ClearPoint Neuro, Inc 10-Q for FY2025 Q2
ClearPoint Neuro, Inc. (CLPT)
About this 10-Q
ClearPoint Neuro, Inc filed this 10-Q on August 12, 2025, covering the quarter ended June 30, 2025 (FY2025 Q2).
Headline figures
Quarter ended June 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $9.22M
- up 17.3% from $7.86M a year earlier
- Net loss
- $5.84M
- compared with a net loss of $4.41M a year earlier
- Diluted EPS
- -$0.21
- compared with -$0.16 a year earlier
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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 |
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For the quarterly period ended |
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Or |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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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) |
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(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 |
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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 August 6, 2025, there were
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CLEARPOINT NEURO, INC.
TABLE OF CONTENTS
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®, and ClearPoint Advanced Laboratories™ are all trademarks of ClearPoint Neuro, Inc. 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 contains “forward-looking statements” as defined under U.S. federal securities laws. These forward-looking statements relate to our expectations for performance, revenues and costs, and the adequacy of cash and cash equivalent balances and short-term investments to support operations and meet future obligations. These 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. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements 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 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, 2024, which we filed with the United States Securities and Exchange Commission (“SEC”) on February 26, 2025 (the “2024 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 1.A 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 share and per share data)
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June 30, |
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2025 |
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December 31, |
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(Unaudited) |
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2024 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable, net |
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Inventory, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease, right-of-use assets |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued compensation |
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Other accrued liabilities |
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Operating lease liabilities, current portion |
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Contract liabilities, current portion |
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Total current liabilities |
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Operating lease liabilities, net of current portion |
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Contract liabilities, net of current portion |
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Long-term note payable, net |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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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)
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For the Three Months Ended June 30, |
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2025 |
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2024 |
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Revenue: |
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Product revenue |
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$ |
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$ |
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Service and other revenue |
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Total revenue |
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Cost of revenue |
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Gross profit |
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Research and development costs |
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Sales and marketing expenses |
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General and administrative expenses |
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Operating loss |
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Other income (expense): |
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Other income (expense), net |
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( |
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Interest income (expense), net |
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( |
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Net loss before income taxes |
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( |
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( |
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Income tax expense |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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Net loss per share attributable to common stockholders: |
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Basic and diluted |
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$ |
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$ |
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Weighted average shares outstanding: |
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Basic and diluted |
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For the Six Months Ended June 30, |
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2025 |
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2024 |
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Revenue: |
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Product revenue |
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$ |
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$ |
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Service and other revenue |
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Total revenue |
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Cost of revenue |
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Gross profit |
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Research and development costs |
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Sales and marketing expenses |
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General and administrative expenses |
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Operating loss |
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Other income (expense): |
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Other expense, net |
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( |
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Interest income, net |
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Net loss before income taxes |
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( |
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( |
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Income tax expense |
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( |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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Net loss per share attributable to common stockholders: |
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Basic and diluted |
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$ |
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$ |
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Weighted average shares outstanding: |
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Basic and diluted |
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See accompanying notes to Condensed Consolidated Financial Statements.
2
CLEARPOINT NEURO, INC.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
(Dollars in thousands)
For the Three and Six Months Ended June 30, 2025 |
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Common Stock |
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Additional |
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Shares |
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Amount |
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Paid-in |
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Accumulated |
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Total |
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Balances, January 1, 2025 |
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$ |
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$ |
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$ |
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$ |
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Issuances of common stock: |
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Share-based compensation |
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— |
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Option exercises (cash and cashless) |
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— |
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— |
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Payments for taxes related to net share settlement of equity awards |
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( |
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( |
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( |
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— |
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( |
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Net loss for the period |
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— |
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— |
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— |
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( |
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( |
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Balances, March 31, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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Issuances of common stock: |
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Registered direct offering of common stock |
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— |
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Share-based compensation |
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— |
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Option exercises (cash) |
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— |
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— |
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Payments for taxes related to net share settlement of equity awards |
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( |
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— |
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( |
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— |
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( |
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Issuance of common stock under employee stock purchase plan |
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— |
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— |
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Net loss for the period |
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— |
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— |
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— |
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( |
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( |
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Balances, June 30, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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For the Three and Six Months Ended June 30, 2024 |
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Common Stock |
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Additional |
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Shares |
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Amount |
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Paid-in |
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Accumulated |
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Total |
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Balances, January 1, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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Issuances of common stock: |
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Public offering of common stock |
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— |
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Share-based compensation |
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— |
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Option exercises (cash) |
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— |
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— |
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Payments for taxes related to net share settlement of equity awards |
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( |
) |
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— |
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( |
) |
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— |
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( |
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Net loss for the period |
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— |
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— |
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— |
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( |
) |
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( |
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Balances, March 31, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Issuances of common stock: |
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Share-based compensation |
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— |
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Option exercises (cashless) |
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— |
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— |
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— |
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— |
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Payments for taxes related to net share settlement of equity awards |
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( |
) |
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— |
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( |
) |
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— |
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( |
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Issuance of common stock under employee stock purchase plan |
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— |
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Net loss for the period |
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— |
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— |
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— |
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( |
) |
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( |
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Balances, June 30, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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See accompanying notes to Condensed Consolidated Financial Statements.
