Clearpoint Neuro (CLPT) Investor Presentation summary

Platform and market opportunity

• Unique platform enables precise navigation for cell, gene, and device therapies targeting brain and spine disorders, integrating clinical products and drug development services for BioPharma partners.

• Over 15 years developing a comprehensive drug delivery ecosystem, including navigation, predictive modeling, delivery devices, and infusion monitoring software.

• Current portfolio addresses a $500M market, with a $10B potential diversified across 60+ partners and 20+ indications.

• More than 100 global centers activated, scaling capacity for cell and gene therapy patients.

• Growth fueled by new product launches in MRI/CT navigation, laser ablation, surgical access, and preclinical CRO services.

Clinical and regulatory milestones

• Partner received FDA approval for a neuro gene therapy (Kebilidi) co-labeled with SmartFlow Neuro Cannula, the only FDA-authorized device for its delivery.

• Nine partners have programs selected for expedited FDA review, including RMAT and Fast Track designations.

• Active clinical-stage partners target indications such as AADC deficiency, Huntington's, Parkinson's, epilepsy, and more.

• FDA and global bodies recognize urgency, supporting rapid development and commercialization of therapies.

Business model and partnerships

• Diversified across 60+ BioPharma partners and 20+ indications, with many partners running multiple programs.

• Flexible partnership structures include supply assurance, co-development, milestone payments, royalties, and strategic retainers.

• Sophisticated infrastructure with ISO-certified manufacturing, global supply, and extensive regulatory experience.

• Portfolio approach offers exposure to multiple therapies without direct drug development risk.