ClearPoint Neuro, Inc 10-Q for FY2026 Q3
ClearPoint Neuro, Inc. (CLPT)
About this 10-Q
ClearPoint Neuro, Inc filed this 10-Q on October 28, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).
ClearPoint Neuro, Inc. reported $35.1 million revenue for the nine months ended September 30, 2026, up 32%, while net loss increased 60%. Cash was $46.2 million, sufficient for at least the next twelve months. AI summary
Headline figures
Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $12.08M
- up 36.3% from $8.86M a year earlier
- Net loss
- $7.46M
- compared with a net loss of $5.89M a year earlier
- Diluted EPS
- -$0.24
- compared with -$0.21 a year earlier
|
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
|
|
|
For the quarterly period ended |
|
|
Or |
|
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
|
|
|
For the transition period from_____to _____ |
Commission file number:
(Exact Name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(IRS Employer |
of Incorporation or Organization) |
Identification Number) |
|
|
(Address of Principal Executive Offices) |
(Zip Code) |
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. þ
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o |
Accelerated filer ☐ |
Smaller reporting company |
|
|
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. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes
As of October 21, 2026, there were
|
CLEARPOINT NEURO, INC.
TABLE OF CONTENTS
|
|
Page Number |
1 |
||
|
|
|
1 |
||
|
Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 |
1 |
|
2 |
|
|
3 |
|
|
5 |
|
|
6 |
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
24 |
|
33 |
||
33 |
||
|
|
|
|
||
|
|
|
33 |
||
33 |
||
35 |
||
35 |
||
35 |
||
35 |
||
36 |
||
|
|
|
37 |
||
Trademarks, Trade Names and Service Marks
ClearPoint Neuro®, ClearPoint®, SmartFlow®, SmartFrame®, SmartGrid®, Inflexion®, ClearPoint Maestro®, SmartFrame Array®, SmartFrame OR®, ClearPoint Neuro Orchestra®, ClearPoint Prism®, ClearPointer®, When Your Path is Unclear, We Point The Way®, ClearPoint Advanced Laboratories™, IRRAS®, and IRRAFLOW® are all trademarks of ClearPoint Neuro, Inc. and its affiliates. Any other trademarks, trade names or service marks referred to in this Quarterly Report on Form 10-Q (this “Quarterly Report”) are the property of their respective owners.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” as defined under the U.S. federal securities laws. All statements, other than statements of historical fact, in this Quarterly Report, including statements relating to our expectations for performance, revenues and costs, and the adequacy of cash and cash equivalent balances to support operations and meet future obligations, are forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements, expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these words. We caution you that the forward-looking statements in this Quarterly Report are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
In evaluating forward-looking statements, you should refer to: (i) the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which we filed with the United States Securities and Exchange Commission (“SEC”) on March 17, 2026 (the “2025 Form 10-K”); (ii) Item 2 of this Quarterly Report, under the heading “Management's Discussion and Analysis of Financial Condition and Results of Operations -- Factors Which May Influence Future Results of Operations;” and (iii) Part II, Item 1A of this Quarterly Report. As a result of these risk factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We do not undertake to update any of the forward-looking statements after the date of this Quarterly Report, except to the extent required by applicable securities laws.
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CLEARPOINT NEURO, INC.
Condensed Consolidated Balance Sheets
(in thousands, except for par value and share data)
|
|
September 30, |
|
|
|
|
||
|
|
2026 |
|
|
December 31, |
|
||
|
|
(Unaudited) |
|
|
2025 |
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Accounts receivable, net |
|
|
|
|
|
|
||
Inventory, net |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
|
|
|
|
||
Operating lease right-of-use assets |
|
|
|
|
|
|
||
Goodwill |
|
|
|
|
|
|
||
Intangible assets, net |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Total assets |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Other accrued liabilities |
|
|
|
|
|
|
||
Operating lease liabilities, current portion |
|
|
|
|
|
|
||
Contract liabilities, current portion |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Operating lease liabilities, net of current portion |
|
|
|
|
|
|
||
Contract liabilities, net of current portion |
|
|
|
|
|
|
||
Long-term notes payable, net |
|
|
|
|
|
|
||
Accrued interest payable |
|
|
|
|
|
|
||
Deferred tax liabilities, net |
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|||
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, $ |
|
|
|
|
|
|
||
Common stock, $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Shares to be issued |
|
|
|
|
|
|
||
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total stockholders’ equity |
|
|
|
|
|
|
||
Total liabilities and stockholders’ equity |
|
$ |
|
|
$ |
|
||
See accompanying notes to Condensed Consolidated Financial Statements.
1
CLEARPOINT NEURO, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except for share and per share data)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Service and other revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense), net |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss before income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Income tax (benefit) expense |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss per share attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
See accompanying notes to Condensed Consolidated Financial Statements.
2
CLEARPOINT NEURO, INC.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
(Dollars in thousands)
|
|
Three and Nine Months Ended September 30, 2026 |
|
|||||||||||||||||||||
|
|
Common Stock |
|
|
Additional |
|
|
|
|
|
|
|
|
|
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
Paid-in |
|
|
Shares to be Issued |
|
|
Accumulated |
|
|
Total |
|
||||||
Balances, December 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Issuances of common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Option exercises (cash and cashless) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Acquisition of IRRAS |
|
|
|
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
||
Payments for taxes related to net share settlement of equity awards |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Net loss for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances, March 31, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Issuances of common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Option exercises (cash and cashless) |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Acquisition of IRRAS |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|||
Issuance of common stock under employee stock purchase plan |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Net loss for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances, June 30, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Issuances of common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Share-based compensation |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Option exercises (cash and cashless) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of common stock under at-the-market equity offering program, net of issuance costs of $ |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Net loss for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances, September 30, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
3
|
|
Three and Nine Months Ended September 30, 2025 |
|
|||||||||||||||||
|
|
Common Stock |
|
|
Additional |
|
|
|
|
|
|
|
||||||||
|
|
Shares |
|
|
Amount |
|
|
Paid-in |
|
|
Accumulated |
|
|
Total |
|
|||||
Balances, December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Issuances of common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Option exercises (cash and cashless) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Payments for taxes related to net share settlement of equity awards |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances, March 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Issuances of common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Registered direct offering of common stock |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Option exercises (cash) |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Payments for taxes related to net share settlement of equity awards |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Issuance of common stock under employee stock purchase plan |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Net loss for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances, June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Issuances of common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Share-based compensation |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Option exercises (cashless) |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balances, September 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
See accompanying notes to Condensed Consolidated Financial Statements.
4
CLEARPOINT NEURO, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
(Recovery of) provision for bad debt expense |
|
|
( |
) |
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
||
Amortization of intangible assets |
|
|
|
|
|
|
||
Share-based compensation |
|
|
|
|
|
|
||
Payment-in-kind interest |
|
|
|
|
|
|
||
Amortization of debt issuance costs and original issue discounts |
|
|
|
|
|
|
||
Amortization of lease right-of-use assets, net of accretion in lease liabilities |
|
|
|
|
|
|
||
Deferred income taxes |
|
|
( |
) |
|
|
|
|
Increase (decrease) in cash resulting from changes in: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
( |
) |
|
|
|
|
Inventory, net |
|
|
( |
) |
|
|
( |
) |
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
( |
) |
Other assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable and accrued expenses |
|
|
( |
) |
|
|
( |
) |
Lease liabilities |
|
|
( |
) |
|
|
( |
) |
Contract liabilities |
|
|
( |
) |
|
|
( |
) |
Accrued interest payable |
|
|
|
|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from offerings of common stock, net of offering costs |
|
|
|
|
|
|
||
Proceeds from issuance of note payable, net of financing costs and discount |
|
|
|
|
|
|
||
Proceeds from stock option exercises |
|
|
|
|
|
|
||
Payments for taxes related to net share settlement of equity awards |
|
|
( |
) |
|
|
( |
) |
Proceeds from issuance of common stock under at-the-market equity offering program, net of issuance costs of $ |
|
|
|
|
|
|
||
Proceeds from issuance of common stock under employee stock purchase plan |
|
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net change in cash, cash equivalents and restricted cash |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, end of period |
|
$ |
|
|
$ |
|
||
Cash and cash equivalents |
|
|
|
|
|
|
||
Restricted cash included in other current assets and other assets, non-current |
|
|
|
|
|
|
||
Total cash, cash equivalents and restricted cash |
|
$ |
|
|
$ |
|
||
SUPPLEMENTAL CASH FLOW INFORMATION |
|
|
|
|
|
|
||
Cash paid for: |
|
|
|
|
|
|
||
Income taxes |
|
$ |
|
|
$ |
|
||
Interest |
|
$ |
|
|
$ |
|
||
Non-cash investing and financing transactions: |
|
|
|
|
|
|
||
Property and equipment included in accounts payable and other accrued liabilities |
|
$ |
|
|
$ |
|
||
Net transfers of reusable components between property and equipment and inventory |
|
$ |
|
|
$ |
|
||
Right-of-use assets obtained in exchange for operating lease liabilities |
|
$ |
|
|
$ |
|
||
See accompanying notes to Condensed Consolidated Financial Statements.
