Core Viewpoint - The company remains on track with its performance despite challenging market conditions, indicating resilience and a focus on long-term growth [1][2]. Group 1: Performance Overview - The company has performed well under current conditions, with appreciation for the efforts of its 31,000 global employees [2]. - There are signs of improvement in certain geographies, suggesting potential for better performance in the future [2]. Group 2: Financial Insights - The focus should be on trends rather than exact figures, as various factors such as tax rates, interest costs, and seasonality can affect financial results [3]. - The currency fluctuations, particularly the rand, are also influencing financial performance [3].

Company Performance - ClearPoint Neuro (CLPT) reported weak results in the third quarter, contributing to a decline in share price [1] - The reasons for the weak growth in recent quarters remain unclear, but quarterly volatility is expected due to the company's nascent state [1] Investment Strategy - Narweena, an asset manager led by Richard Durant, focuses on identifying market dislocations caused by misunderstandings of long-term business prospects [1] - The firm aims to achieve 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] - Conversely, some businesses may encounter rising costs and diseconomies of scale, impacting their performance negatively [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]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Motorsport Games Inc. (MSGM) has seen a substantial increase of 122%, trading at $4.88 [3] - Globus Medical, Inc. (GMED) is up 27%, currently priced at $78.75 [3] - JFrog Ltd. (FROG) has risen by 26%, trading at $59.60 [3] - FIGS, Inc. (FIGS) is up 19%, with a trading price of $8.97 [3] - Organogenesis Holdings Inc. (ORGO) has increased by 18%, trading at $4.59 [3] - PureCycle Technologies, Inc. (PCT) is up 17%, currently priced at $11.31 [3] - Expedia Group, Inc. (EXPE) has risen by 16%, trading at $255.10 [3] - 10x Genomics, Inc. (TXG) is up 13%, currently priced at $14.72 [3] - Abacus Global Management, Inc. (ABL) has increased by 12%, trading at $5.95 [3] - GigaCloud Technology Inc. (GCT) is up 9%, currently priced at $27.80 [3] Premarket Losers - Davis Commodities Limited (DTCK) has experienced a significant decline of 65%, trading at $2.23 [4] - Eledon Pharmaceuticals, Inc. (ELDN) is down 46%, currently priced at $2.19 [4] - Treace Medical Concepts, Inc. (TMCI) has decreased by 35%, trading at $4.00 [4] - Energys Group Limited (ENGS) is down 30%, currently priced at $2.77 [4] - Intellia Therapeutics, Inc. (NTLA) has seen a decline of 27%, trading at $8.89 [4] - Fox Factory Holding Corp. (FOXF) is down 24%, currently priced at $16.60 [4] - Opendoor Technologies Inc. (OPEN) has decreased by 24%, trading at $4.94 [4] - AirSculpt Technologies, Inc. (AIRS) is down 21%, currently priced at $8.27 [4] - Power Solutions International, Inc. (PSIX) has seen a decline of 20%, trading at $64.25 [4] - ClearPoint Neuro, Inc. (CLPT) is down 17%, currently priced at $15.00 [4]

