Company Performance - ClearPoint Neuro (NASDAQ: CLPT) reported solid second quarter results, with expansion in all segments [1] - Some investors may find the results disappointing due to modest system placements and ongoing losses, but this is not seen as particularly concerning [1] Investment Strategy - Narweena, an asset manager led by Richard Durant, focuses on identifying market dislocations caused by poor long-term business prospects [1] - The firm aims for excess risk-adjusted returns by targeting businesses with secular growth opportunities in markets with barriers to entry [1] - Narweena's research emphasizes company and industry fundamentals to uncover unique insights, with a high risk appetite and long-term investment horizon [1] Market Trends - An aging population with low growth and stagnating productivity is expected to create new investment opportunities, differing from past trends [1] - Many industries may face stagnation or secular decline, which could paradoxically enhance business performance due to reduced competition [1] - The economy is increasingly dominated by 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]

Financial Performance - ClearPoint Neuro reported a quarterly loss of $0.21 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.20, and compared to a loss of $0.16 per share a year ago, indicating a negative earnings surprise of -5.00% [1] - The company posted revenues of $9.22 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 3%, but showing an increase from $7.86 million in the same quarter last year [2] - ClearPoint Neuro has not surpassed consensus EPS estimates over the last four quarters, and has topped consensus revenue estimates only twice during that period [2] Stock Performance - ClearPoint Neuro shares have declined approximately 31.1% since the beginning of the year, contrasting with the S&P 500's gain of 8.4% [3] - The current Zacks Rank for ClearPoint Neuro is 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $10.2 million, and for the current fiscal year, it is -$0.76 on revenues of $39.4 million [7] - The outlook for the Medical - Instruments industry, where ClearPoint Neuro operates, is currently in the bottom 41% of over 250 Zacks industries, which may impact the stock's performance [8]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $9.2 million, representing a 17% increase from $7.9 million in Q2 2024 [8][10] - Gross margin decreased to 60% in Q2 2025 from 63% in Q2 2024, primarily due to higher inventory reserves [10] - Operating expenses increased by 16% to $11.2 million in Q2 2025 from $9.7 million in Q2 2024 [10][11] - Cash and cash equivalents rose to $41.5 million as of June 30, 2025, compared to $20.1 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 10% to $4.7 million in Q2 2025, driven by a 12% rise in product revenue and an 8% increase in service revenue [8][9] - Neurosurgery Navigation revenue grew by 33% to $3.4 million, attributed to new product offerings and additional placements [9] - Capital Equipment and Software revenue rose by 11% to $1 million, primarily due to increased service revenue [9] Market Data and Key Metrics Changes - ClearPoint technology is now available at over 100 centers globally, with regulatory clearance in 36 countries [6][24] - The company has activated two new sites in Q2 2025 and expects to activate between 15 and 20 new sites by the end of the year [24] Company Strategy and Development Direction - The company is focused on extending its lead in cell and gene therapy through a comprehensive drug delivery ecosystem [4][5] - Plans to evolve the product portfolio to enhance hospital efficiency and throughput [5] - Aiming to expand the global installed base and generate scale for wider access to ClearPoint technology [6][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth across all business pillars, supported by a strong cash position [13][14] - The company is preparing for significant demand as new restorative therapies become available [5][14] - Management highlighted the importance of regulatory approvals and collaborations with biopharma partners for future growth [16][18] Other Important Information - The company has secured foundational funding from Oberlin Capital to support its strategic initiatives [6] - ClearPoint has submitted applications for new ICD-10 codes to assist in tracking commercial use of its technologies [18] Q&A Session Summary Question: Can you provide more details on the biologic partner opportunity and revenue contribution from Cabildy? - Management indicated that while early opportunities are significant, they are not expected to be massive revenue drivers in the near term, serving more as milestones for larger market opportunities [31][32] Question: What is the status of the ClearPoint 3.0 rollout and its impact on margins? - Management confirmed that there is currently no margin impact from ClearPoint 3.0, and the deployment has been the fastest in the company's history, with 35 sites now using the software [36][40] Question: How will MRI suite availability impact the launch of therapies? - Management discussed strategies to improve efficiency in both MRI and operating room settings to mitigate bottlenecks and enhance capacity for procedures [51][53]