3
CLEARPOINT NEURO, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
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For the Six Months Ended June 30, |
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2025 |
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2024 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
) |
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$ |
( |
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Adjustments to reconcile net loss to net cash flows from operating activities: |
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Allowance for credit losses (recoveries) |
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Depreciation and amortization |
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Share-based compensation |
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Payment-in-kind interest |
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Amortization of debt issuance costs and original issue discounts |
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Amortization of lease right of use assets, net of accretion in lease liabilities |
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Increase (decrease) in cash resulting from changes in: |
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Accounts receivable |
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Inventory, net |
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( |
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Prepaid expenses and other current assets |
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( |
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( |
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Other assets |
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( |
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Accounts payable and accrued expenses |
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( |
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Lease liabilities |
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( |
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( |
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Contract liabilities |
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( |
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( |
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Net cash flows from operating activities |
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( |
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( |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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( |
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Net cash flows from investing activities |
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( |
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Cash flows from financing activities: |
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Proceeds from offerings of common stock, net of offering costs |
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Proceeds from issuance of note payable, net of financing costs and discount |
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Proceeds from stock option exercises |
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Payments for taxes related to net share settlement of equity awards |
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( |
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( |
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Proceeds from issuance of common stock under employee stock purchase plan |
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Net cash flows from financing activities |
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Net change in cash, cash equivalents and restricted cash |
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Cash, cash equivalents and restricted cash, beginning of period |
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Cash, cash equivalents and restricted cash, end of period |
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$ |
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$ |
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Cash and cash equivalents |
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Restricted cash included in other assets, non-current |
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Total cash, cash equivalents and restricted cash |
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$ |
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$ |
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SUPPLEMENTAL CASH FLOW INFORMATION |
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Cash paid for: |
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Income taxes |
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$ |
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$ |
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Interest |
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$ |
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$ |
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NON-CASH INVESTING AND FINANCING TRANSACTIONS:
4
See accompanying notes to Condensed Consolidated Financial Statements.
5
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. |
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Description of the Business and Financial Condition |
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. From the Company’s inception in 1998, the Company has deployed significant resources to fund its efforts to develop the capabilities for enabling neurosurgery interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies it develops. In 2021, the Company’s efforts expanded beyond the MRI suite to encompass development and commercialization of new neurosurgical device products for the operating room setting. In 2022, the Company commercialized the ClearPoint Prism Neuro Laser Therapy System as its first therapy product offering. The Company has exclusive global commercialization rights to the ClearPoint Prism Neuro Laser Therapy System through its Swedish partner, Clinical Laserthermia Systems (“CLS”).
Since 2021, a growing part of the Company’s revenue is derived from consulting services to pharmaceutical and biotech companies, academic institutions, and contract research organizations having a focus on biologics and drug delivery. The Company’s services include protocol consultation and solutions for pre-clinical study design and execution for the delivery of pharmaceutical agents to the brain. Currently, the Company has more than
Macroeconomic Trends
The Company continues to monitor the impacts of various macroeconomic trends, such as inflationary pressure, changes in monetary policy, decreasing consumer confidence and spending, the introduction of or changes in tariffs or trade barriers, and global or local recession. Such changes in domestic and global macroeconomic conditions may lead to increased costs for the 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. 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 in the future may not be available on commercially reasonable terms, if at all. The rapid development and fluidity of these situations precludes any prediction as to the ultimate impact they will have on the Company’s business, financial condition, results of operation and cash flows, which will depend largely on future developments.
Liquidity
The Company has incurred net losses since its inception, which has resulted in a cumulative deficit at June 30, 2025 of $
6
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
existing cash and cash equivalent balances at June 30, 2025 are sufficient to support the Company's operations and meet its obligations for at least the next twelve months.
In May 2025, the Company entered into a Stock Purchase Agreement (the “2025 SPA”) with TPC Investments III LP, an affiliate of Oberland Capital Management LLC (the “2025 Investor”) relating to the purchase and sale in a registered direct offering of an aggregate of
Contemporaneously with the 2025 SPA, the Company entered into a note purchase agreement (the “2025 NPA”) under which the Company may sell to the 2025 Investor and the 2025 Investor may buy from the Company, tranches of notes in an aggregate principal amount of up to $
Refer to footnotes 8 and 6, respectively, for more information regarding the 2025 SPA and 2025 NPA.
In March 2024, the Company completed a follow-on public offering of
2. |
|
Basis of Presentation and Summary of Significant Accounting Policies |
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, 2024 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 Company’s 2024 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2024 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 six months ended June 30, 2025, may not be indicative of the results to be expected for the entire year or any future periods.
7
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Restricted cash
The Company has restricted cash pledged as a security deposit to comply with the terms of the San Diego lease entered into in June 2025. The Company arranged for its bank to issue a letter of credit in the amount of $
Inventory
Inventory 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. Items in inventory relate predominantly to the Company’s ClearPoint system and related disposables. The Company periodically reviews its inventory for excess and obsolete items and provides a reserve upon identification of potentially excess or obsolete items.
Intangible Assets
The Company is a party to a license agreement that provides rights to the Company for the development and commercialization of products. Under the terms of the license agreement, the Company made payments to the licensor upon execution of the license agreement for access to the underlying technology, and future payments will be based upon achievement of regulatory and commercialization milestones as defined in the license agreement. In 2022, the Company made a payment to the licensor for the achievement of a regulatory milestone, which acts as a prepayment for future royalties.
