ClearPoint Neuro (NASDAQ: CLPT) grows 2025 revenue, targets $52–$56M in 2026
Rhea-AI Filing Summary
ClearPoint Neuro reported strong top-line growth for 2025 while remaining loss-making and investing heavily for future expansion. Total revenue rose to $37.0 million from $31.4 million, an 18% increase, with fourth-quarter revenue up to $10.4 million from $7.8 million, or 34% growth.
Biologics and drug delivery revenue grew 10% to $19.0 million, and neurosurgery navigation and therapy revenue rose 44% to $14.8 million, while capital equipment and software declined 18% to $3.1 million. Gross margin held at 61%, but operating expenses increased 21% to $46.9 million, driving a wider net loss of $25.5 million versus $18.9 million.
The company completed the IRRAS Holdings acquisition, added access to an extra $20.0 million under its Oberland Capital note facility, and ended 2025 with $45.9 million in cash and cash equivalents, up from $20.1 million. For 2026, ClearPoint Neuro projects revenue between $52.0 million and $56.0 million.
Positive
- Robust revenue growth: 2025 revenue increased 18% to $37.0 million, with fourth-quarter revenue up 34% to $10.4 million versus the prior year period.
- High-growth segments and stable margins: neurosurgery navigation and therapy revenue rose 44% to $14.8 million and biologics and drug delivery grew 10% to $19.0 million, while overall gross margin remained strong at 61%.
- Stronger cash position and ambitious 2026 outlook: cash and cash equivalents more than doubled to $45.9 million, and the company expects 2026 revenue between $52.0 million and $56.0 million.
Negative
- Widening losses: operating loss increased to $24.2 million and net loss grew to $25.5 million in 2025 from $18.9 million in 2024, reflecting higher operating expenses.
- Rising operating costs: operating expenses rose 21% to $46.9 million, driven by IRRAS integration, development spending, professional services, and personnel-related expenses.
- Higher financial leverage: long-term notes payable reached $49.1 million at December 31, 2025, introducing ongoing interest expense and balance sheet risk alongside continued negative operating cash flow of $23.9 million.
Insights
ClearPoint is delivering rapid revenue growth and bold 2026 guidance, but losses and leverage remain significant.
ClearPoint Neuro grew 2025 revenue 18% to
Gross margin stayed solid at
Cash and cash equivalents increased to
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 17, 2026, ClearPoint Neuro, Inc. (the “Company”) issued a press release announcing its financial results for the fourth fiscal quarter and full year ended December 31, 2025. A copy of the press release is furnished herewith as Exhibit 99.1.
The information in Item 2.02 of this Form 8-K, as well as Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
On March 17, 2026, the Company posted an updated investor presentation to its website at http://ir.stockpr.com/clearpointneuro/investor-presentations. A copy of the investor presentation is being furnished herewith as Exhibit 99.2. The Company may use the investor presentation from time to time in conversations with analysts, investors and others.
The information in Item 7.01 of this Form 8-K, as well as Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished herewith:
Exhibit 99.1 |
Press Release dated March 17, 2026 |
Exhibit 99.2 |
Investor Presentation dated March 17, 2026 |
Exhibit 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
CLEARPOINT NEURO, INC. |
|
|
|
|
Date: |
March 17, 2026 |
By: |
/s/ Danilo D'Alessandro |
|
|
|
Danilo D'Alessandro |
Exhibit 99.1
ClearPoint Neuro Reports Fourth Quarter and Full Year 2025 Results
Record Revenue and IRRAS Holdings Acquisition Highlight the Company's ‘Fast. Forward.' Strategy
SOLANA BEACH, CA, March 17, 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 fourth quarter and full year ended December 31, 2025.
2025 Full Year and Fourth Quarter Highlights
“Our Company ended 2025 on a high note with the strongest financial quarter of the year, a newly acquired and commercialized neurocritical care product line, and a genuine excitement regarding our 2026 opportunities,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “We have invested more than $100 million over the past five years to build a strong foundation, made up of four growing product categories, a vetted pipeline of new development programs, an expanded manufacturing footprint, a thoroughly audited quality system, a collection of global regulatory approvals, an expansive IP portfolio, an installed base of more than 150 global centers, and the cash position and investor base to execute on our strategy. Most importantly, through our unique biologics and drug delivery ecosystem, we have attracted more than 60 active biopharma partners, we are currently supporting more than 25 global clinical trials, and more than 10 of our biopharma partner programs have now been accepted to some form of FDA expedited regulatory review. Our Company has never been in a stronger position than we are right now.”
“As we look ahead, we have now entered the next two phases of our growth strategy:”
“The first phase, which we call “Fast. Forward.” is to penetrate an existing $1 billion market opportunity made up of four distinct product segments: 1) pre-commercial drug delivery products and services, 2) neurosurgery navigation and robotics, 3) laser therapy and access, and 4) neurocritical fluid management. We expect all four of these product lines to grow double digits in 2026 through the expansion of our commercial organization, approval of products in new geographies, additional site activations, generation of clinical data, and the execution and launch of new products in our development pipeline.”
“The second phase, which we call “Essential. Everywhere.” is to build a new market that does not yet exist for commercial cell and gene therapy delivery. This is a market in which we believe that the unique ClearPoint Neuro ecosystem will play an essential role. This ecosystem will include brain segmentation tools, predictive drug-delivery modeling, pre-planning and navigation software, frame and robotic delivery options, drug loading and mechanized infusion technologies, an array of cell and gene therapy routes-of-administration, and post procedure quality confirmation software to meticulously track proper delivery. All of these workflow steps will be supported by our talented team of clinical specialists and scientists who will be there in the room, assisting our partners when these new-to-world therapies are first commercialized.”