[PART I – FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) The first part details ClearPoint Neuro, Inc.'s unaudited financial statements, management's discussion, market risks, and internal controls for the period ended June 30, 2025 [Item 1. Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited Q2 2025 financial statements reflect increased total assets to $62.9 million, driven by cash and a new note payable, alongside a widened net loss of $11.9 million for the six-month period [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the balance sheet shows a substantial increase in cash and total assets, accompanied by a significant rise in total liabilities due to a new long-term note payable Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $41,541 | $20,104 | | Total current assets | $53,991 | $33,363 | | Total assets | $62,869 | $39,189 | | **Liabilities & Equity** | | | | Total current liabilities | $7,398 | $10,353 | | Long-term note payable, net | $28,845 | $— | | Total liabilities | $43,126 | $13,800 | | Total stockholders' equity | $19,743 | $25,389 | | Total liabilities and stockholders' equity | $62,869 | $39,189 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q2 2025, revenue increased to $9.2 million, and for the six-month period, revenue grew to $17.7 million, though net losses widened due to higher operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $9,215 | $7,858 | $17,700 | $15,497 | | Gross profit | $5,556 | $4,988 | $10,688 | $9,513 | | Operating loss | $(5,680) | $(4,724) | $(11,843) | $(8,941) | | Net loss | $(5,837) | $(4,408) | $(11,863) | $(8,554) | | Net loss per share | $(0.21) | $(0.16) | $(0.42) | $(0.32) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $19.7 million at June 30, 2025, primarily due to the net loss, partially offset by proceeds from a registered direct offering and share-based compensation - Total stockholders' equity declined to **$19.7 million** at June 30, 2025, from **$25.4 million** at January 1, 2025, mainly due to the net loss for the period[19](index=19&type=chunk) - During the first six months of 2025, the company issued common stock through a registered direct offering, share-based compensation, option exercises, and its employee stock purchase plan[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $8.7 million for the six months ended June 30, 2025, while significant financing activities resulted in a net increase in cash of $21.6 million Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash from operating activities | $(8,724) | $(6,508) | | Net cash from investing activities | $(274) | $— | | Net cash from financing activities | $30,615 | $16,213 | | **Net change in cash** | **$21,617** | **$9,705** | | Cash, end of period | $41,541 | $32,845 | - Financing activities in the first half of 2025 were driven by net proceeds of **$28.7 million** from a new note payable and **$3.3 million** from a common stock offering[23](index=23&type=chunk)[162](index=162&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's neurosurgery and biologics business, confirm sufficient liquidity for 12 months post-financing, and provide revenue breakdowns and details on the new $105 million note purchase agreement - The company's business is focused on minimally invasive neurosurgical platforms and providing consulting services to over **60 biologics and drug delivery customers**[28](index=28&type=chunk)[29](index=29&type=chunk) - Despite a cumulative deficit of **$203.2 million**, management has determined that existing cash of **$41.5 million** is sufficient to fund operations for at least the next twelve months, supported by recent financing[31](index=31&type=chunk)[33](index=33&type=chunk) Revenue by Service Line - Six Months Ended June 30 (in thousands) | Service Line | 2025 | 2024 | | :--- | :--- | :--- | | Biologics and drug delivery | $9,430 | $8,634 | | Neurosurgery navigation and therapy | $6,709 | $4,513 | | Capital equipment and software | $1,561 | $2,350 | | **Total revenue** | **$17,700** | **$15,497** | - In May 2025, the company entered into a note purchase agreement for up to **$105.0 million**, with an initial tranche of **$30.0 million** funded, providing net proceeds of approximately **$28.7 million**[35](index=35&type=chunk)[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q2 2025 revenue growth of 17% and a 14% increase for six months, driven by neurosurgery and biologics, but notes widened net losses due to higher operating expenses, with recent financing ensuring liquidity [Overview](index=26&type=section&id=Overview) The company operates two main business lines: minimally invasive brain surgery platforms and preclinical/clinical trial support for biologics, with the latter identified as the largest growth opportunity