Carlsmed, Inc 10-Q for FY2025 Q3
Carlsmed, Inc. (CARL)
About this 10-Q
Carlsmed, Inc filed this 10-Q on November 6, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $13.07M
- up 98.4% from $6.59M a year earlier
- Net loss
- $8.53M
- compared with a net loss of $7.81M a year earlier
- Diluted EPS
- -$0.40
- compared with -$2.06 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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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.
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).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 |
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Accelerated filer |
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Emerging growth company |
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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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 3, 2025, the registrant had
Table of Contents
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PART I. |
1 |
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Item 1. |
1 |
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Condensed Balance Sheets as of September 30, 2025 and December 31, 2024 |
1 |
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2 |
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3 |
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Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024 |
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7 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
Item 3. |
33 |
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Item 4. |
33 |
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PART II. |
34 |
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Item 1. |
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Item 1A. |
34 |
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Item 2. |
34 |
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Item 3. |
34 |
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Item 4. |
34 |
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Item 5. |
34 |
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Item 6. |
35 |
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36 |
i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains express or implied forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance and 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 these forward-looking statements. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
The forward-looking statements in this Quarterly Report on Form 10-Q represent our views as of the date on which the statements are made. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q.
ii
We own certain trademarks and trademark applications used in this Quarterly Report on Form 10-Q that are important to our business, including, among others, Carlsmed®, aprevo®, and myaprevo®. We also intend to apply for various trademarks that we use in connection with the operation of our business. This Quarterly Report on Form 10-Q may also contain trademarks, service marks, and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names, or products in this prospectus is not intended to, and does not, imply a relationship with, or endorsement or sponsorship by, us. Solely for convenience, the trademarks, service marks, and trade names referred to in this prospectus may appear without the “™,” “®,” or “SM” symbol, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable owner of these trademarks, service marks, and trade names.
iii
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
CARLSMED, INC.
CONDENSED BALANCE SHEETS
(in thousands, except for share and par value amounts)
(unaudited)
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September 30, 2025 |
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December 31, 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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Restricted cash |
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Accounts receivable, net of allowances of $ |
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Inventory |
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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, Convertible Preferred Stock, and Stockholders’ Equity (Deficit) |
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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 liabilities |
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Accrued compensation |
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Short-term operating lease liabilities |
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Total current liabilities |
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Long-term portion of term loan, net |
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Long-term operating lease liabilities |
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Warrant liabilities |
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Other long-term liabilities |
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Total liabilities |
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and contingencies (Note 9) |
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Series A convertible preferred stock, $ |
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Series B convertible preferred stock, $ |
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Series C convertible preferred stock, $ |
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Stockholders’ equity (deficit): |
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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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( |
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( |
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Total stockholders’ equity (deficit) |
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( |
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Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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$ |
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$ |
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The accompanying notes are an integral part of these Condensed Financial Statements.
1
CARLSMED, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Cost of sales |
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Gross profit |
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Operating expenses: |
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Research and development |
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Sales and marketing |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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( |
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Other income (expense): |
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Interest expense |
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( |
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( |
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( |
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( |
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Interest income |
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Change in fair value of warrant liabilities |
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( |
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( |
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( |
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Total other income (expense), net |
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( |
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( |
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Net loss and comprehensive loss |
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( |
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( |
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( |
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( |
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Deemed dividend to preferred stockholders |
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( |
) |
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( |
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( |
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Net loss attributable to common stockholders |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Net loss per share attributable to common stockholders, basic |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted-average number of common shares used to compute |
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The accompanying notes are an integral part of these Condensed Financial Statements.
2
CARLSMED, INC.
CONDENSED STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except for share amounts)
(unaudited)
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Nine Months Ended September 30, 2025 |
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Series A Convertible |
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Series B Convertible |
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Series C Convertible |
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity (Deficit) |
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Balance as of December 31, 2024 |
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$ |
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$ |
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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 Series C convertible preferred stock, net of issuance costs of $ |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Deemed dividend related to issuance of Series C convertible preferred stock |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Vesting of early exercised stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of vested stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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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 |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance as of March 31, 2025 |
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$ |
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$ |
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$ |
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$ |
— |
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$ |
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$ |
( |
) |
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$ |
( |
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Vesting of early exercised stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of vested stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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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 |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance as of June 30, 2025 |
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$ |
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$ |
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$ |
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$ |
— |
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$ |
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$ |
( |
) |
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$ |
( |
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Conversion of convertible preferred stock into common stock on initial public offering |
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( |
) |
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( |
) |
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( |
) |
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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 in initial public offering, net of underwriting discounts and commissions and offering costs of $ |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Reclassification of warrants from liability classified to equity classified |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Cashless exercise of warrants |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Vesting of early exercised stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of vested stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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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 |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance as of September 30, 2025 |
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— |
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$ |
— |
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— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
) |
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$ |
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3
CARLSMED, INC.
CONDENSED STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except for share amounts)
(unaudited)
|
|
Nine Months Ended September 30, 2024 |
|
||||||||||||||||||||||||||||||||||||||||||
|
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Series A Convertible |
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Series B Convertible |
|
|
Series C Convertible |
|
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
|||||||||||||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Equity (Deficit) |
|
|||||||||||
Balance as of December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
Issuance of Series C convertible preferred stock, net of issuance costs of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Issuance of common stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Exercise of vested stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of March 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||||
Exercise of vested stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||||
Issuance of Series C convertible preferred stock, net of issuance costs of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Deemed dividend related to issuance of Series C convertible preferred stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Vesting of early exercised stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Exercise of vested stock options |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of September 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
|
|
|
$ |
— |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||||
The accompanying notes are an integral part of these Condensed Financial Statements.
4
CARLSMED, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Cash flows from operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Non-cash interest |
|
|
|
|
|
|
||
Loss on remeasurement of warrant liabilities |
|
|
|
|
|
|
||
Non-cash lease expense |
|
|
|
|
|
|
||
Provision for credit losses |
|
|
|
|
|
|
||
Provision for excess and obsolete inventory |
|
|
|
|
|
|
||
Other non-cash items |
|
|
|
|
|
— |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable, net |
|
|
( |
) |
|
|
( |
) |
Inventory |
|
|
( |
) |
|
|
( |
) |
Prepaid expenses and other assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable |
|
|
|
|
|
|
||
Accrued liabilities |
|
|
|
|
|
|
||
Accrued compensation |
|
|
|
|
|
( |
) |
|
Lease liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchase of property and equipment |
|
|
( |
) |
|
|
( |
) |
Capitalized internal use software costs |
|
|
( |
) |
|
|
— |
|
Payment of initial direct costs related to operating leases |
|
|
( |
) |
|
|
— |
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from initial public offering, net of underwriting discounts and commissions |
|
|
|
|
|
— |
|
|
Payments for deferred initial public offering costs |
|
|
( |
) |
|
|
— |
|
Proceeds from issuance of Series C convertible preferred stock, net of issuance costs |
|
|
|
|
|
|
||
Proceeds from term loan, net of issuance costs |
|
|
— |
|
|
|
|
|
Proceeds from exercises of stock options |
|
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Increase in cash, cash equivalents, and restricted cash |
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash at beginning of the period |
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash at end of the period |
|
$ |
|
|
$ |
|
||
5
CARLSMED, INC.
CONDENSED STATEMENTS OF CASH FLOWS - CONTINUED
(in thousands)
(unaudited)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Supplemental Disclosure of Noncash Investing and Financing Activities: |
|
|
|
|
|
|
||
Conversion of convertible preferred stock upon initial public offering |
|
$ |
|
|
$ |
— |
|
|
Reclassification of warrants from liability classified to equity classified |
|
$ |
|
|
$ |
— |
|
|
Vesting of early exercised common stock options |
|
$ |
|
|
$ |
|
||
Right-of-use asset obtained in exchange for lease liability |
|
$ |
|
|
$ |
— |
|
|
Preferred stock warrants issued in connection with term loan modifications |
|
$ |
— |
|
|
$ |
|
|
Cash, Cash Equivalents, and Restricted Cash Information: |
|
|
|
|
|
|
||
Cash and cash equivalents, beginning of period |
|
$ |
|
|
$ |
|
||
Restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents, end of period |
|
|
|
|
|
|
||
Restricted cash, end of period |
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash, end of period |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these Condensed Financial Statements.
6
CARLSMED, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
1. Organization
Description of Business
Carlsmed, Inc. (the “Company”) is a commercial-stage company within the surgical device with enabling technology sector. The Company was incorporated in Delaware in June 2018 and is headquartered in Carlsbad, California. The Company designs, manufactures, and markets aprevo®, a comprehensive technology platform for spine fusion surgery procedures.
The aprevo platform includes proprietary surgical planning software, using outcomes-based algorithms that are aided with artificial intelligence, and resulting custom-built, anatomically designed vertebral interbody implants. These implants provide each patient with a personalized vertebral fit to address their pathology and anatomy.