5
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
ClearPoint Neuro, Inc. (the “Company”) is a commercial-stage medical device company focused on the development and commercialization of innovative platforms for performing minimally invasive surgical procedures in the brain. The Company deployed significant resources to fund its efforts to develop the foundational capabilities for enabling MRI-guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies it develops. Over the past several years, the Company’s efforts expanded beyond the MRI suite to encompass development and commercialization of new neurosurgical device products for the operating room setting, as well as consulting services for pharmaceutical and biotech companies, academic institutions, and contract research organizations. The Company was incorporated in the state of Delaware in March 1998, and has headquarters located in Solana Beach, California.
The Company’s initial product offering, the ClearPoint system, is an integrated system comprised of capital equipment and disposable products, designed to allow minimally invasive procedures in the brain to be performed in an MRI suite. The SmartFrame Array Neuro Navigation System and Software, introduced in 2021, allows for operating room placement and completion of the procedure in the MRI suite. Both systems provide guidance for the placement and operation of instruments or devices during the planning and operation of neurosurgical procedures. The Company received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) in 2010 to market the ClearPoint system in the United States for general neurosurgical interventional procedures; in February 2011, the Company also obtained CE marking for its ClearPoint system. In 2011 and 2018, the Company received 510(k) clearance and CE marking, respectively, for its SmartFlow Neuro cannula which is being used, or is under evaluation, along with the Company's services, by more than
In 2025, through the acquisition of IRRAS, the Company expanded its portfolio into neurocritical care. IRRAS is a commercial-stage medical technology company focused on treatments for intracerebral hemorrhage, intraventricular hemorrhage, and other conditions requiring intracranial fluid management.
The Company has several foreign wholly owned subsidiaries, primarily established for the purpose of employing the Company’s software team in Canada and clinical services representatives serving the Company’s customers in the United Kingdom and the EU. The activities of all subsidiaries are reflected in these condensed consolidated financial statements.
Macroeconomic Trends
The Company continues to monitor the impacts of various macroeconomic trends, such as inflationary pressure, changes in monetary policy, constraints on hospital capital spending, the introduction of or changes in tariffs or trade barriers, and global or local recession and geopolitical instability. Such changes in domestic and global macroeconomic conditions may lead to increased costs for the Company's business. Additionally, these macroeconomic trends could adversely affect the Company’s customers, which could impact their willingness to spend on the Company’s products and services, or their ability to make payments, which could harm the collection of accounts receivable and financial results. In particular, a portion of the Company's revenue is derived from
6
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
products and services supporting pharmaceutical and biotechnology partners' preclinical and clinical development programs, and constraints in the funding environment for these partners, whether due to capital markets conditions or changes in government research funding, could cause partners to delay, scale back or discontinue programs utilizing the Company's products and services. The world’s financial markets remain susceptible to significant stresses, resulting in reductions in available credit and government spending, economic downturn or stagnation, foreign currency fluctuations and volatility in the valuations of securities generally. As a result, the Company’s ability to access capital markets and other funding sources may not be available in the future on commercially reasonable terms, if at all. The Company cannot predict with certainty the ultimate impact of these trends on its business, financial condition, results of operations or cash flows, which will depend on future developments. To date, these trends have not had a material adverse impact on the Company's business, financial condition or results of operations.
Liquidity
The Company has incurred net losses since its inception, which has resulted in a cumulative deficit at September 30, 2026 of $
In May 2025, the Company received net proceeds of approximately $
Also in May 2025, the Company entered into a note purchase agreement (the “2025 NPA”) under which it may sell tranches of notes (the “Notes”) in an aggregate principal amount of up to $
In November 2024, the Company established an at-the-market ("ATM") equity offering program under which the Company may offer and sell, from time to time, shares of its common stock having aggregate sales proceeds of up to $
As required by accounting principles generally accepted in the United States (“GAAP”), the Company has evaluated its ability to continue as a going concern for at least the next twelve months from the date of issuance of these financial statements. The Company has determined that based on its current forecasts, its existing cash and cash equivalent balances at September 30, 2026 are sufficient to support the Company’s operations and meet its obligations for at least the next twelve months from the date of issuance of these financial statements.
7
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Basis of Presentation and Use of Estimates
In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2025 audited consolidated financial statements, and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth therein. These condensed consolidated financial statements have been prepared in accordance with SEC rules for interim financial information, and, therefore, omit certain information and footnote disclosures necessary to present such statements in accordance with GAAP. The preparation of these condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures at the date of the financial statements and during the reporting period. Actual results could materially differ from these estimates. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 2025 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2025 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by GAAP for a complete set of financial statements. The results of operations for the three and nine months ended September 30, 2026, may not be indicative of the results to be expected for the entire year or any future periods.
Restricted Cash
The Company has restricted cash pledged as a security deposit and collateral related to its operating leases. Amounts related to the cash pledged as collateral expected to be released within twelve months of the accompanying condensed consolidated balance sheets are classified in other current assets. The remaining noncurrent balance is presented in other assets in the accompanying condensed consolidated balance sheets.
Inventory
Inventory, which consists of raw materials, work in process, and finished goods available for sale, is carried at the lower of cost or net realizable value. The costs of inventory are determined using the standard cost method, which approximates actual cost based on a first-in, first-out method. The Company periodically reviews its inventory for excess and obsolete items and provides a reserve upon identification of potentially excess or obsolete items.
Business Combinations
Under the acquisition method of accounting, the Company allocates the fair value of the total consideration transferred to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the date of acquisition. These valuations require the Company to make estimates and assumptions, especially with respect to intangible assets. The excess consideration over the aggregate fair value of tangible and intangible assets, net of liabilities assumed, is recorded as goodwill. Costs incurred to complete a business combination, such as legal and other professional fees, are expensed as incurred.
If the initial accounting for a business combination is incomplete by the end of a reporting period that falls within the measurement period, the Company reports provisional amounts in the financial statements. During the measurement period, the Company adjusts the provisional amounts recognized at the acquisition date to reflect new information obtained about facts and circumstances that existed as of the acquisition date that, if known, would have affected the measurement of the amounts recognized as of that date. These adjustments to the provisional amounts are recorded
8
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
with a corresponding offset to goodwill. Any adjustments identified after the measurement period are recorded in the consolidated statements of operations.
Goodwill, Intangible Assets and Other Long-Lived Assets
Assets acquired, including intangible assets, and liabilities assumed are measured at fair value as of the acquisition date. Goodwill, which has an indefinite useful life, represents the excess of cost over fair value of the net assets acquired.
Goodwill is not amortized; however, it is reviewed for impairment at least annually, or more frequently if an event occurs indicating the potential for impairment. Goodwill is considered to be impaired if the carrying value of the reporting unit exceeds its respective fair value.
The Company performs the goodwill impairment analysis at the reporting unit level, which aligns with its reporting and operating segment structure and availability of discrete financial information. During the goodwill impairment review, the Company assesses qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than the carrying amount, including goodwill. The qualitative factors include, but are not limited to, macroeconomic conditions, industry and market considerations, and the Company's overall financial performance. If this qualitative assessment indicates that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, the Company performs a quantitative goodwill impairment test. If the carrying amount of the reporting unit exceeds the fair value, the Company records an impairment loss based on the difference. The qualitative assessment for the reporting unit may be bypassed and instead the Company may proceed directly to the quantitative goodwill impairment test.
