ClearPoint Neuro, Inc. Common Stock 2026 Q2 Earnings Call

Thank you. As always, thank you to all the investors, analysts and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuro ecosystem 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. We at Clearpoint believe that we can play an important, if not essential, role in this exciting future. The 2Q of 2026 in itself has been an exciting one and possibly one of the most important series of events in our history.

While our long-term vision remains unchanged, anchored by our four-pillar growth strategy, there has been substantial progress leading us to up prioritize certain parts of the strategy and to take advantage of this new information from the last few months. Today, instead of looking to the horizon and reconfirming our long-term strategy, I will focus on these three most important and elevated priorities that are right in front of us. These three activities will represent the largest time and financial investment for the second half of this year. First, we have all seen regulatory updates from pharma partners demonstrating an accelerated pathway to phase III trial enrollment and even commercial approval. This revised potential schedule is much faster than what we believed just six months ago, and once again has highlighted the need to pursue commercial readiness activities in support of our partners' global launch plans.

Second, as of July, we have now taken possession of the 30,000 sq ft CAL preclinical facility in Torrey Pines, California, which includes our analytical lab space. This milestone has enabled us to sign our very first statement of work for GLP services, which we expect to complete in the first half of 2027, when all of our equipment and procedures are in place. We believe that this asset will fuel growth in our preclinical services business, starting here in the second half of 2026, with continued growth in 2027 and beyond. Third, the announcement of our partnership in focused ultrasound, which when combined with our in development robotic system and Harmony 1.0 control software, will be designed to assist our partners in the next phase of drug delivery growth after approval, which will be commercial expansion, scale and efficiency.

These three foundational activities have become paramount over the last few months and warrant a greater demand of our focus and our attention. I will now hand the call over to Danilo D'Alessandro, our CFO, to review financials in the quarter, after which I will spend some time detailing the second half 2026 priorities.

Danilo. Thank you, Joe, and thank you all for joining us today.

Looking at the second quarter 2026 results, total revenue was $10.9 million for the three months ended June 30th, 2026, and $9.2 million for the three months ended June 30th, 2025, which represents 18% growth versus the second 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 utilizing our products. Biologics and Drug Delivery revenue decreased 15% to $4 million in the second quarter, down from $4.7 million in 2025.

This decrease was mainly due to a decrease in product revenue of $0.9 million due to a single customer order that occurred in the quarter of the prior year and did not recur in the current quarter. The ADD service revenue increased $0.2 million from prior year. 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 to $5.6 million for the second quarter 2026, driven primarily by additional revenues due to sales of the IRRAflow product, as well as the introduction of our 3.0 operating room navigation software, which has positively impacted procedural volumes in the operating room during the three months ended June 30th, 2026, compared to the same period in 2025.

Capital Equipment and Software revenue consisting of sales of our reusable hardware and software and of related services increased 24% to $1.3 million in the quarter from $1 million for the same period in 2025, due to an increase in the placement of ClearPoint navigation systems, Prism laser units and IRRAflow control units. Gross margin for the second quarter 2026 was 62%, an increase of 2% compared to 60% in Q2 2025, mostly related to a decrease in excess and obsolete inventory. Research and Development costs were $4.6 million for the three months ended June 30th, 2026, compared to $3.8 million for the same period in 2025, an increase of $0.8 million or 21%. The increase was due primarily to higher personnel costs of $0.8 million.

Sales and Marketing expenses were $6.8 million for Q2, compared to $4 million for the same period in 2025, an increase of $2.7 million, or 68%. This increase was due primarily to additional personnel cost of $1.8 million and increases in travel costs of $0.3 million, resulting from the expansion of our clinical and sales teams. The increase was also driven by additional amortization expense of acquired intangible assets of $0.2 million, and marketing material cost of $0.2 million. General and Administrative expenses were $5.6 million for the second quarter, an increase of $2.2 million or 64%. This increase was due primarily to increases in occupancy costs of $0.7 million, professional service fees of $0.5 million, personnel costs of $0.3 million, general corporate costs of $0.3 million, and IT and software costs of $0.2 million.

As of June 30th, 2026, we had cash and cash equivalents totaling $29.4 million as compared to $45.9 million at December 31st, 2025. The cash reduction was primarily due to the operational cash burn of $15 million through Q2 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We do expect the operational cash burn to decrease in the second half of the year as we benefit from the completion of the IRRAS integration. I'd like now to turn the call back to Joe.

Thank you, Danilo. As mentioned earlier on the call, our long-term four-pillar growth strategy remains unchanged. There are a number of priority adjustments that we have made this year to be responsive to the best and latest information that we have in hand. As a smaller but agile company, we believe that this is one of our strengths, and I want to spend some time walking through these priorities and the rationale and results that we plan to achieve for 2026. The first of these priorities is our clinical capacity. The most noteworthy change since our last call is that the FDA has seemingly reversed course on their regulatory approach surrounding some rare diseases. Therapies for these diseases can be very challenging to test clinically due to the speed of disease progression and challenges with patient enrollment.

When we started this year, we believed that the additional requirement of multi-year sham studies in these difficult patient populations would be required for U.S. approval, pushing the potential timing of a gene therapy approval out years into the future. Recent news from key biopharma partners seem to indicate that the FDA is once again open to creative trial designs and strategies that could support BLA submissions in the second half of this year. For Clearpoint, we want to ensure that the access to our technology and the support of our clinical team are not bottlenecks to the success of these launches. As a result of this new information, we have once again reactivated our clinical support growth strategy to meet this need, as we believe it may become a necessity as early as 2027.

We intend to invest in growing our clinical specialist team globally and to train them to support these phase III and commercial drug delivery cases. To provide the level of expertise that our surgeons demand is not a small task. We believe we have about 12 to 15 months to really get ready, so the time to hire and begin training is now. It is important to note that this is not only a U.S. strategy, as our partners are pursuing therapy submissions beyond the United States as well. We have accelerated our investment into the global approvals for our products and drug delivery ecosystem and have once again started hiring clinical specialists around the world. As an example, we have recently hired clinical support teammates in the United States, European Union, Canada, and Japan.

This same expanded team will also be used to support multiple phase III trials in the next 12 to 18 months, which often include patient populations up to 10 times what a phase I trial would require. In fact, we expect between 10 and 15 trials using ClearPoint technology to be enrolling patients in the next 18 months. When combined with potential commercial drug approvals, we believe that the time is now to prioritize this investment. This is a very exciting role to recruit for as well, as we expect our team to be in the room for many first-of-their-kind gene and cell therapy cases in the years ahead, which is a pretty rare thing for a technical and clinical specialist and a chance to build an exciting and meaningful career.