The U.S. Food and Drug Administration (“FDA”) cleared the aprevo interbody implants through its 510(k) regulatory pathway for the correction of adult lumbar spinal deformity in December 2020 and several degenerative conditions of the lumbar spine in August 2022. The Company commenced its limited clinical release with its first U.S. patient implant in February 2021, and in October 2021, the Company commenced its U.S. commercial launch of aprevo.
Reverse Stock Split
On July 10, 2025, the Company effectuated a -for-5.58 reverse stock split of the Company’s issued and outstanding shares of common stock, Series A, Series B, and Series C convertible preferred stock, as well as stock option awards to purchase shares of common stock, restricted stock units (“RSUs”), and warrants to purchase shares of common stock, Series B convertible preferred stock, and Series C convertible preferred stock. Consequently, all issued and outstanding shares of stock, stock option awards, RSUs, warrants, and per share data have been retroactively adjusted in these financial statements to reflect the reverse stock split for all periods presented. The par value of the common stock and convertible preferred stock remain unchanged. As the number and issuance price of all outstanding convertible preferred stock were adjusted, the conversion ratios for each series of the Company’s convertible preferred stock were unchanged. Stockholders entitled to fractional shares as a result of the reverse stock split received cash payment in lieu of receiving fractional shares.
Initial Public Offering
On July 24, 2025, the Company completed its initial public offering of
Liquidity and Capital Resources
As of September 30, 2025, the Company had $
On July 24, 2025, the Company completed the IPO and received net proceeds of $
The Company expects to continue to generate operating losses for the foreseeable future as it continues to expand commercial operations and develop its product portfolio. The Company believes that its existing cash on hand will be sufficient to meet anticipated capital requirements for its operations for at least 12 months from the date of the issuance of the accompanying Condensed Financial Statements.
7
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited Condensed Financial Statements have been prepared by management in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and as required by S-X, Rule 10-1. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for a complete set of financial statements. In the opinion of the Company’s management, the accompanying unaudited Condensed Financial Statements and notes have been prepared on the same basis as the audited financial statements for the year ended December 31, 2024, and include all adjustments (consisting of normal recurring adjustments) necessary for a fair statement of the interim periods presented.
The accompanying unaudited Condensed Financial Statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s final prospectus, dated July 22, 2025, filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”) on July 24, 2025. The Company’s results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other interim period.
Use of Estimates
The preparation of the unaudited Condensed Financial Statements in conformity with GAAP requires management to make informed estimates that require assumptions that affect the reported amounts in the accompanying unaudited Condensed Financial Statements. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ materially under different assumptions and conditions.
Cash and Cash Equivalents
“Cash and cash equivalents” in the accompanying condensed Balance Sheets consist of bank deposits and highly liquid investments, including money market fund accounts, that are readily convertible into cash without penalty, with original maturities of three months or less from the purchase date. The carrying amounts reported in the accompanying condensed Balance Sheets for cash and cash equivalents are valued at cost, which approximate their fair value.
Restricted Cash
“Restricted cash” in the accompanying condensed Balance Sheets as of September 30, 2025 and December 31, 2024 represents cash held as collateral for the Company’s facility leases.
Accounts Receivable and Allowance for Credit Losses
“Accounts receivable, net of allowances” in the accompanying condensed Balance Sheets are presented net of allowances for credit losses. The Company maintains an allowance for expected credit losses for accounts receivable, which is recorded as an offset to accounts receivable. Changes in this allowance are recorded as “general and administrative” expense in the condensed Statements of Operations and Comprehensive Loss. Expected credit losses include losses expected based on known credit issues with certain customers as well as a general expected credit loss allowance based on relevant information, including historical loss rates, current conditions, and reasonable economic forecasts that affect collectability. The Company maintained an allowance for credit losses accounts of $
Concentrations of Financial Instrument Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents in deposits at financial institutions that may exceed federally insured limits and certain accounts receivable balances. Risks associated with cash and cash equivalents are mitigated by banking with creditworthy institutions with platforms that administer deposits across multiple banks within federally insured limits. The Company mitigates potential losses from uncollectible accounts receivable through its credit approval and ongoing collection and customer monitoring activities. To date, the Company has not experienced any losses on its financial instruments and believes that it has adequately recorded allowances for uncollectible accounts receivable in each reported period.
8
As of September 30, 2025, the Company had
Fair Value of Financial Instruments
Assets and liabilities are recorded at fair value on a recurring basis in the accompanying condensed Balance Sheets. These accounts are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative accounting guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
The carrying amounts of the Company’s condensed financial instruments consisting of cash, cash equivalents, accounts receivables, prepaid expenses, accounts payable, and accrued liabilities approximate fair value due to the short maturities for each.
Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy.
(in thousands) |
|
Total |
|
|
Quoted |
|
|
Significant |
|
|
Significant |
|
||||
As of September 30, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds (1) |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Total financial assets |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Total financial liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
As of December 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds (1) |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Total financial assets |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Total financial liabilities |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
(1) Included as a component of “cash and cash equivalents” on the accompanying condensed Balance Sheets.
9
Inventory
The Company maintains minimal inventories because aprevo is made specific to each patient’s anatomy to address their pathology and is not otherwise made-to-stock. Work-in-process inventory consists of titanium alloy implants for spine fusion surgical procedures, pending sterilization and packaging. Finished goods inventory is ready for shipment to the customer for use in a spine fusion surgical procedure.
Inventories are valued at the lower of cost or net realizable value, determined by the specific identification method. At each balance sheet date, the Company evaluates its inventories for obsolescence, based on notification of permanently canceled surgeries and ongoing estimates of permanent cancellations. The Company records the corresponding charge for obsolete inventory through “cost of sales.”
The components of reported “inventory” are as follows:
(in thousands) |
|
As of September 30, 2025 |
|
|
As of December 31, 2024 |
|
||
Finished goods |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Warrant Liabilities
Prior to the closing of the IPO on July 24, 2025, the Company had issued warrants to purchase convertible preferred stock in conjunction with the Customers Loan Agreement (see Note 4). The Company accounted for its issued convertible preferred stock warrants as liabilities in accordance with ASC 480. The liability-classified warrants were initially measured at fair value, resulting in an implied discount on the related financing arrangement that was deferred as an asset as it relates to tranches of the Customers Loan Agreement. The deferred asset is recorded within “other assets” on the accompanying condensed Balance Sheets and is amortized into interest expense using the straight-line method over the period in which the Company can draw on the remaining tranches of the credit facility. Changes in fair value of the warrant liabilities are recognized in the condensed Statements of Operations and Comprehensive Loss.
In conjunction with the IPO, all of the outstanding shares of convertible preferred stock were converted into common stock. As a result, the Series B Warrant and Series C Warrant that had previously been exercisable for convertible preferred stock became exercisable for common stock. Upon the closing of the IPO on July 24, 2025, the Series B Warrant that was exercisable into
Subsequently, as of September 30, 2025, the Company achieved a revenue milestone, causing
As of September 30, 2025, the Series B Warrant contains
10
The fair value of the warrant liabilities was determined based on significant inputs not observable in the market, which represents a “Level 3” measurement within the fair value hierarchy. Prior to the IPO, the fair values of the warrant liabilities were measured using the “hybrid method.” The hybrid method is often used when a company is expecting a liquidity event in the near future and is a combination of the option-pricing and probability-weighted expected return methods. Estimates and assumptions impacting the fair value measurement included the fair value per share of the underlying shares of convertible preferred stock, the remaining contractual term of the warrants, and probability of number of shares the warrants will become exercisable into. The most significant assumption in the model impacting the fair value of the warrants was the fair value of the Company’s convertible preferred stock as of each remeasurement date. Subsequent to the IPO, the fair value of the warrant liabilities is measured using the Black-Scholes option pricing model.
A summary of the changes in the total fair value of the warrant liabilities for the nine months ended September 30, 2025 and 2024, is as follows:
(in thousands) |
|
Warrant |
|
|
Fair value as of December 31, 2024 |
|
$ |
|
|
Change in fair value of warrant liabilities |
|
|
|
|
Reclassification of warrants from liability classified to equity classified |
|
|
( |
) |
Fair value as of September 30, 2025 |
|
$ |
|
|
|
|
|
|
|
Fair value as of December 31, 2023 |
|
$ |
— |
|
Issuance of Series B preferred stock warrants |
|
|
|
|
Change in fair value of warrant liabilities |
|
|
|
|
Fair value as of September 30, 2024 |
|
$ |
|
|
Deferred Offering Costs
The Company capitalizes certain legal, professional, accounting, and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in “stockholders’ equity (deficit)” or the applicable series of convertible preferred stock as a reduction of proceeds generated as a result of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the condensed Statements of Operations and Comprehensive Loss. As of September 30, 2025 and December 31, 2024, there were
The Company completed its IPO on July 24, 2025. As a result, the deferred offering costs were offset against the proceeds of the IPO (see Note 1).