In conformity with Accounting Standards Codification Section (“ASC”) 350, “Intangibles – Goodwill and Other,” the Company amortized the payments related to the license rights described above over an expected useful life of
Revenue Recognition
The Company’s revenue is comprised primarily of: (1) product revenue resulting from the sale of neurosurgery, navigation, therapy, biologics and drug delivery disposable products, and the sale of ClearPoint capital equipment and 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 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
8
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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:
9
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company may also enter into contracts with customers who own ClearPoint 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 3 for additional information regarding revenue recognition.
10
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 comprise the Company’s outstanding common stock options and unvested restricted stock units, as described in Note 8, 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 may at times invest its excess cash in interest bearing accounts and U.S. government debt securities. It 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 the remainder of its cash and cash equivalents on deposit with financial institutions in the U.S. insured by the Federal Deposit Insurance Corporation. At June 30, 2025, the Company had approximately $
At June 30, 2025, there were two customers whose accounts receivable balances represented
One pharmaceutical customer, a related party who is a stockholder, a former noteholder, and whose chief executive officer is a designated director on 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 June 30, 2025 and December 31, 2024 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; dependence on third-party collaboration, license and joint development partners; changes in general economic conditions and interest rates; 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 cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company’s supply requirements may negatively impact future operating results.
11
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Recent Accounting Standards Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” The amendments improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, the amendments enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, provide new segment disclosure requirements for entities with a single reportable segment, and contain other disclosure requirements. The Company
Recent Accounting Standards Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures,” which requires that an entity, on an annual basis, disclose additional income tax information, primarily related to the rate reconciliation and income taxes paid. The provisions of the ASU are intended to enhance the transparency and decision usefulness of income tax disclosures. The guidance will be applied on a prospective basis with the option to apply the standard retrospectively and is effective for calendar year-end public business entities in the 2025 annual period and in 2026 for interim periods with early adoption permitted. Except for the required expanded disclosures, the Company does not expect the adoption of this ASU to have a material effect on the consolidated financial statements.
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. Except for the required expanded disclosures, the Company does not expect the adoption of this ASU to have a material effect on the consolidated financial statements.
Reclassification
The accompanying consolidated statement of operations for the three and six months ended June 30, 2025 contains income tax expense formerly classified as general and administrative expense as a separate line on the consolidated statement of operations. The accompanying condensed consolidated statement of operations for the three and six months ended June 30, 2024 has been adjusted to conform to the 2025 presentation.
12
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
3. |
|
Revenue Recognition |
Revenue by Service Line
|
|
Three Months Ended June 30, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
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 |
|
$ |
|
|
$ |
|
||
|
|
For the Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
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 |
|
$ |
|
|
$ |
|
||
Contract Balances
(in thousands) |
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
Accounts receivable, net |
|
$ |
|
|
$ |
|
||
Other contract assets |
|
|
|
|
|
|
||
Unbilled receivables |
|
$ |
|
|
$ |
|
||
13
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(in thousands) |
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
Contract liabilities |
|
$ |
|
|
$ |
|
||
During the three and six months ended June 30, 2025, the Company recognized approximately $
Transaction price allocated to remaining performance obligations represents contracted revenue that has not yet been recognized, which includes deferred revenue 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 $
4. |
Fair Value Measurement |
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 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 $
14
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
5. |
Inventory |
Inventory consists of the following as of June 30, 2025 and December 31, 2024:
(in thousands) |
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
Raw materials and work in process |
|
$ |
|
|
$ |
|
||
Finished goods |
|
|
|
|
|
|
||
Reserve for excess and obsolete inventory |
|
|
( |
) |
|
|
( |
) |
|
|
$ |
|
|
$ |
|
||
6. |
Note Payable |
On May 12, 2025, the Company entered into the 2025 NPA with CALW SA LLC, an affiliate of Oberland Capital Management LLC, as Purchaser Agent, and the 2025 Investor.
Under the 2025 NPA, the Company may sell to the 2025 Investor, and the 2025 Investor may buy from the Company, tranches of notes (collectively, the “Notes”) in an aggregate principal amount of up to $
The purchase price of the Notes is, in each case,
The Notes will mature on the sixth anniversary of the applicable Purchase Date (as defined in the 2025 NPA) 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 on January 1, 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
15
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(as defined in the 2025 NPA).
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 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.
Scheduled principal payment as of June 30, 2025 with respect to the First Purchase Note is summarized as follows:
Years ending December 31, |
|
(in thousands) |
|
|
2031 |
|
$ |
|
|
Total scheduled principal payments |
|
|
|
|
Less: unamortized discounts and financing costs |
|
|
( |
) |
Total carrying amount |
|
$ |
|
|
7. |
Commitments and Contingencies |
Operating Leases
The Company subleases office space in Solana Beach, California, that serves as its corporate headquarters and houses certain management and personnel. The sublease term commenced on December 15, 2020, is set to expire on December 31, 2026, and is 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
The aforementioned leases are classified as operating leases in conformity with GAAP. The aggregate lease costs were $
16
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Legal Contingencies
The Company previously disclosed that it was named as a defendant to a lawsuit filed by a patient who suffered an adverse outcome in connection with a surgical procedure in which the Company’s ClearPoint Navigation System was used. In August 2025, the Company settled this matter. The settlement amount is expected to be paid by insurance, and the resolution is not expected to have a material impact on the Company's consolidated financial statements.