despite a history of losses - The company's business is structured around two core areas: medical devices for neurosurgery (e.g., ClearPoint system) and services for the biologics and drug delivery space[115](index=115&type=chunk)[116](index=116&type=chunk) - The biologics and drug delivery business, with over **60 partners**, is considered the company's largest growth opportunity, contingent on partners' clinical and regulatory success[116](index=116&type=chunk)[126](index=126&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Q2 2025 revenue grew 17% to $9.2 million, driven by neurosurgery, but gross margin declined and net loss increased by 32% to $5.8 million due to higher operating expenses Q2 2025 vs Q2 2024 Performance (in thousands) | Metric | Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | Total Revenue | $9,215 | $7,858 | 17% | | Gross Profit | $5,556 | $4,988 | 11% | | Net Loss | $(5,837) | $(4,408) | 32% | - Q2 2025 revenue growth was led by a **33% increase** in Neurosurgery navigation and therapy revenue, attributed to new offerings like SmartFrame OR and Prism Laser Therapy[135](index=135&type=chunk) Six Months 2025 vs Six Months 2024 Performance (in thousands) | Metric | H1 2025 | H1 2024 | % Change | | :--- | :--- | :--- | :--- | | Total Revenue | $17,700 | $15,497 | 14% | | Gross Profit | $10,688 | $9,513 | 12% | | Net Loss | $(11,863) | $(8,554) | 39% | - The **34% increase** in G&A expenses for the first six months of 2025 was primarily due to higher bad debt expense, personnel costs, and professional service fees[151](index=151&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company bolstered its liquidity in May 2025 with $3.3 million from a stock offering and $28.7 million from a note agreement, bringing cash to $41.5 million, deemed sufficient for the next twelve months - The company's cash and cash equivalents increased to **$41.5 million** at June 30, 2025, which management deems sufficient to support operations for at least the next 12 months[158](index=158&type=chunk) - In May 2025, the company raised approximately **$3.3 million** net from a registered direct stock offering and **$28.7 million** net from an initial note issuance under a new purchase agreement[154](index=154&type=chunk)[155](index=155&type=chunk) - Net cash used in operating activities increased to **$8.7 million** for the first six months of 2025, up from **$6.5 million** in the same period of 2024, primarily due to a higher net loss and increased working capital needs[159](index=159&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its new note payable, which has a capped variable rate, while foreign currency risk is not considered material - The company's main market risk is interest rate sensitivity from its **$30.2 million** note payable, which bears a variable interest rate[166](index=166&type=chunk)[168](index=168&type=chunk) - The interest rate on the note is capped at **9.50%**, limiting the maximum potential annual interest expense increase to approximately **$0.4 million** based on the current principal balance[168](index=168&type=chunk) - Foreign currency risk is not considered material at this time due to limited transactions in currencies other than the U.S. dollar[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[171](index=171&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the quarter ended June 30, 2025[172](index=172&type=chunk) [PART II – OTHER INFORMATION](index=35&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, other information, and exhibits for ClearPoint Neuro, Inc.'s Q2 2025 report [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) A previously disclosed lawsuit was settled in August 2025, with the settlement amount expected to be covered by insurance and not anticipated to materially impact financial statements - A lawsuit involving a patient who suffered an adverse outcome was settled in August 2025[95](index=95&type=chunk) - The settlement is expected to be paid by insurance and is not anticipated to have a material impact on the company's financial condition[95](index=95&type=chunk)[174](index=174&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - No material changes have been made to the risk factors disclosed in the 2024 Form 10-K[175](index=175&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[176](index=176&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) During Q2 2025, CEO Joseph M. Burnett and Director Lynnette C. Fallon adopted Rule 10b5-1 trading arrangements in accordance with the company's insider trading policy - CEO Joseph M. Burnett and Director Lynnette C. Fallon adopted new Rule 10b5-1 trading plans on June 11, 2025[182](index=182&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report, including corporate governance documents, recent financing agreements, lease agreements, and required officer certifications - The report includes exhibits for the Stock Purchase Agreement and Note Purchase Agreement, both dated May 12, 2025[184](index=184&type=chunk) - A new lease agreement dated June 16, 2025, for a facility in San Diego, California, is also filed as an exhibit[184](index=184&type=chunk)