Intangible assets with finite lives are amortized using the straight-line method over the estimated economic lives of the assets, which range from to
Revenue Recognition
The Company’s revenue is comprised primarily of: (1) product revenue resulting from the sale of disposable products related to neurosurgery navigation, therapy, neurocritical care, and biologics and drug delivery, as well as ClearPoint and IRRAflow capital equipment and ClearPoint software; and (2) service revenue resulting from development services and consultation revenue in connection with customer-sponsored preclinical and clinical trials, as well as revenue resulting from the service, installation, training, and shipping related to ClearPoint capital equipment and software. The Company recognizes revenue when (i) control of the Company’s products is transferred to its customers or (ii) services are provided to customers, each in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services, in a process that involves identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the distinct performance obligations in the contract, and recognizing revenue when or as the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. When a contract calls for the satisfaction of multiple performance obligations for a single contract price, the Company typically allocates the contract price among the performance obligations based on the relative stand-alone selling prices for each such performance obligation customarily charged by the Company. The Company considers a
9
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control.
Lines of Business; Timing of Revenue Recognition
Product Revenue:
For both types of capital equipment and software sales described above, the determination of the point in time at which to recognize revenue represents that point at which the customer has legal title, physical possession, and the risks and rewards of ownership, and the Company has a present right to payment.
Service Revenue:
10
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company may also enter into contracts with customers for capital equipment, which bundle maintenance and support services and access to software and hardware upgrades made commercially available over the term of the contract, for a single contract price, typically paid on an annual basis. The Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation and recognizes the revenue ratably on a monthly basis. A time-elapsed output method is used as the Company is providing a stand-ready service for each of the performance obligations.
Payment terms under contracts with customers generally are in a range of
The Company's terms and conditions do not provide for a right of return unless for: (a) product defects; or (b) other conditions subject to the Company's approval.
See Note 4 below for additional information regarding revenue recognition.
11
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Net Loss Per Share
The Company computes net loss per share using the weighted-average number of common shares outstanding during the period. Basic and diluted net loss per share are the same because the conversion, exercise or issuance of all potential common stock equivalents, which consist of the Company’s outstanding common stock options and unvested restricted stock units, as described in Note 10, would be anti-dilutive, due to the reporting of a net loss for each of the periods in the accompanying condensed consolidated statements of operations.
Concentration Risks and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company classifies all highly liquid investments with original stated maturities of three months or less from the date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months but less than twelve months as short-term investments.
The Company holds substantially all its cash and cash equivalents on deposit with financial institutions in the U.S. that are insured by the Federal Deposit Insurance Corporation or in U.S. government debt securities. At September 30, 2026, the Company had approximately $
There were no customers whose accounts receivable balances represented greater than
One pharmaceutical customer, a related party who is a former stockholder and former noteholder, and whose chief executive officer is a member of the Company's Board of Directors, for whom the Company provides hardware, software, clinical services and market development services in support of the customer's clinical trials, and from whom the Company earns a quarterly fee, accounted for
Prior to granting credit to a customer, the Company generally performs credit evaluations of the customers’ financial condition. In general, the Company does not require collateral from customers in connection with an extension of credit. The accounts receivable balance is reduced by an allowance for credit losses from the potential inability of the Company's customers to make required payments. The allowance for credit losses at September 30, 2026 and December 31, 2025 was $
The Company is subject to risks common to emerging companies in the medical device industry, including, but not limited to: new technological innovations; acceptance and competitiveness of its products; dependence on key personnel; dependence on key suppliers; its ability to maintain its third-party collaboration, license and joint development partners; changes in general economic conditions and interest rates; its ability to obtain additional funding to support its business; regulatory uncertainty; protection of proprietary technology; compliance with changing government regulations; uncertainty of widespread market acceptance of products; access to credit for capital purchases by customers; and product liability claims. Certain components used in manufacturing have relatively few alternative sources of supply and establishing additional or replacement suppliers for such components
12
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company’s supply requirements may negatively impact future operating results.
Recent Accounting Standards Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, “Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,” which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement. The new disclosure requirements are effective for the Company's annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of this pronouncement on its related disclosures.
In September 2025, the FASB issued ASU 2025-06, “Intangibles - Goodwill and Other - Internal Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software,” which improves the operability of the accounting for internal-use software by removing all references to software development project stages so that the guidance is neutral to different software development methods. This standard is effective for annual periods beginning after December 15, 2027, including interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the potential impact of the new pronouncement.
In December 2025, the FASB issued ASU 2025-11, “Interim Reporting (Topic 270): Narrow-Scope Improvements,” which clarifies the guidance in Topic 270 to improve the consistency of interim financial reporting. ASU 2025-11 provides a comprehensive list of required interim disclosures and introduces a disclosure principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. This standard is effective for fiscal years beginning after December 15, 2027, including interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the potential impact of the new pronouncement.
Reclassification
Certain prior period amounts have been reclassified to conform to the current period presentation. On the condensed consolidated statements of operations, interest (expense) income, net was disaggregated into interest expense and interest income. On the condensed consolidated balance sheets, "Other long-term liabilities" was renamed "Accrued interest payable." On the condensed consolidated statements of cash flows, "Allowance for credit losses (recoveries)" was renamed "(Recovery of) provision for bad debt expense," and the change in accrued interest payable was presented separately from accounts payable and accrued expenses. These reclassifications had no effect on previously reported net loss, total assets, total liabilities, stockholders’ equity, or net cash used in operating activities.
Subsequent Events
The Company evaluated subsequent events and transactions that occurred after the balance sheet date through the date that the condensed consolidated financial statements were issued. Material subsequent events that required recognition or additional disclosure in the condensed consolidated financial statements are presented.
On
13
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
certain adjustments including for indebtedness, working capital and the satisfaction of indemnification obligations. As described below, the former equityholders of IRRAS are also eligible for earnout cash payments.
Of the total consideration, payable as of closing, (i) the Company paid $
Of the $
The Company also agreed to pay the former equityholders of IRRAS a contingent cash payment equal to
The acquisition of IRRAS has been accounted for as a business combination using the acquisition method of accounting in accordance with ASC 805, “Business Combinations,” with the Company treated as the accounting acquirer, which requires, among other things, that the assets acquired and liabilities assumed be recognized at their fair value as of the acquisition date. The Company is still finalizing the allocation of the purchase price and changes to this allocation may occur as additional information becomes available related to the valuation of the intangible assets, indemnification claims, and accrued expenses, with such changes recorded as an adjustment to goodwill during the measurement period. The Company has not recorded any measurement period adjustments during the three or nine months ended September 30, 2026.
Revenue by Service Line
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Biologics and drug delivery |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Disposable products |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Services and license fees |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Subtotal – Biologics and drug delivery revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Neurosurgery navigation and therapy |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Disposable products |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Subtotal – Neurosurgery navigation and therapy revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Capital equipment and software |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Systems and software products |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Services |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Subtotal – Capital equipment and software revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
14
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Contract Balances
(in thousands) |
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Accounts receivable, net |
|
$ |
|
|
$ |
|
||
Other contract assets |
|
|
|
|
|
|
||
Unbilled receivables |
|
$ |
|
|
$ |
|
||
Deferred contract costs |
|
$ |
|
|
$ |
|
||
(in thousands) |
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Contract liabilities |
|
$ |
|
|
$ |
|
||
During the three and nine months ended September 30, 2026, the Company recognized approximately $
Transaction price allocated to remaining performance obligations represents contracted revenue that has not yet been recognized, which includes contract liabilities that will be recognized as revenue in future periods. The majority of the remaining performance obligations relate to capital equipment and software-related service agreements and the upfront payments discussed under the heading "Contract Balances" above, which amounted to approximately $
Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either
15
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
directly or indirectly; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.
