ClearPoint Neuro Reports Second Quarter 2025 Results

Record Revenue and Substantial Cash Infusion Highlight the Company's ‘Fast. Forward.' Strategy SOLANA BEACH, CA / ACCESS Newswire / August 12, 2025 / 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 second quarter ended June 30, 2025. Second Quarter Highlights Reported record quarterly revenue of $9.2 million, a 17% year-over-year increase compared with the second quarter of 2024; Neurosurgery navigation and therapy revenue grew 33% to $3.4 million year-over-year fueled by SmartFrame® Family Navigation devices and ClearPoint PRISM® Laser Therapy Applicators; Entered into a note financing arrangement with Oberland Capital Management of up to $105.0 million, with $30.0 million of gross proceeds funded at closing; Entered into a stock purchase agreement with Oberland Capital Management for the purchase of shares of the Company's common stock for an additional $3.5 million of gross proceeds; and Reported cash and cash equivalents totaling $41.5 million as of June 30, 2025. "The team has continued to deliver strong results here in the second quarter, both financially and strategically," commented Joe Burnett, President and CEO at ClearPoint Neuro. "From a financial perspective we achieved record revenue, benefiting from sales contributions across all four of our growth pillars. Strategically, we were able to achieve key milestones that give us confidence that we will see continued growth across our entire portfolio. This is an exciting phase for the company, which we call the ‘Fast. Forward.' phase as we now have multiple growth vectors taking shape at the same time including: 1) the expansion into the operating room, 2) the expansion into laser therapy and access, 3) the expansion of regulatory approvals into new geographies, 4) the addition of multiple new BioPharma Partners, 5) the addition of new products and services to offer BioPharma, 6) the expansion of our site capacity for larger preclinical studies, and 7) the progression of Biopharma partners into larger phase III clinical trials and eventual commercialization of these new-to-the-world cell and gene therapies. All of this is taking place against the backdrop of our strongest cash position in years and the confidence to use that capital to move all of these growth vectors forward…. Fast. Forward." Business Outlook The Company reaffirms its full year 2025 revenue outlook between $36.0 million and $41.0 million. Financial Results - Quarter Ended June 30, 2025 Total revenue was $9.2 million for the three months ended June 30, 2025, and $7.9 million for the three months ended June 30, 2024, which represents an increase of $1.4 million, or 17%. Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials, increased 10% to $4.7 million for the three months ended June 30, 2025, from $4.3 million for the same period in 2024. This increase is attributable to $0.2 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials, and $0.2 million increase in service revenue and other revenue. Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 33% to $3.4 million for the three months ended June 30, 2025, from $2.6 million for the same period in 2024. The increase is driven by higher sales for new offerings of SmartFrame OR, Prism Laser Therapy, and introduction of our 3.0 operating room navigation software, during the three months ended June 30, 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, increased 11% to $1.0 million for the three months ended June 30, 2025, from $0.9 million for the same period in 2024 due to an increase in service revenue. The Company achieved a gross margin of 60% on its sales for the three months ended June 30, 2025, as compared to 63% in the same period in 2024. The decrease in gross margin was primarily due to higher excess and obsolete inventory reserves for the three months ended June 30, 2025, as compared to the same period in 2024. Operating expenses were $11.2 million for the three months ended June 30, 2025, compared with $9.7 million for same period in 2024, an increase of 16%. The increase was mainly driven by higher product and software development costs, an increase in the allowance for credit losses, and personnel-related expenses, including share-based compensation, as we increased headcount to fuel the expansion of the research and development, clinical, and support organizations. At June 30, 2025, the Company had cash and cash equivalents totaling $41.5 million as compared to $20.1 million at December 31, 2024, with the increase resulting from the net proceeds of the note payable and stock offering of $32.0 million, partially offset by the use of $8.7 million in cash for operating activities. Teleconference Information Investors and analysts are invited to listen to a live broadcast review of the Company's 2025 second quarter results on Tuesday, August 12, 2025 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=3mqLeBhl . 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 September 11, 2025, 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 Neuro ClearPoint 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 Statements Statements 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 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 and the market for cell and gene therapies, the anticipated adoption of the Company's products and services for use in the delivery of gene and cell therapies, the Company's expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, as well as 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: 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 protectionism and economic nationalism; future revenue from sales of the Company's products and services; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company's products and services in their delivery of therapies; the Company's ability to maintain its current relationships with biologics and drug delivery partners or enter into new relationships with such partners; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company's ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company's ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of the Company's new products and the new products of its biologics and drug delivery partners. More detailed information on these and additional factors that could affect the Company's actual results are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2025, both of which have been filed with the Securities and Exchange Commission, and the Company's Quarterly Report on Form 10-Q for the three months ended June 30, 2025, which the Company intends to file with the Securities and Exchange Commission on or before August 14, 2025. The Company does not assume any obligation to update these forward-looking statements. Contact: Investor Relations: Danilo D'Alessandro, Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.com CLEARPOINT NEURO, INC. Consolidated Statements of Operations (Unaudited) (in thousands, except for share and per share data) For the Three Months Ended June 30, 2025 2024 Revenue: Product revenue $ 5,997 $ 4,944 Service and other revenue 3,218 2,914 Total revenue 9,215 7,858 Cost of revenue 3,659 2,870 Gross profit 5,556 4,988 Research and development costs 3,829 3,120 Sales and marketing expenses 4,019 3,834 General and administrative expenses 3,388 2,758 Operating loss (5,680 ) (4,724 ) Other income (expense): Other income (expense), net (52 ) 5 Interest income (expense), net (80 ) 326 Net loss before income taxes (5,812 ) (4,393 ) Income tax expense (25 ) (15 ) Net loss $ (5,837 ) $ (4,408 ) Net loss per share attributable to common stockholders: Basic and diluted $ (0.21 ) $ (0.16 ) Weighted average shares outstanding: Basic and diluted 28,258,305 27,468,378 For the Six Months Ended June 30, 2025 2024 Revenue: Product revenue $ 11,288 $ 8,579 Service and other revenue 6,412 6,918 Total revenue 17,700 15,497 Cost of revenue 7,012 5,984 Gross profit 10,688 9,513 Research and development costs 7,208 5,745 Sales and marketing expenses 7,853 7,124 General and administrative expenses 7,470 5,585 Operating loss (11,843 ) (8,941 ) Other income (expense): Other expense, net (48 ) (21 ) Interest income, net 71 437 Net loss before income taxes (11,820 ) (8,525 ) Income tax expense (43 ) (29 ) Net loss $ (11,863 ) $ (8,554 ) Net loss per share attributable to common stockholders: Basic and diluted $ (0.42 ) $ (0.32 ) Weighted average shares outstanding: Basic and diluted 27,990,102 26,460,237 CLEARPOINT NEURO, INC. Consolidated Balance Sheets (in thousands, except for share and per share data) June 30, 2025 December 31, (Unaudited) 2024 ASSETS Current assets: Cash and cash equivalents $ 41,541 $ 20,104 Accounts receivable, net 4,260 4,713 Inventory, net 6,293 6,863 Prepaid expenses and other current assets 1,897 1,683 Total current assets 53,991 33,363 Property and equipment, net 2,019 2,005 Operating lease, right-of-use assets 6,139 3,086 Other assets 720 735 Total assets $ 62,869 $ 39,189 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,531 $ 1,340 Accrued compensation 2,949 4,885 Other accrued liabilities 1,210 1,450 Operating lease liabilities, current portion 331 557 Contract liabilities, current portion 1,377 2,121 Total current liabilities 7,398 10,353 Operating lease liabilities, net of current portion 6,280 3,011 Contract liabilities, net of current portion 603 436 Long-term note payable, net 28,845 - Total liabilities 43,126 13,800 Commitments and contingencies Stockholders' equity: Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at June 30, 2025 and December 31, 2024 - - Common stock, $0.01 par value; 90,000,000 shares authorized at June 30, 2025 and December 31, 2024; 28,423,611 and 27,617,415 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 284 276 Additional paid-in capital 222,692 216,483 Accumulated deficit (203,233 ) (191,370 ) Total stockholders' equity 19,743 25,389 Total liabilities and stockholders' equity $ 62,869 $ 39,189 CLEARPOINT NEURO, INC. Consolidated Statements of Cash Flows (Unaudited) (in thousands) For the Six Months Ended June 30, 2025 2024 Cash flows from operating activities: Net loss $ (11,863 ) $ (8,554 ) Adjustments to reconcile net loss to net cash flows from operating activities: Allowance for credit losses (recoveries) 217 (507 ) Depreciation and amortization 499 476 Share-based compensation 4,177 3,300 Payment-in-kind interest 172 - Amortization of debt issuance costs and original issue discounts 21 29 Amortization of lease right of use assets, net of accretion in lease liabilities 461 461 Increase (decrease) in cash resulting from changes in: Accounts receivable 237 244 Inventory, net 482 (320 ) Prepaid expenses and other current assets (136 ) (294 ) Other assets - (39 ) Accounts payable and accrued expenses (1,944 ) 726 Lease liabilities (471 ) (401 ) Contract liabilities (576 ) (1,629 ) Net cash flows from operating activities (8,724 ) (6,508 ) Cash flows from investing activities: Purchases of property and equipment (274 ) - Net cash flows from investing activities (274 ) - Cash flows from financing activities: Proceeds from offerings of common stock, net of offering costs 3,263 16,183 Proceeds from issuance of note payable, net of financing costs and discount 28,653 - Proceeds from stock option exercises 49 21 Payments for taxes related to net share settlement of equity awards (1,661 ) (279 ) Proceeds from issuance of common stock under employee stock purchase plan 311 288 Net cash flows from financing activities 30,615 16,213 Net change in cash, cash equivalents and restricted cash 21,617 9,705 Cash, cash equivalents and restricted cash, beginning of period 20,104 23,140 Cash, cash equivalents and restricted cash, end of period $ 41,721 $ 32,845 Cash and cash equivalents 41,541 32,845 Restricted cash included in other assets, non-current 180 - Total cash, cash equivalents and restricted cash $ 41,721 $ 32,845 SUPPLEMENTAL CASH FLOW INFORMATION Cash paid for: Income taxes $ 12 $ 41 Interest $ 172 $ 370 SOURCE: ClearPoint Neuro, Inc. 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