Core Insights - ClearPoint Neuro, Inc. reported a quarterly loss of $0.21 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.20, marking a year-over-year increase from a loss of $0.18 per share [1] - The company generated revenues of $8.86 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 10.5%, but showing an increase from $8.12 million in the same quarter last year [2] - ClearPoint Neuro's stock has increased by approximately 10.4% since the beginning of the year, underperforming compared to the S&P 500's gain of 15.6% [3] Earnings Outlook - The earnings outlook for ClearPoint Neuro is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.19 on revenues of $10.7 million, and for the current fiscal year at -$0.81 on revenues of $38.3 million [7] - The company's Zacks Rank is currently 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Instruments industry, to which ClearPoint Neuro belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Revenue and Profitability - Total revenue for the three months ended September 30, 2025, was $8.861 million, a 9.1% increase from $8.122 million in the same period of 2024[18]. - Product revenue for the nine months ended September 30, 2025, reached $16.649 million, up 18.4% from $14.053 million in the prior year[18]. - Gross profit for the three months ended September 30, 2025, was $5.600 million, compared to $4.847 million for the same period in 2024, reflecting a 15.5% increase[18]. - For the nine months ended September 30, 2025, total revenue reached $26.561 million, up 12.3% from $23.619 million in the prior year[74]. - Revenue from biologics and drug delivery services for the three months ended September 30, 2025, was $4.402 million, slightly down from $4.431 million in 2024[72]. - Neurosurgery navigation and therapy revenue for the three months ended September 30, 2025, increased to $3.422 million from $2.860 million in 2024, representing a 19.6% growth[72]. - Capital equipment and software revenue for the three months ended September 30, 2025, totaled $1.037 million, compared to $831,000 in the same period of 2024, marking a 25% increase[72]. - The company recognized approximately $1.2 million of revenue from contract liabilities during the nine months ended September 30, 2025[77]. Losses and Expenses - The net loss for the three months ended September 30, 2025, was $5.891 million, compared to a net loss of $4.974 million in the same period of 2024, indicating a 18.4% increase in losses[18]. - For the nine months ended September 30, 2025, the company reported a net loss of $17.8 million, compared to a net loss of $13.5 million for the same period in 2024, representing a 31.5% increase in losses[27]. - Cash flows from operating activities resulted in a net cash outflow of $11.8 million for the nine months ended September 30, 2025, compared to a net cash outflow of $7.7 million for the same period in 2024, indicating a 53.2% increase in cash used[27]. - Share-based compensation expense for the three months ended September 30, 2025, was $2.022 million, compared to $1.904 million for the same period in 2024[108]. Assets and Liabilities - Total assets as of September 30, 2025, were $60.357 million, significantly higher than $39.189 million as of December 31, 2024[16]. - Total liabilities increased to $44.483 million as of September 30, 2025, compared to $13.800 million at the end of 2024[16]. - The total stockholders' equity decreased to $15.874 million as of September 30, 2025, down from $25.389 million at the end of 2024[16]. - The cumulative deficit at September 30, 2025, reached $209.1 million, highlighting ongoing financial challenges since inception[35]. Cash and Financing - Cash and cash equivalents increased to $38.221 million as of September 30, 2025, from $20.104 million at the end of 2024[16]. - The company had cash, cash equivalents, and restricted cash totaling $38.4 million at the end of the period, up from $21.6 million at the end of September 2024, reflecting a 78.1% increase[27]. - The company raised approximately $3.3 million from a stock purchase agreement in May 2025, selling 275,808 shares at $12.69 per share[38]. - The company also secured approximately $28.7 million from the issuance of notes payable under a note purchase agreement, with an initial sale of $30 million principal amount of notes[39]. - The Company entered into a 2025 NPA allowing for the sale of notes up to $105 million, with an initial sale of $30 million completed[84]. - The interest rate on the outstanding principal amount of the notes is a minimum of 8.25%, with a cap of 9.50%, and 50% of the interest due for the first six quarters will be paid-in-kind[87]. - The company expects to access an additional $20.0 million in funding to support integration activities and new growth initiatives following the merger[119]. Customer and Market Insights - The company has over 60 biologics and drug delivery customers currently evaluating or using its products and services, indicating a growing market opportunity[33]. - One pharmaceutical customer accounted for 8% of total sales for the three and nine months ended September 30, 2025[63]. Legal and Compliance - The Company settled a legal contingency in August 2025, with the settlement amount covered by insurance and not materially impacting financial statements[99]. Lease and Asset Management - A new lease for a building in San Diego, California, was recorded with a right-of-use asset and operating lease liability of $3.3 million[30]. - The Company has commitments for operating leases, with aggregate lease costs of $0.4 million for the three months ended September 30, 2025[98]. - The Company has a right-of-use asset and lease liability of $3.3 million related to a new lease agreement for office and R&D space in San Diego[97]. Stock and Equity - As of September 30, 2025, the outstanding stock options totaled 1,321,179 with a weighted average exercise price of $5.78 and an intrinsic value of $21,166,000[110]. - The restricted stock awards outstanding decreased to 16,341 with a weighted average fair value of $9.77 as of September 30, 2025[111]. - The restricted stock units outstanding were 1,654,007 with a weighted average fair value of $9.16 as of September 30, 2025, after granting 638,482 units at an average fair value of $13.33[112]. - In the first offering period of 2025, 30,610 shares were purchased under the Employee Stock Purchase Plan at an average offering price of $10.15[115]. Merger and Acquisition - On November 6, 2025, the company entered into a merger agreement with IRRAS Holdings, Inc., involving $5.0 million in cash and 1,325,000 shares of common stock[118]. - The merger agreement includes earnout consideration equal to 25% of net sales of certain IRRAS products above specified thresholds during three one-year periods[118].