The fair value of cash and cash equivalents of $
Inventory consists of the following as of September 30, 2026 and December 31, 2025:
(in thousands) |
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Raw materials and work in process |
|
$ |
|
|
$ |
|
||
Finished goods |
|
|
|
|
|
|
||
Reserve for excess and obsolete inventory |
|
|
( |
) |
|
|
( |
) |
Total inventory, net |
|
$ |
|
|
$ |
|
||
Goodwill
A summary of the activity impacting goodwill is presented below (in thousands):
Balance as of December 31, 2025 |
|
$ |
|
|
Measurement period adjustments |
|
|
|
|
Balance as of September 30, 2026 |
|
$ |
|
Intangible Assets
The following table shows the cost, accumulated amortization, and weighted average remaining life for the acquired intangible assets as of the dates indicated in the tables below (in thousands):
|
|
September 30, 2026 |
|
|||||||||||
|
|
Weighted average remaining life |
|
Gross Carrying Value |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
|||
Developed Technology |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Customer Relationships |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Trademark/Trade Name |
|
< |
|
|
|
|
|
( |
) |
|
|
|
||
Total intangible assets |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
December 31, 2025 |
|
|||||||||||
|
|
Weighted average remaining life |
|
Gross Carrying Value |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
|||
Developed Technology |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Customer Relationships |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Trademark/Trade Name |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total intangible assets |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
16
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The tables below set forth amortization expense for the periods presented (in thousands):
|
|
|
|
Three Months Ended September 30, |
|
|||||
Intangible asset |
|
Location |
|
2026 |
|
|
2025 |
|
||
Developed Technology |
|
Cost of revenue |
|
$ |
|
|
$ |
|
||
Customer Relationships |
|
Sales and marketing expenses |
|
|
|
|
|
|
||
Trademark/Trade Name |
|
Sales and marketing expenses |
|
|
|
|
|
|
||
Total amortization expense |
|
|
|
$ |
|
|
$ |
|
||
|
|
|
|
Nine Months Ended September 30, |
|
|||||
Intangible asset |
|
Location |
|
2026 |
|
|
2025 |
|
||
Developed Technology |
|
Cost of revenue |
|
$ |
|
|
$ |
|
||
Customer Relationships |
|
Sales and marketing expenses |
|
|
|
|
|
|
||
Trademark/Trade Name |
|
Sales and marketing expenses |
|
|
|
|
|
|
||
Total amortization expense |
|
|
|
$ |
|
|
$ |
|
||
The estimated future annual amortization of finite-lived intangible assets is shown in the following table (in thousands). Actual amortization expense to be reported in future periods could differ from these estimates as a result of acquisitions, divestitures, and asset impairments, among other factors.
Year: |
|
Amortization Expense |
|
|
Remainder of 2026 |
|
$ |
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total |
|
$ |
|
|
On May 12, 2025, the Company entered into a note purchase agreement (the “2025 NPA”) with TPC Investments III, LP, an affiliate of Oberland Capital Management LLC (the “2025 Investor”), and CALW SA, LLC, as purchaser agent, under which the Company may sell to the 2025 Investor tranches of notes (“Notes”) in an aggregate principal amount of up to $
In connection with the signing of the merger agreement pursuant to which the Company acquired IRRAS, the Company and the 2025 Investor entered into an amendment to the 2025 NPA pursuant to which the 2025 Investor agreed to purchase $
The purchase price of the Notes is, in each case,
17
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
respectively, was approximately $
The outstanding principal amount of the Notes bears interest at a rate per annum equal to the sum of: (i) the greater of the Term SOFR (as defined in the 2025 NPA) and
For the three and nine months ended September 30, 2026, the Company recognized interest expense of $
The Notes mature on the sixth anniversary of their Purchase Date or the date on which all amounts owing to the 2025 Investor have been paid in full (the “Maturity Date”). Upon the occurrence and during the continuance of an Event of Default (as defined in the 2025 NPA) under the 2025 NPA, the then-applicable interest rate on all outstanding obligations will increase by
Beginning with the first fiscal quarter of 2027 and continuing until the Maturity Date of the First Purchase Note, the 2025 Investor will receive
All of the Notes may be redeemed prior to the Maturity Date at the option of the Company, subject to payment of the Repayment Amount (as defined in the 2025 NPA). The 2025 Investor may demand redemption of the Notes prior to the Maturity Date in the event of a Change of Control (as defined in the 2025 NPA) of the Company or an Event of Default. The Repayment Amount will be: (a) if redemption occurs before the first anniversary of the date of issuance of a Note,
The 2025 NPA contains no financial covenants. The Company’s obligations under the 2025 NPA are subject to customary covenants, including limitations on the Company’s ability to dispose of assets, undergo a change of control, merge with or acquire other entities, incur debt, incur liens, pay dividends or other distributions to holders of its capital stock, repurchase stock and make investments, in each case subject to certain exceptions. The
18
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Company’s obligations under the 2025 NPA are secured by a security interest on substantially all of the Company’s assets, including its intellectual property. The obligations of the 2025 Investor to purchase Notes are subject to certain customary conditions precedent.
The Company assessed the provisions of the 2025 NPA to determine if the agreement included any embedded derivative features by evaluating each feature against the nature of the host instrument. The only embedded feature which was determined to meet the characteristics of a derivative and require bifurcation and separate accounting was the 2025 Investor's right to demand redemption prior to the Maturity Date in the event of a Change of Control or an Event of Default. The fair value of the identified derivative was determined to be nominal as the probability of Change of Control or Event of Default was negligible at inception and at September 30, 2026. For each subsequent reporting period, the Company will evaluate the probability of the Investor's right to demand redemption and record the applicable fair value as of the end of each reporting period.
Scheduled principal payments as of September 30, 2026 with respect to the Notes are summarized as follows (in thousands):
Year ending December 31, |
|
|
|
|
2031 |
|
$ |
|
|
Total scheduled principal payments |
|
|
|
|
Less: unamortized discounts and financing costs |
|
|
( |
) |
Total carrying amount |
|
$ |
|
|
Operating Leases
The Company subleases office space in Solana Beach, California, which serves as its corporate headquarters and houses certain management and personnel. The sublease term commenced on December 15, 2020, was set to expire on December 31, 2026, and was renewable for an additional
The Company leases space in Carlsbad, California, that serves as office space and a manufacturing facility under a lease that commenced on June 1, 2023 and ends on May 31, 2033. The Company has
On June 16, 2025, the Company entered into a lease agreement to expand into approximately
19
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
to commence after occupation of the third phase. The monthly base rent will be abated: (i) for the second through thirteenth months after the second phase occupation for the first and second phases; and (ii) for the first through twelfth months after the third phase occupation solely for the third phase. The Company determined that the three phases of the lease agreement constitute separate lease components, and calculated the right-of-use assets and lease liabilities of the first, second, and third phases of $
In connection with the IRRAS acquisition, the Company assumed an operating lease for
The aforementioned leases are classified as operating leases in conformity with GAAP. The aggregate lease costs were $
As of September 30, 2026, future minimum lease payments are as follows (in thousands):
Year: |
|
|
|
|
Remainder of 2026 |
|
$ |
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total minimum payments |
|
|
|
|
Less: discount to present value of lease payments |
|
|
( |
) |
Discounted present value of lease payments |
|
$ |
|
|
Purchase Commitments
The Company is a party to various purchase arrangements related to its manufacturing and research and development activities. At September 30, 2026, there was approximately $
2025 Stock Purchase Agreement (“2025 SPA”)
On May 12, 2025, the Company entered into the 2025 SPA with TPC Investments III, LP, an affiliate of Oberland Capital Management, relating to the purchase and sale in a registered direct offering of an aggregate of
2024 At-The-Market Equity Offering
In November 2024, the Company entered into an At-The-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated, as sales agent (the “ATM Agreement”) to, from time to time, sell shares of its
20
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
common stock having aggregate sales proceeds of up to $
Equity Compensation Plans
The Seventh Amended and Restated 2013 Incentive Compensation Plan became effective in May 2026, which amended and restated the previous plan primarily to increase the number of shares of common stock available for awards by
The Company's equity awards granted to certain employees provide for net share settlement, pursuant to which shares otherwise issuable upon vesting are withheld to satisfy the applicable employee's statutory tax withholding obligations. The Company remits cash to the applicable taxing authorities related to these withheld shares at the time of vesting.
Share-Based Compensation Expense
The Company records share-based compensation expense on a straight-line basis over the vesting periods of the related grants and recognizes forfeitures as they occur.