8. |
Stockholders’ Equity |
2025 Stock Purchase Agreement (“2025 SPA”)
On May 12, 2025, the Company entered into the 2025 SPA with the 2025 investor relating to the purchase and sale in a registered direct offering of an aggregate of
2024 Public Offering
In March 2024, the Company completed a public offering of
Net proceeds from the offering totaled approximately $
The underwriting agreement contains representations, warranties, agreements and indemnification obligations by the Company that are customary for this type of transaction.
2024 At-The-Market (“ATM”) Equity Offering
In November 2024, the Company entered into the ATM Agreement to, from time to time, sell shares of its common stock having aggregate sales proceeds of up to $
Equity Compensation Plans
The Sixth Amended and Restated 2013 Incentive Compensation Plan became effective in May 2025, which amended the previous plan to increase the number of shares of common stock available for awards by
17
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
and consultants of the Company. The equity incentive plans are more fully described in Note 9 to the consolidated financial statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2024.
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 June 30, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Cost of revenue |
|
$ |
|
|
$ |
|
||
Research and development |
|
|
|
|
|
|
||
Sales and marketing |
|
|
|
|
|
|
||
General and administrative |
|
|
|
|
|
|
||
Share-based compensation expense |
|
$ |
|
|
$ |
|
||
|
|
For the Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Cost of revenue |
|
$ |
|
|
$ |
|
||
Research and development |
|
|
|
|
|
|
||
Sales and marketing |
|
|
|
|
|
|
||
General and administrative |
|
|
|
|
|
|
||
Share-based compensation expense |
|
$ |
|
|
$ |
|
||
Share-based compensation expense by type of share-based award is summarized below:
|
|
Three Months Ended June 30, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Stock options |
|
$ |
|
|
$ |
|
||
RSAs and RSUs |
|
|
|
|
|
|
||
ESPP |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
|
|
For the Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Stock options |
|
$ |
|
|
$ |
|
||
RSAs and RSUs |
|
|
|
|
|
|
||
ESPP |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
18
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Total unrecognized compensation expense by type of award and the weighted-average remaining requisite period over which such expense is expected to be recognized (in thousands, unless otherwise noted):
|
|
June 30, 2025 |
|
|||||
|
|
Unrecognized |
|
|
Remaining |
|
||
Stock options |
|
$ |
|
|
|
|
||
RSAs and RSUs |
|
$ |
|
|
|
|
||
Stock Option Activity
Stock option activity during the six months ended June 30, 2025 is summarized below:
|
|
Stock |
|
|
Weighted- |
|
|
Weighted- |
|
|
Intrinsic |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Forfeited or expired |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and expected to vest at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
(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 Award Activity
Restricted stock award (“RSA”) activity for the six months ended June 30, 2025 is summarized below:
|
|
Restricted Stock |
|
|
Weighted- |
|
||
Outstanding at December 31, 2024 |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
$ |
|
|
Forfeited or expired |
|
|
( |
) |
|
$ |
|
|
Outstanding at June 30, 2025 |
|
|
|
|
$ |
|
||
19
CLEARPOINT NEURO, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Restricted Stock Unit Activity
Restricted stock unit (“RSU”) activity for the six months ended June 30, 2025 is summarized below:
|
|
Restricted Stock |
|
|
Weighted- |
|
||
Outstanding at December 31, 2024 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
$ |
|
|
Forfeited or expired |
|
|
( |
) |
|
$ |
|
|
Outstanding at June 30, 2025 |
|
|
|
|
$ |
|
||
ESPP
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 common shares reserved for issuance from
9. |
Segment Disclosures |
The Company is a device, cell, and gene-therapy enabling company offering precise navigation to the brain, and provides clinical products and preclinical development services for controlled drug and device delivery. 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”).
20
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” appearing in our 2024 Form 10-K and in Part II, Item 1.A 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 innovative platforms for performing minimally invasive surgical procedures in the brain. We have deployed significant resources to fund our efforts to develop the capabilities for enabling neurosurgery interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies developed by our company.
The foundational part of our business is providing medical devices for neurosurgery applications. Our primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software, which is in commercial use globally. The primary applications for the ClearPoint system are to target and guide the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters, as well as 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 allow for operating room placement of the ClearPoint system, and in 2024, we commenced limited market release of the SmartFrame OR Stereotactic System, which allows for complete procedures to be performed in the operating room. In 2022, we commercialized the ClearPoint Prism Neuro Laser Therapy System as our first therapy product offering. We have exclusive global commercialization rights to the ClearPoint Prism Neuro Laser Therapy System through our Swedish partner, CLS.
The second part of our business is focused on partnerships in the biologics and drug delivery space. Our services include protocol consultation and solutions for preclinical study design and execution for studies relating to the delivery of pharmaceutical agents to the brain. 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 partnerships involve drug development programs that are 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 customers, such customers' continuation of research and development plans, and such customers' achievement of success in completion of clinical trials and subsequent regulatory approvals of their biologics and drugs.
Substantially all our revenue for the three and six months ended June 30, 2025 and 2024 relates to (i) sales of our ClearPoint system products and related services and (ii) consulting services from our customers in the biologics and drug delivery space. We have financed our operations and internal growth primarily through the sale of equity securities and the issuance of notes payable. We have incurred significant losses since our inception in 1998 as we have devoted substantial efforts to research and development. As of June 30, 2025, we had accumulated losses of $203.2 million. We may continue to incur operating losses as we expand our ClearPoint system platform, consulting services to our pharmaceutical and other medical technology customers, and our business generally.