“For 2026, we now expect revenues to be in the range of $52.0 - $56.0 million. In parallel, we will continue to support our biopharma partners through the global regulatory process, which will generate additive revenue in the years ahead, as we enter the “Essential. Everywhere.” phase.”
Business Outlook
The Company estimates revenue in 2026 to be between $52.0 million and $56.0 million.
Financial Results – Year Ended December 31, 2025
Total revenue was $37.0 million and $31.4 million for the years ended December 31, 2025 and 2024, respectively.
Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 10% to $19.0 million for the year ended December 31, 2025, from $17.3 million for the same period in 2024. This increase is attributable to a $1.7 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials.
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 44% to $14.8 million during the year ended December 31, 2025, from $10.3 million for the same period in 2024. The increase is driven by an increased customer base, additional revenues due to the IRRAflow product line acquisition completed in November 2025, and higher sales for new offerings of SmartFrame OR, Prism Laser Therapy, and introduction of our 3.0 operating room software, during the year ended December 31, 2025, compared to the same period in 2024.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 18% to $3.1 million for the year ended December 31, 2025, from $3.8 million for the same period in 2024, due to a decrease in the placements of ClearPoint navigation capital and software and Prism laser units.
The Company achieved a gross margin of 61% on its sales for 2025, and is broadly in line with gross margin of 61% in the same period in 2024.
Operating expenses were $46.9 million for the full year 2025, compared with $38.9 million for 2024, an increase of 21%. The increase was mainly driven by the integration of IRRAS, higher product and software development costs, acquisition-related expenses, professional services fees, and personnel-related expenses, including share-based compensation, as we increased headcount due to the IRRAS acquisition and to fuel the expansion of the research and development, clinical, and support organizations.
Financial Results – Quarter Ended December 31, 2025
Total revenue was $10.4 million for the three months ended December 31, 2025, in comparison to $7.8 million for the three months ended December 31, 2024.
Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 23% to $5.2 million for the three months ended December 31, 2025, from $4.2 million for the same period in 2024. This increase is attributable to $1.1 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials, partially offset by lower service revenue of $0.1 million.
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 61% to $4.7 million for the three months ended December 31, 2025, from $2.9 million for the same period in 2024. The increase is driven by an increased customer base and additional revenues due to the IRRAflow product line acquisition completed in November 2025, during the three months ended December 31, 2025, compared to the same period in 2024.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 18% to $0.5 million for the three months ended December 31, 2025, from $0.6 million for the same period in 2024.
The Company achieved a gross margin of 62% on its sales for the three months ended December 31, 2025, and is broadly in line with gross margin of 61% in the same period in 2024.
Operating expenses were $13.4 million for the three months ended December 31, 2025, compared with $10.4 million for the same period in 2024, an increase of 30%. The increase was mainly driven by the acquisition of IRRAS and increased professional services fees.
At December 31, 2025, the Company had cash and cash equivalents totaling $45.9 million as compared to $20.1 million at December 31, 2024, with the increase resulting from the net proceeds of the notes payable and stock offering of $51.4 million, and cash acquired as part of the IRRAS acquisition of $1.1 million, partially offset by the use of $23.9 million in cash for operating activities and $1.9 million in cash paid for taxes related to the net share settlement of equity awards.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's 2025 fourth quarter and full year results on Tuesday, March 17, 2026 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=XzyAJzOm. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until April 16, 2026, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the market opportunity and rate of sales and revenue growth for the Company’s products and services, including for the Company’s preclinical CRO facility and its products and services, the Company’s neuronavigational products, the IRRAflow Active Fluid Exchange System, and the PRISM Laser Therapy System; the Company’s expectations for achieving key growth drivers for its sales including its ability to expand its commercial organization, receive regulatory approval for its products in new geographies, activate additional customer sites, generate clinical and economic data to support and expand the adoption rate for its products, and its development of new products; the Company’s ability to successfully develop new products for gene and cell therapy delivery, including brain segmentation tools, predictive drug-delivery modeling, new pre-planning and navigation software, frame and robotic delivery options, drug loading and mechanized infusion technologies, cell and gene therapy routes-of-administration, and post procedure quality confirmation software; the adoption of the Company’s products and services for use in the delivery of gene and cell therapies; the regulatory approval and commercialization of cell and gene therapies being developed by the Company’s biotech Partners; and the Company’s expectations for revenues, operating expenses, and management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s biotech Partners’ risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech Partners’ therapies; the limitation or modification of the FDA’s eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the
Company’s biotech Partner’s continued use of the Company’s products and services in their delivery of gene and cell therapies; the Company’s ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; risks inherent in the research, development, and regulatory approval of the Company’s new products; the future market for preclinical services and products and the investment required to expand such services, which could divert resources from the Company’s other business operations; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company’s failure to integrate IRRAS into its business in accordance with expectations; deviations from the expected market potential of the IRRAS products; diversion of management’s attention on the integration of IRRAS into its business; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as instability, protectionism and economic nationalism; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's research and development programs and the expansion of its commercial organization; the ability of the Company to manage the growth of its business; and the Company’s ability to attract and retain its key employees. For a detailed description of the Company’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contact:
Investor Relations:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
CLEARPOINT NEURO, INC.
