ClearPoint Neuro, Inc. (CLPT) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.15. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -46.67%. A quarter ago, it was expected that this company would post a loss of $0.15 per share when it actually produced a loss of $0.20, delivering a surprise of -33.33%.Over the last four quarters, the company has ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $8.5 million, an 11% increase from $7.6 million in Q1 2024 [7] - Gross margin improved to 60%, up from 59% in Q1 2024 [10] - Cash and cash equivalents decreased to $12.4 million from $20.1 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 9% to $4.7 million, driven by a $1.2 million increase in product revenue [8] - Neurosurgery Navigation revenue surged 70% to $3.3 million, attributed to higher sales of new product offerings [9] - Capital Equipment and Software revenue fell 63% to $500,000 due to fewer new placements of navigation and laser units [10] Market Data and Key Metrics Changes - The company activated two new sites in Q1 2025, which were both capital placements [51] - The introduction of the three point zero navigation software has allowed expansion into operating rooms, enhancing market reach [14] Company Strategy and Development Direction - The company aims to extend its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4] - Plans to evolve the product portfolio to focus on fast, simple, and predictable workflows to increase hospital efficiency [5] - The company is pursuing global scale by expanding its installed base and generating more access to its ecosystem [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for additional cell and gene therapy platforms to gain approvals in the next two years [16] - The recent partnership with Overland Capital provides the company with the necessary funding to execute its strategy [6] - Management anticipates that operational cash burn will continue to increase but expects to generate meaningful cash flow as new drugs come online [31] Other Important Information - The company has implemented a Pathfinder subscription program to smooth capital revenue recognition over time [22] - The three point zero navigation software has been well received, with positive feedback from surgeons regarding efficiency and accuracy [18] Q&A Session Questions and Answers Question: Are there initiatives that can be prioritized now with access to incremental capital? - Management confirmed that there are opportunities to accelerate hiring and expand preclinical resources in response to partner requests [29] Question: How does the new capital runway relate to achieving sustained breakeven? - Management believes the new debt facility can support the company towards cash breakeven, especially with the flexibility of an interest-only period [31] Question: How is the neuro franchise tracking relative to expectations? - Management stated that the neuro franchise is on plan and expects significant growth throughout the year, with potential upside from new product launches [34] Question: What is the expected mix of MRI versus OR procedures in the future? - Management indicated that while MRI procedures currently dominate, there is potential for OR procedures to grow faster as new therapies are introduced [40] Question: What is the status of GLP certification and customer interest? - Management confirmed that they are on track for GLP certification by the end of the year and noted strong interest from pharma partners for studies once certified [42][46]