21
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, decreasing consumer confidence and spending, the introduction of or changes in tariffs or trade barriers, and global or local recession. 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. 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 in the future may not be available on commercially reasonable terms, if at all. The rapid development and fluidity of these situations precludes any prediction as to the ultimate impact they will have on our business, financial condition, results of operation and cash flows, which will depend largely on future developments.
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 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. The Prism laser represents the first therapy product we have commercialized. 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.
Future revenue from sales of our ClearPoint platform products and services 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.
Generating recurring revenue from the sale of products is an important part of our business model for our ClearPoint system. Our product revenue was $6.0 million and $11.3 million for the three and six months ended June 30, 2025, respectively, and was almost entirely related to our ClearPoint system. Our service revenue was $3.2 million and $6.4 million for the three and six months ended June 30, 2025, respectively, of which 89% and 91%, respectively, is 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.
Underlying the revenue from sales of products and services to our biologics and drug delivery customers is the number of direct customers and end users of our products and/or services (“Partners”). Our Partners consist of pharmaceutical and biotech companies, academic institutions, or customer-sponsored contract research organizations that are developing
22
methods to deliver a wide variety of molecules, genes or proteins to targeted brain tissue or structures 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, on the outcome of those trials. While our revenue from sales of products and services to our biologics and drug delivery customers is indicative of growth, the number of Partner relationships is also 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 June 30, 2025, we had more than 60 Partners, as compared to more than 50 Partners as of the same date in 2024.
Cost of Revenue
Cost of revenue includes the direct costs associated with the assembly and purchase of components for functional neurosurgery navigation products, biologics and drug delivery products, non-neurosurgery therapy products, and ClearPoint capital equipment and software that we have sold, and for which we have recognized the revenue in accordance with our revenue recognition policy, as well as labor hours and materials for the cost of providing preclinical, consulting, and service revenue. 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 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 intended for delivery of therapeutics into the central nervous system, (ii) expand products into the operating room and therapeutics space, and (iii) expand the application of our technological platforms internationally.
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 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. Our sales and marketing expenses are expected to continue to increase due to costs associated with the continued commercialization of our products and services and the increased headcount necessary to support growth in operations.
Critical Accounting Policies and Estimates
There have been no significant changes in our critical accounting policies and estimates during the six months ended June 30, 2025, as compared to the critical accounting policies and estimates described in our 2024 Form 10-K.
23
Results of Operations
Three Months Ended June 30, 2025, Compared to the Three Months Ended June 30, 2024
|
|
Three Months Ended June 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Product revenue |
|
$ |
5,997 |
|
|
$ |
4,944 |
|
|
|
21 |
% |
Service and other revenue |
|
|
3,218 |
|
|
|
2,914 |
|
|
|
10 |
% |
Total revenue |
|
|
9,215 |
|
|
|
7,858 |
|
|
|
17 |
% |
Cost of revenue |
|
|
3,659 |
|
|
|
2,870 |
|
|
|
27 |
% |
Gross profit |
|
|
5,556 |
|
|
|
4,988 |
|
|
|
11 |
% |
Research and development costs |
|
|
3,829 |
|
|
|
3,120 |
|
|
|
23 |
% |
Sales and marketing expenses |
|
|
4,019 |
|
|
|
3,834 |
|
|
|
5 |
% |
General and administrative expenses |
|
|
3,388 |
|
|
|
2,758 |
|
|
|
23 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|||
Other income (expense), net |
|
|
(52 |
) |
|
|
5 |
|
|
NM |
|
|
Interest income (expense), net |
|
|
(80 |
) |
|
|
326 |
|
|
|
(124 |
)% |
Income tax expense |
|
|
(25 |
) |
|
|
(15 |
) |
|
NM |
|
|
Net loss |
|
$ |
(5,837 |
) |
|
$ |
(4,408 |
) |
|
|
32 |
% |
NM – The percentage change is not meaningful.
Revenue. Total revenue was $9.2 million for the three months ended June 30, 2025, and $7.9 million for the three months ended June 30, 2024, which represents an increase of $1.4 million, or 17%.
|
|
Three Months Ended June 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Biologics and drug delivery |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
$ |
1,871 |
|
|
$ |
1,671 |
|
|
|
12 |
% |
Services and license fees |
|
|
2,868 |
|
|
|
2,656 |
|
|
|
8 |
% |
Subtotal – Biologics and drug delivery revenue |
|
|
4,739 |
|
|
|
4,327 |
|
|
|
10 |
% |
Neurosurgery navigation and therapy |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
|
3,432 |
|
|
|
2,586 |
|
|
|
33 |
% |
Subtotal – Neurosurgery navigation and therapy revenue |
|
|
3,432 |
|
|
|
2,586 |
|
|
|
33 |
% |
Capital equipment and software |
|
|
|
|
|
|
|
|
|
|||
Systems and software products |
|
|
694 |
|
|
|
687 |
|
|
|
1 |
% |
Services |
|
|
350 |
|
|
|
258 |
|
|
|
36 |
% |
Subtotal – Capital equipment and software revenue |
|
|
1,044 |
|
|
|
945 |
|
|
|
11 |
% |
Total revenue |
|
$ |
9,215 |
|
|
$ |
7,858 |
|
|
|
17 |
% |
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials, increased 10% to $4.7 million for the three months ended June 30, 2025, from $4.3 million for the same period in 2024. This increase is attributable to $0.2 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials, and $0.2 million increase in service revenue and other revenue.
