CLPT

EX-99.1

2 clpt-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ClearPoint Neuro Reports Second Quarter 2026 Results

Positive BioPharma Partner Regulatory Progress and Early Success in Focused Ultrasound Technology Platform Expansion

SOLANA BEACH, CA, August 3, 2026 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its second quarter ended June 30, 2026.

Second Quarter 2026 Highlights

• Reported second quarter revenue of $10.9 million, representing 18% overall growth, including the recently acquired IRRAflow Portfolio; Biologics and Drug Delivery Revenue declined 15% in the quarter, primarily due to a decrease in products shipped to biopharma customers supporting new trial initiations compared to the second quarter a year ago. This decline was partially offset by growth in preclinical service revenue in the quarter. As of July 2026, the ClearPoint Advanced Laboratories (CAL) facility is now in the Company’s possession and new services revenue is expected to return the Biologics and Drug Delivery segment to growth in the third quarter;

• Multiple biopharma partners recently received positive feedback from the FDA on their potential BLA submissions, as well as other global regulatory progress, leading us to believe that additional cell and gene therapies could become available commercially by the end of 2027;

• The Company expects 10-15 clinical trials using ClearPoint Neuro technology to be enrolling patients in the next 18 months, along with approximately 10 partner clinical trial data readouts;

• The Company has entered into multiple statements of work for preclinical services at CAL, including our first statement of work involving GLP services, which we expect to complete in the first half of 2027;

• Both our in-development Robotic platform and Harmony 1.0 software were showcased at multiple neurosurgery trade shows in the second quarter; feedback from more than 50 surgeons reinforced our strategy and provided essential user input;

• Announced plans to enter the focused ultrasound market via a partnership with the SONOCARE Lab at Sungkyunkwan University, South Korea, alongside the successful intravenous delivery of tracers across the blood-brain barrier in a preclinical model using the ClearPoint Neuro prototype system; and

• Positive regulatory news has re-activated the need for commercial drug delivery readiness in 2027 leading to a reorganization of the Company’s commercial structure which began in Q2 with an emphasis on installed base expansion and clinical case support.

“Establishing ClearPoint Neuro as the leading neuro cell and gene therapy delivery company has been our number one priority for the last 10 years. Over that time, we have pivoted the company vision, invested more than $200 million, built our unique ecosystem, and earned more than 60 active biopharma partners, many of whom have programs which are now under FDA expedited review,” commented Joe Burnett, President and CEO at ClearPoint

Neuro. “Exciting news over the past few months from our partners, global regulatory bodies, and our own product development teams have only furthered that conviction.”

“First, the FDA recently reversed their guidance on a number of rare disease decisions, once again opening the door for potential partner BLA submissions later this year. This timing could yield commercial approvals as early as 2027, and as a key product and service provider to our partners, we need to ensure that we are ready. This regulatory news, combined with the planned initiation of larger phase III trials, has elevated the priority to invest in building our clinical capacity so that the ClearPoint installed base and our clinical support team are not a bottleneck. We believe the next 18 months will only increase the need for capable sites as we expect between 10 and 15 clinical trials to be enrolling, and approximately 10 data readouts to be presented, creating informative news flow on almost a monthly basis. It is important to note that progress toward commercial cell and gene therapy delivery is not just a U.S. phenomenon, and expanding our global footprint is included in these activities.”

“Second, we are now in possession of the ClearPoint Advanced Laboratories, or the ‘CAL’, our preclinical lab facility in Torrey Pines. Importantly we have now signed our very first statement of work for an IND enabling study involving GLP services at the CAL and we expect it to be performed in the first half of 2027.”

“Third, we announced a 10-year focused ultrasound drug delivery partnership with the SONOCARE Lab at Sungkyunkwan University in South Korea, supported by preclinical proof-of-concept results demonstrating successful delivery of tracers across the blood-brain barrier. In parallel, our in-development ClearPoint Neuro robotic platform continued to advance and received valuable

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