ClearPoint Neuro Inc.

Greetings and welcome to the ClearPoint Neuro, Inc. First Quarter 2026 Financial Results. 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, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of 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 expectations regarding the integration, performance, and anticipated benefits of its recent acquisition of ERAS Holdings Inc., including operational efficiencies and the impact on the company's financial condition and results of operations. 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. You are cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made. Actual results or trends could differ materially. 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. At this time, I would like to turn the call over to Joe Burnett, Chief Executive Officer. Please go ahead.

Thank you, Shamali. And as always, thank you to all of the investors, analysts, and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuroecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine, and we at ClearPoint believe we can play a crucial, if not essential, role in this exciting future. Our company has started 2026 on a strong note by achieving record revenue of 12.1 million for the quarter, driven primarily by organic devices growth of 25%, which includes our historical drug delivery cannulas, navigation disposables, laser ablation applicators, capital systems, and software. This revenue was complemented by inorganic device growth from our acquisition of the new Eraflow product line, which pushed our overall growth rate to 43% company-wide. We continued to realize meaningful revenue and cost synergies as a result of our new completed acquisition of Iris, with the majority of post-merger integration costs now behind us and taking place in Q1. Importantly, we made progress across all four of our growth pillars that are designed to make our unique drug delivery ecosystem more refined and more accessible to biopharma partners, surgeons, and to patients globally. We believe that we are truly a unique hybrid device biotech enabling company that not only has an existing revenue plan of more than $50 million today, but a completely untapped and expansive opportunity in commercial cell and gene therapy delivery built for tomorrow. Our strategy now includes more than 60 active biopharma partners, more than 25 existing clinical trials across more than 15 different disease indications, and more than 10 partner programs that are already under some form of FDA expedited review. That is a significant head start, and through both our team and our investment into this portfolio, we intend to extend our lead. With that, I will turn the call over to Danilo D'Alessandro, our CFO, who will walk through the financial detail, after which I will give a more strategic update on our progress. Danilo?

Thank you, Joe, and thank you all for joining us today. Looking at the first quarter 2026 results, total revenue was $12.1 million for the three months ended March 31st, 2026. and $8.5 million for the three months ended March 31st, 2025, which represents 43% growth versus the first quarter of 2025 and 16% organic growth. 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 utilizing our products. Biologics and drug delivery revenue increased 2% to $4.8 million in the first quarter, up from $4.7 million in 2025. This increase was mainly due to an increase in product revenue of $0.1 million. The NDD service revenue was in line with prior year. Neurosurgery navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint system, the PRISM laser system, and Aeroflux. This revenue segment grew to $5.9 million for the first quarter of 2026, including $2.1 million in airflow disposable revenue. The growth in this segment was primarily due to our increased installation base and the full market release of our PRISM laser system and ICT solution. Capital equipment and software revenue consisting of sales of our reusable hardware and software and related services increased 177% to $1.4 million in the quarter, from $0.5 million for the same period in 2020 of ClearPoint Navigation System, PRISM laser units, and Aeroflow control units. Gross margin for the first quarter of 2026 was 64%, an increase of 4% compared to 60% in Q1 2025, mostly related to a decrease in excess and obsolete inventory reserves. Research and development costs were $4.5 million for the three months ended March 31, 2026, compared to $3.4 million for the same period in 2025, an increase of $1.1 million, or 34%. The increase was due primarily to higher personal costs of $0.6 million and higher product and software development costs of $0.3 million. Sales and marketing expenses were $6.7 million for Q1 2020, compared to $3.8 million for the same period in 2025, an increase of $2.9 million or 75%. This increase was due primarily to additional personal cost of $1.9 million and increase in travel costs of $0.5 million, resulting from the expansion of our clinical and sales teams due to the IRIS integration, as well as additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $5 million for the first quarter, an increase of $0.9 million or 22%. This increase was due primarily to higher occupancy costs of $0.7 million and higher personal costs of $0.2 million. As of March 31, 2026, we held cash and cash equivalents totaling $35.6 million as compared to $45.9 million at December 31, 2025. The cash reduction was primarily due to the operational cash burn of $8 million in Q1 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We expect the operational cash burn to decrease in the coming quarters as we complete the ARIS integration. I'd like now to turn the call back to Joe.