Comprehensive Loss
Comprehensive loss encompasses all changes in equity other than those arising from transactions with stockholders. For the three and nine months ended September 30, 2025 and 2024, the Company had
Recent Accounting Pronouncements
Recently Issued Accounting Standards Not Yet Effective
Expense Disaggregation Disclosures - 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 (“ASU 2024-03”). This ASU requires new financial statement disclosures disaggregating prescribed expense categories within relevant income statement expense captions. ASU 2024-03 will be effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of adopting the standard.
11
Income Taxes - In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Tax Disclosures (“ASU 2023-09”). This ASU expands disclosures in an entity’s income tax rate reconciliation table and regarding cash taxes paid both in the U.S. and foreign jurisdictions. The update will be effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of adopting the standard.
Financial Instruments - Credit Losses - In July 2025, the FASB issued ASU 2025-05, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”). This ASU provides entities with the option to elect a practical expedient that assumes that the current conditions as of the balance sheet date will remain unchanged for the remaining life of the asset when developing a reasonable and supportable forecast as part of estimating expected credit losses on these assets. ASU 2025-05 will be effective for fiscal years beginning after December 15, 2025 and interim periods within those fiscal years. The Company is currently evaluating the impact of adopting the standard.
Internal-Use Software - In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”). This ASU is intended to simplify the capitalization guidance by removing all references to prescriptive and sequential software development stages. This ASU also requires entities to begin capitalizing software costs when management authorizes and commits to funding the software project, and it is probable that the project will be completed and the software will be used for its intended purpose. ASU 2025-06 will be effective for fiscal years beginning after December 15, 2027 and interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact of adopting the standard.
3. Balance Sheet Account Detail
The composition of selected captions within the accompanying condensed Balance Sheets are summarized below:
Property and Equipment, Net
The components of “property and equipment, net” as of September 30, 2025 and December 31, 2024 are as follows:
(in thousands) |
|
As of September 30, 2025 |
|
|
As of December 31, 2024 |
|
||
Office equipment |
|
$ |
|
|
$ |
|
||
Furniture and fixtures |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
— |
|
|
Software |
|
|
|
|
|
— |
|
|
Total |
|
|
|
|
|
|
||
Less: accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
"Depreciation expense" for the three months ended September 30, 2025 and 2024 was $
Accrued Liabilities
The components of “accrued liabilities” as of September 30, 2025 and December 31, 2024 are as follows:
(in thousands) |
|
As of September 30, 2025 |
|
|
As of December 31, 2024 |
|
||
Accrued sales agent commissions |
|
$ |
|
|
$ |
|
||
Accrued clinical studies |
|
|
|
|
|
|
||
Liability associated with stock option exercises prior to vesting |
|
|
|
|
|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
Total accrued liabilities |
|
$ |
|
|
$ |
|
||
12
4. Debt
Customers Bank Credit Facility
As of September 30, 2025, $
In December 2022, the Company and Signature Bank, subsequently succeeded by Customers Bank, entered into a loan and security agreement (the “Customers Loan Agreement”) with an initial maturity to that provided $
The Customers Loan Agreement bore interest at the greater of (a)
On March 7, 2024, the Company amended the Customers Loan Agreement (the “Third Amendment”) to increase the total principal available under the credit facility from $
As part of the Third Amendment, the Success Fee was contractually eliminated and replaced with the issuance of a warrant exercisable for up to
In May 2024, the Company drew $
On December 30, 2024, the Company further amended the Customers Loan Agreement (the “Fourth Amendment”) to expand the credit facility from $
As part of the Fourth Amendment, the Company partially modified the aggregate
13
Additionally, as part of the Fourth Amendment, the Company issued a new warrant that was exercisable into the Company’s Series C convertible preferred stock (“Series C Warrant”), subject to certain revenue and debt draw milestones. The Series C Warrant is exercisable for up to
In connection with the close of the Company's IPO on July 24, 2025, all of the outstanding shares of convertible preferred stock were converted into common stock. As a result, the warrants to purchase convertible preferred stock are now exercisable into common stock. As of September 30, 2025, the Series B and Series C Warrants are exercisable for
Each of the Third Amendment and Fourth Amendment were accounted for as debt modifications with no gain or loss recognized. The carrying value of amounts outstanding under the Customers Loan Agreement approximates its fair value as of September 30, 2025. The fair value of the term loan is classified as a Level 2 measurement because interest rates charged are similar to other financial instruments with similar terms and maturities.
Interest expense on the Customers Loan Agreement was $
On October, 29, 2025, the Company amended the Customers Loan Agreement (the “Fifth Amendment”) to provide for a credit facility consisting of (i) a term loan in the principal amount of up to $
In connection with the Fifth Amendment, the Company partially amended the Series B Warrant, reducing the number of shares of common stock exercisable subject to future draws under the Customers Loan Agreement as of the date of the Fifth Amendment from
14
The following table summarizes contractual principal payments as of September 30, 2025:
Year ending December 31, |
|
(in thousands) |
|
|
Remainder of 2025 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Total future principal payments |
|
|
|
|
Unamortized issuance costs |
|
|
( |
) |
Total term loan, net |
|
$ |
|
|
5. Common Stock
In accordance with the Company’s Amended and Restated Certificate of Incorporation dated July 24, 2025, the Company is authorized to issue two classes of stock—common stock and preferred stock. The Company shall have authority to issue
Common stock reserved for future issuance as of September 30, 2025, consisted of the following:
|
|
As of September 30, 2025 |
|
|
Common stock options outstanding |
|
|
|
|
Restricted stock units outstanding |
|
|
|
|
Shares available for future issuance under the 2025 Plan |
|
|
|
|
Series B Warrant (1) |
|
|
|
|
Series C Warrant (1) |
|
|
|
|
Total common stock reserved for future issuance |
|
|
|
|
(1) The Series B Warrant and Series C Warrant are exercisable into common stock (see Note 2).
SVB Common Stock Warrant
In April 2021, in connection with its entry into a loan and security agreement (the “SVB Loan Agreement”) with Silicon Valley Bank (“SVB”), the Company issued a warrant to purchase up to an aggregate of
6. Stock-Based Compensation
In September 2019, the Company adopted the Carlsmed, Inc. 2019 Stock Incentive Plan, which was subsequently amended, most recently in January 2025 (the “2019 Plan”). The 2019 Plan is administered by the Company’s board of directors (the “Board of Directors”). On July 10, 2025, the Board of Directors adopted, and the Company’s stockholders approved, the Carlsmed, Inc. 2025 Equity Incentive Plan (the “2025 Plan”), which became effective on July 21, 2025. The 2025 Plan replaced the 2019 Plan, as the Board of Directors determined to not make additional grants under the 2019 Plan following the closing of the IPO. However, the 2019 Plan will continue to govern outstanding equity awards granted under the 2019 Plan. The 2025 Plan allows the Company to grant incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other awards. The number of shares initially available for issuance under awards granted pursuant to the 2025 Plan is
15
The exercise price of a share subject to a stock option may not be less than the fair market value of a share of the Company’s common stock at the grant date. Stock options granted to employees typically vest over
The Company also grants stock option awards to non-employees, including members of the Board of Directors. Options granted under the 2019 Plan may be subject to vesting acceleration in connection with a “Corporate Transaction,” as defined in the 2019 Plan.
The 2019 Plan allows for the exercise of certain stock option grants prior to vesting (“early exercise”), with such grants approved by the Board of Directors. For these awards, in the event of employee termination, the Company has the right, but not the obligation, to repurchase the portion of unvested stock at the lower of the exercise price or the then-current fair value. A liability is recorded within “accrued liabilities” on the accompanying condensed Balance Sheets that is equal to the cash received for these early exercises, and this liability is reduced as vesting occurs. Unvested shares that have been early exercised are reflected in “common shares issued” but excluded from “common shares outstanding” on the accompanying Condensed Financial Statements. As of September 30, 2025,
RSUs granted typically have
In the nine months ended September 30, 2025, the Company granted RSUs to an employee that have a contractual term of
Expense for the RSUs begins on the grant date and is recognized over the derived requisite service period of the award. However, no compensation expense was recognized until the performance-based vesting condition was probable of being achieved. On July 24, 2025, the Company completed its IPO, satisfying the performance condition of the RSUs. Consequently, compensation expense has been recognized proportionally for the completed portion of the requisite service period up to the IPO. The remaining unrecognized expense will be amortized over the remaining derived requisite service period associated with the market condition, regardless of whether the market condition is ultimately satisfied.
Stock Options
The following summarizes stock option activity for the Company for the nine months ended September 30, 2025:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and Exercisable at September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
16
The weighted average grant date fair value of options granted during the three months ended September 30, 2025 and 2024 was $
The aggregate intrinsic value in the above table is calculated as the difference between the fair value of the Company’s common stock price and the exercise price of the stock options. The aggregate intrinsic value of stock options exercised during both the three months ended September 30, 2025 and 2024 was less than $
The Company recorded stock-based compensation expense for stock options of $
The grant date fair value of the options is determined using an option pricing model. The assumptions that were used in estimating the grant date fair value of stock options under the option pricing method for the three and nine months ended September 30, 2025 and 2024 were as follows:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Expected stock price volatility (1) |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
Risk-free interest rate (2) |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
Expected annual dividend yield (3) |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
Expected term (years) (4) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
(1) Based on the median stock price volatility for peer public companies over a historic timeframe similar to the expected term, with adjustments for differences in size and capital structure.