Revenue Performance - Quarterly revenue was $8.9 million, a 9% increase year-over-year compared to $8.1 million in Q3 2024[8] - Neurosurgery navigation and therapy revenue increased 20% to $3.4 million from $2.9 million in the same period last year, driven by higher sales of Prism Laser Therapy[10] - Capital equipment and software revenue rose 25% to $1.0 million from $0.8 million in Q3 2024 due to increased hardware sales and rental revenue[11] - Total revenue for Q3 2025 was $8,861,000, an increase of 9.1% compared to $8,122,000 in Q3 2024[24] - Product revenue decreased slightly to $5,361,000 from $5,474,000, while service and other revenue increased to $3,500,000 from $2,648,000[24] - The total combined revenue for ClearPoint Neuro and IRRAS in 2026 is projected to be between $54.0 million and $60.0 million[7] Financial Position - Cash and cash equivalents totaled $38.2 million as of September 30, 2025, compared to $20.1 million at the end of 2024[14] - Cash and cash equivalents increased to $38,221,000 as of September 30, 2025, up from $20,104,000 at the end of 2024[26] - Total assets rose to $60,357,000 from $39,189,000, indicating significant growth in the company's financial position[26] Profitability and Loss - Gross margin improved to 63% in Q3 2025, up from 60% in Q3 2024, primarily due to higher margins on biologics and drug delivery service revenue[12] - Gross profit for Q3 2025 was $5,600,000, up from $4,847,000 in Q3 2024, representing a gross margin improvement[24] - Net loss for Q3 2025 was $5,891,000, compared to a net loss of $4,974,000 in Q3 2024, reflecting a 18.4% increase in losses[24] - Operating loss for the nine months ended September 30, 2025, was $17,119,000, compared to $14,098,000 in the prior year, indicating a 21.4% increase in operating losses[24] Operating Expenses - Operating expenses increased by 9% to $10.9 million from $10.0 million in Q3 2024, mainly due to higher product development costs and increased headcount[13] - Research and development costs for the nine months ended September 30, 2025, were $10,660,000, compared to $9,060,000 for the same period in 2024, reflecting a 17.7% increase[24] Strategic Initiatives - The acquisition of IRRAS Holdings, Inc. is expected to expand the company's market presence and potentially double the size of its commercial organization[5] - The company activated 5 new global customers in Q3 2025, continuing to expand its market reach[3] - The company anticipates continued development and commercialization of its proprietary Robotic Neuro-Navigation platform, with a focus on expanding market opportunities[21] - The company narrowed its full-year revenue guidance to between $36.0 million and $38.0 million[6] Shareholder Information - The company reported a weighted average of 28,137,528 shares outstanding for the nine months ended September 30, 2025, compared to 26,840,119 shares in the same period of 2024[24]

Core Insights - ClearPoint Neuro, Inc. reported a quarterly revenue of $8.9 million, reflecting a 9% year-over-year increase compared to Q3 2024 [1] - The company narrowed its full-year revenue forecast for 2025 to a range between $36.0 million and $38.0 million [1] - ClearPoint Neuro continues to support over 60 active biopharma partners, with nine partner programs accepted for FDA expedited review [1] Financial Performance - Quarterly revenue reached $8.9 million, marking a 9% increase year-over-year [1] - Cash and cash equivalents totaled $38.2 million as of September 30, 2025 [1] Strategic Developments - The company completed the transition to its new Pre-clinical CRO Facility, ClearPoint Advanced Laboratories, which became operational in Q4 2025 [1] - ClearPoint Neuro announced the development of a prototype Robotic Neuro-Navigation System to enhance minimally invasive cranial surgical procedures [1] - The company received FDA 510(k) clearance for the ClearPoint PRISM Laser Therapy System, expanding its compatibility with 1.5T MRI guidance [1] Regulatory and Market Expansion - ClearPoint Neuro achieved several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan, totaling 34 countries worldwide [1] - An agreement was signed for the acquisition of IRRAS Holdings, Inc., which will enhance the company's presence in the neurocritical care space [1] - Five new global customers were activated in the third quarter [1]

Core Insights - ClearPoint Neuro, Inc. has announced the acquisition of IRRAS Holdings, Inc., enhancing its drug delivery portfolio and expanding its market presence in the treatment of intracranial bleeding [1] Company Overview - ClearPoint Neuro is a global company specializing in device, cell, and gene therapy, providing precise navigation solutions for brain and spine procedures [1] - IRRAS Holdings focuses on neurocritical care, particularly in treating conditions like intracerebral hemorrhage and chronic subdural hematoma [1] Product Details - The cornerstone product of IRRAS is the IRRAflow® system, which is FDA-cleared and CE-marked, offering continuous irrigation, aspiration, and real-time intracranial pressure monitoring [1] Market Potential - The acquisition positions ClearPoint Neuro to tap into a $0.5 billion market dedicated to the treatment of intracranial bleeding, thereby increasing its commercial scale and adding new indications [1]

WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY. Nasdaq: CLPT November 2025 DISCLAIMER This presentation and discussion contain forward - looking statements within the context of the federal securities laws, including the Company's expectation for revenues, gross margin, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of the Company's products and services, the Company's belief about the outcome of regulatory interactions with respect to its ...

Core Insights - ClearPoint Neuro, Inc. will participate in multiple global healthcare conferences in the fourth quarter of 2025, showcasing its commitment to engaging with investors and stakeholders in the healthcare sector [1][2]. Conference Participation - The company is scheduled to present at the following conferences: - 2025 UBS Global Healthcare Conference on November 10, 2025 [2] - 2025 Stifel Healthcare Conference on November 13, 2025 [2] - 37th Annual Piper Sandler Healthcare Conference on December 3, 2025 [2] - ClearPoint Neuro management will be available for in-person investor meetings at these events [2]. Company Overview - ClearPoint Neuro specializes in device, cell, and gene therapy-enabling technologies, providing precise navigation solutions for the brain and spine [3]. - The flagship product, the ClearPoint Neuro Navigation System, has received FDA clearance and is CE-marked, indicating its regulatory compliance and market readiness [3]. - The company collaborates with healthcare and research centers across North America, Europe, Asia, and South America, and partners with leading pharmaceutical and biotech firms [3]. - Thousands of procedures have been supported by the company's clinical specialist team, highlighting its operational experience and market presence [3].