UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or o 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) Q2 2023 Earnings Conference Call August 8, 2023 4:30 PM ET Company Participants Joe Burnett - Chief Executive Officer Danilo D'Alessandro - Chief Financial Officer Conference Call Participants Nelson Cox - Lake Street Capital William Wood - B. Riley Operator Greetings, and welcome to the ClearPoint Neuro, Inc. Second Quarter 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. Comments made on this call may inc ...

• Functional neurosurgery navigation and therapy services: The Company recognizes revenue for such services at the point in time that the performance obligation has been satisfied. • Biologics and drug delivery services and other revenue: ◦ Consultation Services: The Company recognizes consultation revenue over time as the services are delivered to the customer based on the extent of progress towards completion of the performance obligation. ◦ Clinical Service Access Fees: For contracts in which the Company ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q1 2023 Results Conference Call May 11, 2023 4:30 PM ET Company Participants Joe Burnett - CEO Danilo D'Alessandro - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Operator Greetings, and welcome to the ClearPoint Neuro Inc. First Quarter 2023 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 [Operator Instructions]. Comments made on this c ...

FORM 10-Q Commission file number: 001-34822 Securities registered pursuant to Section 12(b) of the Act: Large accelerated filer o Accelerated filer ☐ Non-accelerated filer þ Smaller reporting company þ Emerging growth company o TABLE OF CONTENTS This Quarterly Report contains "forward-looking statements" as defined under the United States federal securities laws. The forwardlooking statements relate to our expectations for performance, revenues and costs, and the adequacy of cash and cash equivalent balance ...

Financial Data and Key Metrics Changes - ClearPoint Neuro reported total revenues of $20.6 million for the year ended December 31, 2022, representing a 26% increase from $16.3 million in 2021 [11] - Gross margin for the full year 2022 was 66%, down from 68% in 2021, primarily due to increased indirect labor costs and higher inventory reserves [28] - Net interest expense decreased to $0.1 million in 2022 from $1 million in 2021 due to the conversion of convertible debt into equity [30] Business Line Data and Key Metrics Changes - Functional neurosurgery navigation revenue increased 13% to $9.1 million in 2022 from $8.1 million in 2021 [12] - Biologics and drug delivery revenue rose 34% to $9.1 million in 2022, up from $6.8 million in 2021, driven by increased commitments from existing partners and new pharmaceutical partners [27] - Capital equipment and software revenue increased 61% to $2.3 million in 2022 compared to 2021 [28] Market Data and Key Metrics Changes - The company ended 2022 with cash, cash equivalents, and short-term investments of $37.5 million, down from $54.1 million at the end of 2021, primarily due to operating cash needs [33] - The company expects revenue in the range of $25 million to $27 million for 2023, representing growth between 21% and 31% year-over-year [58] Company Strategy and Development Direction - The company is focused on a four-pillar growth strategy, which includes biologics and drug delivery, functional neurosurgery navigation, therapy and access products, and achieving global scale [25] - The company plans to continue adding new partners in 2023, aiming to achieve more than 20% growth across all four growth pillars [25][40] - A new 20,000 square foot manufacturing and development facility in Carlsbad, California, is expected to be operational by the end of 2023, aimed at improving product flow and margin [39] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging global environment but emphasized their commitment to helping patients and executing their growth strategy [6] - The company anticipates achieving operational cash breakeven by the fourth quarter of 2025 and full-year cash breakeven in 2026, contingent on maintaining patient demand and timely product launches [43] - Management noted that the cancellation and postponement rates for procedures have been elevated, currently sitting in the 25% to 28% range, compared to historical rates of 10% to 15% [82] Other Important Information - Research and development costs increased to $10.9 million in 2022 from $9.3 million in 2021, primarily due to personnel costs and regulatory fees [13] - Sales and marketing expenses rose to $9.4 million in 2022 from $7.2 million in 2021, driven by increased personnel costs and marketing activities [29] Q&A Session Summary Question: What is the status of clinical trials and their potential revenue impact? - Management indicated that several trials are expected to continue in 2023, particularly in rare childhood genetic disorders, which may require less rigorous protocols [45][46] Question: How has the initial commercial launch of the laser therapy system been received? - Feedback has been strong, with initial cases performed under clinical trial protocols in Europe showing positive results [48] Question: What are the expectations for revenue growth across different segments in 2023? - Management expects biologics and drug delivery to be the largest growth contributor, with functional neurosurgery and capital software also experiencing growth in the 15% to 20% range [74]

• properly identify and anticipate customer needs; • identify, retain, and manage third-party design and development firms, where appropriate, to accelerate development; • develop and introduce new products or services in a timely manner; • adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties; • obtain and retain third-party licenses required for the development, commercialization, and/or utilization of new products; • demonstrate the safet ...

●● ..... ..... ●● CLEARPOINT® NEURO WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY." Nasdaq: CLPT November 2022 Statements herein 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, as well as management's expectations, beliefs, pl ...

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q3 2022 Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Joe Burnett - CEO Danilo D’Alessandro - CFO Conference Call Participants William Wood - B. Riley Frank Takkinen - Lake Street Capital Operator Greetings, and welcome to the ClearPoint Neuro, Inc. Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator In ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 Or o 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 Registran ...