UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or O ...

Part I [Business](index=7&type=section&id=Item%201.%20Business) ClearPoint Neuro develops MRI-guided neuro-navigation platforms for minimally invasive brain surgeries, emphasizing recurring revenue from high-margin disposable products - The company's core business is the ClearPoint system, a neuro-navigation platform for minimally invasive brain surgeries performed under MRI guidance, primarily for deep brain stimulation (DBS) electrode placement and laser catheter insertion[35](index=35&type=chunk)[36](index=36&type=chunk)[39](index=39&type=chunk) - A key growth area is the biologics and drug delivery segment, where its SmartFlow cannula is used by approximately **25 pharmaceutical partners** in clinical trials to deliver therapies directly to the brain, bypassing the blood-brain barrier[37](index=37&type=chunk)[45](index=45&type=chunk)[74](index=74&type=chunk) - The business model focuses on generating recurring revenue from high-margin disposable components, with reusable hardware sold at lower margins or placed under evaluation programs to drive adoption and use of disposables[66](index=66&type=chunk) - As of March 18, 2021, the company had **67 full-time employees**, with **22 in R&D**, **27 in sales/clinical support**, **13 in manufacturing/QA**, and **5 in administration**[144](index=144&type=chunk) - The company holds a significant intellectual property portfolio with **65 U.S. patents** and over **30 U.S. patent applications**, either wholly-owned, co-owned, or licensed[78](index=78&type=chunk) - Customer concentration is notable, with the five largest hospital customers accounting for **35% of functional neurosurgery disposable revenue** in 2020, and one biologics/drug delivery partner accounting for **60% of that segment's revenue**[73](index=73&type=chunk)[74](index=74&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including COVID-19 impacts, market acceptance, supply chain reliance, customer concentration, historical losses, competition, and regulatory hurdles - The COVID-19 pandemic poses a significant risk by causing the postponement or cancellation of elective surgical procedures, which historically represent approximately **80% of the procedures** using the ClearPoint system[147](index=147&type=chunk) - The company faces market acceptance risk, as physicians and hospitals may be slow to adopt the ClearPoint system due to the procedural shift from the operating room to the MRI suite, cost considerations, and existing practice patterns[150](index=150&type=chunk) - Significant customer concentration exists, with one pharmaceutical customer accounting for **28% of total revenues** in 2020, and the five largest hospital customers representing approximately **36% of functional neurosurgery navigation revenues**[162](index=162&type=chunk) - The company has a history of incurring losses since its inception in 1998, with a cumulative net loss of approximately **$120 million** through December 31, 2020, and may require additional funding to sustain operations[188](index=188&type=chunk)[191](index=191&type=chunk) - Reliance on single-source suppliers for many components of the ClearPoint system creates risks related to pricing, availability, quality, and potential production disruptions[166](index=166&type=chunk)[167](index=167&type=chunk) - The medical device market is highly competitive, with competition from large, well-established companies like Medtronic, Brainlab, and Zimmer Biomet that have substantially greater financial and marketing resources[90](index=90&type=chunk)[181](index=181&type=chunk) [Unresolved Staff Comments](index=44&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - Not applicable[282](index=282&type=chunk) [Properties](index=44&type=section&id=Item%202.%20Properties) The company's principal executive office and operations are located in a leased facility of approximately 7,400 square feet in Irvine, California, with the lease expiring in September 2023 - The company leases approximately **7,400 square feet** of space in Irvine, California, for its principal executive office and operations, with the lease expiring in September 2023[283](index=283&type=chunk) [Legal Proceedings](index=44&type=section&id=Item%203.%20Legal%20Proceedings) The company states that it is not aware of any material pending legal proceedings to which it is a party - The company is not aware of any material pending legal proceedings[284](index=284&type=chunk) [Mine Safety Disclosures](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[285](index=285&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=45&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) ClearPoint Neuro's common stock trades on Nasdaq under "CLPT", with 20.7 million shares outstanding, and no plans for future cash dividends - The company's common stock is traded on the Nasdaq Capital Market under the symbol "**CLPT**"[289](index=289&type=chunk) - As of March 18, 2021, there were **20,672,779 shares** of common stock outstanding[289](index=289&type=chunk) - The company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future[290](index=290&type=chunk) [Selected Financial Data](index=45&type=section&id=Item%206.