Consolidated Statements of Operations
(in thousands, except for share and per share data)
|
|
Year Ended December 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Revenue: |
|
|
|
|
|
|
||
Product revenue |
|
$ |
23,859 |
|
|
$ |
18,626 |
|
Service and other revenue |
|
|
13,112 |
|
|
|
12,764 |
|
Total revenue |
|
|
36,971 |
|
|
|
31,390 |
|
Cost of revenue |
|
|
14,279 |
|
|
|
12,268 |
|
Gross profit |
|
|
22,692 |
|
|
|
19,122 |
|
Research and development costs |
|
|
13,897 |
|
|
|
12,392 |
|
Sales and marketing expenses |
|
|
16,461 |
|
|
|
14,478 |
|
General and administrative expenses |
|
|
16,498 |
|
|
|
11,986 |
|
Operating loss |
|
|
(24,164 |
) |
|
|
(19,734 |
) |
Other income (expense): |
|
|
|
|
|
|
||
Other expense, net |
|
|
(146 |
) |
|
|
(40 |
) |
Interest income |
|
|
1,213 |
|
|
|
1,390 |
|
Interest expense |
|
|
(2,388 |
) |
|
|
(518 |
) |
Net loss before income taxes |
|
|
(25,485 |
) |
|
|
(18,902 |
) |
Income tax expense |
|
|
55 |
|
|
|
12 |
|
Net loss |
|
$ |
(25,540 |
) |
|
$ |
(18,914 |
) |
Net loss per share attributable to common stockholders: |
|
|
|
|
|
|
||
Basic and diluted |
|
$ |
(0.90 |
) |
|
$ |
(0.70 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
||
Basic and diluted |
|
|
28,315,254 |
|
|
|
27,027,692 |
|
CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(in thousands, except for share and per share data)
|
|
December 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
45,923 |
|
|
$ |
20,104 |
|
Accounts receivable, net |
|
|
6,549 |
|
|
|
4,713 |
|
Inventory, net |
|
|
8,359 |
|
|
|
6,863 |
|
Prepaid expenses and other current assets |
|
|
2,769 |
|
|
|
1,683 |
|
Total current assets |
|
|
63,600 |
|
|
|
33,363 |
|
Property and equipment, net |
|
|
2,621 |
|
|
|
2,005 |
|
Operating lease, right-of-use assets |
|
|
8,430 |
|
|
|
3,086 |
|
Goodwill |
|
|
7,472 |
|
|
|
— |
|
Intangible assets, net |
|
|
13,922 |
|
|
|
— |
|
Other assets |
|
|
1,702 |
|
|
|
735 |
|
Total assets |
|
$ |
97,747 |
|
|
$ |
39,189 |
|
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
1,256 |
|
|
$ |
1,340 |
|
Accrued compensation |
|
|
4,360 |
|
|
|
4,885 |
|
Other accrued liabilities |
|
|
2,786 |
|
|
|
1,450 |
|
Operating lease liabilities, current portion |
|
|
694 |
|
|
|
557 |
|
Contract liabilities, current portion |
|
|
1,669 |
|
|
|
2,121 |
|
Total current liabilities |
|
|
10,765 |
|
|
|
10,353 |
|
|
|
|
|
|
|
|
||
Operating lease liabilities, net of current portion |
|
|
8,461 |
|
|
|
3,011 |
|
Contract liabilities, net of current portion |
|
|
581 |
|
|
|
436 |
|
Long-term notes payable, net |
|
|
49,077 |
|
|
|
— |
|
Deferred tax liabilities, net |
|
|
354 |
|
|
|
— |
|
Other long-term liabilities |
|
|
489 |
|
|
|
— |
|
Total liabilities |
|
|
69,727 |
|
|
|
13,800 |
|
Commitments and contingencies |
|
|
|
|
|
|
||
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, $0.01 par value; 25,000,000 shares authorized at December 31, 2025 and 2024; none issued and outstanding at December 31, 2025 and 2024 |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 90,000,000 shares authorized at December 31, 2025 and 2024; 29,368,760 and 27,617,415 shares issued and outstanding at December 31, 2025 and 2024, respectively |
|
|
294 |
|
|
|
276 |
|
Additional paid-in capital |
|
|
238,995 |
|
|
|
216,483 |
|
Shares to be issued |
|
|
5,641 |
|
|
|
— |
|
Accumulated deficit |
|
|
(216,910 |
) |
|
|
(191,370 |
) |
Total stockholders’ equity |
|
|
28,020 |
|
|
|
25,389 |
|
Total liabilities and stockholders’ equity |
|
$ |
97,747 |
|
|
$ |
39,189 |
|
CLEARPOINT NEURO, INC.
Consolidated Statements of Cash Flows
(in thousands)
|
|
Year Ended December 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
(25,540 |
) |
|
$ |
(18,914 |
) |
Adjustments to reconcile net loss to net cash flows from operating activities: |
|
|
|
|
|
|
||
Allowance for credit losses (recoveries) |
|
|
21 |
|
|
|
(296 |
) |
Depreciation and amortization |
|
|
814 |
|
|
|
980 |
|
Amortization of intangible assets |
|
|
168 |
|
|
|
— |
|
Share-based compensation |
|
|
8,180 |
|
|
|
6,907 |
|
Payment-in-kind interest |
|
|
908 |
|
|
|
— |
|
Amortization of debt issuance costs and original issue discounts |
|
|
83 |
|
|
|
51 |
|
Amortization of lease right of use assets, net of accretion in lease liabilities |
|
|
1,255 |
|
|
|
923 |
|
Increase (decrease) in cash resulting from changes in: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
(268 |
) |
|
|
(1,206 |
) |
Inventory, net |
|
|
(103 |
) |
|
|
743 |
|
Prepaid expenses and other current assets |
|
|
(397 |
) |
|
|
262 |
|
Other assets |
|
|
(195 |
) |
|
|
(39 |
) |
Accounts payable and accrued expenses |
|
|
(7,520 |
) |
|
|
3,105 |
|
Lease liabilities |
|
|
(1,012 |
) |
|
|
(869 |
) |
Contract liabilities |
|
|
(319 |
) |
|
|
(597 |
) |
Net cash flows from operating activities |
|
|
(23,925 |
) |
|
|
(8,950 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
||
Cash acquired in business combination, net of cash paid |
|
|
1,137 |
|
|
|
— |
|
Purchases of property and equipment |
|
|
(522 |
) |
|
|
(275 |
) |
Net cash flows from investing activities |
|
|
615 |
|
|
|
(275 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from offerings of common stock, net of offering costs |
|
|
3,263 |
|
|
|
16,149 |
|
Proceeds from issuance of notes payable, net of financing costs and discount |
|
|
48,086 |
|
|
|
— |
|
Repayment of 2020 senior secured convertible note |
|
|
— |
|
|
|
(10,000 |
) |
Proceeds from stock option exercises |
|
|
127 |
|
|
|
21 |
|
Payments for taxes related to net share settlement of equity awards |
|
|
(1,856 |
) |
|
|
(424 |
) |
Proceeds from issuance of common stock under employee stock purchase plan |
|
|
559 |
|
|
|
443 |
|
Net cash flows from financing activities |
|
|
50,179 |
|
|
|
6,189 |
|
Net change in cash, cash equivalents and restricted cash |
|
|
26,869 |
|
|
|
(3,036 |
) |
Cash, cash equivalents and restricted cash, beginning of year |
|
|
20,104 |
|
|
|
23,140 |
|
Cash, cash equivalents and restricted cash, end of year |
|
$ |
46,973 |
|
|
$ |
20,104 |
|
Cash and cash equivalents |
|
|
45,923 |
|
|
|
20,104 |
|
Restricted cash included in other current assets and other assets, non-current |
