,389 Total liabilities and stockholders' equity $97,747 $39,189 CLEARPOINT NEURO, INC.
Consolidated Statements of Cash Flows
(in thousands) Year Ended December 31, 2025 2024 Cash flows from operating activities: Net loss $(25,540) $(18,914)Adjustments to reconcile net loss to net cash flows from operating activities: Allowance for credit losses (recoveries) 21 (296)Depreciation and amortization 814 980 Amortization of intangible assets 168 - Share-based compensation 8,180 6,907 Payment-in-kind interest 908 - Amortization of debt issuance costs and original issue discounts 83 51 Amortization of lease right of use assets, net of accretion in lease liabilities 1,255 923 Increase (decrease) in cash resulting from changes in: Accounts receivable (268) (1,206)Inventory, net (103) 743 Prepaid expenses and other current assets (397) 262 Other assets (195) (39)Accounts payable and accrued expenses (7,520) 3,105 Lease liabilities (1,012) (869)Contract liabilities (319) (597)Net cash flows from operating activities (23,925) (8,950)Cash flows from investing activities: Cash acquired in business combination, net of cash paid 1,137 - Purchases of property and equipment (522) (275)Net cash flows from investing activities 615 (275)Cash flows from financing activities: Proceeds from offerings of common stock, net of offering costs 3,263 16,149 Proceeds from issuance of notes payable, net of financing costs and discount 48,086 - Repayment of 2020 senior secured convertible note - (10,000)Proceeds from stock option exercises 127 21 Payments for taxes related to net share settlement of equity awards (1,856) (424)Proceeds from issuance of common stock under employee stock purchase plan 559 443 Net cash flows from financing activities 50,179 6,189 Net change in cash, cash equivalents and restricted cash 26,869 (3,036)Cash, cash equivalents and restricted cash, beginning of year 20,104 23,140 Cash, cash equivalents and restricted cash, end of year $46,973 $20,104 Cash and cash equivalents 45,923 20,104 Restricted cash included in other current assets and other assets, non-current 1,050 - Total cash, cash equivalents and restricted cash $46,973 $20,104 SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for: Income taxes $69 $62 Interest $908 $480 SOURCE: ClearPoint Neuro, Inc.View the original press release on ACCESS NewswireOriginal: ClearPoint Neuro Reports Fourth Quarter and Full Year 2025 Results