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Cost of revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Share-based compensation expense by type of share-based award is summarized below:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Stock options |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
RSAs and RSUs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
ESPP |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
21
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Total unrecognized compensation expense by type of award and the weighted-average remaining requisite service period over which such expense is expected to be recognized:
|
|
September 30, 2026 |
|
|||||
|
|
Unrecognized |
|
|
Remaining |
|
||
RSUs |
|
$ |
|
|
|
|
||
Stock Option Activity
Stock option activity for the nine months ended September 30, 2026 is summarized below:
|
|
Stock |
|
|
Weighted- |
|
|
Weighted- |
|
|
Intrinsic |
|
||||
Outstanding as of December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Forfeited or expired |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding as of September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable as of September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
(1) |
Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options. |
Restricted Stock Unit Activity
Restricted stock unit activity for the nine months ended September 30, 2026 is summarized below:
|
|
Restricted Stock |
|
|
Weighted- |
|
||
Outstanding as of December 31, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
$ |
|
|
Forfeited or expired |
|
|
( |
) |
|
$ |
|
|
Outstanding as of September 30, 2026 |
|
|
|
|
$ |
|
||
Employee Stock Purchase Plan
In June 2021, the Company’s stockholders adopted and approved the ClearPoint Neuro, Inc. Employee Stock Purchase Plan (the “ESPP”), which allows eligible employees to acquire shares of the Company’s common stock through payroll deductions at a discount to market price. In May 2025, the ESPP was amended to increase the number of shares of common stock reserved for issuance from
22
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company is a medical device company offering precise navigation to the brain, and provides clinical products and preclinical development services for controlled drug and device delivery. Even with the acquisition of IRRAS, the Company's operations are based in, and revenues are derived predominantly in, the United States, and business activities are managed on a consolidated basis. The Company operates in
The Company's is the Chief Operating Decision Maker (“CODM”).
23
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and the related notes thereto appearing in Part I, Item 1 of this Quarterly Report. This discussion and analysis contains forward-looking statements that are based upon current expectations and involve risks, assumptions and uncertainties. You should review the section titled “Risk Factors” in our 2025 Form 10-K and in Part II, Item 1A of this Quarterly Report for a discussion of important risk factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis. In addition, historical results and trends that might appear in this Quarterly Report should not be interpreted as being indicative of future operations.
Overview
We are a commercial-stage medical device company that develops and commercializes integrated systems used in minimally invasive neurosurgical procedures in the brain. We have deployed significant resources to fund our efforts to develop the foundational capabilities for enabling MRI-guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies developed by our company. Over the past several years, we have expanded our capabilities beyond the MRI suite to include operating room based neurosurgical device products and a growing portfolio of services that support pharmaceutical and biotechnology partners developing gene and cell therapies. In 2025, with the acquisition of IRRAS, we expanded our portfolio into neurocritical care, focusing on treatments for intracerebral hemorrhage, intraventricular hemorrhage, and other conditions requiring intracranial fluid management.
Our business today consists of two integrated components: (i) a business providing medical devices for neurosurgical applications, and (ii) a business focused on partnerships in the biologics and drug delivery space.
Our primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software. The primary applications for the ClearPoint system are to target and guide: (a) the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters; and (b) the infusion of pharmaceuticals into the brain. The ClearPoint system was originally designed for use in an MRI setting. In 2021, we launched the SmartFrame Array Neuro Navigation System and Software, which allows for operating room placement of the ClearPoint system and completion of the procedure in the MRI suite. In 2024, we introduced the SmartFrame OR Stereotactic System to the market, which allows for complete procedures to be performed in the operating room. In 2025, we released the ClearPoint Navigation Software Version 3.0, which allows for the ClearPoint system navigation software to support end-to-end procedures in the operating room.
In 2022, we commenced commercialization of the ClearPoint Prism Neuro Laser Therapy System, a laser ablation system. The ClearPoint Prism Neuro Laser Therapy System was developed and is manufactured for us by CLS. We have exclusive global rights to commercialize the system for neuro applications.
In 2025, through the acquisition of IRRAS, we added the IRRAflow system to our portfolio of medical devices. The IRRAflow system integrates continuous irrigation, drainage, and real-time intracranial pressure monitoring to provide controlled, automated intracranial fluid management within neurocritical care and operating room settings.
The second component of our business is focused on partnerships in the biologics and drug delivery space, supporting our customers from the earliest stages of their research through their clinical study and commercialization process. Since 2021, a growing and significant part of the revenue from our business has been derived from preclinical development services, which include protocol consultation and solutions for preclinical study design and execution. Our consulting services include a core competency of in vivo biology services in large and small research models to assist our customers with establishing drug safety prior to and in support of their human clinical trials.
24
Currently, we have more than 60 biologics and drug delivery customers who are evaluating using our products and services in trials to inject gene and cell therapies directly into the brain. These customers have drug development programs at various stages of development, ranging from preclinical research to late-stage regulatory trials for multiple distinct disease states. This part of our business potentially represents the largest opportunity for growth; however, our ability to grow in this market is dependent on our ability to maintain and establish new relationships with pharmaceutical company customers, such customers' continuation of research and product development plans, such customers successfully completing clinical trials and obtaining regulatory approvals of their drugs and biologics, and such customers’ realization of commercial success for their therapies, including overcoming barriers in reimbursement, physician adoption, and patient access to their therapies. In 2024, the U.S. Food and Drug Administration (the “FDA”) granted marketing authorization for our SmartFlow cannula to be used to deliver a gene therapy for the treatment of aromatic L-amino acid decarboxylase deficiency to regions of interest within the brain.
Factors Which May Influence Future Results of Operations
The following is a description of factors that may influence our future results of operations, and that we believe are important to an understanding of our business and results of operations.
Macroeconomic Trends
We continue to monitor the impacts of various macroeconomic trends, such as inflationary pressure, changes in monetary policy, constraints on hospital capital spending, the introduction of or changes in tariffs or trade barriers, and global or local recession and geopolitical instability. Such changes in domestic and global macroeconomic conditions may lead to increased costs for our business. Additionally, these macroeconomic trends could adversely affect our customers, which could impact their willingness to spend on our products and services, or their ability to make payments, which could harm our collection of accounts receivable and financial results. In particular, a portion of our revenue is derived from products and services supporting pharmaceutical and biotechnology partners' preclinical and clinical development programs, and constraints in the funding environment for these partners, whether due to capital markets conditions or changes in government research funding, could cause partners to delay, scale back or discontinue programs utilizing our products and services. The world’s financial markets remain susceptible to significant stresses, resulting in reductions in available credit and government spending, economic downturn or stagnation, foreign currency fluctuations and volatility in the valuations of securities generally. As a result, our ability to access capital markets and other funding sources may not be available in the future on commercially reasonable terms, if at all. We cannot predict with certainty the ultimate impact of these trends on our business, financial condition, results of operations or cash flows, which will depend on future developments. To date, these trends have not had a material adverse impact on our business, financial condition or results of operations.
Revenue
In 2010, we received 510(k) clearance from the FDA to market our ClearPoint system in the U.S. for general neurosurgical procedures; in February 2011 and May 2018, we also obtained CE marking for our ClearPoint system and SmartFlow Neuro cannula, respectively; and in June 2020 we obtained CE marking for version 2.0 of our ClearPoint software and our Inflexion head fixation frame. In January 2021, we received 510(k) clearance for the SmartFrame Array Neuro Navigation System. In September 2022, the ClearPoint Prism Neuro Laser Therapy System, for which we have exclusive global rights to commercialize, received 510(k) clearance through our Swedish partner, CLS. In January 2024, we received 510(k) clearance from the FDA for the SmartFrame OR Stereotactic System.
In 2021, we started providing consulting services to our pharmaceutical and other medical technology customers for improving outcome predictability and optimizing preclinical and clinical workflows. Our expertise is concentrated in benchtop testing, preclinical studies, clinical trial support, regulatory consultation, and over-arching translation from the preclinical to the clinical setting to enhance accuracy and precision of drug delivery.
25
Our neurosurgery navigation and therapy revenue primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint and IRRAflow systems. Generating recurring revenue from the sale of disposable products is an important part of our business model. Future revenue from sales of such products is difficult to predict and may not be sufficient to offset our continuing research and development expenses and our increasing selling, general and administrative expenses. As a result of the IRRAS acquisition, we expect revenue to grow over the coming years due to a larger combined organization, expanded product offerings, and increased customer reach, both in the U.S. and internationally, although there can be no assurance that we will realize the anticipated benefits of the acquisition.