|
|
1,050 |
|
|
|
— |
|
Total cash, cash equivalents and restricted cash |
|
$ |
46,973 |
|
|
$ |
20,104 |
|
SUPPLEMENTAL CASH FLOW INFORMATION |
|
|
|
|
|
|
||
Cash paid for: |
|
|
|
|
|
|
||
Income taxes |
|
$ |
69 |
|
|
$ |
62 |
|
Interest |
|
$ |
908 |
|
|
$ |
480 |
|
WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY. Nasdaq: CLPT March 2026 1 © 2026 CLEARPOINT NEURO
DISCLAIMER Statements in this presentation and discussion concerning ClearPoint Neuro’s (the “Company’s”) plans, growth, and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the continued development, anticipated timing, and potential commercial opportunity of the Company’s pipeline of products and services under development, including its proprietary Robotic Neuro-Navigation platform System, cell and gene therapy delivery devices and routes of administration, software modeling and navigation tools, and preclinical service capabilities; the expected future role of the Company’s products and services in addressing unmet needs in neurological diseases and the potential market opportunity for therapies targeting those indications; the Company’s belief about the outcome of regulatory interactions with respect to its biotech Partners’ therapies, the benefits of regulatory expedited review with respect to accelerating the timing of commercialization of such therapies, and the market potential for such therapies; the size of total addressable markets or the market opportunity for the Company’s products and services, including for the PRISM Laser Therapy System; the Company’s preclinical CRO facility, the IRRAflow Active Fluid Exchange System, and the Company’s navigation technology; the anticipated adoption of the Company’s products and services for use in the delivery of gene and cell therapies; the Company’s ability to scale its operations, commercialization, and increase utilization of its products in neurosurgical centers; the Company's 4-Pillar Product pipeline; the Company’s future looking 4-phase strategy; the Company’s four and five pillar growth strategy for 2026 and beyond; the Company’s expectations for revenues, market share, operating expenses, and management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s biotech Partners’ risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech Partners’ therapies; the limitation or modification of the FDA’s eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the Company’s biotech Partner’s continued use of the Company’s products and services in their delivery of gene and cell therapies; the Company’s ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; risks inherent in the research, development, and regulatory approval of the Company’s new pipeline products; the future market for preclinical services and the investment required to expand such services, which could divert resources from the Company’s other business operations; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company’s failure to integrate IRRAS into its business in accordance with expectations; deviations from the expected market potential of the IRRAS products; diversion of management’s attention on the IRRAS proposed transaction; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as instability, protectionism and economic nationalism; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's research and development programs and commercialization efforts; the ability of the Company to manage the growth of its business; and the Company’s ability to attract and retain its key employees. For a detailed description of the Company’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. © 2026 CLEARPOINT NEURO
Neuro Navigation and Robotics* Ablation Therapy and Access Neurocritical Management Biologics and Drug Delivery *Robotic product is in development phase. Commercialization is subject to successful development, testing, and applicable regulatory clearance. © 2026 CLEARPOINT NEURO OUR COMPANY We Enable Delivery of Both Drug and Device Therapies by Offering Precise Navigation to the Brain and Spine Our Unique Platform Includes Proven Clinical Products Used by Hospitals and Neurosurgeons, and Drug Development Services Used by BioPharma Partners
The Future of Neuro Biologics and Drug Delivery is Here Today Our Company Stroke Rehabilitation (7.0m) More than 30 Million people in the U.S. alone are estimated to suffer from severe and debilitating neurological disorders. Neurological diseases cost Americans nearly $800 Billion annually. To reduce these costs, we must improve both the therapies and the access to care. 30 Million Patients Indicated in the U.S. <300k treated to date with minimally-invasive neurosurgery <1% penetration 30 Million Patients U.S. prevalence pool Parkinson’s Disease & Movement Disorders (8.0m) Epilepsy (2.9m) Alzheimer's & Other Dementias (6.9m) Tumor & Glioblastoma (84k) Severe OCD (1.0m) Treatment Resistant Depression (2.9m) ALS & Spinal Cord Injury (300k) Neuropathic Pain (2.0m) Hemorrhagic Stroke, Subdural Hematoma, Infection (400k) Prevalence estimates are based on publicly available sources. Categories shown are representative and may not be mutually exclusive. ClearPoint Neuro believes that biologics and drug delivery, including cell and gene therapies, will be the answer and that our minimally invasive tools will make these therapies accessible. © 2026 CLEARPOINT NEURO
The Future of Neuro Biologics and Drug Delivery is Here Today Our Company Of those 30 million patients, 2.1 million in the U.S. alone have disorders where a ClearPoint BioPharma Partner has already been accepted for FDA expedited review. Importantly, this gene therapy is labeled as a combination product with the ClearPoint SmartFlow Neuro Cannula Parkinson’s Disease (1.0m) Drug Resistant Epilepsy (1.0m) Frontal Temporal Lobe Dementia (60k) Huntington’s Disease (41k) Glioblastoma (22k) Friedrich's Ataxia (5k) AADC Deficiency (rare) Hunter Syndrome (rare) © 2026 CLEARPOINT NEURO ClearPoint Neuro has 60+ Active Pharma Partners, with 10+ programs accepted for FDA expedited review. In 2024, the first gene therapy delivered directly to the brain was approved.
