ClearPoint Neuro — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the quarter ended September 30, 2026, was $12.1 million, a 36% increase from $8.9 million in the same period in 2025.
• Biologics and drug delivery revenue increased 11% year-over-year to $4.9 million (from $4.4 million).
• Neurosurgery navigation and therapy revenue increased 59% year-over-year to $5.4 million (from $3.4 million).
• Capital equipment and software revenue increased 68% year-over-year to $1.7 million (from $1.0 million).
• Gross margin was 58% for the quarter, down from 63% in the same period in 2025, primarily due to overhead costs at the new ClearPoint Advanced Laboratories facility and amortization of acquired intangible assets.
• Operating expenses were $13.4 million, a 23% increase from $10.9 million in the prior year period, driven by the IRRAS acquisition, higher personnel costs, and increased occupancy and travel costs.
• Net loss was $7.46 million for the quarter, compared to a net loss of $5.89 million in the same period in 2025.
• Net loss per share (basic and diluted) was $0.24 for the quarter, compared to $0.21 in the prior year period.
• Cash and cash equivalents totaled $46.2 million as of September 30, 2026, up from $45.9 million at December 31, 2025.
• Long-term notes payable, net, stood at $50.8 million as of September 30, 2026, compared to $49.1 million at December 31, 2025.
• Net cash used in operating activities was $20.1 million for the nine months ended September 30, 2026.

Guidance and Future Outlook:

• The Company estimates full-year 2026 revenue to be between $48.0 million and $50.0 million.
• Management highlighted that revenue growth of 36% outpaced operating expense growth of 23% in the third quarter.
• The product pipeline includes AI Derived Planning and Simulation, Neuro Navigation in the MRI and Operating Room, Laser Therapy and Access, IRRAflow CSF management, Robotic Surgery, Focused Ultrasound, and a comprehensive drug delivery ecosystem.

Business Segments and Product Lines:

• The Neurosurgery navigation and therapy segment includes navigation, laser, drill, and IRRAflow products.
• The biologics and drug delivery segment includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials.
• The acquisition of IRRAS in the fourth quarter of 2025 contributed significantly to the growth in neurosurgery navigation and therapy revenue.
• A first formal Biologics License Application (BLA) was submitted by a partner for the treatment of Huntington's Disease.
• The Company is an industry partner in a five-year, $2.98 million competitively awarded NCI R01 grant led by Dartmouth Health to advance MR-guided laser therapy for spinal metastases using the ClearPoint Prism system.

Market and Competitive Landscape:

• The Company operates globally with healthcare and research center partnerships in North America, Europe, Asia, and South America.
• The flagship ClearPoint Neuro Navigation System holds FDA clearance and CE-marking.
• The Company is positioned as a comprehensive drug delivery ecosystem partner for biopharma companies, academic centers, and contract research organizations.

Risks and Challenges:

• Risks include the ability to achieve broader market adoption, timing and outcomes of partner clinical trials, and regulatory submission results.
• Potential risks involve the integration of acquired businesses (including IRRAS), GLP compliance at ClearPoint Advanced Laboratories, and supply chain disruptions.
• Financial risks include the ability to fund operations, service indebtedness, and general economic or geopolitical conditions.

Management Commentary and Tone:

• Joe Burnett, President and CEO, stated that the acceleration in financial performance was driven by core organic clinical product revenue and biologics/drug delivery revenue returning to double-digit growth.
• Management expressed confidence in the $46.2 million cash balance to fund the product pipeline and noted that the completion of the IRRAflow product integration has enabled improved operating leverage.
• The tone emphasized building a comprehensive drug delivery ecosystem and becoming the premier therapy enabling company in the cranial neurosurgery space.

Other Key Points:

• The Company received net proceeds of $22.0 million from an at-the-market equity offering program.
• The Company acquired the IRRAflow portfolio in connection with the acquisition of IRRAS in the fourth quarter of 2025.
• Weighted average shares outstanding for the quarter were 30,983,193 (basic and diluted).
• The Company has a total of thousands of procedures performed and supported by its field-based clinical specialist team.