ClearPoint Neuro Inc.

Greetings and welcome to ClearPoint Neuro Q3 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. Comments made on this call may include statements that are forward-looking within the meeting of the securities laws. These forward-looking statements may include, without limitation, statements related to anticipated industry trends, the company's plans, prospects, and strategies, both preliminary and projected, the size of total addressable markets, or the market opportunity for the company's products and services, the company's expectation for future development, Regulatory approval, timing, commercialization, and the market for cell and gene therapies, and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies, and management's expectations, beliefs, estimates, or projections regarding future revenue and results of operations. We are cautioned not to place undue reliance on forward-looking statements which speak only as of the date The company undertakes no obligation to revise forward-looking statements for new information or future events. For more information about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8K, Form 10K, and Form 10Q. All the company's filings may be obtained from the SEC or the company's website at www.ClearPointNeuro.com. I would now like to turn the conference over to your host, Mr. Joe Burnett, Chief Executive Officer. Thank you. You may begin.

Thank you, Rob. And good evening to all the investors, analysts, and partners joining us for today's ClearPoint Neuro third quarter earnings call. Our company remains dedicated to developing therapies that can help restore function and improve outcomes for millions of patients worldwide living with serious neurological disorders. We are thrilled to have your continued interest and support as a part of this journey. In the third quarter, we continued to make substantial progress with our neuro drug delivery strategy, focused on establishing ClearPoint as the gold standard for cell and gene therapy delivery. We have spent more than a decade building a leadership position in this market, and we are committed to maintaining and expanding that lead. This strategic progress includes pipeline development for our comprehensive and uniquely positioned drug delivery ecosystem, including AI segmentation and modeling tools, periprocedural navigation software and frames, surgical robotics, laser therapy and access drills, cannulas and new routes of administration, Focus Ultrasound, and Confirmatory Drug Infusion Software. In addition to our investment in this product portfolio, we continue to expand our ClearPoint Advanced Laboratories Drug Discovery Facility in Torrey Pines, California, adding capacity, new capabilities, and services. We also stand ready to support our more than 60 active biopharma partners who continue to announce both data readouts and global clinical trial initiations including multiple phase three studies that are either enrolling or expected to initiate in 2027. We look forward to the next regulatory milestones for our partner, Unicure's BLA submission to the FDA for AMT130 to treat Huntington's disease during the weeks and months ahead, which could result in the very first FDA approved gene therapy for this terrible disease. To complement the strategic progress, we have made financial progress as well in the quarter, growing overall revenue by 36% compared to operating expenses, which grew 23%, a result that reflects the scalability. This result was possible due to our continued integration activities post the IRIS acquisition and the reorganization of our clinical field team to get ready for phase three trials and eventual drug delivery commercialization. In order to fund these hiring activities in support of our clinical field team expansion and the startup costs of our Cal expansion, we used our existing ATM facility for the first time, generating net proceeds of $22 million and ended the quarter with cash and cash equivalents of $46.2 million. This gives us the balance sheet flexibility to continue advancing our comprehensive drug delivery ecosystem, including robotics and focused ultrasound, and to prepare our field team for new commercial product launches that we expect in 2027. I will now turn the call over to Danilo D'Alessandro to discuss our financial results, after which I will provide a bit more detail on our four pillar growth strategy. Danilo?

Thank you, Joe. And thank you all for joining us today. Looking at the third quarter 2026 results, total revenue was $12.1 million for the three months ended September 30th, 2026, and $8.9 million for the three months ended September 30th, 2025, which represents 36% growth versus the third quarter of 2025. Our revenue is made up of three components, biologics and drug delivery, neurosurgery, navigation and therapy, and capital equipment and software. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials. Biologics and drug delivery revenue increased 11% to $4.9 million in the third quarter, up from $4.4 million for the same period in 2025. This increase is primarily attributable to higher service revenue performed at ClearPoint Advanced Laboratories. Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system, the PRISM laser system, and Aeroflow. This revenue grew 59% to $5.4 million in the third quarter of 2026, from $3.4 million for the same period in 2025, driven primarily by additional revenues due to sales of the Aeroflow product, which we acquired in connection with our acquisition of ERAS in the fourth quarter of 2025, and in conjunction with growth of our legacy neurosurgery products. Capital equipment and software revenue consisting of sales of our reusable hardware and software and related services increased 68% to $1.7 million in the quarter from $1 million for the same period in 2025 due to an increase in the placements of ClearPoint navigation systems, PRISM laser units and ERA flow control units. The gross margin for Q3 2026 was 58%, a decrease of 5 percentage points compared to 63% in Q3 2025, primarily due to overhead costs at the new Cal facility and additional amortization expense of acquired intangible assets, partially offset by a decrease in other costs of revenue. Research and development costs were $4 million for the three months ended September 30th, 2026, compared to $3.5 million for the same period in 2025, an increase of $0.6 million or 16%. That increase was due primarily to higher personal cost of $0.6 million. Sales and marketing expenses were $5.5 million for Q3, compared to $3.8 million for the same period in 2025, an increase of $1.7 million or 44%. This increase was due primarily to additional personnel cost of $1.2 million, an increase in travel cost of $0.2 million resulting from the expansion of our clinical and sales team, and additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $3.8 million for the third quarter, an increase of $0.3 million or 7%. This increase was due primarily to increases in occupancy costs of $0.5 million, information, technology, and software costs of $0.2 million, and general corporate costs of $0.1 million. These were partially offset by a decrease in VAT at expense of $0.6 million. In the aggregate, our operating expenses in Q3 were $13.4 million, a meaningful decrease from the nearly $17 million in OPEX last quarter. As of September 30th, 2026, we had cash and cash equivalents totaling $46.2 million as compared to $45.9 million at December 31st, 2025. The cash increase was primarily due to the net proceeds of $22 million from the aftermarket equity offering program, partially offset by the operational cash burn of $20.1 million through Q3 2026. I'd like now to turn the call back to Joe.