Our biologics and drug delivery revenue comes from sales of products, including disposable products, and services related to customer-sponsored preclinical and clinical trials utilizing our products. Our biologics and drug delivery customers are pharmaceutical and biotech companies, academic institutions, and customer-sponsored contract research organizations that are developing methods to deliver a wide variety of molecules, genes or proteins to targeted brain tissue or structures (our “Partners”) that would need to bypass the blood-brain barrier for the treatment of a variety of disorders. This is a novel area in which commercialization must be preceded by FDA-mandated clinical trials, which are expensive and time consuming to conduct, and for which the commercial success is uncertain, pending, in part, the outcome of those trials. The number of Partner relationships is of importance as we recognize the possibility that some Partners’ research will reach commercial success, and others may not. To the extent our Partners achieve commercial success, our expectation is that we will share in such success through our Partners’ use of our products and services in their delivery of therapies. At September 30, 2026, we had more than 60 Partners, similar to the number of Partners as of the same date in 2025.
Our capital equipment and software revenue consists of sales of ClearPoint and IRRAflow reusable hardware and software and related services.
Substantially all our revenue for the three and nine months ended September 30, 2026 and 2025 relates to: (i) sales of our ClearPoint and IRRAflow system products and related services; and (ii) consulting services provided to our biologics and drug delivery customers. Our product revenue was $7.9 million and $24.1 million for the three and nine months ended September 30, 2026, respectively. Our service revenue was $4.2 million and $11.0 million for the three and nine months ended September 30, 2026, respectively, of which 89% and 88%, respectively, were related to the biologics and drug delivery service line.
Our revenue recognition policies are more fully described in Note 2 to the condensed consolidated financial statements included above in Part I, Item 1 in this Quarterly Report.
Cost of Revenue
Cost of revenue includes the direct costs associated with the assembly and purchase of components for neurosurgery navigation products, biologics and drug delivery products, non-neurosurgery therapy products, and capital equipment that we have sold, and for which we have recognized revenue in accordance with our revenue recognition policy, as well as labor hours for the cost of providing preclinical and consulting services. Cost of revenue also includes the allocation of manufacturing overhead costs and depreciation of loaned systems installed under our ClearPoint placement program, as well as provisions for obsolete, impaired, or excess inventory.
Research and Development Costs
Our research and development costs consist primarily of costs associated with the conceptualization, design, testing, and prototyping of our ClearPoint system products, cannulas, and enhancements. Such costs include salaries, travel, and benefits for research and development personnel; materials and laboratory supplies in research and development activities; outside consultant costs; and licensing costs related to technology not yet commercialized. We anticipate that, over time, our research and development costs may increase as we: (i) develop devices and services for delivery of therapeutics into the central nervous system, (ii) expand products into the operating room and therapeutics space, (iii) expand the application of our
26
technological platforms internationally, (iv) invest in the IRRAflow product portfolio and clinical evidence, and (v) develop robotics and focused ultrasound technologies.
Product development timelines, likelihood of success, and total costs can vary widely by product candidate. There are also risks inherent in the regulatory clearance and approval process. At this time, we are unable to estimate with any certainty the costs that we will incur in our efforts to expand the application of our technological platforms.
Sales and Marketing, and General and Administrative Expenses
Our sales and marketing, and general and administrative expenses consist primarily of salaries, incentive-based compensation, travel and benefits, including related share-based compensation; marketing costs; professional fees, including fees for outside attorneys and accountants; occupancy costs; insurance; and other general and administrative expenses, which include, but are not limited to, corporate licenses, director fees, hiring costs, taxes, postage, office supplies, information technology and meeting costs. We expect increases in our sales and marketing expenses as a result of a larger combined sales organization following the IRRAS acquisition, primarily reflecting higher salary and personnel-related costs associated with the larger commercial team following the IRRAS acquisition.
Critical Accounting Policies and Estimates
There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 30, 2026, as compared to the critical accounting policies and estimates described in our 2025 Form 10-K.
Results of Operations
Three Months Ended September 30, 2026, Compared to the Three Months Ended September 30, 2025
|
|
Three Months Ended September 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Product revenue |
|
$ |
7,891 |
|
|
$ |
5,361 |
|
|
|
47 |
% |
Service and other revenue |
|
|
4,184 |
|
|
|
3,500 |
|
|
|
20 |
% |
Total revenue |
|
|
12,075 |
|
|
|
8,861 |
|
|
|
36 |
% |
Cost of revenue |
|
|
5,016 |
|
|
|
3,261 |
|
|
|
54 |
% |
Gross profit |
|
|
7,059 |
|
|
|
5,600 |
|
|
|
26 |
% |
Research and development costs |
|
|
4,018 |
|
|
|
3,452 |
|
|
|
16 |
% |
Sales and marketing expenses |
|
|
5,532 |
|
|
|
3,838 |
|
|
|
44 |
% |
General and administrative expenses |
|
|
3,841 |
|
|
|
3,586 |
|
|
|
7 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|||
Other income (expense), net |
|
|
22 |
|
|
|
(64 |
) |
|
|
(134 |
)% |
Interest income |
|
|
292 |
|
|
|
396 |
|
|
|
(26 |
)% |
Interest expense |
|
|
(1,446 |
) |
|
|
(939 |
) |
|
|
54 |
% |
Net loss before income taxes |
|
|
(7,464 |
) |
|
|
(5,883 |
) |
|
|
27 |
% |
Income tax (benefit) expense |
|
|
(4 |
) |
|
|
8 |
|
|
NM |
|
|
Net loss |
|
$ |
(7,460 |
) |
|
$ |
(5,891 |
) |
|
|
27 |
% |
NM – The percentage change is not meaningful.
Revenue. Total revenue was $12.1 million for the three months ended September 30, 2026, and $8.9 million for the three months ended September 30, 2025, which represents an increase of $3.2 million, or 36%.
27
|
|
Three Months Ended September 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Biologics and drug delivery |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
$ |
1,185 |
|
|
$ |
1,292 |
|
|
|
(8 |
)% |
Services and license fees |
|
|
3,710 |
|
|
|
3,110 |
|
|
|
19 |
% |
Subtotal – Biologics and drug delivery revenue |
|
|
4,895 |
|
|
|
4,402 |
|
|
|
11 |
% |
Neurosurgery navigation and therapy |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
|
5,438 |
|
|
|
3,422 |
|
|
|
59 |
% |
Subtotal – Neurosurgery navigation and therapy revenue |
|
|
5,438 |
|
|
|
3,422 |
|
|
|
59 |
% |
Capital equipment and software |
|
|
|
|
|
|
|
|
|
|||
Systems and software products |
|
|
1,268 |
|
|
|
647 |
|
|
|
96 |
% |
Services |
|
|
474 |
|
|
|
390 |
|
|
|
22 |
% |
Subtotal – Capital equipment and software revenue |
|
|
1,742 |
|
|
|
1,037 |
|
|
|
68 |
% |
Total revenue |
|
$ |
12,075 |
|
|
$ |
8,861 |
|
|
|
36 |
% |
Biologics and drug delivery revenue increased 11% to $4.9 million for the three months ended September 30, 2026, from $4.4 million for the same period in 2025. This increase is primarily attributable to higher revenue from services performed at the CAL facility.
Neurosurgery navigation and therapy revenue increased 59% to $5.4 million for the three months ended September 30, 2026, from $3.4 million for the same period in 2025. The increase is driven primarily by additional revenues due to sales of the IRRAflow product, which we acquired in connection with our acquisition of IRRAS in the fourth quarter of 2025.
Capital equipment and software revenue increased 68% to $1.7 million for the three months ended September 30, 2026, from $1.0 million for the same period in 2025 primarily due to an increase in placements of ClearPoint navigation capital and software, IRRAflow control units, and Prism laser units.
Cost of Revenue and Gross Profit. Cost of revenue was $5.0 million, resulting in gross profit of $7.1 million for the three months ended September 30, 2026, and was $3.3 million, resulting in gross profit of $5.6 million for the three months ended September 30, 2025. Gross margin was 58% for the three months ended September 30, 2026, compared to 63% in the same period in 2025. The decrease in gross margin is primarily due to overhead costs at the new CAL facility and additional amortization expense of acquired intangible assets, partially offset by a decrease in other cost of revenue, for the three months ended September 30, 2026, as compared to the same period in 2025.
Research and Development Costs. Research and development costs were $4.0 million for the three months ended September 30, 2026, compared to $3.5 million for the same period in 2025, an increase of $0.6 million, or 16%. The increase was due primarily to higher personnel costs of $0.6 million.