(2) Based on the U.S. Treasury yield curve in effect as of the valuation date.
(3) The Company has not paid and does not currently anticipate paying a cash dividend on its common stock.
(4) The expected term of stock options granted to employees represents the weighted average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term, which calculates the expected term as the average time-to-vesting and the contractual life of the options for stock options issued to employees and non-employees.
Restricted Stock Units
The Company did not have any RSUs granted or outstanding during the nine months ended September 30, 2024.
The following summarizes RSU activity for the Company for the nine months ended September 30, 2025:
|
|
Number of |
|
|
Weighted Average Grant Date Fair Value |
|
||
Non-vested - December 31, 2024 |
|
|
— |
|
|
$ |
— |
|
Granted |
|
|
|
|
|
|
||
Vested |
|
|
— |
|
|
|
|
|
Forfeited |
|
|
— |
|
|
|
|
|
Non-vested - September 30, 2025 |
|
|
|
|
$ |
|
||
The Company recorded stock-based compensation expense for RSUs of $
17
Stock-based Compensation Cost
The compensation cost that has been included in the Company’s condensed Statements of Operations and Comprehensive Loss for all stock-based compensation arrangements is detailed as follows:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
(in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
General and administrative |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
7. Convertible Preferred Stock
In March 2024, the Company issued a total of
In September 2024, the Company issued a total of
The Company closed the IPO on July 24, 2025 and all of the outstanding shares of convertible preferred stock were converted into
8. Net Loss Per Share
Basic net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding, net of the weighted-average unvested restricted stock subject to repurchase by the Company, if any, during the period. Diluted loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding, adjusted for the effects of potentially dilutive common stock, which are comprised of stock options and stock warrants, using the “treasury-stock method,” and convertible preferred stock, using the “if-converted method.”
Because the Company reported net losses for the period presented, all potentially dilutive common stock is antidilutive for this period and therefore basic and diluted net loss per common share are the same. The convertible preferred stock are considered participating securities; however, they were excluded from the computation of basic loss per share in the periods of net loss as there is no contractual obligation for the holders to share in the losses of the Company.
18
The following table presents the number of anti-dilutive shares excluded from the calculation of diluted net loss per share as of September 30, 2025 and 2024:
|
|
As of September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Common stock options outstanding (1) |
|
|
|
|
|
|
||
Convertible preferred stock (common stock equivalent) (2) |
|
|
— |
|
|
|
|
|
Restricted stock units outstanding (3) |
|
|
|
|
|
— |
|
|
Series B Warrant (4) |
|
|
|
|
|
|
||
Series C Warrant (5) |
|
|
|
|
|
— |
|
|
SVB Common Stock Warrant (6) |
|
|
— |
|
|
|
|
|
Total |
|
|
|
|
|
|
||
(1)
(2) Convertible preferred stock was eligible to convert to common stock on a 1:1 basis upon the holder’s election or upon a Deemed Liquidation Event. Convertible preferred stock was converted into common stock on the IPO (see Note 7).
(3) No restricted stock units are vested as of September 30, 2025.
(4) Series B Warrant exercisable into
(5) Series C Warrant exercisable into
(6) On August 14, 2025, the SVB Common Stock Warrant was exercised (see Note 5).
9. Commitment and Contingencies
Legal Matters
The Company from time to time is involved in legal matters incidental to the conduct of its business. In the opinion of management, there are
Operating Lease
The first lease encompasses
On May 15, 2025, the Company entered into a second amendment to its original lease agreement, which modified the lease terms to lease an additional suite comprising an additional
Total lease expenses for the three months ended September 30, 2025 and 2024 were $
The Company’s real estate taxes, insurance costs, and common area maintenance, are included in monthly rent and not separately itemized. Rent expense is allocated to cost of sales, research and development, sales and marketing, and general and administrative expenses in the accompanying condensed Statements of Operations and Comprehensive Loss.
The weighted-average lease terms and discount rates are as follows:
|
|
As of September 30, 2025 |
|
|
As of December 31, 2024 |
|
||
Weighted-average remaining lease term |
|
|
|
|
|
|
||
Weighted-average discount rate |
|
|
% |
|
|
% |
||
19
The aggregate future minimum lease payments under this lease as of September 30, 2025, are as follows:
(in thousands) |
|
|
|
|
Year ending December 31, |
|
Payments |
|
|
Remainder of 2025 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Total undiscounted lease payments |
|
$ |
|
|
Less: imputed interest |
|
|
( |
) |
Present value of future lease payments |
|
$ |
|
|
Short-term operating lease liabilities |
|
|
|
|
Long-term operating lease liabilities |
|
|
|
|
Total operating lease liabilities |
|
$ |
|
|
The operating cash outflows included in the measurement of the operating lease liabilities was $
10. Segment Reporting
The following table provides the operating financial results of the Company’s single reportable segment.
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
(in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Marketing expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product and software development costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical, medical, and regulatory expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other segment expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Change in fair value of warrant liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
* Other segment expenses primarily include corporate, compliance, and research and development support expenses.
11. Income Taxes
In determining quarterly provisions for income taxes, the Company uses the annual estimated effective tax rate applied to the actual year-to-date income (loss), adjusted for discrete items, if any, that are taken into account in the relevant period. The Company’s annual estimated effective tax rate differs from the statutory rate primarily as a result of state taxes and changes in the Company’s valuation allowance.
The Company did
20
There were
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, which enacts significant changes to U.S. tax and related laws. Some of the provisions of the new tax law affecting corporations include, but are not limited to, expensing of domestic research expenses, increasing the limit of the deduction of interest expense deduction to thirty percent of EBITDA, and one hundred percent bonus depreciation on eligible property acquired after January 19, 2025. The provisions of the OBBBA became effective for the Company during the three months ended September 30, 2025.
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operations and financial condition. You should read this discussion and analysis in conjunction with our unaudited financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and the related notes and the discussion under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for the year ended December 31, 2024 included in the IPO Prospectus. Unless the context otherwise requires, references to “Carlsmed,” the “Company,” “we,” “us,” and “our” refer to Carlsmed, Inc., a Delaware corporation. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions, and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of the IPO Prospectus. See the section titled “Special Note Regarding Forward-Looking Statements.” Our historical results are not necessarily indicative of the results that may be expected for any period in the future.
Overview
Company Summary
We are a commercial-stage medical technology company pioneering artificial intelligence (“AI”)-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. We are focused on becoming the standard of care for spine fusion surgery. The aprevo Technology Platform consists of AI-enabled software solutions, and interbody implants that we custom design for each patient’s unique pathology and vertebral bone topography, and single-use surgical instruments. The aprevo Technology Platform was designed to address the limitations of traditional spine fusion surgery and aims to optimize patient outcomes and reduce the need for revision surgeries.
The aprevo Technology Platform is powered by AI-enabled, outcome-based algorithms and provides personalized surgical plans and interbody implants for custom vertebral fit. The aprevo Technology Platform supports surgeons in achieving proper spinal alignment for patients with degenerative disc disease (“DDD”), which can improve clinical outcomes and reduce the likelihood of revision surgeries. We currently market the aprevo Technology Platform for lumbar spine fusion surgery and are expanding the platform for use in cervical spine fusion surgeries, which we expect to launch commercially in early 2026.
We market and sell the aprevo Technology Platform to hospitals in the United States through a combination of our direct sales team and independent sales agents. Our direct sales team consists of Area Business Directors, Regional Sales Directors, Account Managers, and Strategic and National Account leadership, who are primarily responsible for selling the aprevo Technology Platform to surgeons and working with hospitals to secure product approval. They are also responsible for recruiting indirect sales agents that cover each surgery, generating leads, and training clinics. Our direct sales team is supported by a team of independent sales agents, who are responsible for generating leads, providing surgical instruments, and covering cases. While our current commercial focus is on the United States, in the future we plan to engage in market access initiatives to evaluate strategic international regions.
Since we began commercializing the aprevo Technology Platform in 2021, we have experienced sequential quarterly and annual revenue growth from its rapid commercial adoption. For the three months ended September 30, 2025 and 2024, we recognized revenue of $13.1 million and $6.6 million, respectively, representing period-over-period growth of 98.4%. For the nine months ended September 30, 2025 and 2024, we recognized revenue of $35.3 million and $17.8 million, respectively, representing period-over-period growth of 99.1%.
Our business model depends on our ability to timely deliver aprevo interbody implants in order to allow surgeons to maintain surgical schedules for their patients. In November 2024, we launched our digital production system (“DPS”), which we developed to enable us to deliver our aprevo interbody implants to hospitals within 10 business days of surgical plan approval. Starting in October 2025, this lead time has been further reduced to eight business days. Our implants are manufactured to our specifications by contract manufacturing organizations (“CMOs”) who meet our manufacturer qualification standards. Our streamlined DPS manages both the upstream and downstream processes involved in producing our implants.