Financial Performance - Total revenue for Q1 2025 was $8.485 million, a 11.1% increase from $7.639 million in Q1 2024[20] - Product revenue increased to $5.291 million in Q1 2025, up 45.5% from $3.635 million in Q1 2024[20] - Gross profit for Q1 2025 was $5.132 million, compared to $4.525 million in Q1 2024, reflecting a gross margin improvement[20] - Net loss for Q1 2025 was $6.026 million, compared to a net loss of $4.146 million in Q1 2024, indicating increased operational costs[20] - Total revenue for the three months ended March 31, 2025, was $8.485 million, an increase of 11.1% compared to $7.639 million for the same period in 2024[71] Research and Development - Research and development costs rose to $3.379 million in Q1 2025, up 28.8% from $2.625 million in Q1 2024[20] - Research and development share-based compensation increased to $484,000 in Q1 2025, up from $337,000 in Q1 2024, reflecting a 43.7% rise[94] Cash and Liquidity - Cash and cash equivalents decreased to $12.387 million at the end of Q1 2025 from $20.104 million at the end of Q4 2024[25] - Cash and cash equivalents were $12.4 million as of March 31, 2025, down from $20.1 million at December 31, 2024, reflecting a decrease of 38.3%[78] - The company has evaluated its ability to continue as a going concern and determined that existing cash balances are sufficient to support operations for at least the next twelve months[34] Assets and Liabilities - Total assets decreased to $30.070 million as of March 31, 2025, down from $39.189 million as of December 31, 2024[18] - Total liabilities decreased to $10.083 million as of March 31, 2025, down from $13.800 million as of December 31, 2024[18] Customer and Revenue Recognition - The company recognizes revenue primarily from product sales, including neurosurgery navigation products and service revenue from development services and consultation[43] - As of March 31, 2025, one customer accounted for 12% of accounts receivable, while two customers represented 24% of accounts receivable as of December 31, 2024[61] - A pharmaceutical customer accounted for 9% of total sales for the three-month periods ended March 31, 2025, and 2024[62] - The company recognized approximately $0.8 million of revenue from deferred revenue during the three months ended March 31, 2025[75] Offerings and Financing - The company completed a follow-on public offering in March 2024, raising approximately $16.2 million from the sale of 2,653,848 shares of common stock[36] - The company has an At-the-Market Equity Offering Sales Agreement allowing for the sale of up to $50 million in common stock, but no shares have been issued under this agreement as of March 31, 2025[36] - The company repaid the remaining $10 million under a Securities Purchase Agreement in August 2024, which had raised gross proceeds of $25 million[37] - The company completed a public offering in March 2024, raising net proceeds of approximately $16.2 million from the sale of 2,653,848 shares at a price of $6.50 per share[91] - The company has not issued any shares under the At-The-Market (ATM) Agreement, which allows for sales of up to $50 million in common stock[92] - The company may sell notes up to an aggregate principal amount of $105 million under a note purchase agreement, with a minimum interest rate of 8.25%[106] Inventory and Deferred Revenue - Inventory totaled $6.689 million as of March 31, 2025, compared to $6.966 million at December 31, 2024, a decline of 4.0%[80] - Deferred revenues decreased to $1.975 million as of March 31, 2025, down from $2.557 million at December 31, 2024, indicating a reduction of 22.7%[75] - The company expects to recognize approximately 79% of the remaining performance obligations, valued at $1.7 million, over the next twelve months[76] Stock and Compensation - Share-based compensation expense for Q1 2025 totaled $1,908,000, an increase of 27% from $1,504,000 in Q1 2024[94] - The total unrecognized compensation expense as of March 31, 2025, is $13,499,000, with a weighted-average recognition period of 1.99 years[96] - The company has 1,352,615 stock options outstanding as of March 31, 2025, with an average exercise price of $6.16 and an intrinsic value of $8,897,000[97] - Restricted Stock Units (RSUs) granted in Q1 2025 totaled 541,771, with an average grant date fair value of $13.55[100] Business Operations - The company operates in one reportable segment, primarily generating revenue in the United States[101] - The company has not recorded significant foreign currency sales and does not currently engage in hedging transactions[158] - The company has over 60 biologics and drug delivery customers currently evaluating or using its products and services[32] - The ClearPoint Prism Neuro Laser Therapy System was commercialized in 2022, marking a significant product development milestone[31] Accounting Standards - The company is currently evaluating the impact of new accounting standards on its consolidated financial statements, including ASU 2023-07 and ASU 2023-09[65][68]

Exhibit 99.1 Business Outlook The Company reaffirms its full year 2025 revenue outlook between $36.0 million and $41.0 million. Financial Results – Quarter Ended March 31, 2025 ClearPoint Neuro Reports First Quarter 2025 Results Record Revenue Highlighted by 70% Growth in Single-Use Navigation and Therapy Products SOLANA BEACH, CA, May 13, 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, ...

Shares of ClearPoint Neuro, Inc. (CLPT) have gained 18.2% over the past four weeks to close the last trading session at $13.64, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $27.67 indicates a potential upside of 102.9%.The average comprises three short-term price targets ranging from a low of $25 to a high of $30, with a standard deviation of $2.52. While the lowest estimate ...