Our 4-Phase Strategy Positions ClearPoint for Decades of Growth Our Company 1 With more than $100m of capital invested over the past 5 years, our large commercial footprint, rapidly expanding installed base, high-capacity manufacturing, stress-tested quality system, global regulatory reach and expansive IP portfolio has given us a mature foundation on which to build GROW OUR ACTIVE INSTALLED BASE OF 150+ LEADING GLOBAL INSTITUTIONS AND ADD PROCEDURAL CAPACITY Our one-of-a-kind drug delivery platform including neuro navigation, predictive modeling, co-labeled delivery devices, infusion monitoring software and expert clinical case support has become the leading choice by biopharma developers EXTEND OUR LEAD WITH A UNIQUE DRUG DELIVERY ECOSYSTEM DESIGNED FOR CELL AND GENE THERAPY DESIGN. DISCOVERY. More than 10 of our partners have now been accepted for FDA expedited review and are leveraging our unique ecosystem, clinical trial experience, and proven global regulatory leadership Our next goal is to treat just 1% of patients with these indications under expedited review, generate another $300m in annual revenue BUILD A NEW $10B MARKET ALONGSIDE OUR 60+ BIOPHARMA PARTNERS AND DIVERSIFIED ACROSS 15+ INDICATIONS THAT INCLUDES DRUGS THAT ARE CO-LABELED WITH CLEARPOINT TECHNOLOGY Our current products and pipeline, combined with our growing commercial reach will continue to compete in these four existing markets; Biologics & drug delivery, Neuro navigation & robotics, Ablation therapy and access, Neurocritical management, Our next goal is to earn 20% share, generate $200m in annual revenue LEVERAGE OUR EXISTING PORTFOLIO TO PENETRATE A $1B EXISTING MARKET OPPORTUNITY TODAY 2 FUNDED. FOUNDATION. 3 FAST. FORWARD. 4 ESSENTIAL. EVERYWHERE. 2010 – 2019 2020 – 2025 2026+ 2026+ © 2026 CLEARPOINT NEURO
This Unique ClearPoint Ecosystem Has Been Years in the Making Design. Discovery. ClearPoint Neuro embraced the unmet need in neuro biologics and drug delivery and has invested more than $200m over the past 15 years to build a substantial headstart and leadership position. This expansive platform has been used in more than 10,000 procedures to date and has regulatory approvals across 34 countries and counting.* We are positioned to benefit from the expanded use of our delivery platform to include future cell and gene therapies, new DBS and BCI indications, second generation laser ablation therapy, and more advanced approaches to neurocritical fluid management. *Not all products cleared or approved in all territories. © 2026 CLEARPOINT NEURO Data on file ClearPoint Software v.3.x IRRAflow Active Fluid Exchange System ClearPoint Maestro Brain Model* SmartFrame XG SmartFrame OR with ClearPointer* SmartFrame Array* Inflexion Head Fixation Frame ClearPoint Prism Neuro Laser Fibers* ClearPoint Prism Neuro Laser Therapy System* Velocity MR Power Drill* SmartFlow Neuro Cannula IRRAflow Dual-Lumen Catheter and Tube Set CLEARED FDA MARKED
Our Installed Base Has Grown to More than 150 Active Global Centers Funded. Foundation. © 2026 CLEARPOINT NEURO Active ClearPoint Installation (Additional Sites in Asia, EMEA, LATAM) Over 170 employees worldwide focused exclusively on Neuro
~50% of the Top Ranked Neurosurgery Programs use ClearPoint Technology Funded. Foundation. https://health.usnews.com/best-hospitals/rankings/neurology-and-neurosurgery - Posted July 29, 2025 Methodology components and weights summarized from publicly described Best Hospitals specialty ranking methodology (2025–2026 cycle; specialty-specific adjustments may apply). UCSF Medical Center New York-Presbyterian Hospital-Columbia and Cornell Rush University Medical Center Northwestern Memorial Hospital Johns Hopkins Hospital Hospital of University Pennsylvania UT Southwestern Medical Ctr Massachusetts General Hospital Stanford Health Hospital Cleveland Clinic UCLA Medical Center Houston Methodist Hospital Brigham & Women’s Hospital Barnes-Jewish Hospital Cedars-Sinai Medical Center Mayo Clinic Arizona Mayo Clinic Florida Advent Health Orlando Keck Medical Center of USC Thomas Jefferson University UC Davis Medical Center UCSD Jacobs Medical Center University of Michigan Mount Sinai West University of Kansas Emory University Hospital Hackensack Meridian Health Corewell Beaumont University Yale University Hospital Ohio State University – Wexner University of Alabama at Birmingham University of Minnesota Barrow Institute Duke University Hospital University of Wisconsin, Madison Tampa General Hospital UC Irvine Medical Center Baptist Health Miami Hospital Ochsner Medical Center Penn State Health Milton Inova Fairfax Hospital Oregon Health & Science University University of Colorado Aurora Henry Ford Health University of North Carolina Froedtert Hospital Ohio Health Riverside University of Utah Georgetown University US News & World Report Best Neurology/Neurosurgery Hospitals 2025-2026 are recognized for excelling in the treatment of complex, high-risk neurological specialty cases. Evaluation Criteria Public Transparency 3% Patient Experience 5% Process / Expert Opinion 12% Structure 35% Outcomes 45% © 2026 CLEARPOINT NEURO