Sales and Marketing Expenses. Sales and marketing expenses were $5.5 million for the three months ended September 30, 2026, compared to $3.8 million for the same period in 2025, an increase of $1.7 million, or 44%. This increase was due primarily to additional personnel costs of $1.2 million, an increase in travel costs of $0.2 million, resulting from the expansion of our clinical and sales teams, and additional amortization expense of acquired intangible assets of $0.2 million.
General and Administrative Expenses. General and administrative expenses were $3.8 million for the three months ended September 30, 2026, compared to $3.6 million for the same period in 2025, an increase of $0.3 million, or 7%. This increase was due primarily to increases in occupancy costs of $0.5 million, information technology and software costs of $0.2 million, and general corporate costs of $0.1 million. These were partially offset by a decrease in bad debt expense of $0.6 million.
Interest Income. Interest income was $0.3 million for the three months ended September 30, 2026, compared to $0.4 million for the same period in 2025, a decrease of $0.1 million, which is not significant.
28
Interest Expense. Interest expense was $1.4 million for the three months ended September 30, 2026, compared to $0.9 million for the same period in 2025, an increase of $0.5 million, or 54%. Interest expense increased due to the issuance of notes payable in May and November 2025. See Note 8 to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information with respect to the notes payable issued in May and November 2025.
Nine Months Ended September 30, 2026, Compared to the Nine Months Ended September 30, 2025
|
|
Nine Months Ended September 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Product revenue |
|
$ |
24,069 |
|
|
$ |
16,649 |
|
|
|
45 |
% |
Service and other revenue |
|
|
11,014 |
|
|
|
9,912 |
|
|
|
11 |
% |
Total revenue |
|
|
35,083 |
|
|
|
26,561 |
|
|
|
32 |
% |
Cost of revenue |
|
|
13,558 |
|
|
|
10,273 |
|
|
|
32 |
% |
Gross profit |
|
|
21,525 |
|
|
|
16,288 |
|
|
|
32 |
% |
Research and development costs |
|
|
13,172 |
|
|
|
10,660 |
|
|
|
24 |
% |
Sales and marketing expenses |
|
|
19,015 |
|
|
|
11,691 |
|
|
|
63 |
% |
General and administrative expenses |
|
|
14,392 |
|
|
|
11,056 |
|
|
|
30 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|||
Other expense, net |
|
|
(20 |
) |
|
|
(112 |
) |
|
|
(82 |
)% |
Interest income |
|
|
932 |
|
|
|
832 |
|
|
|
12 |
% |
Interest expense |
|
|
(4,241 |
) |
|
|
(1,304 |
) |
|
NM |
|
|
Net loss before income taxes |
|
|
(28,383 |
) |
|
|
(17,703 |
) |
|
|
60 |
% |
Income tax (benefit) expense |
|
|
(34 |
) |
|
|
51 |
|
|
NM |
|
|
Net loss |
|
$ |
(28,349 |
) |
|
$ |
(17,754 |
) |
|
|
60 |
% |
NM – The percentage change is not meaningful.
Revenue. Total revenue was $35.1 million for the nine months ended September 30, 2026, and $26.6 million for the nine months ended September 30, 2025, which represents an increase of $8.5 million, or 32%.
|
|
Nine Months Ended September 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Biologics and drug delivery |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
$ |
4,023 |
|
|
$ |
4,943 |
|
|
|
(19 |
)% |
Services and license fees |
|
|
9,711 |
|
|
|
8,889 |
|
|
|
9 |
% |
Subtotal – Biologics and drug delivery revenue |
|
|
13,734 |
|
|
|
13,832 |
|
|
|
(1 |
)% |
Neurosurgery navigation and therapy |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
|
16,877 |
|
|
|
10,131 |
|
|
|
67 |
% |
Subtotal – Neurosurgery navigation and therapy revenue |
|
|
16,877 |
|
|
|
10,131 |
|
|
|
67 |
% |
Capital equipment and software |
|
|
|
|
|
|
|
|
|
|||
Systems and software products |
|
|
3,169 |
|
|
|
1,575 |
|
|
|
101 |
% |
Services |
|
|
1,303 |
|
|
|
1,023 |
|
|
|
27 |
% |
Subtotal – Capital equipment and software revenue |
|
|
4,472 |
|
|
|
2,598 |
|
|
|
72 |
% |
Total revenue |
|
$ |
35,083 |
|
|
$ |
26,561 |
|
|
|
32 |
% |
Biologics and drug delivery revenue decreased to $13.7 million for the nine months ended September 30, 2026 from $13.8 million for the nine months ended September 30, 2025. This decrease is primarily attributable to lower product revenue due to a single customer order that occurred in the nine-month period of the prior year and did not recur in the current period. In general, this category of revenue is impacted by timing of our Partners’ drug development programs and tends to be uneven quarter to quarter. This was partially offset by higher service revenue.
Neurosurgery navigation and therapy revenue increased 67% to $16.9 million for the nine months ended September 30, 2026, from $10.1 million for the same period in 2025. The increase is driven primarily by additional revenues due to sales of the
29
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 nine months ended September 30, 2026, compared to the same period in 2025. We acquired the IRRAflow product in connection with our acquisition of IRRAS in the fourth quarter of 2025.
Capital equipment and software revenue increased 72% to $4.5 million for the nine months ended September 30, 2026, from $2.6 million for the same period in 2025 primarily due to an increase in placements of ClearPoint navigation capital and software, IRRAflow control units, and Prism laser units.
Cost of Revenue and Gross Profit. Cost of revenue was $13.6 million, resulting in gross profit of $21.5 million for the nine months ended September 30, 2026, and was $10.3 million, resulting in gross profit of $16.3 million for the nine months ended September 30, 2025. Gross margin was 61% for each of the nine months ended September 30, 2026 and 2025.
Research and Development Costs. Research and development costs were $13.2 million for the nine months ended September 30, 2026, compared to $10.7 million for the same period in 2025, an increase of $2.5 million, or 24%. The increase was due primarily to increases in personnel costs of $2.1 million, repair costs of $0.2 million, and travel costs of $0.1 million.
Sales and Marketing Expenses. Sales and marketing expenses were $19.0 million for the nine months ended September 30, 2026, compared to $11.7 million for the same period in 2025, an increase of $7.3 million, or 63%. This increase was due primarily to additional personnel costs of $4.9 million and increases in travel costs of $1.0 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 $0.6 million and marketing material costs of $0.4 million.
General and Administrative Expenses. General and administrative expenses were $14.4 million for the nine months ended September 30, 2026, compared to $11.1 million for the same period in 2025, an increase of $3.3 million, or 30%. This increase was due primarily to increases in occupancy costs of $1.9 million, information technology and software costs of $0.6 million, general corporate costs of $0.6 million, personnel costs of $0.5 million, and professional service fees of $0.4 million. These were partially offset by a decrease in bad debt expense of $0.9 million.
Interest Income. Interest income was $0.9 million for the nine months ended September 30, 2026, compared to $0.8 million for the same period in 2025, an increase of $0.1 million, or 12%. The increase is due to higher investment in U.S. government debt securities.
Interest Expense. Interest expense was $4.2 million for the nine months ended September 30, 2026, compared to $1.3 million for the same period in 2025, an increase of $2.9 million. Interest expense increased due to the issuance of notes payable in May and November 2025. See Note 8 to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information with respect to the notes payable issued in May and November 2025.
Liquidity and Capital Resources
We have incurred net losses since our inception as we have devoted substantial efforts to research and development, which has resulted in a cumulative deficit at September 30, 2026 of $245.3 million. Our use of cash from operations amounted to $20.1 million for the nine months ended September 30, 2026, and $23.9 million for the year ended December 31, 2025. Our primary uses of cash and operating expenses relate to paying employees and consultants, marketing our products, and supporting our research and development of future product offerings. Since inception, we have financed our operations principally from the sale of equity securities and the issuance of notes payable.
In May 2025, we received net proceeds of approximately $3.3 million, after deducting offering expenses payable by the Company, from a registered direct offering. See Note 10 to the condensed consolidated financial statements included elsewhere in this Quarterly Report.