Initial Public Offering
On July 24, 2025, we completed our initial public offering of 6,700,000 shares of our common stock, at a price to the public of $15.00 per share (the “IPO”). We received net proceeds of $93.5 million from the IPO, after deducting underwriting discounts and commissions and before additional offering expenses of $5.4 million paid by us.
22
Regulatory Overview
aprevo Lumbar
In July 2020, the U.S. Food and Drug Administration (“FDA”) awarded us a Breakthrough Device Designation, indicating that aprevo lumbar interbody implants are likely to provide a more effective treatment than the use of stock implants. In December 2020, the FDA cleared our aprevo interbody implants through its 510(k) regulatory clearance pathway for lumbar fusions to correct adult spinal deformity (“ASD”). After FDA clearance, we commenced the limited clinical release of the aprevo Technology Platform, with the first U.S. aprevo patient procedure completed in February 2021. In August 2022, the FDA cleared the aprevo Technology Platform through its 510(k) regulatory clearance pathway for the treatment of patients with several degenerative conditions of the lumbar spine.
aprevo Cervical
In September 2023, the FDA granted us our second Breakthrough Device Designation for aprevo in cervical spine fusion. In November 2024, we received FDA 510(k) clearance for our aprevo Technology Platform for cervical spine fusion surgery. In July 2025, the first aprevo cervical procedure was successfully completed at UC San Diego Health. Through October 31, 2025, over 50 aprevo cervical procedures have been successfully completed by over a dozen spine surgeons as part of our clinical evaluation program. We expect to commercialize the aprevo Technology Platform for cervical fusion surgery by early 2026.
Key Factors Affecting Our Results of Operations and Performance
Our financial performance has been driven by the following key factors that we believe will persist for the foreseeable future. While each of these factors presents significant opportunities for our business, they also pose important challenges that we must successfully address in order to sustain our growth and improve our results of operations. Our ability to successfully address the factors below is subject to various risks and uncertainties.
Market Adoption and Clinical Evidence
Since its full commercial launch in October 2021, the aprevo Technology Platform for lumbar spine fusion surgery has been used to treat more than 2,600 patients through September 31, 2025. We estimate there are approximately 4,000 surgeons across the United States whose patients could benefit from using our platform.
Over time, we expect to meaningfully grow the base of surgeons using the aprevo Technology Platform and its penetration with existing surgeon users. To achieve this, we plan to grow our commercial infrastructure and expand various market access initiatives, including utilizing medical education programs and surgeon training at top academic institutions.
We are also committed to building upon our strong foundation of clinical evidence demonstrating the efficacy of our aprevo Technology Platform. Clinical data publications are important tools for surgeon education and patient awareness of the benefits of our personalized solution as compared to stock implants.
Our COMPASS Registry is generating ongoing real-world evidence of patient outcomes from lumbar spine surgery with the aprevo Technology Platform. For instance, data presented for 115 aprevo-treated ASD patients at the Scoliosis Research Society (SRS) Annual Meeting in September 2025 demonstrated a 75% reduction in spine fusion revision surgery at two years compared to a patient-matched cohort treated with stock interbody devices.
Expansion of Our Product Portfolio and Investments in Research and Development
Our research and development initiatives are focused on introducing new products, enhancements and capabilities aimed at increasing the value provided by our aprevo Technology Platform to patients, surgeons, and payors. We are developing new iterations of our algorithm and software platform to drive further improvements in surgical planning. We believe that these improvements will strengthen our ability to leverage post-operative data to build predictive analytic models and further enable surgeons to make more informed decisions to best treat their patients.
In November 2024, we received FDA 510(k) clearance for our aprevo interbodies for cervical spine fusion surgery as part of the FDA-cleared aprevo Technology Platform. We expect to receive FDA clearance for our accompanying personalized plating solutions and plan to commercialize the aprevo Technology Platform for cervical spine fusion surgeries by early 2026. We intend to drive initial adoption of this new indication among our existing base of surgeons who are actively using the aprevo Technology Platform for lumbar spine fusion surgeries.
23
We also believe that our technology platform has the potential to be utilized across various spinal indications and disease states such as cervical corpectomy and cervical disc arthroplasty. Additional FDA clearances would be required for these or any other new indications.
Hospital and Outpatient Reimbursement
Future changes in the level of reimbursement that hospitals and outpatient facilities receive from payors for lumbar and cervical fusion surgical procedures could have a significant impact on our results of operations. The level of payors' reimbursement for procedures using our aprevo Technology Platform depends substantially on our continued ability to generate clinical evidence, support from key opinion leaders, and gain advocacy for patient access to our technology with CMS and commercial payors.
aprevo® Lumbar
Procedures using our aprevo Technology Platform are covered by Medicare, Medicare Advantage, and commercial payors. For the three and nine months ended September 30, 2025, we estimate that our hospital customers’ payor mix consisted of approximately 44% and 42% for commercial insurance, respectively, and 56% and 58% for Medicare and Medicare Advantage insurance, respectively. Effective October 2024, CMS adopted a new MS-DRG coding system which reassigns MS-DRG codes for certain lumbar spine fusion procedures when “custom-made anatomically designed interbody fusion devices” (such as our aprevo Technology Platform) are utilized. This provides premium reimbursement for our hospital customers, relative to the use of stock implants. We believe this, among other factors, will support our customers' continued demand for our technology.
aprevo® Cervical
Effective October 1, 2025, cervical fusion procedures utilizing aprevo personalized interbody implants for traditional Medicare beneficiaries are eligible for New Technology Add-on Payments (NTAPs) from CMS. The NTAP program provides additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. These new technologies must demonstrate significant clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives or be designated by the FDA as breakthrough technology. CMS created unique ICD-10-PCS codes to identify cervical fusion procedures using "custom made anatomically designed interbody fusion devices" such as our aprevo Technology Platform. Reimbursement claims submitted with these unique ICD-10-PCS procedure codes may qualify hospitals for up to an additional $21,125 in NTAP reimbursement for eligible inpatient procedures.
For hospital outpatient departments (HOPDs) and ambulatory surgery centers (ASC), where many cervical procedures are performed, an applicable Transitional Pass-Through ("TPT") payment was included in the CMS Outpatient Prospective Payment System (OPPS) Proposed Rule. TPT payments help ensure timely access for Medicare beneficiaries to new and innovative medical technologies prior to CMS having sufficient cost data to permanently assign those items to an Ambulatory Payment Classification (APC). We anticipate that the applicable TPT payment will go into effect in early 2026 and that it will cover the differential of the facilities' cost of purchasing aprevo interbody implants in cervical fusions.
Key Components of Our Results of Operations
Revenue
We sell our aprevo interbody implants and accompanying inserter instruments to hospitals in the United States under standard pricing schedules. We recognize revenue in the period of its use within a spine fusion surgical procedure.
Cost of Sales
Cost of sales includes the costs of creating patient-specific digital surgical plans and the manufacturing costs of our aprevo interbody implants and the accompanying inserter instruments. These costs of sales include allocations for personnel, software, contract manufacturing and other third-party services, packaging, shipping, and overhead cost allocations. We expect that our cost of sales will continue to increase in proportion to recognized revenue.
Gross Profit and Gross Margin
Gross profit (i.e., revenue less cost of sales) and gross margin (i.e., gross profit as a percentage of revenue) have been, and will continue to be, affected by various factors. These include potential changes to our average revenue per procedure, sales volumes, third-party manufacturing costs, direct labor costs, and software costs. We expect our gross margin to remain relatively constant over the short term and to modestly increase over the medium and long term with economies of production scale, increased leverage of our AI technologies, and other planned manufacturing efficiencies.
24
Operating Expenses
Research and Development Expenses
Research and development expenses include personnel costs (i.e., salaries, bonuses, stock-based compensation expense, and benefits), allocated facility costs, product prototype materials, clinical studies aimed at potential new products, allocated software license amortization expenses, and consulting and other service fees. We recognize research and development expenses in the periods in which they are incurred. We expect our research and development expenses to increase as we continue to accelerate product and software innovation, develop additional clinical data, and expand manufacturing capabilities.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of personnel costs (i.e., salaries, commissions, bonuses, stock-based compensation expense, benefits, and travel), independent sales agent commissions, costs associated with generic surgical instruments we may provide to our independent sales agents, various digital and print initiatives to increase market awareness of our product and technology, conference and trade show fees, consulting fees, and medical education expenses.
We expect our sales and marketing expenses to increase in the foreseeable future as we continue to increase the size of our sales organization and scope of our marketing efforts in the United States and into other geographies, expand the indications for our aprevo Technology Platform, and seek to establish international sales channels. While we expect sales and marketing expenses to continue to increase in absolute value, we expect that these costs will decrease as a percentage of revenue over time.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel costs (i.e., salaries, bonuses, stock-based compensation expense, and benefits) for executive, legal, finance, and human resources roles. Other significant costs include legal fees relating to intellectual property and corporate matters, consultant and professional fees, insurance, and facility-related costs. We recognize general and administrative expenses in the periods in which they are incurred. We anticipate that our general and administrative expenses will increase in the future to support our anticipated business growth as a publicly traded company. These increased costs include accounting, audit, legal, regulatory, tax, insurance, investor relations, and compliance with exchange listing and SEC requirements. While we expect general and administrative expenses to continue to increase in absolute value, we expect that these costs will decrease as a percentage of revenue over time.
