ClearPoint Neuro, Inc. (CLPT) shares rallied 6.9% in the last trading session to close at $12.41. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 7.8% loss over the past four weeks. ClearPoint Neuro recorded a strong price rise driven by investors' optimism surrounding the company's upcoming earnings release, expected on Nov. 14, 2024. The Zacks Consensus Estimate for the third quarter suggests a revenue grow ...

SOLANA BEACH, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that on August 23, 2024, it provided for the full early repayment of the principal amount and interest on a $10 million convertible note held by PTC Therapeutics Inc., which would have matured in January 2025 according to its terms. The convertible note was issued by the Comp ...

Core Insights - ClearPoint's business is gaining momentum with significant investments starting to yield results, reflected in a stock price increase of over 70% [1] - The company is expected to continue its growth trajectory as its initiatives begin to financially impact the business [1] Business Expansion - ClearPoint has made substantial investments in catheter and cannula technologies, AI modeling, pre-clinical services, laser therapy, and operating room support, as well as expanding its market presence beyond the US [1] - The company aims to activate 100 global sites by the end of 2025, with eight new customers activated in Q1 and six in Q2 [2] Product Development - ClearPoint plans to introduce an MRI drill in 2025, having exclusive global distribution rights, with the US market for powered drill solutions estimated at approximately 200 million USD [3] - The ClearPoint Prism 3T Neuro Laser Therapy System was fully released in the US, targeting about 50% of the NeuroLITT treatment market [4] Revenue Growth - ClearPoint's revenue segments show strong growth, with biologics revenue at 4.3 million USD (28% growth), neurosurgery navigation and therapy at 2.6 million USD (17% growth), and capital equipment and software at 0.9 million USD (148% growth) [12][15][18] - The company is experiencing a modest revenue boost from capital sales, which will drive future disposable sales [2] Financial Performance - ClearPoint's gross profit margin is improving due to higher volumes and a new manufacturing facility, with expectations for continued upward trends [24][25] - Operating profitability and cash flows are improving, with cash burn declining and over 30 million USD in cash and cash equivalents available [25] Clinical Partnerships - ClearPoint is expanding its pre-clinical and clinical trial services to support drug delivery partners, which includes various regulatory navigation services [7] - The company has seven partner programs on accelerated assessment tracks, indicating progress in clinical trials [20] Market Outlook - The growth in ClearPoint's biologics business is expected to continue, driven by partnerships and advancements in clinical trials [26] - Despite recent stock price increases, the company remains neutral in the short term but is expected to perform well in the long term as growth initiatives materialize [26]