30
Also in May 2025, we entered into a note purchase agreement (the “2025 NPA”) under which we may sell tranches of notes (the “Notes”) in an aggregate principal amount of up to $105.0 million. As of September 30, 2026, we had received net proceeds of approximately $48.1 million from the sale of two Notes thereunder. Interest on the Notes is payable 50% in cash and 50% in kind during each Note’s paid-in-kind (“PIK”) period. The last scheduled PIK payment on the First Purchase Note occurred in September 2026, and the last scheduled PIK payment on the Third Tranche Note (each as defined in Note 8) will occur in March 2027. We may extend each PIK period by up to two quarters by notifying the purchaser agent no later than one business day before the applicable interest payment date. After each PIK period ends, interest on that Note will be payable entirely in cash, which will increase our cash used to service interest obligations. In addition, beginning with the first fiscal quarter of 2027, we will make quarterly revenue participation payments based on Net Revenue (as defined in the 2025 NPA). For additional information regarding the 2025 NPA and the Notes, see Note 8 to the condensed consolidated financial statements included elsewhere in this Quarterly Report.
In November 2024, we established an ATM equity offering program under which we may offer and sell, from time to time, shares of our common stock having aggregate sales proceeds of up to $50.0 million. During the three and nine months ended September 30, 2026, 1,530,000 shares were sold under the ATM equity offering program for net proceeds of $22.0 million, after deducting issuance costs of $0.5 million. As of September 30, 2026, $27.5 million remained unsold and available for sale under the ATM equity offering program. See Note 10 to the condensed consolidated financial statements included elsewhere in this Quarterly Report.
Our cash and cash equivalents totaled $46.2 million at September 30, 2026. In management’s opinion, based on our current forecasts, our cash and cash equivalent balances at September 30, 2026 are sufficient to support our operations and meet our obligations for at least the next twelve months from the date of issuance of the condensed consolidated financial statements included elsewhere in this Quarterly Report.
We may offer and sell additional equity or issue additional notes payable to raise funds for working capital, capital expenditures, or other general corporate purposes.
Cash Flows
Cash activity for the nine months ended September 30, 2026 and 2025 is summarized as follows:
|
|
Nine Months Ended September 30, |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(20,094 |
) |
|
$ |
(11,845 |
) |
Net cash used in investing activities |
|
|
(996 |
) |
|
|
(473 |
) |
Net cash provided by financing activities |
|
|
21,227 |
|
|
|
30,615 |
|
Net change in cash, cash equivalents and restricted cash |
|
$ |
137 |
|
|
$ |
18,297 |
|
Net Cash Used in Operating Activities. Net cash used in operating activities for the nine months ended September 30, 2026 was $20.1 million, an increase of $8.2 million from the nine months ended September 30, 2025. This increase was primarily due to a higher net loss of $10.6 million, which was partially offset by higher non-cash expenses of $3.2 million primarily attributed to amortization of intangible assets, amortization of lease right-of-use assets, net of accretion in lease liabilities, and payment-in-kind interest.
Net Cash Used in Investing Activities. Net cash used in investing activities for the nine months ended September 30, 2026 and September 30, 2025 was $1.0 million and $0.5 million, respectively, and related to equipment acquisitions.
Net Cash Provided by Financing Activities. Net cash provided by financing activities for the nine months ended September 30, 2026 consisted primarily of $22.0 million in proceeds from the issuance of common stock under the ATM Agreement, net of issuance costs of $0.5 million, $0.7 million of proceeds from stock option exercises, and $0.5 million of
31
proceeds from the issuance of common stock under our employee stock purchase plan; partially offset by $2.0 million in payments for taxes related to shares withheld in connection with the vesting of restricted stock awards.
Net cash flows provided by financing activities for the nine months ended September 30, 2025 consisted primarily of proceeds, net of financing costs and discount, of $28.7 million from the issuance of the note payable; proceeds, net of offering costs, of $3.3 million from the registered direct offering of common stock; partially offset by $1.7 million in payments for taxes related to shares withheld in connection with the vesting of restricted stock awards.
Operating Capital and Capital Expenditure Requirements
To date, we have not achieved profitability. We expect to continue to incur net losses as we continue our efforts to expand the commercialization of our products and services and pursue additional applications for our technology platforms. Our cash and cash equivalents are primarily held in a variety of demand accounts with a view to liquidity and capital preservation.
Our short- and long-term liquidity requirements include the obligations under notes payable and under lease arrangements related to our office and manufacturing facilities under non-cancellable operating leases. See Notes 8 and 9 to the condensed consolidated financial statements included elsewhere in this Quarterly Report. We typically enter into short-term agreements with vendors and suppliers of goods and services in the normal course of business through purchase orders, which are settled in cash upon our receipt of such goods or services. We may also at times enter into long-term commitments or license and collaboration agreements which require commitments that are noncancellable. See Note 9 to the condensed consolidated financial statements included elsewhere in this Quarterly Report.
Because of the numerous risks and uncertainties associated with the development and commercialization of medical devices, we are unable to estimate the exact amounts of capital outlays and operating expenditures necessary to successfully commercialize our products and pursue additional applications for our technology platforms. Our future capital requirements will depend on many factors, including, but not limited to, the following:
32
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this Item.
ITEM 4. CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures
We have established disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”). Our disclosure controls and procedures are designed to ensure that material information relating to us is made known to our principal executive officer and principal financial officer by others within our organization. Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of September 30, 2026 to ensure that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of September 30, 2026.
Changes in Internal Control Over Financial Reporting
During the quarter ended September 30, 2026, there were no changes in our internal control over financial reporting that materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
In the ordinary course of our business, we may be subject to various claims, pending and potential legal actions for damages, investigations relating to governmental laws and regulations and other matters arising out of the normal conduct of our business. Regardless of outcome, litigation and other legal proceedings can have an adverse impact on us because of defense and settlement costs, diversions of management resources and other factors. As of the date of filing this Quarterly Report, we are not aware of any material pending legal proceeding to which we are a party or to which any of our property is subject.
ITEM 1A. RISK FACTORS.
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
33
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,
34
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.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
None.
ITEM 5. OTHER INFORMATION.
(a) None.
(b) None.
(c)
35
ITEM 6. EXHIBITS.
The exhibits listed below are filed, furnished, or incorporated by reference as part of this Quarterly Report.
Exhibit Number |
|
Exhibit Description |
|
|
|
3.1 |
|
|
3.2 |
|
|
3.3 |
|
|
3.4 |
|
|
3.5 |
|
|
3.6 |
|
|
10.1++ |
|
|
31.1* |
|
|
31.2* |
|
|
32+ |
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
|
Cover page formatted as Inline XBRL and contained in Exhibit 101 |
+ This certification is being furnished solely to accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, and it is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
++ Indicates management contract or compensatory plan.
36
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 thereunto duly authorized.
Date: October 28, 2026 |
|
|
|
|
|
|
CLEARPOINT NEURO, INC. |
|
|
|
|
|
By: |
/s/ Joseph M. Burnett |
|
|
Joseph M. Burnett |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
|
|
By: |
/s/ Danilo D’Alessandro |
|
|
Danilo D’Alessandro |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer and Principal Accounting Officer) |
37
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO RULE 13a-14(a) UNDER
THE SECURITIES EXCHANGE ACT OF 1934
I, Joseph M. Burnett, certify that:
Date: October 28, 2026 |
/s/ Joseph M. Burnett |
|
Joseph M. Burnett |
|
Chief Executive Officer |
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO RULE 13a-14(a) UNDER
THE SECURITIES EXCHANGE ACT OF 1934
I, Danilo D’Alessandro, certify that:
Date: October 28, 2026 |
/s/ Danilo D’Alessandro |
|
Danilo D’Alessandro |
|
Chief Financial Officer |
Exhibit 32
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
CHIEF FINANCIAL OFFICER PURSUANT TO RULE 13a-14(b) UNDER
THE SECURITIES EXCHANGE ACT OF 1934 AND SECTION 1350 OF
CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE
Each of the undersigned, Joseph M. Burnett and Danilo D’Alessandro, certifies pursuant to Rule 13a-14(b) under the Securities Exchange Act of 1934 and Section 1350 of Chapter 63 of Title 18 of the United States Code, that (1) this quarterly report on Form 10-Q for the quarter ended September 30, 2026, of ClearPoint Neuro, Inc. (the “Company”) fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, and (2) the information contained in this quarterly report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: October 28, 2026 |
|
|
/s/ Joseph M. Burnett |
|
Joseph M. Burnett |
|
Chief Executive Officer |
|
|
|
/s/ Danilo D’Alessandro |
|
Danilo D’Alessandro |
|
Chief Financial Officer |