Interest Expense
Interest expense consists of interest coupon payments and non-cash amortization of debt issuance costs as part of the Customers Loan Agreement.
Interest Income
Interest income is attributable to bank interest on our cash and cash equivalents.
Change in Fair Value of Warrant Liabilities
Prior to the closing of the IPO on July 24, 2025, we had issued warrants for the purchase of our convertible preferred stock in conjunction with the loan and security agreement with Customers Bank (the "Customers Loan Agreement"). We accounted for these liability-classified warrants, initially measured at fair value, in accordance with ASC Topic 480. Changes in fair value of warrant liabilities have been recognized in the Statements of Operations and Comprehensive Loss. See Note 2—Summary of Significant Accounting Policies in the notes to our unaudited Condensed Financial Statements for information regarding the Series B Warrant and the Series C Warrant in connection with the Customers Loan Agreement.
25
Results of Operations
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
The following tables set forth our results of operations, variances versus the prior period, and percentage of revenue for each presented caption. The period-to-period comparison is not necessarily indicative of financial results to be achieved in future periods.
|
|
Three Months Ended September 30, |
|
|
$ |
|
|
% |
|
|
|
Percentage of Revenue |
|
|
||||||||||||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
Change |
|
|
|
2025 |
|
|
|
2024 |
|
|
|||||||||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Revenue |
|
$ |
|
13,074 |
|
|
$ |
|
6,590 |
|
|
$ |
|
6,484 |
|
|
|
98.4 |
|
% |
|
|
100.0 |
|
% |
|
|
100.0 |
|
% |
Cost of sales |
|
|
|
3,147 |
|
|
|
|
1,792 |
|
|
|
|
1,355 |
|
|
|
75.6 |
|
% |
|
|
24.1 |
|
|
|
|
27.2 |
|
|
Gross profit |
|
|
|
9,927 |
|
|
|
|
4,798 |
|
|
|
|
5,129 |
|
|
|
106.9 |
|
% |
|
|
75.9 |
|
|
|
|
72.8 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development |
|
|
|
4,445 |
|
|
|
|
4,035 |
|
|
|
|
410 |
|
|
|
10.2 |
|
% |
|
|
34.0 |
|
|
|
|
61.2 |
|
|
Sales and marketing |
|
|
|
9,610 |
|
|
|
|
6,622 |
|
|
|
|
2,988 |
|
|
|
45.1 |
|
% |
|
|
73.5 |
|
|
|
|
100.5 |
|
|
General and administrative |
|
|
|
4,907 |
|
|
|
|
1,918 |
|
|
|
|
2,989 |
|
|
|
155.8 |
|
% |
|
|
37.5 |
|
|
|
|
29.1 |
|
|
Total operating expenses |
|
|
|
18,962 |
|
|
|
|
12,575 |
|
|
|
|
6,387 |
|
|
|
50.8 |
|
% |
|
|
145.0 |
|
|
|
|
190.8 |
|
|
Loss from operations |
|
|
|
(9,035 |
) |
|
|
|
(7,777 |
) |
|
|
|
(1,258 |
) |
|
|
16.2 |
|
% |
|
|
(69.1 |
) |
|
|
|
(118.0 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Interest expense |
|
|
|
(380 |
) |
|
|
|
(402 |
) |
|
|
|
22 |
|
|
|
(5.5 |
) |
% |
|
|
(2.9 |
) |
|
|
|
(6.1 |
) |
|
Interest income |
|
|
|
954 |
|
|
|
|
394 |
|
|
|
|
560 |
|
|
|
142.1 |
|
% |
|
|
7.3 |
|
|
|
|
6.0 |
|
|
Change in fair value of warrant |
|
|
|
(65 |
) |
|
|
|
(28 |
) |
|
|
|
(37 |
) |
|
|
132.1 |
|
% |
|
|
(0.5 |
) |
|
|
|
(0.5 |
) |
|
Total other income (expense), net |
|
|
|
509 |
|
|
|
|
(36 |
) |
|
|
|
545 |
|
|
** |
|
|
|
|
3.9 |
|
|
|
|
(0.6 |
) |
|
|
Net loss and comprehensive loss |
|
$ |
|
(8,526 |
) |
|
$ |
|
(7,813 |
) |
|
$ |
|
(713 |
) |
|
|
9.1 |
|
% |
|
|
(65.2 |
) |
% |
|
|
(118.6 |
) |
% |
** Change not meaningful
|
|
Nine Months Ended September 30, |
|
|
$ |
|
|
% |
Percentage of Revenue |
|
|
||||||||||||||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
Change |
|
|
2025 |
|
|
|
2024 |
|
|
|||||||||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Revenue |
|
$ |
|
35,346 |
|
|
$ |
|
17,757 |
|
|
$ |
|
17,589 |
|
|
|
99.1 |
|
% |
|
100.0 |
|
% |
|
|
100.0 |
|
% |
Cost of sales |
|
|
|
8,914 |
|
|
|
|
4,733 |
|
|
|
|
4,181 |
|
|
|
88.3 |
|
% |
|
25.2 |
|
|
|
|
26.7 |
|
|
Gross profit |
|
|
|
26,432 |
|
|
|
|
13,024 |
|
|
|
|
13,408 |
|
|
|
102.9 |
|
% |
|
74.8 |
|
|
|
|
73.3 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development |
|
|
|
11,755 |
|
|
|
|
11,289 |
|
|
|
|
466 |
|
|
|
4.1 |
|
% |
|
33.3 |
|
|
|
|
63.6 |
|
|
Sales and marketing |
|
|
|
24,218 |
|
|
|
|
15,092 |
|
|
|
|
9,126 |
|
|
|
60.5 |
|
% |
|
68.5 |
|
|
|
|
85.0 |
|
|
General and administrative |
|
|
|
11,715 |
|
|
|
|
6,068 |
|
|
|
|
5,647 |
|
|
|
93.1 |
|
% |
|
33.1 |
|
|
|
|
34.2 |
|
|
Total operating expenses |
|
|
|
47,688 |
|
|
|
|
32,449 |
|
|
|
|
15,239 |
|
|
|
47.0 |
|
% |
|
134.9 |
|
|
|
|
182.8 |
|
|
Loss from operations |
|
|
|
(21,256 |
) |
|
|
|
(19,425 |
) |
|
|
|
(1,831 |
) |
|
|
9.4 |
|
% |
|
(60.1 |
) |
|
|
|
(109.5 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Interest expense |
|
|
|
(1,100 |
) |
|
|
|
(943 |
) |
|
|
|
(157 |
) |
|
|
16.6 |
|
% |
|
(3.1 |
) |
|
|
|
(5.3 |
) |
|
Interest income |
|
|
|
1,670 |
|
|
|
|
920 |
|
|
|
|
750 |
|
|
|
81.5 |
|
% |
|
4.7 |
|
|
|
|
5.2 |
|
|
Change in fair value of warrant |
|
|
|
(335 |
) |
|
|
|
(89 |
) |
|
|
|
(246 |
) |
|
|
276.4 |
|
% |
|
(1.0 |
) |
|
|
|
(0.4 |
) |
|
Total other income (expense), net |
|
|
|
235 |
|
|
|
|
(112 |
) |
|
|
|
347 |
|
|
|
(309.8 |
) |
% |
|
0.6 |
|
|
|
|
(0.5 |
) |
|
Net loss and comprehensive loss |
|
$ |
|
(21,021 |
) |
|
$ |
|
(19,537 |
) |
|
$ |
|
(1,484 |
) |
|
|
7.6 |
|
% |
|
(59.5 |
) |
% |
|
|
(110.0 |
) |
% |
Revenue
Revenue was $13.1 million and $6.6 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $6.5 million, or 98.4%, was primarily driven by increased volume of surgical procedures with the aprevo Technology Platform in the current quarter, with our average revenue per procedure substantially constant between these periods.
26
Revenue was $35.3 million and $17.8 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $17.6 million, or 99.1%, was primarily driven by increased volume of surgical procedures with the aprevo Technology Platform in the current nine month period, with our average revenue per procedure substantially constant between these periods.
Cost of Sales and Gross Margin
Cost of sales was $3.1 million and $1.8 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $1.4 million, or 75.6%, was primarily driven by increased sales of aprevo interbody implants in the current quarter and the associated increase in contract manufacturing materials and costs for the three months ended September 30, 2025 with this sales volume, as compared to the three months ended September 30, 2024.
Gross margin was 75.9% for the three months ended September 30, 2025, as compared to 72.8% for the three months ended September 30, 2024 with the improvement primarily due to a reduction in the per unit production fees charged by our contract manufacturer and decreased inventory reserve expenses.