Stress-Tested QMS and Operations Funded. Foundation. We have invested in our Research & Development, Quality and Manufacturing infrastructure to build confidence for both hospitals and biopharma partners We bring medical device expertise and regulatory combination product acumen to pharmaceutical companies ClearPoint Neuro assets available to our partners: HQ & training facility in Solana Beach, CA Advanced Research Laboratory in Torrey Pines, CA R&D and manufacturing facility in Carlsbad, CA ISO 13485 / MDSAP / EU MDR certified QMS Proven audit history with pharma partners, FDA and global regulatory body inspections © 2026 CLEARPOINT NEURO
Growth Continues Today While We Prepare for Commercial Drug Approvals Funded. Foundation. For the year ended December 31, 2025 For the Trailing Twelve Months (TTM) Including owned and licensed patents Solana Beach, CA HEADQUARTERS $37.0m(A) 2025 REVENUE 130+(C) PATENTS ISSUED 170+ EMPLOYEES Carlsbad, CA R&D, MANUFACTURING $45.9m(A) CASH & CASH EQUIVALENTS 61%(A,B) GROSS MARGIN Torrey Pines, CA ADVANCED RESEARCH LABORATORIES 2026 2025 2024 2023 2022 2021 2020 2019 2018 $7.4 $11.2 $12.8 $16.3 $20.6 $24.0 $31.4 $37.0 $52-$56 (est) PRISM LASER THERAPY EXPANSION EU EXPANSION OPERATING ROOM EXPANSION PRECLINICAL EXPANSION IRRAflow ACQUISITION © 2026 CLEARPOINT NEURO *All Annual Totals in Millions
Experienced Leadership in Place Funded. Foundation. Joe Burnett President & Chief Executive Officer Megan Faulkenberry Senior Vice President of Quality Jeremy Stigall Chief Business Officer Mary McNamara-Cullinane Senior Vice President of Regulatory Affairs Danilo D’Alessandro Chief Financial Officer Rob Korn Senior Vice President of Sales Ernesto Salegio, PhD Vice President of Translational & Pre-Clinical Research Ellisa Cholapranee General Counsel Lyubomir Zagorchev, PhD Vice President of Clinical Science & Applications Paul Larson, MD Chief Medical Officer Mazin Sabra Chief Operating Officer Tim Orr Vice President of Software Development EXECUTIVE LEADERSHIP TEAM Proven industry operators with decades of experience in medical devices, biopharmaceuticals, and clinical research. © 2026 CLEARPOINT NEURO
Our 4-Pillar Growth Strategy Fast. Forward. Collective $1.0B Existing Market Opportunity Today *Not all products cleared or approved in all territories. Increasing Global Scale with Clearances in 34 Countries Worldwide* Pre-Commercial Biologics & Drug Delivery Neurosurgery Navigation & Robotics Laser Ablation Therapy & Access Neurocritical Care & Active CSF Exchange $300m+ Existing Market $125m+ Existing Market $75m+ Existing Market $500m+ Existing Market Our Fast. Forward. 4-Pillar Growth Strategy is to Win 20% of an Existing $1.0B Global Market Opportunity, Generate $200m in Annual Revenue, and to Achieve Cash Breakeven and Profitability Along the Way © 2026 CLEARPOINT NEURO FAST. FORWARD.
Pillar 1: Pre-Commercial Biologics & Drug Delivery Fast. Forward. Leverage Both Commercial and In-Development Delivery and Navigation Tools SmartFlow Software & Biophysical Modeling in Collaboration with NE Scientific $300m+ Existing Market ClearPoint Neuro currently offers a boutique, neuro-focused CRO complete with device co-development services, pre-clinical testing capabilities, and validated clinical trial products to support and de-risk our more than 60 active pharma partners and generate revenue before reaching the drug commercialization stage. Hardware Software Pre-Commercial Biologics & Drug Delivery Combining Services & Technology Benchtop Testing Preclinical Studies Device compatibility testing Custom device development Delivery system validation Performance assessment Running preclinical studies Surgical planning & strategy Dosing & surgical expertise Post-procedure analysis © 2026 CLEARPOINT NEURO
Pillar 2: Neuro Navigation & Robotics Fast. Forward. ClearPoint will provide unmatched flexibility by having a single pre-planning software offering several workflows deployed via either MRI, iCT and eventually Robotics. This strategy balances the consistency of delivery that biopharma partners desire with the optionality and adaptability for surgeons to choose their desired technique. $125m+ Existing Market SmartFrame XG and Accessory Kit ClearPoint Robotic Platform using the KUKA LBR Robotic Arm SmartFrame OR and ClearPointer Optical Wand *Robotic product is in development phase. Commercialization is subject to successful development, testing, and applicable regulatory clearance. Pre-Planning & Navigation Software Select Optimal Delivery Method Neurosurgery Navigation & Robotics © 2026 CLEARPOINT NEURO