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 33% to $3.4 million for the three months ended June 30, 2025, from $2.6 million for the same period in 2024. The increase is driven by higher sales for new offerings of SmartFrame OR, Prism Laser Therapy, and introduction of our 3.0 operating room navigation software, during the three months ended June 30, 2025, compared to the same period in 2024.
24
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, increased 11% to $1.0 million for the three months ended June 30, 2025, from $0.9 million for the same period in 2024 due to an increase in service revenue.
Cost of Revenue and Gross Profit. Cost of revenue was $3.7 million, resulting in gross profit of $5.6 million for the three months ended June 30, 2025, and was $2.9 million, resulting in gross profit of $5.0 million for the three months ended June 30, 2024. Gross margin was 60% for the three months ended June 30, 2025, as compared to 63% in the same period in 2024. The decrease in gross margin is primarily due to higher excess and obsolete inventory reserves for the three months ended June 30, 2025, as compared to the same period in 2024.
Research and Development Costs. Research and development costs were $3.8 million for the three months ended June 30, 2025, compared to $3.1 million for the same period in 2024, an increase of $0.7 million, or 23%. The increase was due primarily to higher product and software development costs of $0.8 million, partially offset by lower personnel costs, including share-based compensation of $0.1 million.
Sales and Marketing Expenses. Sales and marketing expenses were $4.0 million for the three months ended June 30, 2025, compared to $3.8 million for the same period in 2024, an increase of $0.2 million, or 5%. This increase was due primarily to additional personnel costs, including share-based compensation, resulting from increases in headcount of $0.4 million, partially offset by lower travel costs and other marketing costs of $0.2 million.
General and Administrative Expenses. General and administrative expenses were $3.4 million for the three months ended June 30, 2025, compared to $2.8 million for the same period in 2024, an increase of $0.6 million, or 23%. This increase was due primarily to higher bad debt expense of $0.4 million and higher personnel costs, including share-based compensation, of $0.2 million.
Interest Income (Expense), net. Net interest expense was $0.1 million for the three months ended June 30, 2025, compared to net interest income of $0.3 million for the three months ended June 30, 2024. Interest income decreased in the three months ended June 30, 2025 as a result of lower investment in U.S. Government securities as compared with the same period in 2024. Additionally, interest expense increased in the three months ended June 30, 2025 as a result of the note payable entered into in May 2025. See Note 6 to the Condensed Consolidated Financial Statements included in Part 1, Item 1 in this Quarterly Report for additional information with respect to the note payable.
Six Months Ended June 30, 2025, Compared to the Six Months Ended June 30, 2024
|
|
For the Six Months Ended June 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Product revenue |
|
$ |
11,288 |
|
|
$ |
8,579 |
|
|
|
32 |
% |
Service and other revenue |
|
|
6,412 |
|
|
|
6,918 |
|
|
|
(7 |
)% |
Total revenue |
|
|
17,700 |
|
|
|
15,497 |
|
|
|
14 |
% |
Cost of revenue |
|
|
7,012 |
|
|
|
5,984 |
|
|
|
17 |
% |
Gross profit |
|
|
10,688 |
|
|
|
9,513 |
|
|
|
12 |
% |
Research and development costs |
|
|
7,208 |
|
|
|
5,745 |
|
|
|
25 |
% |
Sales and marketing expenses |
|
|
7,853 |
|
|
|
7,124 |
|
|
|
10 |
% |
General and administrative expenses |
|
|
7,470 |
|
|
|
5,585 |
|
|
|
34 |
% |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|||
Other expense, net |
|
|
(48 |
) |
|
|
(21 |
) |
|
NM |
|
|
Interest income, net |
|
|
71 |
|
|
|
437 |
|
|
|
(84 |
)% |
Income tax expense |
|
|
(43 |
) |
|
|
(29 |
) |
|
NM |
|
|
Net loss |
|
$ |
(11,863 |
) |
|
$ |
(8,554 |
) |
|
|
39 |
% |
25
NM – The percentage change is not meaningful.
Revenue. Total revenue was $17.7 million for the six months ended June 30, 2025, and $15.5 million for the six months ended June 30, 2024, which represents an increase of $2.2 million, or 14%.
|
|
For the Six Months Ended June 30, |
|
|
Percentage |
|
||||||
(Dollars in thousands) |
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Biologics and drug delivery |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
$ |
3,651 |
|
|
$ |
2,224 |
|
|
|
64 |
% |
Services and license fees |
|
|
5,779 |
|
|
|
6,410 |
|
|
|
(10 |
)% |
Subtotal – Biologics and drug delivery revenue |
|
|
9,430 |
|
|
|
8,634 |
|
|
|
9 |
% |
Neurosurgery navigation and therapy |
|
|
|
|
|
|
|
|
|
|||
Disposable products |
|
|
6,709 |
|
|
|
4,513 |
|
|
|
49 |
% |
Subtotal – Neurosurgery navigation and therapy revenue |
|
|
6,709 |
|
|
|
4,513 |
|
|
|
49 |
% |
Capital equipment and software |
|
|
|
|
|
|
|
|
|
|||
Systems and software products |
|
|
928 |
|
|
|
1,842 |
|
|
|
(50 |
)% |
Services |
|
|
633 |
|
|
|
508 |
|
|
|
25 |
% |
Subtotal – Capital equipment and software revenue |
|
|
1,561 |
|
|
|
2,350 |
|
|
|
(34 |
)% |
Total revenue |
|
$ |
17,700 |
|
|
$ |
15,497 |
|
|
|
14 |
% |
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials, increased 9% to $9.4 million for the six months ended June 30, 2025, from $8.6 million for the same period in 2024. This increase is attributable to $1.4 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials, partially offset by $0.6 million decrease in service revenue and other revenue due to less work performed in preclinical trials and consulting during the six months ended June 30, 2025, compared to the same period in 2024.