%20Selected%20Financial%20Data) This item is not applicable as per the report - Not applicable[292](index=292&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenues increased 14% to $12.8 million in 2020, driven by service revenue growth, leading to a $6.8 million net loss, with liquidity significantly improved by financing Comparison of Financial Results (Years Ended Dec 31) | Metric (in thousands) | 2020 | 2019 | % Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$12,829** | **$11,217** | **14%** | | Product Revenues | $8,789 | $9,796 | (10)% | | Service Revenues | $4,040 | $1,421 | 184% | | **Gross Margin** | **71%** | **65%** | **-** | | R&D Costs | $4,686 | $2,810 | 67% | | **Net Loss** | **$(6,782)** | **$(5,540)** | **22%** | - The decrease in product revenue was primarily due to the COVID-19 pandemic, which caused postponement of elective surgeries that historically represent about **80% of ClearPoint system case volume**[298](index=298&type=chunk)[327](index=327&type=chunk) - Biologics and drug delivery revenues grew **109% to $5.0 million**, driven by a **302% increase in service revenue** from a related-party customer supporting their clinical trials[328](index=328&type=chunk) - The company's cash position increased significantly to **$20.1 million** at year-end 2020 from **$5.7 million** in 2019, primarily due to net proceeds of **$24.3 million** from the issuance of secured convertible notes[338](index=338&type=chunk)[354](index=354&type=chunk) - Net cash used in operating activities increased to **$7.8 million** in 2020 from **$2.8 million** in 2019[348](index=348&type=chunk) - Subsequent to year-end, in February 2021, the company completed a public offering with net proceeds of approximately **$46.8 million**, further strengthening its capital resources[345](index=345&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable as per the report - Not applicable[359](index=359&type=chunk) [Financial Statements and Supplementary Data](index=54&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for 2020 and 2019, noting a significant $46.8 million public offering in February 2021 Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $20,099 | $5,696 | | Total Assets | $29,518 | $11,927 | | Total Liabilities | $27,141 | $7,341 | | Total Stockholders' Equity | $2,377 | $4,586 | Consolidated Statement of Operations Highlights (in thousands) | Account | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2019 | | :--- | :--- | :--- | | Total Revenues | $12,829 | $11,217 | | Operating Loss | $(6,220) | $(4,594) | | Net Loss | $(6,782) | $(5,540) | | Net Loss Per Share | $(0.43) | $(0.42) | - A significant subsequent event occurred on February 23, 2021, when the company completed a public offering of common stock, raising net proceeds of approximately **$46.8 million**[569](index=569&type=chunk)[570](index=570&type=chunk) - In January and December 2020, the company issued secured convertible notes for aggregate proceeds of approximately **$24.3 million**, net of costs[341](index=341&type=chunk)[453](index=453&type=chunk)[454](index=454&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=54&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[361](index=361&type=chunk) [Controls and Procedures](index=55&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2020, management concluded the company's disclosure controls and internal control over financial reporting were effective, with no material changes - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2020[363](index=363&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2020[365](index=365&type=chunk) - No material changes in internal control over financial reporting were identified during the year ended December 31, 2020[367](index=367&type=chunk) [Other Information](index=55&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[369](index=369&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=56&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2021 annual meeting proxy statement - Information is incorporated by reference from the definitive proxy statement to be filed for the 2021 annual meeting of stockholders[372](index=372&type=chunk) [Executive Compensation](index=56&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation information is incorporated by reference from the 2021 annual meeting proxy statement - Information is incorporated by reference from the definitive proxy statement to be filed for the 2021 annual meeting of stockholders[375](index=375&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=56&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership details for beneficial owners and management are incorporated by reference from the 2021 annual meeting proxy statement - Information is incorporated by reference from the definitive proxy statement to be filed for the 2021 annual meeting of stockholders[376](index=376&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=56&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2021 annual meeting proxy statement - Information is incorporated by reference from the definitive proxy statement to be filed for the 2021 annual meeting of stockholders[377](index=377&type=chunk) [Principal Accounting Fees and Services](index=56&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Principal accounting fees and services information is incorporated by reference from the 2021 annual meeting proxy statement - Information is incorporated by reference from the definitive proxy statement to be filed for the 2021 annual meeting of stockholders[378](index=378&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=57&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides a comprehensive list of financial statements, schedules, and exhibits filed with the Form 10-K report - This item lists the financial statements filed under Item 8 and provides a detailed index of all exhibits filed with the annual report[381](index=381&type=chunk)[383](index=383&type=chunk)