Pillar 3: Laser Therapy & Access Fast. Forward. $75m+ Existing Market VelocityALPHA MRI Conditional Power Drill With Optional ClearPoint Navigation Synergies A Versatile Power Solution for SmartFrame in the MRI and OR ClearPoint Prism is a mobile laser therapy system featuring innovative non‑cooled applicator technology that simplifies setup, reduces power and potentially ablation time, and enables efficient workflows. Surgeons can capitalize on workflow efficiency and total system accuracy when Prism is combined with ClearPoint Navigation. Laser Ablation Therapy & Access © 2026 CLEARPOINT NEURO The VelocityALPHA MR High Speed Surgical Drill System is a versatile cutter system designed to reduce procedure times in both the MRI suite and the operating room. One System One Team One Room
Pillar 4: Neurocritical Management Fast. Forward. ClearPoint’s recent acquisition of IRRAS expands the portfolio with a unique and disruptive solution for neurocritical care and intracranial fluid management. IRRAflow enables active irrigation and controlled drainage of hemorrhage, toxins, and clots to therapeutically treat intracranial pathologies. $500m+ Existing Market Active Fluid Exchange System Components IRRAflow Tube Set & Intelligent Digital Cassette IRRAflow Control Unit & Drainage Collection Bag IRRAflow Dual-Lumen Catheter Neurocritical Care & Active CSF Exchange © 2026 CLEARPOINT NEURO
Clear and Continued Investment in ClearPoint’s 4-Pillar Product Pipeline Fast. Forward. 1H 2026 2H 2026 1H 2027 2H 2027 2028+ 1 CAL Facility Operational Radiopharma Formulation MRI/CT Imaging Live GLP Study Capable Cell Culture Capability PET/SPECT Imaging Live Radiolabeling Active Histopathology Active Bioanalytic Lab Active Pathology Lab Active Hot Cell F-18 Radiochemistry Translational Models for tumor, stroke and spinal cord injury 2 CE Mark for 3.x Software Global Installed Base with OR iCT capability SmartFrame Accessory Kit Pre-Clinical Robotic System Active at the CAL Harmony 1.0 Software Sub-Nuclei Segmentation SmartFrame Duet Maestro CT Harmony 2.0 Software Robotic System DBS/BCI Area of Activation Non-Rigid Fusion 3 1.5T Compatibility Velocity MRI Power Drill Philips MRI Compatibility Interoperable 3D Damage Model CE Mark Prism System 3D Thermal Modeling Study Initiated Predictive Ablation Software Spine LITT Data Readout 4 Shoreline Software Cranial Access Bolt IRRAflow Dart Cranial Access Bolt Kit ARCH RCT Data Readout Next Gen IRRAflow Catheter Subdural Indication IRRAflow Rapid Evacuation System VASH Trial Data Readout CRYSTAL Registry Readout Bedside Navigation System © 2026 CLEARPOINT NEURO
3 2 2026+ LASER ABLATION THERAPY & ACCESS Add Ablation Coverage & AI Predictive Thermal Modeling Software Launch MRI Conditional Power Drill for Faster Procedure Times 4 NEUROCRITICAL CARE & ACTIVE CSF EXCHANGE Expand Existing Portfolio Into Multiple New Indications Launch Shoreline Software, Cranial Bolt, IRRAflow Dart, Next-Gen IRRAflow Catheter and a Subdural Hemorrhage Catheter Kit 1 PRE-COMMERCIAL BIOLOGICS & DRUG DELIVERY Expand Neuro Pre-Clinical CRO Services Portfolio and Capacity including larger GLP Study Capability Expand Partnerships to Include Co-Development, Commercial Pricing, Drug Clinical Milestones & Royalty Based Agreements Execute on Development Pipeline for Drug Infusion Monitoring/Modeling, Cell Therapy Actuation, Indwelling Catheters and Spinal Routes of Administration NEUROSURGERY NAVIGATION AND ROBOTICS Expand into the Operating Room w/ 3.0 Software, ClearPoint Duet, and Robotics Launch Maestro CT, sub-nuclei segmentation, Non-Rigid Fusion, Area-of-Activation Harmony Software © 2026 CLEARPOINT NEURO Our Fast. Forward. 4-Pillar Growth Strategy is to Win 20% of an Existing $1.0B Global Market Opportunity, Generate $200m in Annual Revenue, and to Achieve Cash Breakeven and Profitability Along the Way
What Does it Mean to be Essential to Future of Cell and Gene Therapy? Essential. Everywhere. It starts by being unique. Our Essential. Everywhere. Strategy is to build a new market from the ground up where our unique ecosystem plays an essential role and enables 20,000 annual Cell & Gene Therapy procedures. Our Goal is to create the capacity for 20,000 CGT patients per year and generate an additional $300m annually. *Not all products cleared or approved in all territories. ESSENTIAL. EVERYWHERE. © 2026 CLEARPOINT NEURO 20 © 2026 CLEARPOINT NEURO Increasing Global Scale with Clearances in 34 Countries Worldwide* 60+ Active Pharma Partners Exclusively co-labeled with: Pre-Commercial Biologics & Drug Delivery Neurosurgery Navigation & Robotics Laser Ablation Therapy & Access Neurocritical Care & Active CSF Exchange 25+ Active Clinical Trials 15+ Neuro-Focused Indications 10+ Under Regulatory Expedited Review 1 Approved Combination Device
Our Unique Ecosystem Will Play An Essential Role for Cell and Gene Therapy Essential. Everywhere. Comprehensive Pre-Planning Navigation Software Modules Flexible Options for Surgeon Selected Navigation Including Frames, Robotics Multiple Biologic Specific & Co-Labeled Routes-of-Administration Every Step Fully Supported by a Team of 30+ Expert Field-Based Clinical Specialists Confirmatory Volumetric Dosing Data for Quality of Delivery Documentation A.I. Derived Patient and Tissue Specific Segmentation Therapy and Patient Specific Biophysics Modeling Tools All products in development phase. Commercialization is subject to successful development, testing, and applicable regulatory clearance. © 2026 CLEARPOINT NEURO