[Q2 2025 Financial Highlights and Business Outlook](index=1&type=section&id=ClearPoint%20Neuro%20Reports%20Second%20Quarter%202025%20Results) [Key Achievements and Strategic Update](index=1&type=section&id=Second%20Quarter%20Highlights) ClearPoint Neuro reported record Q2 2025 revenue of $9.2 million, a 17% year-over-year increase, driven by growth across all business pillars, securing up to $105 million in financing to boost cash to $41.5 million for its 'Fast. Forward.' growth strategy | Metric | Q2 2025 | YoY Change | | :--- | :--- | :--- | | **Total Revenue** | $9.2 million | +17% | | **Neurosurgery Navigation & Therapy Revenue** | $3.4 million | +33% | | **Cash and Cash Equivalents** | $41.5 million | N/A | - The company entered a new strategic phase termed 'Fast. Forward.', focusing on multiple growth vectors including expansion into the operating room, laser therapy, new geographies, and supporting Biopharma partners in late-stage clinical trials[3](index=3&type=chunk) - A significant financing deal was secured with Oberland Capital Management, providing up to **$105.0 million** through a note arrangement and an additional **$3.5 million** from a stock purchase, with an initial **$30.0 million** funded at closing[4](index=4&type=chunk) [Business Outlook](index=2&type=section&id=Business%20Outlook) The company has reaffirmed its previously stated revenue guidance for the full fiscal year 2025 - ClearPoint Neuro reaffirms its full-year 2025 revenue outlook to be between **$36.0 million** and **$41.0 million**[5](index=5&type=chunk) [Detailed Financial Performance Analysis (Q2 2025)](index=2&type=section&id=Financial%20Results%20%E2%80%93%20Quarter%20Ended%20June%2030%2C%202025) [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Total revenue for Q2 2025 increased by 17% year-over-year to $9.2 million, with Neurosurgery Navigation and Therapy revenue showing the strongest performance at 33% growth, followed by Capital Equipment and Software at 11% and Biologics and Drug Delivery at 10% [Biologics and Drug Delivery Revenue](index=2&type=section&id=Biologics%20and%20drug%20delivery%20revenue) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | $4.7 million | $4.3 million | +10% | - The increase was driven by a **$0.2 million** rise in product revenue from higher demand as partners progress in trials, and a **$0.2 million** increase in service revenue[7](index=7&type=chunk) [Neurosurgery Navigation and Therapy Revenue](index=2&type=section&id=Neurosurgery%20navigation%20and%20therapy%20revenue) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | $3.4 million | $2.6 million | +33% | - Growth was fueled by higher sales from new offerings, including SmartFrame OR, Prism Laser Therapy, and the new 3.0 operating room navigation software[8](index=8&type=chunk) [Capital Equipment and Software Revenue](index=2&type=section&id=Capital%20equipment%20and%20software%20revenue) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | $1.0 million | $0.9 million | +11% | - The increase in this segment was primarily due to a rise in service revenue[9](index=9&type=chunk) [Profitability and Expenses](index=2&type=section&id=Profitability%20and%20Expenses) Gross margin for Q2 2025 declined to 60% from 63% in the prior-year period, primarily due to higher inventory reserves, while operating expenses increased by 16% to $11.2 million, driven by higher costs in R&D and personnel as the company invests in expansion - Gross margin decreased to **60%** for Q2 2025, compared to **63%** in Q2 2024, mainly due to higher excess and obsolete inventory reserves[10](index=10&type=chunk) - Operating expenses rose **16%** to **$11.2 million**, driven by increased product development costs, higher allowance for credit losses, and increased headcount in R&D and clinical organizations[11](index=11&type=chunk) [Liquidity and Capital Resources](index=2&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash position strengthened significantly, with cash and cash equivalents reaching $41.5 million at the end of Q2 2025, more than double the $20.1 million balance at year-end 2024, primarily from $32.0 million in net proceeds from a note payable and stock offering - Cash and cash equivalents totaled **$41.5 million** as of June 30, 2025, a substantial increase from **$20.1 million** at December 31, 2024[12](index=12&type=chunk) - The increase in cash was primarily due to net proceeds of **$32.0 million** from a note payable and stock offering, partially offset by **$8.7 million** used in operating activities[12](index=12&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) For the second quarter of 2025, ClearPoint Neuro reported total revenue of $9.2 million, a gross profit of $5.6 million, an operating loss of $5.7 million, and a net loss of $5.8 million or $(0.21) per share, compared to a net loss of $4.4 million or $(0.16) per share in the