Jacob Wackerhausen/iStock via Getty Images While it has taken time for ClearPoint Neuro, Inc. (NASDAQ:CLPT) to establish itself as an industry leader, I think the company has finally done so, as it is now poised to be a growth leader with a very large addressable market in front of it. As such, it's currently my favorite growth stock. Though I've written about the company previously, given that it's been a while, I'll begin by summarizing the company's offerings and potential allure to investors before gett ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $7.9 million, representing a 32% increase from $6 million in Q2 2023 [8][9] - Gross margin improved to 63% in Q2 2024, up from 53% in Q2 2023, primarily due to lower costs and higher volumes [10] - Operating expenses decreased to $9.7 million in Q2 2024 from $10.3 million in Q2 2023, reflecting operational leverage [11][12] - Cash and cash equivalents increased to $32.8 million as of June 30, 2024, compared to $23.1 million at the end of 2023 [12] Business Line Data and Key Metrics Changes - Biologics and drug delivery revenue rose 28% to $4.3 million in Q2 2024, driven by a 383% increase in product revenue [9][10] - Neurosurgery navigation revenue increased 17% to $2.6 million, attributed to new product offerings and placements [10] - Capital equipment and software revenue surged 148% to $0.9 million, due to increased placements of ClearPoint Navigation and PRISM laser units [10] Market Data and Key Metrics Changes - The company activated 14 new customer sites in 2024, with 8 in Q1 and 6 in Q2, indicating strong demand for its systems [21][32] - The SmartFrame OR platform is gaining traction, with multiple evaluations and approvals underway [22][24] Company Strategy and Development Direction - The company focuses on four growth pillars: biologics and drug delivery, neurosurgery navigation, therapy and access products, and achieving global scale [4][8] - The strategy includes expanding partnerships with pharmaceutical companies and enhancing product offerings to diversify revenue streams [7][19] - The company aims for cash flow breakeven by the end of 2025, supported by a strong cash position and reduced operational cash burn [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, citing a 36% revenue increase and a 39% reduction in operational cash burn in the first half of 2024 [14][27] - The company anticipates continued demand for its products and services, particularly in the cell and gene therapy market [15][16] - Management noted that funding in the biopharma sector remains healthy, with no significant project pauses observed [42] Other Important Information - The company has executed strategic agreements with pharmaceutical partners, enhancing its role in the cell and gene therapy market [17][19] - The PRISM anchor bolt accessory received FDA clearance, expanding the use of the PRISM laser system [23] Q&A Session Summary Question: Clarification on revenue guidance range - Management explained that the guidance range of $30 million to $33 million reflects uncertainties in timing for pharmaceutical services, which could swing revenue by $1 million to $1.5 million [29][30] Question: Onboarding process for new sites - Management indicated that most new sites activated have been for traditional MRI navigation, with hospitals preparing for clinical trials in gene and cell therapy [31][32] Question: Economies of scale in biologics business - Management highlighted that the same ClearPoint platform supports various procedures, allowing for economies of scale and margin expansion as larger orders are fulfilled [36][38] Question: Involvement in Phase 1 and Phase 2 trials - Management stated that while they do not act as clinical trial monitors, they provide product support and clinical education during these trials [44][45] Question: Revenue cadence with new contract types - Management noted that new contracts may introduce more revenue lumpiness in the short term, but overall growth trends are expected to stabilize over time [46][48]

ClearPoint Neuro, Inc. (CLPT) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 15.79%. A quarter ago, it was expected that this company would post a loss of $0.19 per share when it actually produced a loss of $0.16, delivering a surprise of 15.79%. Over the last four quarters, the company has ...

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 June 30, 2024 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 Othe ...

Exhibit 99.1 ClearPoint Neuro Reports Second Quarter 2024 Results Second Quarter Revenue Growth +32%; Record Revenue Achieved SOLANA BEACH, CA, August 7, 2024 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its second quarter ended June 30, 2024. Second Quarter Highlights | --- | |-------------------------------------------------------------------------- ...

SOLANA BEACH, Calif., July 17, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ: CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that it will release financial results for its 2024 second quarter on Wednesday, August 7th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2024 second quarter on Wednesday, August 7th at 4:30 p.m. Eastern ti ...

Company Overview - ClearPoint Neuro, Inc. (CLPT) shares increased by 16.9% to $6.58 in the last trading session, contrasting with a 1.9% loss over the past four weeks [1] - The stock's price surge was driven by investor optimism regarding its partner Aspen Neuroscience, Inc. using the ClearPoint Neuro Navigation System in the ASPIRO clinical trial for Parkinson's disease [4] Earnings and Revenue Expectations - ClearPoint Neuro is expected to report a quarterly loss of $0.18 per share, reflecting a year-over-year change of +37.9% [5] - Revenue for the upcoming quarter is projected to be $7.5 million, which is a 26% increase from the same quarter last year [5] - The consensus EPS estimate for ClearPoint Neuro has remained unchanged over the last 30 days, indicating stability in earnings expectations [6] Industry Context - ClearPoint Neuro operates within the Zacks Medical - Instruments industry, which includes other companies like Alphatec (ATEC) [7] - Alphatec's consensus EPS estimate for its upcoming report is -$0.26, showing a year-over-year change of +39.5% [3]