ClearPoint Neuro, Inc.

An investment in shares of our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in our 2025 Form 10-K, in addition to other information in this report, before investing in our common stock. The occurrence of any of these risks could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In these circumstances, the market price of our common stock could decline, and you may lose all or part of your investment. There have been no material changes to the risk factors disclosed under Part I, Item 1A. "Risk Factors" in our 2025 Form 10-K, other than the risks discussed below:

Establishing and operating our preclinical CRO facility (CAL) is capital intensive and subject to significant execution risk, and we may not realize the anticipated benefits of this investment. Our facility leases also impose significant long-term fixed obligations.

We are investing significant capital and management resources to build out, equip, and operate our preclinical contract research organization facility (CAL) to provide preclinical services, including Good Laboratory Practice (GLP) study services, to biopharmaceutical customers. Standing up and scaling this facility is capital intensive and requires substantial expenditures, including facility rent and related occupancy costs, leasehold improvements and construction, the purchase and installation of specialized capital equipment, and the hiring, training, and retention of qualified scientific and technical personnel. Many of these costs are fixed or must be incurred in advance of, and without assurance of, corresponding revenue.

The build-out and commissioning of the facility are subject to risks that could delay or increase the cost of making it fully operational, including construction and permitting delays, cost overruns, supply chain constraints or delays in the delivery, installation, and qualification of capital equipment, contractor or vendor performance issues, and other factors, some of which are beyond our control. Delays in building out, remediating, or commissioning the facility could delay our ability to generate associated revenue. Although we have begun performing services at the facility, the build-out is ongoing, and delays in completing it could limit the capacity and range of services we are able to offer.

In addition, we may require additional space, whether at the facility or elsewhere, and we may rely from time to time on temporary or short-term arrangements to perform certain services, whether on an interim or ongoing basis. Such arrangements may be limited in duration, depend on the consent or cooperation of third parties, and may not be extended. If we are unable to obtain additional space on acceptable terms or within the timeframe we expect, or if temporary arrangements expire or otherwise become unavailable, we may be required to relocate those operations, which may not be possible on a timely basis, on acceptable terms, or at all, and our ability to perform those services and generate associated revenue could be adversely affected.

Our ability to perform certain services, including GLP-compliant studies, depends on achieving and maintaining the appropriate regulatory and quality standards for the facility and its processes. We may be unable to establish, validate, or maintain GLP compliance or other required standards on the timeline we anticipate or at all, which could prevent us from performing GLP studies. Any failure or delay in achieving or maintaining these standards, or any finding of noncompliance, could result in lost or delayed revenue, reputational harm, loss of customers, or the need for additional expenditures to remediate.

As we continue to scale operations at the facility, we may be unable to attract sufficient customer demand, execute or retain a sufficient volume of statements of work, or scale our capacity and throughput to the levels necessary to utilize the facility efficiently. Customer statements of work may be delayed, rescheduled, reduced in scope, or terminated, and demand for our preclinical services may not materialize at the levels or on the timeline we expect. Our ability to expand capacity depends on factors including facility readiness, equipment availability, and our ability to recruit and retain qualified personnel, and we may be unable to scale on the timeline we anticipate or at all.

As a result of these factors, the revenue generated by the facility may be insufficient to offset the significant fixed and variable costs of building, equipping, and operating it, and we may not achieve a return on this investment that justifies the capital and resources deployed, or may not do so within the timeframe we expect. The investment required to establish and expand the facility may also divert capital and management attention from our other business operations. If we are unable to complete the build-out of the facility, achieve and maintain required compliance standards, generate sufficient demand, or scale efficiently, our business, financial condition, and results of operations could be materially and adversely affected. In addition, the lease for the CAL facility has an initial term that expires approximately eleven years after the last portion of the premises was delivered to us with the landlord's improvements substantially complete, and our rent obligations under the lease, which are subject to annual increases, are fixed regardless of whether the facility generates sufficient revenue. If we are unable to utilize the facility as anticipated, we may be unable to sublease the space or otherwise exit the lease on acceptable terms or at all, and we could be required to record impairment charges related to the right-of-use assets and leasehold improvements associated with the facility.

More generally, we lease our corporate headquarters and our manufacturing, laboratory, and office facilities under non-cancelable operating leases with fixed, multi-year payment obligations. We may be unable to renew these leases on acceptable terms or to sublease or exit space we no longer need, and any need to relocate our manufacturing operations could be costly and time-consuming and could disrupt our ability to supply products, including because of the need to qualify a new facility.