prior year | (in thousands, except per share data) | For the Three Months Ended June 30, 2025 | For the Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Total revenue** | $9,215 | $7,858 | | **Gross profit** | $5,556 | $4,988 | | **Operating loss** | $(5,680) | $(4,724) | | **Net loss** | $(5,837) | $(4,408) | | **Net loss per share (Basic and diluted)** | $(0.21) | $(0.16) | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, the company's total assets significantly increased to $62.9 million from $39.2 million at year-end 2024, driven by a rise in cash to $41.5 million, while total liabilities also increased to $43.1 million due to a new long-term note payable of $28.8 million | (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $41,541 | $20,104 | | **Total current assets** | $53,991 | $33,363 | | **Total assets** | $62,869 | $39,189 | | **Long-term note payable, net** | $28,845 | $— | | **Total liabilities** | $43,126 | $13,800 | | **Total stockholders' equity** | $19,743 | $25,389 | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the first six months of 2025, the company used $8.7 million in cash for operating activities, while financing activities provided $30.6 million, primarily from a note payable and common stock offerings, resulting in a net cash increase of $21.6 million | (in thousands) | For the Six Months Ended June 30, 2025 | For the Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net cash flows from operating activities** | $(8,724) | $(6,508) | | **Net cash flows from investing activities** | $(274) | $— | | **Net cash flows from financing activities** | $30,615 | $16,213 | | **Net change in cash** | $21,617 | $9,705 | | **Cash, cash equivalents and restricted cash, end of period** | $41,721 | $32,845 | [Other Information](index=2&type=section&id=Other%20Information) [Teleconference Information](index=2&type=section&id=Teleconference%20Information) The company will host a teleconference and webcast for investors and analysts to review its Q2 2025 financial results on Tuesday, August 12, 2025, at 4:30 p.m. Eastern time, with access details for the live event and a replay provided - An investor call is scheduled for August 12, 2025, at 4:30 p.m. ET to discuss the quarterly results, with a replay available until September 11, 2025[13](index=13&type=chunk)[14](index=14&type=chunk) [About ClearPoint Neuro](index=3&type=section&id=About%20ClearPoint%20Neuro) ClearPoint Neuro focuses on enabling precise navigation to the brain and spine for device, cell, and gene therapies, offering clinical products like its FDA-cleared ClearPoint Neuro Navigation System and preclinical development services to a global customer base - ClearPoint Neuro is a device, cell, and gene therapy-enabling company that provides precise navigation to the brain and spine for both clinical procedures and preclinical development[16](index=16&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section provides a standard safe harbor statement, cautioning that statements regarding the company's future plans, growth, and financial performance are forward-looking and subject to significant risks and uncertainties, including macroeconomic conditions, regulatory changes, market acceptance of new products, and the success of its biopharma partners - The press release contains forward-looking statements concerning the company's plans, growth, and future performance, which are subject to inherent business risks and uncertainties[17](index=17&type=chunk) - Key risks identified include macroeconomic conditions, regulatory uncertainty, market acceptance for new products, and reliance on the commercial success of its biologics and drug delivery partners[17](index=17&type=chunk)

Company Overview - ClearPoint Neuro enables cell, gene, and device therapies by offering precise navigation to the brain and spine[6] - The company's platform includes clinical products for neurosurgeons and drug development services for BioPharma partners[6] - ClearPoint Neuro has built a complete drug delivery ecosystem over 15+ years[8] - The company has 100+ active global centers and 60+ partners across 20+ indications[8] Market Opportunity - The company estimates its current portfolio provides access to a ≈$500 million market opportunity[8] - ClearPoint Neuro sees a $10 billion potential diversified market[9] - Over 30 million people in the U S are estimated to suffer from severe and debilitating neurological disorders[10] - Neurological diseases cost Americans nearly $800 billion annually[10] Financial Performance - The company's 2024 revenue was $31.4 million[52] - As of June 30, 2025, the company had $41.5 million in cash and cash equivalents[52] - The company's gross margin is 60%[52] - The company's 2024 operational cash burn was ($9.0 million)[52]