Group 1 - ClearPoint's share price has been volatile, but there is a steady flow of positive news regarding its business fundamentals [1] - Richard Durant leads Narweena, an asset manager focused on identifying market dislocations due to poor long-term business prospects understanding [1] - Narweena aims for excess risk-adjusted returns by targeting businesses with secular growth opportunities in markets with barriers to entry [1] Group 2 - Narweena's research emphasizes company and industry fundamentals to uncover unique insights, with a high risk appetite and long-term investment horizon [1] - The firm focuses on smaller cap stocks and markets where competitive advantages are not immediately apparent [1] - An aging population with low growth and stagnating productivity is expected to create new investment opportunities, contrasting with past trends [1] Group 3 - Many industries may face stagnation or secular decline, potentially improving business performance due to reduced competition [1] - Other businesses may encounter rising costs and diseconomies of scale, affecting their performance negatively [1] - The economy is increasingly dominated by asset-light businesses, leading to a declining need for infrastructure investments over time [1] Group 4 - A large pool of capital is pursuing a limited set of investment opportunities, resulting in rising asset prices and compressed risk premia [1] - Richard Durant holds undergraduate degrees in engineering and finance and an MBA, and has passed the CFA exams [1]

Group 1 - ClearPoint's fourth quarter results were somewhat soft, which is not surprising given that many of the company's growth initiatives are still ramping [1] - Guidance for ClearPoint was also weak, partly due to the timing of events [1] Group 2 - Narweena, an asset manager led by Richard Durant, focuses on finding market dislocations resulting from a poor understanding of long-term business prospects [1] - Narweena believes excess risk-adjusted returns can be achieved by identifying businesses with secular growth opportunities in markets with barriers to entry [1] - The research process at Narweena is centered on company and industry fundamentals to uncover unique insights [1] Group 3 - Narweena has a high risk appetite and a long-term investment horizon, targeting deeply undervalued stocks, particularly in smaller cap stocks and markets with less obvious competitive advantages [1] - The firm anticipates that an aging population with low growth and stagnating productivity will create new investment opportunities [1] - Many industries may face stagnation or secular decline, which could paradoxically enhance business performance due to reduced competition [1] Group 4 - There is a trend of increasing dominance of asset-light businesses, leading to a declining need for infrastructure investments over time [1] - A large pool of capital is pursuing a limited set of investment opportunities, resulting in rising asset prices and compressed risk premia [1] Group 5 - Richard Durant holds undergraduate degrees in engineering and finance from the University of Adelaide and an MBA from Nanyang Technological University [1] - Durant has passed the CFA exams, indicating a strong background in finance [1]

ClearPoint Neuro, Inc. (NASDAQ:CLPT) Q4 2024 Earnings Conference Call February 26, 2025 4:30 PM ET Company Participants Joe Burnett - CEO Danilo D'Alessandro - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Markets Anderson Schock - B. Riley Securities Operator Greetings. Welcome to ClearPoint Neuro, Inc. Fourth Quarter and Full Year 2024 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Opera ...

ClearPoint Neuro, Inc. (CLPT) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.15. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -33.33%. A quarter ago, it was expected that this company would post a loss of $0.17 per share when it actually produced a loss of $0.18, delivering a surprise of -5.88%.Over the last four quarters, the company has ...