Cost of sales was $8.9 million and $4.7 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $4.2 million, or 88.3%, was primarily driven by increased sales of aprevo interbody implants in the current nine month period and the associated increase in contract manufacturing materials and costs for the nine months ended September 30, 2025 with this sales volume, as compared to the nine months ended September 30, 2024.
Gross margin was 74.8% for the nine months ended September 30, 2025, as compared to 73.3% for the nine months ended September 30, 2024 with the improvement primarily driven by a reduction in per unit production fees charged by our contract manufacturer and decreased inventory reserve expenses.
Research and Development Expenses
Research and development expenses were $4.4 million and $4.0 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $0.4 million, or 10.2%, was primarily due to higher personnel costs to support product development and AI initiatives; this was partially offset by decreased prototype and materials costs and reduced COMPASS registry costs following enrollment completion in the second half of 2024.
Research and development expenses were $11.8 million and $11.3 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $0.5 million, or 4.1% was primarily due to higher personnel costs to support product development and AI initiatives; this was partially offset by decreased costs for external services and prototype parts and materials and reduced COMPASS registry costs following enrollment completion in second half of 2024.
Sales and Marketing Expenses
Sales and marketing expenses were $9.6 million and $6.6 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $3.0 million, or 45.1%, was primarily driven by a $1.6 million increase in personnel-related costs (including increased headcount, sales compensation for employees, employee bonuses, and stock-based compensation), a $1.3 million increase in commissions to independent sales agents, a $0.7 million increase in various marketing costs, and a $0.3 million increase in other costs. These increases were partially offset by a decrease in professional service fees of $0.9 million.
Sales and marketing expenses were $24.2 million and $15.1 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $9.1 million, or 60.5%, was primarily driven by a $4.3 million increase in personnel-related costs (including increased headcount, sales compensation for employees, employee bonuses and stock-based compensation), a $3.7 million increase in commissions to independent sales agents, a $1.7 million increase in various marketing costs, a $0.3 million increase in employee travel costs, and a $0.6 million increase in other costs. These increases were partially offset by a decrease in professional service fees of $1.5 million.
General and Administrative Expenses
General and administrative expenses were $4.9 million and $1.9 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $3.0 million, or 155.8%, was primarily driven by a $1.6 million increase in professional service and legal fees for corporate and intellectual property matters, a $1.1 million increase in costs for personnel additions to support business growth and compliance and operational requirements as a public company, and a $0.3 million increase in other administrative costs.
27
General and administrative expenses were $11.7 million and $6.1 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $5.6 million, or 93.1%, was primarily driven by a $3.0 million increase in professional service and legal fees for corporate and intellectual property matters, a $1.8 million increase in costs for personnel additions to support business growth, compliance and operational requirements as a public company, and a $0.8 million increase in other administrative costs.
Interest Expense
Interest expense remained consistent at $0.4 million for both the three months ended September 30, 2025 and 2024 due to consistent borrowings outstanding under the Customers Loan Agreement during both periods.
Interest expense was $1.1 million and $0.9 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $0.2 million, or 16.6%, was primarily driven by an increased amount of borrowings outstanding under the Customers Loan Agreement.
Interest Income
Interest income was $1.0 million and $0.4 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $0.6 million, or 142.1%, was due to an increase in bank interest on our higher daily average cash and cash equivalent balances resulting from the proceeds from our IPO in July 2025.
Interest income was $1.7 million and $0.9 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $0.8 million, or 81.5%, was due to an increase in bank interest on our higher daily average cash and cash equivalent balances resulting from the proceeds from our IPO in July 2025.
Change in Fair Value of Warrant Liabilities
The fair value of warrant liabilities increased by less than $0.1 million and $0.2 million during the three and nine months ended September 30, 2025 compared to the three and nine months ended September 30, 2024, respectively.
Non-GAAP Financial Measures
In addition to our results determined in accordance with GAAP, we utilize and present financial measures that are not calculated and presented in accordance with GAAP. Our non-GAAP financial measures include EBITDA and Adjusted EBITDA, each of which is described below. We use our non-GAAP financial measures in evaluating our operating performance and for internal planning purposes. We believe that these non-GAAP financial measures, when taken together with the corresponding GAAP financial measures, provide meaningful supplemental information regarding our performance by excluding certain items that may not be indicative of our business, results of operations, or outlook. We believe that the presentation of our GAAP and non-GAAP financial measures, in combination, is helpful to investors in assessing our trending business performance in the currently reported period and versus prior periods. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. In addition, other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. A reconciliation is provided below for each non-GAAP financial measure to the most directly comparable financial measure stated in accordance with GAAP. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business.
EBITDA and Adjusted EBITDA
EBITDA and Adjusted EBITDA are non-GAAP financial measures used by management as a supplemental measure in evaluating our operating performance. EBITDA and Adjusted EBITDA should not be considered as alternatives to, or more meaningful than, net loss or any other measure as determined in accordance with GAAP. Our computation of EBITDA and Adjusted EBITDA may not be comparable to EBITDA and Adjusted EBITDA of other companies.
We define “EBITDA” as net income (loss), adjusted to exclude: (i) net interest (income) expense, (ii) income tax expense (benefit), (iii) depreciation expense from property and equipment, and (iv) amortization expense from long-lived assets. We define “Adjusted EBITDA” as EBITDA adjusted to exclude stock-based compensation expense and change in fair value of warrant liabilities.
28
The following tables present a reconciliation of EBITDA and Adjusted EBITDA to the GAAP financial measure of net loss for each of the periods indicated:
|
|
Three Months Ended September 30, |
|
|
|
$ |
|
|
% |
|
|
|||||||||
|
|
|
2025 |
|
|
|
2024 |
|
|
|
Change |
|
|
Change |
|
|
||||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
|
(8,526 |
) |
|
$ |
|
(7,813 |
) |
|
$ |
|
(713 |
) |
|
|
9.1 |
|
% |
Interest (income) expense |
|
|
|
(574 |
) |
|
|
|
8 |
|
|
|
|
(582 |
) |
|
** |
|
|
|
Income taxes |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
Depreciation and amortization |
|
|
|
82 |
|
|
|
|
33 |
|
|
|
|
49 |
|
|
|
148.5 |
|
% |
EBITDA |
|
|
|
(9,018 |
) |
|
|
|
(7,772 |
) |
|
|
|
(1,246 |
) |
|
|
16.0 |
|
% |
Stock-based compensation |
|
|
|
704 |
|
|
|
|
66 |
|
|
|
|
638 |
|
|
|
966.7 |
|
% |
Change in fair value of warrant liabilities |
|
|
|
65 |
|
|
|
|
28 |
|
|
|
|
37 |
|
|
|
132.1 |
|
% |
Adjusted EBITDA |
|
$ |
|
(8,249 |
) |
|
$ |
|
(7,678 |
) |
|
$ |
|
(571 |
) |
|
|
7.4 |
|
% |
**Change not meaningful
|
|
Nine Months Ended September 30, |
|
|
$ |
|
|
% |
||||||||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
Change |
|
|
|||||||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
|
(21,021 |
) |
|
$ |
|
(19,537 |
) |
|
$ |
|
(1,484 |
) |
|
|
7.6 |
|
% |
Interest (income) expense |
|
|
|
(570 |
) |
|
|
|
23 |
|
|
|
|
(593 |
) |
|
** |
|
|
|
Income taxes |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
Depreciation and amortization |
|
|
|
183 |
|
|
|
|
108 |
|
|
|
|
75 |
|
|
|
69.4 |
|
% |
EBITDA |
|
|
|
(21,408 |
) |
|
|
|
(19,406 |
) |
|
|
|
(2,002 |
) |
|
|
10.3 |
|
% |
Stock-based compensation |
|
|
|
1,137 |
|
|
|
|
153 |
|
|
|
|
984 |
|
|
|
643.1 |
|
% |
Change in fair value of warrant liabilities |
|
|
|
335 |
|
|
|
|
89 |
|
|
|
|
246 |
|
|
|
276.4 |
|
% |
Adjusted EBITDA |
|
$ |
|
(19,936 |
) |
|
$ |
|
(19,164 |
) |
|
$ |
|
(772 |
) |
|
|
4.0 |
|
% |
**Change not meaningful
Liquidity and Capital Resources
We have incurred net losses and negative cash flows from operations since our inception. We have historically financed operations primarily through the net proceeds that we have received from the sale of shares of our convertible preferred stock, borrowings under our debt facilities, and cash generated from the sales of aprevo interbody implants. On July 24, 2025, we completed our IPO and received $93.5 million in net proceeds, after deducting underwriting discounts and commissions and before additional offering expenses of $5.4 million paid by us. As of September 30, 2025, we had $115.4 million of cash and cash equivalents, $15.6 million of principal outstanding under the Customers Loan Agreement, and an accumulated deficit of $92.2 million.