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 49% to $6.7 million for the six months ended June 30, 2025, from $4.5 million for the same period in 2024. The increase is driven by an increased customer base, and higher sales for new offerings of SmartFrame OR, Prism Laser Therapy, and introduction of our 3.0 operating room software, during the six months ended June 30, 2025, compared to the same period in 2024.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 34% to $1.6 million for the six months ended June 30, 2025, from $2.4 million for the same period in 2024 due to a decrease in the placements of ClearPoint navigation capital and software and Prism laser units.
Cost of Revenue and Gross Profit. Cost of revenue was $7.0 million, resulting in gross profit of $10.7 million for the six months ended June 30, 2025, and was $6.0 million, resulting in gross profit of $9.5 million for the six months ended June 30, 2024. Gross margin was 60% for the six months ended June 30, 2025, and broadly in line with gross margin of 61% in the same period in 2024.
Research and Development Costs. Research and development costs were $7.2 million for the six months ended June 30, 2025, compared to $5.7 million for the same period in 2024, an increase of $1.5 million, or 25%. The increase was due primarily to higher product and software development costs of $1.5 million.
Sales and Marketing Expenses. Sales and marketing expenses were $7.9 million for the six months ended June 30, 2025, compared to $7.1 million for the same period in 2024, an increase of $0.7 million, or 10%. This increase was due primarily
26
to additional personnel costs, including share-based compensation, resulting from increases in headcount, of $0.9 million, partially offset by lower travel costs and other marketing costs of $0.2 million.
General and Administrative Expenses. General and administrative expenses were $7.5 million for the six months ended June 30, 2025, compared to $5.6 million for the same period in 2024, an increase of $1.9 million, or 34%. This increase was due primarily to higher bad debt expense of $0.7 million, higher personnel costs, including share-based compensation, of $0.7 million, higher professional service fees of $0.3 million, and higher IT costs of $0.2 million.
Interest Income, net. Net interest income was $0.1 million for the six months ended June 30, 2025, compared to $0.4 million for the six months ended June 30, 2024. The decrease in net interest income is mainly as a result of decreased investment in U.S. Government securities.
Liquidity and Capital Resources
We have incurred net losses since our inception, which has resulted in a cumulative deficit at June 30, 2025 of $203.2 million. In addition, our use of cash from operations amounted to $8.7 million for the six months ended June 30, 2025, and $9.0 million for the year ended December 31, 2024. Since inception, we have financed our operations principally from the sale of equity securities and the issuance of notes payable.
In May 2025, the Company entered into the 2025 SPA with the 2025 Investor relating to the purchase and sale in a registered direct offering of an aggregate of 275,808 shares of Company’s common stock, par value $0.01 per share at a price of $12.69 per share, based on the trailing 30-trading day volume-weighted average price of the Company’s common stock. The aggregate net proceeds to the Company from the offering totaled approximately $3.3 million after deducting offering expenses payable by the Company.
Contemporaneously with the 2025 SPA, the Company entered into the 2025 NPA under which the Company may sell to the 2025 Investor, and the 2025 Investor may buy from the Company, tranches of notes in an aggregate principal amount of up to $105.0 million. As of June 30, 2025, the net proceeds in connection with the issuance of the First Purchase Note, after deducting the debt discount and debt issuance costs of $0.6 million and $0.7 million, respectively, was approximately $28.7 million.
In March 2024, we completed a public offering of 2,653,848 shares of our common stock from which the net proceeds totaled approximately $16.2 million after deducting our payment of underwriting discounts and commissions and other offering expenses. In November 2024, we entered into an ATM Agreement pursuant to which we may offer and sell, from time to time, shares of our common stock, having aggregate sales proceeds of up to $50 million, subject to the terms and conditions of the ATM Agreement. We have not issued any shares of common stock under the ATM Agreement.
Additional information with respect to the stock offerings and the 2025 NPA is in Notes 8 and 6, respectively, to the condensed consolidated financial statements included in Part 1, Item 1 in this Quarterly Report.
As a result of these transactions and our business operations, our cash and cash equivalents totaled $41.5 million at June 30, 2025. In management’s opinion, based on our current forecasts for revenue, expense and cash flows, our existing cash and cash equivalent balances at June 30, 2025, are sufficient to support our operations and meet our obligations for at least the next twelve months.
