ClearPoint Neuro, Inc. Common Stock 2026 Q3 Earnings Call

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, focused 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 III studies that are either enrolling or expected to initiate in 2027.

We look forward to the next regulatory milestones for our partner, uniQure's BLA submission to the FDA for AMT-130 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 IRRAS acquisition and the reorganization of our clinical field team to get ready for phase III 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 facilities 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-pillared 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 30, 2026, and $8.9 million for the three months ended September 30, 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 contract 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 IRRAflow. This revenue grew 59% to $5.4 million in the third quarter 2026 from $3.4 million for the same period in 2025, driven primarily by additional revenues due to sales of the IRRAflow product, which we acquired in connection with our acquisition of IRRAS 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 of 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 IRRAflow control units.

Gross margin for the third quarter 2026 was 58%, a decrease of five 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 30, 2026, compared to $3.5 million for the same period in 2025, an increase of $0.6 million or 16%. The increase was due primarily to higher personnel costs 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 decrease in bad debt 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 30, 2026, we had cash and cash equivalents totaling $46.2 million as compared to $45.9 million at December 31, 2025.

The cash increase was primarily due to the net proceeds of $22 million from the at-the-market equity offering program, partially offset by the operational cash burn of $20.1 million through Q3 2026. I would like now to turn the call back to Joe.

Thank you, Danilo. I will now provide some further details organized by our continued four-pillar growth strategy. Starting with pillar number one, Biologics and drug delivery. The most noteworthy headline has been the BLA regulatory submission by one of our partners, uniQure, for their AMT-130 program to treat Huntington's disease. We continue to support uniQure on the device-related aspects of the submission, and our device documentation is now on file with the agency. Subject to the FDA's review, we expect the next two regulatory steps would be, first, that the FDA would formally accept the AMT-130 submission for review, and second, that ClearPoint would submit a companion 510(k) for our product to address its specific use with AMT-130. This is the same pathway we pursued for Kebilidi, the only other neurogene therapy that has received FDA approval for administration directly to the brain.