Group 1 - ClearPoint Neuro's stock has faced pressure due to soft first-quarter results and additional capital raising, but strong consumables growth indicates underlying business progress [1] - System placements are highlighted as a positive aspect of ClearPoint's business performance [1] - Narweena, an asset manager, focuses on identifying market dislocations and believes in achieving excess risk-adjusted returns through 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 aging population, low population growth, and stagnating productivity growth are expected to create new investment opportunities, differing from past trends [1] - Many industries may experience stagnation or secular decline, potentially improving business performance due to decreased competition [1] Group 3 - The economy is increasingly dominated by 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] - Richard Durant, the leader of Narweena, has a strong educational background in engineering, finance, and an MBA, along with passing the CFA exams [1]

Company Overview - ClearPoint Neuro enables cell, gene, and device therapies by offering precise navigation to the brain and spine[6] - The company's platform includes clinical products for neurosurgeons and drug development services for BioPharma partners[6] - ClearPoint Neuro has built a complete drug delivery ecosystem over 15+ years, including navigation solutions, predictive modeling, delivery devices, infusion monitoring software, and clinical case support[8] - The company has 100+ active global centers and 60+ partners across 20+ indications[8] Market Opportunity - The company estimates a current portfolio provides access to a ≈$500 million market opportunity[8] - ClearPoint Neuro sees a $10 billion potential diversified market[9, 117] - Neurological diseases cost Americans nearly $800 billion annually[10] Financial Performance and Growth - The company's 2024 revenue was $31.4 million[51] - The company had $12.4 million in cash and cash equivalents as of March 31, 2025, excluding $33.5 million gross proceeds received on May 12, 2025[51, 52] - The gross margin was 61% for the trailing twelve months[51] - The company estimates 2025 revenue between $36 million and $41 million[52]

Industry Overview - The medical instruments industry is experiencing a transformative phase driven by the rapid adoption of generative artificial intelligence (genAI) and digital therapeutics, which are expected to significantly impact the healthcare sector [1] - Since early 2023, there has been mass adoption of AI and the Internet of Medical Things in digital healthcare options across hospitals and healthcare settings [1] Generative AI Impact - GenAI is demonstrating its capabilities in various healthcare fields, including administrative tasks, technological discovery, and clinical trials, by analyzing complex genetic and molecular data [2] - The technology is anticipated to enhance predictive treatment options and smart hospital systems [2] Investment Opportunities - It is advisable to invest in stocks from the Zacks-defined Medical Instrument industry that have a favorable Zacks Rank, with five selected stocks showing double-digit returns amid market volatility [3][4] Selected Stocks - **DexCom Inc. (DXCM)**: Benefiting from strong performance in the Sensor segment, with expected revenue and earnings growth rates of 14.3% and 23.2% respectively for the current year [7][8] - **IDEXX Laboratories Inc. (IDXX)**: Demonstrating robust strategic execution with expected revenue and earnings growth rates of 5.8% and 14% respectively for the current year [9][11] - **NeuroPace Inc. (NPCE)**: Focused on developing a brain-responsive neuromodulation system for treating drug-resistant focal epilepsy, with expected revenue and earnings growth rates of 18.1% and 15.1% respectively for the current year [12][13] - **Fresenius Medical Care AG (FMS)**: Benefiting from strong organic growth and operational improvements, with expected revenue and earnings growth rates of 1.6% and 28.3% respectively for the current year [14][15] - **ClearPoint Neuro Inc. (CLPT)**: Specializing in minimally invasive surgical procedures in the brain, with expected revenue and earnings growth rates of 24.1% and 11.4% respectively for the current year [16][17]

分组1 - ClearPoint Neuro, Inc. reported a quarterly loss of $0.22 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.15, representing an earnings surprise of -46.67% [1] - The company posted revenues of $8.49 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 2.85%, and showing an increase from $7.64 million in the same quarter last year [2] - ClearPoint Neuro has surpassed consensus revenue estimates three times over the last four quarters, while it has only surpassed consensus EPS estimates once in the same period [2] 分组2 - The stock has underperformed the market, losing about 11.3% since the beginning of the year compared to the S&P 500's decline of -0.6% [3] - The current consensus EPS estimate for the coming quarter is -$0.16 on revenues of $9.2 million, and for the current fiscal year, it is -$0.62 on revenues of $38.95 million [7] - The Medical - Instruments industry, to which ClearPoint Neuro belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]