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Clearpoint Neuro (CLPT) investor relations material

Clearpoint Neuro Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary6 Nov, 2025

Executive summary

  • Announced a strategic merger agreement to acquire IRRAS Holdings, Inc., expanding into neurocritical care and cranial irrigation markets, and enhancing operational scale with a combined commercial team of over 50 professionals.

  • Revenue for Q3 2025 increased 9% year-over-year to $8.9 million, driven by growth in service revenue and neurosurgery navigation and therapy sales.

  • Supported over 60 biopharma partners, with nine programs accepted for FDA expedited review and expanded global regulatory clearances to 34 countries.

  • Transitioned to a two-part growth strategy: "fast forward" to penetrate existing billion-dollar markets and "essential everywhere" to build a new multi-billion-dollar neurodrug delivery market.

  • Demonstrated a prototype Robotic Neuro-Navigation System and received FDA clearance for PRISM Laser Therapy System compatibility with 1.5T MRI, expanding addressable market.

Financial highlights

  • Q3 2025 revenue was $8.9 million, up 9% year-over-year from $8.1 million in Q3 2024.

  • Gross margin improved to 63% from 60% in the prior year quarter, driven by higher service margins and favorable product mix.

  • Cash and equivalents stood at $38.2 million as of September 30, 2025, up from $20.1 million at year-end 2024, reflecting $32 million in new financing offset by $11.8 million in operating cash use.

  • Net loss for Q3 2025 was $5.9 million, compared to $5.0 million in Q3 2024, with net loss per share of $(0.21).

  • Operating expenses increased 9% to $10.9 million, driven by R&D, professional services, and personnel costs.

Outlook and guidance

  • 2025 full-year revenue forecast narrowed to $36–$38 million, in line with prior guidance.

  • Post-merger, 2026 revenue for the combined entity expected between $54–$60 million, with further updates after integration.

  • Biologics and drug delivery expected to return to double-digit growth in Q4 2025 and accelerate in 2026–2027.

  • Cash reserves projected to be sufficient to support operations for at least the next twelve months.

  • Long-term vision targets $500 million annual revenue and 70% gross margins.

IRRAS acquisition's impact on cash breakeven
How will site activation drive C&GT commercialization?
CAL facility's impact on Biologics revenue growth
What are the key operational synergies from IRRAS?
How will ClearPoint derisk cell/gene therapy supply?
New CRO facility: magnitude of future studies?
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Frequently asked questions

ClearPoint Neuro, Inc. operates as a medical device company primarily in the United States. The company develops and commercializes platforms for performing minimally invasive surgical procedures in the brain under direct, and intra-procedural magnetic resonance imaging guidance. It offers ClearPoint software, a platform that provides direct visualization of MRI that enables physicians to image the patient's brain in real-time;

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