ClearPoint Neuro Inc.

Greetings and welcome to the ClearPoint Neuro Inc. Second Quarter 2025 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, 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 expectation for future development, regulatory approval, 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, results of operations, or the adequacy of cash and cash equivalent balances to support operations and meet future obligations. 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, please refer to the company's annual report on Form 10-K for the year ended December 31st, 2024, and the company's quarterly report on Form 10-Q for the three months ended March 31st, 2025, both of which have been filed with the Securities and Exchange Commission, and the company's quarterly report on Form 10-Q for the three months ended June 30th, 2025, which the company intends to file with the Securities and Exchange Commission on or before August 14th, 2025. All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. It is now my pleasure to turn the call over to Joe Burnett, Chief Executive Officer. Please go ahead.

Thank you, Kevin, and thank you to all of the investors, partners, and analysts joining us on today's call. 2025 is off to a terrific start here at ClearPoint Neuro as we have officially entered the third phase of our company history, a phase we refer to as Fast Forward. As a brief reminder, this new stage at ClearPoint has three primary tenets. First, we will extend our lead in cell and gene therapy by leveraging our complete and unique drug delivery ecosystem, including navigation hardware, predictive modeling and monitoring software, cannula-based routes of administration, preclinical and clinical drug discovery services, and best-in-class clinical field personnel. We will use this ecosystem to support our more than 60 active biopharma partners on their path to regulatory approval and commercialization, many of which have already been selected for some form of expedited review by the FDA. This now includes the very first US-based commercial cases for neuro cell and gene therapy that have ever been performed as announced just last week. Second, we will evolve our portfolio to focus not only on accuracy and precision, but also on fast, simple, predictable workflows. These new product introductions are designed to increase hospital efficiency and throughput and to create capacity for the significant demand that we believe is coming when patients learn that these new restorative therapies are available and have proven effective. Both our 3.0 ClearPoint ICT navigation software for the operating room and our PRISM laser therapy system have been excellent new product introductions and living up to this mantra of fast, simple and predictable. And third, we will expand our global installed base and generate scale to enable more patients around the world access to the ClearPoint ecosystem that will be used for these novel treatments. ClearPoint technology is now available at more than 100 centers around the world and has regulatory clearance in 36 countries and growing. As previously announced, we have now successfully secured the foundational funding necessary to execute on the strategy for many years to come. This capital, in the form of both debt and equity, has been provided by our new partner, Oberlin Capital. Oberlin has demonstrated that they very much share our vision of securing ClearPoint as the true gold standard for neurocell and gene therapy delivery and extending that lead for years to come. I will now turn the call over to Danilo D'Alessandro, our CFO, to discuss the financial details of the second quarter, after which I will provide additional commentary on our progress in these three fast-forward initiatives here in the second half of 2025. Danilo?

Thank you, Joe, and good afternoon, everyone. Looking at the second quarter 2025 results, total revenue was $9.2 million for the three months ended June 30th, 2025. and $7.9 million for the three months ended June 30th, 2024, which represents 17% growth versus the second quarter of 2024. As a reminder, our revenue is made up of three components, biologics and drug delivery, neurosurgery navigation 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 10% to $4.7 million in the second quarter, up from $4.3 million in 2024. This increase was fueled by a 12% increase in biologics and drug delivery product revenue as multiple pharmaceutical customers progressed in their preclinical and clinical development, and an 8% increase in service revenue. Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system, the PRISM laser system, or SmartFrame OR. This revenue segment increased 33% to $3.4 million for the second quarter of 2025. The revenue growth is primarily attributable to our new product offerings and our new recent additional placements. Capital equipment and software revenue consisting of sales of ClearPoint reusable hardware and software and of related services increased 11% to $1 million in the quarter. The increase was driven by an increase in service revenue. Gross margin for the second quarter 2025 was 60% as compared to a gross margin of 63% for the second quarter 2024. The decrease in gross margin is primarily due to higher excess and obsolete inventory reserves for the three months ended June 30th, 2025. In the second quarter of 2025, our operating expenses were $11.2 million compared to $9.7 million for the second quarter of 2024, an increase of 16%. Specifically, research and development costs were $3.8 million for three months ended June 30th, 2025, compared to $3.1 million for the same period in 2024, an increase of $.7 million or 23%. The increase was due primarily to higher product and software development costs as we invest in expanding and upgrading our product offering. Sales and marketing expenses were $4 million for the second quarter. compared to $3.8 million for the same period in 2024, an increase of $0.2 million or 5%. This increase was due primarily to additional personal costs, including share-based compensation, resulting from increases in hand count of $0.4 million, partially offset by lower travel costs and other marketing costs of $0.2 million. General and administrative expenses were $3.4 million for the second quarter, compared to $2.8 million for the same period in 2024, an increase of $0.6 million, or 23%. This increase was due primarily to a higher VAT expense of $0.4 million and a higher personnel cost, including share-based compensation, of $0.2 million. At June 30th, 2025, the company had cash and cash equivalents totaling $41.5 million as compared to $20.1 million at December 31st, 2024. With the increase resulting from the net proceeds of the no payable and stock offerings of $32 million, partially offset by the use of $8.7 million in cash for operating activities. Our operational cash burn in Q2 was $2.6 million, broadly in line with the operational cash burn of the second quarter of 2024. With that, I'd like now to turn the call back to you, Joe. Thank you, Danilo.