ClearPoint Neuro, Inc. (CLPT)

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Acquisition Will Enhance ClearPoint Neuro's Commercial Scale, Drive Operational Leverage, and Support Its Long-Term Strategy in CNS Drug Delivery Innovation SOLANA BEACH, CALIFORNIA / ACCESS Newswire / November 20, 2025 / 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 that it has completed its previously announced acquisition of IRRAS Holdings, Inc. ("IRRAS"). The transaction closed on November 20, 2025 following receipt of IRRAS shareholder approval and satisfaction or waiver of all required closing conditions.

ClearPoint Neuro, Inc. ( CLPT ) Q3 2025 Earnings Call November 6, 2025 5:00 PM EST Company Participants Joseph Burnett - President, CEO & Director Danilo D'Alessandro - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets, LLC, Research Division Presentation Operator [Audio Gap] 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, 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.

ClearPoint's third quarter results were weak, which was at least partly due to resource constraints while its new CRO facility was being opened. The near-term outlook for ClearPoint's biopharma business is also now clouded by FDA uncertainty around uniQure's AMT-130. The new CRO facility, PRISM 1.5T clearance, and IRRAS acquisition set ClearPoint up for much stronger growth going forward.

ClearPoint Neuro, Inc. (CLPT) came out with a quarterly loss of $0.21 per share versus the Zacks Consensus Estimate of a loss of $0.2. This compares to a loss of $0.18 per share a year ago.

Site Readiness Continues for Specialized Treatment Centers Envisioned to Support a Growing Number of Cell and Gene Therapy Trial Patients and Later Commercialization SOLANA BEACH, CA / ACCESS Newswire / November 6, 2025 / 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 third quarter ended September 30, 2025. Third Quarter Highlights Continued to provide supply, development, and strategic support to more than 60 active biopharma partners, including nine partner programs accepted for FDA expedited review, with many partners sharing updates on their scientific and regulatory progress at the 2025 ESGCT Annual Congress in Seville, Spain; Completed transition to the new Pre-clinical CRO Facility named ClearPoint Advanced Laboratories (CAL) located in Torrey Pines, California, which became operational and already began running preclinical studies early in Q4 2025; Announced the development and demonstration of the Company's prototype Robotic Neuro-Navigation System, which is being designed to enable the ClearPoint Neuro Navigation software to operate the KUKA LBR Med Robotic Arm to support all minimally invasive cranial surgical procedures including cell and gene therapy infusions, laser catheter placement, biopsy workflows, deep brain stimulation, and stereotactic EEG lead placements; Received FDA 510(k) clearance expanding compatibility of the ClearPoint PRISM Laser Therapy System with 1.5T MRI guidance in addition to the previously cleared 3T MRI guidance, opening up more than 50% of the existing market for neuro LITT; Announced several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan, bringing the total number of international clearances for key therapy delivery products to 34 countries worldwide; Announced a signed agreement for the acquisition of IRRAS Holdings, Inc., which will expand the Company's footprint into the neurocritical care space and allow the Company to leverage an expanded commercial channel; Activated 5 new global customers in the third quarter; Reported quarterly revenue of $8.9 million, a 9% year-over-year increase compared with the third quarter of 2024 and reaffirmed the prior 2025 full year forecast narrowing the expected revenue range to between $36.0 million and $38.0 million; and Reported cash and cash equivalents totaling $38.2 million as of September 30, 2025.

Acquisition Will Further Expand the Potential of ClearPoint Neuro's Drug Delivery Portfolio While Immediately Adding New Indications and Commercial Scale Across a $0.5 Billion Market for the Treatment of Intracranial Bleeding SOLANA BEACH, CALIFORNIA / ACCESS Newswire / November 6, 2025 / 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 the acquisition of San Diego based, IRRAS Holdings, Inc., a medical technology company focused on neurocritical care, with an emphasis on treatments for intracerebral hemorrhage, chronic subdural hematoma, and other conditions requiring intracranial fluid management. Its cornerstone product is the IRRAflow ® system, an FDA-cleared and CE-marked platform which integrates continuous irrigation, aspiration, and real-time intracranial pressure monitoring.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / November 5, 2025 / 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 it will participate in the following investor conferences: 2025 UBS Global Healthcare Conference - Palm Beach Gardens, FL Presenting on Monday, November 10, 2025 2025 Stifel Healthcare Conference - New York, NY Presenting on Thursday, November 13, 2025 37th Annual Piper Sandler Healthcare Conference - New York, NY Presenting on Wednesday, December 3, 2025 Members of the ClearPoint Neuro management team will be onsite and available for in-person investor meetings who are registered to attend the various conferences. About ClearPoint Neuro ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 7, 2025 / 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 results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy. The study cohort comprised fourteen patients ages 18-80years with primary and recurrent glioblastoma and grade 4 astrocytoma, tumors which are among the most challenging to treat.

The clearly established history across global regulatory bodies is expected to de-risk BioPharma partners' pathways towards achieving global scale and standardization. SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 6, 2025 / 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 several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan.

ClearPoint's new Robotic Neuro-Navigation System merges proven software with KUKA robotics to boost precision in cell and gene therapy delivery.

ClearPoint's stock surged after uniQure announced strong Huntington's data, highlighting the value of its drug delivery platform. CLPT's technology has been validated by the AMT-130 data, positioning the company for improved deal economics in future partnerships. Beyond Huntington's, CLPT's pipeline includes promising programs in Parkinson's and epilepsy.

New Product Category Will Enable Added Flexibility to Support Commercial Launches of Cell and Gene Therapy SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 1, 2025 / 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 formally announced the development and demonstration of the Company's proprietary Robotic Neuro-Navigation System. This new product category will enable the ClearPoint Neuro Navigation software to operate the KUKA LBR Med Robotic Arm to support all minimally invasive cranial surgical procedures including cell and gene therapy infusions, laser catheter placement, biopsy workflows and deep brain stimulation and stereotactic EEG lead placements.

ClearPoint Neuro surged over 100% following positive Huntington's Disease data from partner uniQure, highlighting its drug delivery device's role in AMT-130 trials. CLPT's SmartFlow cannula is already FDA-labeled with Kebilidi, and AMT-130's larger market could make it a meaningful revenue driver if approved. Financially, CLPT expects margin expansion and cash flow breakeven by 2027, with a solid cash runway and manageable debt structure supporting growth.

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 25, 2025 / 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 that Dr. Paul Larson will be joining the company as Chief Medical Officer starting in January 2026. Dr. Larson has a long history of working with ClearPoint Neuro as an advisor, especially supporting education and product development efforts related to cell and gene therapy delivery.