ClearPoint Neuro Inc. 2025年季度报告

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.oIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).oYesþNo CLEARPOINT NEURO, INC. PART I – FINANCIAL INFORMATION PART II – OTHER INFORMATION Trademarks, Trade Names and Service Marks SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report contains “forward-looking statements” as defined under the U.S. federal securities laws. The forward-lookingstatements relate to our expectations for performance, revenues and costs, and the adequacy of cash and cash equivalent balances andshort-term investments to support operations and meet future obligations. These statements involve known and unknown risks, In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,”“intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identifyforward-looking statements, although not all forward-looking statements contain these words. Although we believe that we have a In evaluating forward-looking statements, you should refer to (i) the section titled “Risk Factors” in our Annual Report on Form 10-Kfor the fiscal year ended December 31, 2024, which we filed with the United States Securities and Exchange Commission (“SEC”) onFebruary 26, 2025 (the “2024 Form 10-K”), (ii) Item 2 of this Quarterly Report, under the heading "Management's Discussion andAnalysis of Financial Condition and Results of Operations -- Factors Which May Influence Future Results of Operations" and (iii) PartII, Item 1.A of this Quarterly Report. As a result of these risk factors, we cannot assure you that the forward-looking statements in thisQuarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may CLEARPOINTNEURO, INC.Condensed Consolidated Balance Sheets(in thousands, except for share and per share data) CLEARPOINT NEURO, INC.Condensed Consolidated Statements of Operations(Unaudited) CLEARPOINT NEURO, INC.Condensed Consolidated Statements of Cash Flows(Unaudited)(in thousands) •During the three months ended March 31, 2025, the Company recorded net transfers of ClearPoint reusable componentshaving an aggregate net book value of$0.2millionbetween loaned systems, which are included in property and equipmentin the accompanying condensed consolidated balance sheets, and inventory. The balance of such transfers during the three Description of the Business and Financial Condition 1. ClearPoint Neuro, Inc. (the “Company”) is a commercial-stage medical device company focused on the development andcommercialization of innovative platforms for performing minimally invasive surgical procedures in the brain. From theCompany’s inception in 1998, the Company has deployed significant resources to fund its efforts to develop the capabilities forenabling neurosurgery interventions, building an intellectual property portfolio, and identifying and building out commercialapplications for the technologies it develops. In 2021, the Company’s efforts expanded beyond the MRI suite to encompass Since 2021, a growing part of the Company’s revenue is derived from consulting services to pharmaceutical and biotechcompanies, academic institutions, and contract research organizations having a focus on biologics and drug delivery. TheCompany’s services include protocol consultation and solutions for pre-clinical study design and execution for the delivery ofpharmaceutical agents to the brain.Currently, the Company has more than60biologics and drug delivery customers who areevaluating or using its products and services in trials to inject gene and cell therapies directly into the brain. These relationshipsinvolve drug development programs that are at various stages of development ranging from preclinical research to late-stage Macroeconomic Trends The Company continues to monitor the impacts of various macroeconomic trends, such as inflationary pressure, changes inmonetary policy, decreasing consumer confidence and spending, the introduction of or changes in tariffs or trade barriers, andglobal or local recession. Such changes in domestic and global macroeconomic conditions may lead to increased costs for thebusiness. Additionally, these macroecono