Indication Parkinson’s Disease Epilepsy Huntington’s Rare Genetic Dementias Gliomas Neuromuscular Stroke …and more than 15 additional programs that are undisclosed and in preclinical development. © 2026 CLEARPOINT NEURO ClearPoint Neuro Has 60+ Active Pharma Partners, 25+ Active Clinical Trials Essential. Everywhere. Preclinical Phase 1/2 Phase 3 Commercialization
Parkinson's (Kenai) – RNDP-001 Parkinson's (Aspen) – ANPD001 Frontotemporal Dementia (AviadoBio) – AVB-101 Friedreich's Ataxia – (Undisclosed) Huntington's (uniQure) – AMT-130 AADC Deficiency (PTC) – KEBILIDI / Upstaza Parkinson's (AskBio) – AB-1005 Parkinson's (BlueRock) – BRT-DA01 Hunter Syndrome (REGENXBIO) – RGX121 Glioma (Siren) – SRN-101 Parkinson’s – (Undisclosed) Parkinson’s – (Undisclosed) Epilepsy (MTLE) (Neurona) – NRTX-1001 10+ Programs Are Already Under FDA Expedited Review and Enrolling Essential. Everywhere. Indication © 2026 CLEARPOINT NEURO Preclinical Phase 1/2 Phase 3 Commercialization
Building Surgical Experience and Capacity to Prepare for Drug Commercialization Essential. Everywhere. © 2026 CLEARPOINT NEURO Existing CLPT Navigation Site Experienced CLPT Navigation Site and Participant in Active CGT Trial
5 COMMERCIAL DRUG DELIVERY Add Capacity for 5,000 cell & gene therapy procedures Launch Co-Labeled Products with 10+ partners that are already under FDA Expedited Review across 8 Indications 3 2 2026+ LASER ABLATION THERAPY & ACCESS Add Ablation Coverage & AI Predictive Thermal Modeling Software Launch MRI Conditional Power Drill for Faster Procedure Times 4 NEUROCRITICAL CARE & ACTIVE CSF EXCHANGE Expand Existing Portfolio Into Multiple New Indications Launch Shoreline Software, Cranial Bolt, IRRAflow Dart, Next-Gen IRRAflow Catheter and a Subdural Hemorrhage Catheter Kit 1 PRE-COMMERCIAL BIOLOGICS & DRUG DELIVERY Expand Neuro Pre-Clinical CRO Services Portfolio and Capacity including larger GLP Study Capability Expand Partnerships to Include Co-Development, Commercial Pricing, Drug Clinical Milestones & Royalty Based Agreements Execute on Development Pipeline for Drug Infusion Monitoring/Modeling, Cell Therapy Actuation, Indwelling Catheters and Spinal Routes of Administration NEUROSURGERY NAVIGATION AND ROBOTICS Expand into the Operating Room w/ 3.0 Software, ClearPoint Duet, and Robotics Launch Maestro CT, sub-nuclei segmentation, Non-Rigid Fusion, Area-of-Activation Harmony Software © 2026 CLEARPOINT NEURO Our Essential. Everywhere. Strategy Expands Our Vision into a 5-Pillar Growth Strategy Which Will Include Commercial Drug Delivery and Highlights Our Path to Achieving $500m in Revenue
Our 4-Phase Strategy Positions ClearPoint for Decades of Growth Our Company 1 With more than $100m of capital invested over the past 5 years, our large commercial footprint, rapidly expanding installed base, high-capacity manufacturing, stress-tested quality system, global regulatory reach and expansive IP portfolio has given us a mature foundation on which to build GROW OUR ACTIVE INSTALLED BASE OF 150+ LEADING GLOBAL INSTITUTIONS AND ADD PROCEDURAL CAPACITY Our one-of-a-kind drug delivery platform including neuro navigation, predictive modeling, co-labeled delivery devices, infusion monitoring software and expert clinical case support has become the leading choice by biopharma developers EXTEND OUR LEAD WITH A UNIQUE DRUG DELIVERY ECOSYSTEM DESIGNED FOR CELL AND GENE THERAPY DESIGN. DISCOVERY. More than 10 of our partners have now been accepted for FDA expedited review and are leveraging our unique ecosystem, clinical trial experience, and proven global regulatory leadership Our next goal is to treat just 1% of patients with these indications under expedited review, generate another $300m in annual revenue BUILD A NEW $10B MARKET ALONGSIDE OUR 60+ BIOPHARMA PARTNERS AND DIVERSIFIED ACROSS 15+ INDICATIONS THAT INCLUDES DRUGS THAT ARE CO-LABELED WITH CLEARPOINT TECHNOLOGY Our current products and pipeline, combined with our growing commercial reach will continue to compete in these four existing markets; Biologics & drug delivery, Neuro navigation & robotics, Ablation therapy and access, Neurocritical management, Our next goal is to earn 20% share, generate $200m in annual revenue LEVERAGE OUR EXISTING PORTFOLIO TO PENETRATE A $1B EXISTING MARKET OPPORTUNITY TODAY 2 FUNDED. FOUNDATION. 3 FAST. FORWARD. 4 ESSENTIAL. EVERYWHERE. 2010 – 2019 2020 – 2025 2026+ 2026+ © 2026 CLEARPOINT NEURO
FAQ
How did ClearPoint Neuro (CLPT) perform financially in 2025 versus 2024?
What revenue guidance did ClearPoint Neuro (CLPT) provide for 2026?
How did ClearPoint Neuro’s key revenue segments perform in 2025?
What were ClearPoint Neuro’s profitability and margins in 2025?
How did ClearPoint Neuro’s balance sheet and cash position change in 2025?
What strategic moves did ClearPoint Neuro (CLPT) make in 2025?
What were ClearPoint Neuro’s cash flows from operations in 2025?
Filing Exhibits & Attachments
3 documentsPress Releases