Financial Data and Key Metrics Changes - ClearPoint Neuro reported total revenues of $12.8 million for the year ended December 31, 2020, a 14% increase from $11.2 million in 2019 [8] - The company achieved a gross margin of 71% in 2020, up from 65% in 2019, primarily due to a shift towards higher-margin service revenues [12] - Cash and cash equivalents increased to $20.1 million at the end of December 2020, compared to $5.7 million at the end of 2019, largely due to the issuance of senior secured convertible notes [18] Business Line Data and Key Metrics Changes - Functional neurosurgery navigation and therapy revenue decreased by 12% to $6.3 million in 2020 from $7.1 million in 2019, impacted by COVID-19 [9] - Biologics and drug delivery revenue surged by 109% to $5 million in 2020, up from $2.4 million in 2019, driven by a 302% increase in biologics and drug delivery services [10] - Capital equipment revenue fell by 10% to $1.5 million in 2020 compared to $1.7 million in 2019, as many hospitals postponed capital equipment acquisitions due to the pandemic [11] Market Data and Key Metrics Changes - The company expects to return to pre-COVID case volumes in the second half of 2021, as hospitals begin to reopen and schedule cases again [26] - Case volume for Q1 of 2021 is projected to be between 190 to 200 cases, an increase from 175 cases in Q4 2020 [26] Company Strategy and Development Direction - ClearPoint Neuro is focused on a four-pillar growth strategy, which includes expanding its biologics and drug delivery services, enhancing functional neurosurgery navigation, developing therapeutic programs, and pursuing global expansion [20][33] - The company aims to innovate with a cadence of annual product releases, including a next-generation SmartFrame Array and partnerships with Blackrock Microsystems and Philips [27][29] - ClearPoint is also looking to facilitate earlier engagement with pharma partners to enhance service revenue potential [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about returning to pre-COVID case volumes and highlighted the importance of the rapid deployment of vaccines [5] - The company noted that while COVID-19 has impacted case volumes, it has also provided opportunities to develop new partnerships and expand service offerings [6][21] - Management anticipates multiple new clinical trials to be initiated in 2021 as COVID-19 fears subside [22] Other Important Information - Research and development costs increased by 67% to $4.7 million in 2020, reflecting investments in personnel and collaborative research [12] - Sales and marketing expenses rose by 13% to $5.4 million in 2020, primarily due to increased compensation costs [13] Q&A Session Summary Question: Additional color on the move into the operating room and margin profile differences - Management clarified that not all procedures will migrate to the operating room, and the focus will be on simpler procedures where less troubleshooting is needed [37] Question: Insights on the Philips Maestro brain model partnership - The new system is expected to significantly reduce analysis time from 14-20 minutes to under 1 minute, enhancing peri-procedural applications [44] Question: Overhead expectations for expanding biologics and drug delivery segment - Management indicated that they will partner with existing companies for translational services rather than building in-house capabilities [48] Question: Potential for negotiating royalties in clinical trials - Management confirmed they are exploring opportunities for milestone payments and royalties in early-stage partnerships [71] Question: Barriers to increasing DBS market penetration - Management identified patient anxiety about awake procedures as a significant barrier and emphasized the need for education on advancements in technology [80]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q3 2020 Earnings Conference Call November 11, 2020 4:30 PM ET Company Participants Joe Burnett - Chief Executive Officer Harold Hurwitz - Chief Financial Officer Conference Call Participants Andrew D'Silva - B. Riley FBR Sall Yanchus - Brookline Capital Markets Henry Melon - Melon Group LLC Operator Greetings and welcome to ClearPoint Neuro's 2020 Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-ans ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or Othe ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q2 2020 Results Conference Call August 12, 2020 4:30 PM ET Company Participants Joe Burnett - CEO Harold Hurwitz - CFO Conference Call Participants Sall Yanchus - Brookline Capital Markets Andrew D'Silva - B. Riley FBR Operator Greetings, and welcome to ClearPoint Neuro’s Second Quarter and Six Months 2020 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. [Opera ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to _____ Commission file number: 001-34822 ClearPoint Neuro, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 58-2394628 (State or Oth ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________ FORM 10-K ___________________________ ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______. Commission File Number: 001-34822 CLEARPOINT NEURO, INC. (Exact name of registrant as specified in i ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q4 2019 Earnings Conference Call February 12, 2020 4:30 PM ET Company Participants Joseph Burnett - Chief Executive Officer Harold Hurwitz - Chief Financial Officer Conference Call Participants Brandon Hedgepath - RTM Capital Advisors Operator Greetings. Welcome to the ClearPoint Neuro Incorporated Fourth Quarter and Fiscal Year 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the ...