27
Cash Flows
Cash activity for the six months ended June 30, 2025 and 2024 is summarized as follows:
|
|
For the Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Cash used in operating activities |
|
$ |
(8,724 |
) |
|
$ |
(6,508 |
) |
Cash used in investing activities |
|
|
(274 |
) |
|
|
— |
|
Cash provided by financing activities |
|
|
30,615 |
|
|
|
16,213 |
|
Net change in cash and cash equivalents |
|
$ |
21,617 |
|
|
$ |
9,705 |
|
Net Cash Flows from Operating Activities. Net cash flows used in operating activities for the six months ended June 30, 2025 were $8.7 million, an increase of $2.2 million from the six months ended June 30, 2024. This increase was primarily due to a higher net loss of $3.3 million and increased working capital requirements, mainly due to higher payments made as a result of bonus payouts. This was partially offset by an increase in non-cash expenses, including share-based compensation and the allowance for credit losses.
Net Cash Flows from Investing Activities. Net cash flows used in investing activities for the six months ended June 30, 2025 were $0.3 million and related to equipment acquisitions.
The Company did not have any net cash flows from investing activities for the six months ended June 30, 2024.
Net Cash Flows from Financing Activities. Net cash flows provided by financing activities for the six months ended June 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.
Net cash flows provided by financing activities for the six months ended June 30, 2024 consisted of proceeds, net offering costs, of $16.2 million received from the public offering of our common stock and $0.3 million in proceeds from the issuance of common stock under the employee stock purchase plan. This is partially offset by payments of $0.3 million 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 could 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 balances are primarily held in a variety of demand accounts with a view to liquidity and capital preservation.
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:
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Interest Rate Risk
Our exposure to market risk is limited primarily to interest income and expense sensitivity, which is affected by changes in the general level of U.S. interest rates.
Our investments are in short-term bank deposits, short-term U.S. Government debt securities, and institutional money market funds. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. In the event we invest in short-term investments, due to the nature of our short-term investments and the Company's intent to hold such debt securities to maturity, we believe that we are not subject to any material market risk exposure.
At June 30, 2025, we had $30.2 million of principal outstanding under the First Purchase Note, which is subject to interest rate fluctuations. The outstanding principal balance bears interest at a rate equal to the sum of (i) the greater of the Term SOFR (as defined in the 2025 NPA) and 4.30%, and (ii) 3.95%, with a minimum rate of 8.25% and a cap of 9.50%. Given the rate is capped, the difference between the minimum rate and maximum rate is approximately $0.4 million in annual interest expense, based on the principal outstanding balance at June 30, 2025.
Foreign Currency Risk
To date, we have not recorded a significant amount of sales in currencies other than U.S. dollars, and have only limited business transactions in foreign currencies. We do not currently engage in hedging or similar transactions to reduce our foreign currency risks, which at present, are not material. We do not believe we have material exposure to risk from changes in foreign currency exchange rates at this time. We will continue to monitor and evaluate our internal processes relating to foreign currency exchange, including the potential use of hedging strategies.
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
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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 June 30, 2025 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 June 30, 2025.
Changes in Internal Control Over Financial Reporting
During the quarter ended June 30, 2025, 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.
We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a medical device company, and may include product liability, intellectual property, employment matters, and other general claims.
We make provisions for liabilities when it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. We are currently not aware of any such legal proceedings or claim that we believe will have, individually or in the aggregate, a material adverse effect on our consolidated results of operations, cash flows, or financial condition. See Note 7 to the condensed consolidated financial statements included elsewhere in this Quarterly Report for further disclosure.
ITEM 1A. RISK FACTORS.
There have been no material changes to the risk factors disclosed in our 2024 Form 10-K.
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.
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ITEM 5. OTHER INFORMATION.
During the quarter ended June 30, 2025, the following Section 16 officers adopted Rule 10b5-1 trading arrangements, as defined in Item 408(a) of Regulation S-K:
The Rule 10b5-1 trading arrangements described above were adopted and precleared in accordance with the Company's Insider Trading Policy and actual sale transactions made pursuant to such trading arrangements will be disclosed publicly in future Section 16 filings with the SEC.
No other directors or officers
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ITEM 6. EXHIBITS.
The exhibits listed below are filed, furnished, or incorporated by reference as part of this Quarterly Report.
Exhibit Number |
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Exhibit Description |
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3.1 |
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3.2 |
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3.3 |
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3.4 |
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3.5 |
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3.6 |
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10.1 |
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10.2 |
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10.3 |
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10.4 |
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10.5 |
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31.1* |
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31.2* |
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32+ |
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101.INS |
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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 |
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Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
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Cover page formatted as Inline XBRL and contained in Exhibit 101 |
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+ 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.
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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: August 12, 2025 |
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CLEARPOINT NEURO, INC. |
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By: |
/s/ Joseph M. Burnett |
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Joseph M. Burnett |
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Chief Executive Officer |
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(Principal Executive Officer) |
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By: |
/s/ Danilo D’Alessandro |
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Danilo D’Alessandro |
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Chief Financial Officer |
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(Principal Financial Officer and Principal Accounting Officer) |
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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: August 12, 2025 |
/s/ Joseph M. Burnett |
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Joseph M. Burnett |
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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: August 12, 2025 |
/s/ Danilo D’Alessandro |
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Danilo D’Alessandro |
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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 June 30, 2025, 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: August 12, 2025 |
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/s/ Joseph M. Burnett |
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Joseph M. Burnett |
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Chief Executive Officer |
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/s/ Danilo D’Alessandro |
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Danilo D’Alessandro |
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Chief Financial Officer |