Product Development and Innovation - The ClearPoint system is an integrated system for neurosurgical applications, with over 90 centers globally utilizing its technology[24]. - The ClearPoint Prism Neuro Laser Therapy System was commercialized in 2022, developed and manufactured by CLS, with exclusive global rights for neuro applications[28]. - The SmartFrame Array Neuro Navigation System was launched in 2021, allowing for operating room placement of the ClearPoint system[27]. - In 2022, the ClearPoint Maestro Brain Model software received FDA approval, automating the identification and quantification of brain structures in MRI images[36]. - The ClearPoint Prism Neuro Laser Therapy System is indicated for soft tissue necrosis or coagulation under 3.0T MRI guidance, enhancing treatment precision[37]. - The SmartFlow cannula received 510(k) clearance for various applications, including the injection of Cytarabine and removal of cerebrospinal fluid, and was granted De Novo marketing authorization for AADC deficiency treatment[40]. - The SmartFrame OR Stereotactic System obtained 510(k) clearance in 2024, intended for stereotactic guidance in neurological procedures[42]. - The ClearPoint system received 510(k) clearance from the FDA for general neurosurgical procedures, allowing marketing in the U.S. and similar approvals in the EU, UK, Israel, Taiwan, Turkey, and Brazil[39]. - The SmartFlow cannula was granted De Novo marketing authorization in 2024 for AADC deficiency treatment, indicating a significant advancement in product offerings[44]. - The company has focused on developing its intellectual property portfolio and commercial applications since its inception in 1998[24]. Market Potential and Revenue - The market potential for the biologics and drug delivery segment is estimated to be approximately $7 billion, dependent on maintaining relationships with pharmaceutical customers[30]. - The company estimates over 140,000 potential neurosurgical procedures annually in the U.S. where ClearPoint products could be utilized[44]. - The ClearPoint business model focuses on high-margin revenue from disposable product sales, with reusable components sold at lower margins to secure hospital installations[45]. - Approximately 31% of neurosurgery navigation disposable product revenues in 2024 came from the five largest hospital customers[52]. - The company has commercial relationships with over 60 pharma/biotech partners, contributing to its biologics and drug delivery revenues[53]. - ClearPoint's revenue from preclinical development services has been growing significantly since 2021, contributing to its overall business[29]. Regulatory Compliance and Challenges - The company is subject to extensive regulation by the FDA, which includes premarket clearance and approval requirements for its medical devices[73]. - The company must comply with stringent quality management system regulations (QMSR) to maintain compliance with FDA and other regulations[92]. - The company is required to report any incidents involving its products that may have caused or contributed to serious injuries or deaths[89]. - The company faces potential enforcement actions from regulatory authorities for non-compliance, which could result in significant penalties[94]. - The company must navigate varying international regulations for medical device approvals, which can differ substantially from U.S. requirements[94]. - The Medical Devices Regulation (Regulation 2017/745) went into effect in May 2021, establishing a uniform regulatory framework across the EU for medical devices[101]. Competition and Market Position - The company faces significant competition from larger firms such as Medtronic and Brainlab in the medical device industry for neurosurgical applications[71]. - The medical device industry is highly competitive, with significant competition from companies like Monteris Medical, Medtronic, and others offering similar neurosurgical devices[71]. - The company focuses on image-guided drug delivery, facing competition from firms like Brainlab and Renishaw, which have greater resources[72]. Partnerships and Collaborations - The company has over 60 partners in pharma/biotech and academic sectors involved in trials for gene and cell therapies[30]. - The company entered into a multi-year license agreement with UCB in March 2023 for drug delivery platforms related to UCB's gene therapy portfolio, with success-based milestone fees[63]. - The company has expanded its collaboration with Philips to include additional technology for CT imaging and subnuclei segmentation in 2023[62]. - The company entered into a new license agreement with UCSF in 2023 to develop a radially branching cellular delivery device, committing to pay royalties based on future sales[66]. - The company has several software license arrangements for products like ClearPoint Software, committing to pay royalties for each copy sold or loaned[68]. Financial Performance and Employee Management - The company has incurred losses since inception and may continue to do so, indicating potential challenges in achieving profitability[23]. - The reliance on single-source suppliers poses risks to meeting product demand and could impact revenue[21]. - The company had 115 full-time employees as of February 18, 2025, with no employees covered by collective bargaining agreements[137]. - The company emphasizes cultural fit and energy in recruiting, aiming to provide market-based compensation to retain employees[137]. - New employees receive industry-relevant compliance training and are introduced to the company's Code of Business Conduct and Ethics[137].