Our losses primarily resulted from the costs incurred in the development and sales and marketing of our products and providing general and administrative support for our operations. We may continue to incur losses and expend significant amounts of cash in the foreseeable future as we continue to scale our business, invest in research and development activities, increase sales and marketing expenses to support commercial expansion, and increase general and administrative expenses associated with operating as a publicly traded company.
Customers Loan Agreement
As of September 30, 2025, $15.6 million of principal was outstanding under the Customers Loan Agreement that matures on October 31, 2029. As of September 30, 2025, an aggregate $11.9 million was available to draw. The Customers Loan Agreement was amended in October 2025, as discussed below and in Note 4 in the accompanying notes to our unaudited Condensed Financial Statements, to increase borrowing capacity and achieve other related objectives.
29
On October 29, 2025, we amended the Customers Loan Agreement (the "Fifth Amendment") to expand this credit facility which currently consists of (i) a term loan in the principal amount of up to $50.0 million (the “Term Loan”), $17.5 million of which is contingent upon the achievement of requisite revenue milestones, and (ii) a $10.0 million non-formula revolving line of credit (the “Non-Formula Revolving Line”). The maximum availability for draw under the Term Loan and Non-Formula Revolving Line now aggregates to $42.5 million.
The maturity date of the Term Loan was extended to October 15, 2030, with an interest-only period through October 15, 2027, followed by principal repayment over 36 months thereafter. Upon achievement of certain revenue milestones, the interest-only period and repayment terms of the Term Loan may be extended through April 15, 2028 followed by principal repayment over 30 months, and upon achievement of an additional milestone, may be further extended through October 15, 2028, followed by principal repayment over 24 months thereafter. The Non-Formula Revolving Line will mature on October 15, 2028. The applicable per annum interest rate did not change as a result of the Fifth Amendment and remains as the greater of (a) WSJ Prime Rate + 0.25% or (b) 5.25%.
Future Funding Requirements
Based on our current operating plan, we believe our existing cash and cash equivalents, the expected cash generated from sales of our aprevo interbody implants, and amounts currently available for future borrowings under our Customers Loan Agreement will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside of our control and, as a result, may not fully reflect the underlying performance of our business. Fluctuation in quarterly and annual results may decrease the value of our common stock.
Our future capital requirements will depend on many factors, including, but not limited to:
If these sources of cash are insufficient to satisfy our liquidity requirements, we may need to engage in equity or debt financings to secure additional funds. If we raise additional funds through further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity or convertible debt securities we issue could have rights, preferences, and privileges superior to those of holders of our common stock. In addition, the incurrence of indebtedness would increase our fixed obligations and include covenants or other restrictions that would impede our ability to manage our operations.
30
Our ability to raise additional funds may be adversely impacted by deteriorating global economic conditions and the disruptions to and volatility in the credit and financial markets in the United States and fluctuations in interest rates. If additional financing is needed, we may not be able to obtain additional financing on terms favorable to us, or at all. Our inability to obtain adequate financing or financing on terms satisfactory to us, when we require it, could significantly limit our ability to continue supporting our business growth and responding to business challenges and opportunities.
Cash Flows
The following table summarizes our cash flows for each of the periods presented:
|
|
Nine Months Ended September 30, |
|
|||||||
|
|
2025 |
|
|
2024 |
|
||||
(in thousands) |
|
|
|
|
|
|
|
|
||
Net cash provided by (used in): |
|
|
|
|
|
|
|
|
||
Net cash flows used in operating activities |
|
$ |
|
(23,656 |
) |
|
$ |
|
(21,263 |
) |
Net cash used in investing activities |
|
$ |
|
(1,253 |
) |
|
$ |
|
(119 |
) |
Net cash flows provided by financing activities |
|
$ |
|
100,157 |
|
|
$ |
|
58,550 |
|
Operating activities
For the nine months ended September 30, 2025, net cash used in operating activities was $23.7 million. Cash payments to vendors during the nine months ended September 30, 2025 totaled $34.4 million and payroll-related cash payments totaled $19.8 million. We received $30.5 million from our customers for sales of aprevo interbody implants in the nine months ended September 30, 2025 and recognized $35.3 million of revenue, based on the timing of aprevo interbody implants use in surgical procedures in this period.
For the nine months ended September 30, 2024, net cash used in operating activities was $21.3 million. Cash payments to vendors during the nine months ended September 30, 2024 totaled $24.2 million and payroll-related cash payments totaled $12.5 million. We received $15.4 million from our customers for sales of aprevo interbody implants in the nine months ended September 30, 2024 and recognized $17.8 million of revenue based on the timing of aprevo interbody implants use in surgical procedures in this period.
Investing activities
For the nine months ended September 30, 2025, net cash used in investing activities was $1.3 million and consisted primarily of purchases of property and equipment of $0.6 million, capitalized internal use software costs of $0.6 million, and payment of initial direct costs of $0.1 million for a new operating lease entered into in May 2025.
For the nine months ended September 30, 2024, net cash used in investing activities was $0.1 million and consisted of purchases of property and equipment.
Financing activities
For the nine months ended September 30, 2025, net cash provided by financing activities was $100.2 million, consisting primarily of proceeds from its initial public offering of $93.5 million, net of underwriting discounts and commissions, net proceeds from the issuance of Series C convertible preferred stock of $11.9 million and proceeds from the exercise of stock options of $0.2 million. This was partially offset by payments for deferred offering costs of $5.4 million in connection with our IPO.
For the nine months ended September 30, 2024, net cash provided by financing activities was $58.5 million, consisting primarily of net proceeds from the issuance of Series C convertible preferred stock of $52.3 million and borrowings under the Customers Loan Agreement of $6.2 million.
31
Contractual Obligations and Other Material Cash Commitments
Our contractual obligations as of September 30, 2025, include:
Debt
Total principal amount outstanding under the Customers Loan Agreement as of September 30, 2025, was $15.6 million. As of September 30, 2025, this debt matured on October 31, 2029, with an interest-only period through January 31, 2027, followed by principal repayment over 33 months thereafter.
As discussed further above, on October, 29, 2025, we amended this arrangement and this maturity date was extended to October 15, 2030, with an interest-only period through October 15, 2027, followed by principal repayment over 36 months thereafter. Upon achievement of certain revenue milestones, the interest-only period and repayment terms may be further extended to an interest-only period through October 15, 2028, followed by principal repayment over 24 months thereafter. The applicable per annum interest rate did not change as a result of the Fifth Amendment and remains as the greater of (a) WSJ Prime Rate + 0.25% or (b) 5.25%.
Operating leases
As of September 30, 2025, contractual obligations for operating lease payments (substantially related to our Carlsbad, California office leases with lease terms to July 1, 2028) totaled $2.4 million and are due over 33 months after September 30, 2025.
Critical Accounting Policies and Significant Judgments and Estimates
In our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section within the IPO Prospectus, we identified the critical accounting policies which affect our more significant estimates and assumptions used in preparing our financial statements. There have been no material changes to our critical accounting policies from those previously disclosed in the IPO Prospectus.
Recently Issued and Adopted Accounting Pronouncements
See “Note 2 – Summary of Significant Accounting Policies” in the accompanying notes to our unaudited Condensed Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for information about recent accounting pronouncements, the timing of their adoption, and our assessment, if any, of their potential impact on our financial condition and results of operations.
Emerging Growth Company and Smaller Reporting Company Status
We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:
32
We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of the IPO; (iii) the date on which we have issued more than $1.0 billion in non-convertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC. We may choose to take advantage of some but not all of these exemptions. We have taken advantage of reduced reporting requirements in this Quarterly Report on Form 10-Q. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock. In addition, the JOBS Act permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We have chosen to “opt out” of this provision, and, as a result, we will comply with new or revised accounting standards as required when they are adopted. This decision to opt out of the extended transition period is irrevocable.
We are also a “smaller reporting company,” because the market value of our shares held by non-affiliates is less than $700.0 million, and our annual revenue was less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than $250.0 million or (ii) our annual revenue was less than $100.0 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time that we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K, and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that these disclosures controls were effective at a reasonable assurance level as of September 30, 2025.
Changes in Internal Control
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
Our management team, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal controls over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, the effectiveness of any internal control over financial reporting is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to completely eliminate all potential for misconduct. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitations in any cost-effective control system, misstatements due to error or fraud may occur and not be detected.
33
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
For discussion regarding legal proceedings, please refer to “Note 9 – Commitments and Contingencies” in the accompanying notes to our Condensed Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.
Item 1A. Risk Factors.
Our business is subject to a variety of risks and uncertainties that are difficult to predict and many of which are outside of our control. For a detailed discussion of the risks that affect our business, refer to the section entitled “Risk Factors” included in the IPO Prospectus. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risk factors previously described in the IPO Prospectus. The matters specifically identified are not the only risks and uncertainties facing our company, and risks and uncertainties not known to us or not specifically identified also may impair our business operations. If any of these risks and uncertainties occur, our business, financial condition, results of operations and cash flows could be negatively affected, which could negatively impact the value of an investment in our company.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Unregistered Sales of Equity Securities
None.
Use of Proceeds
On July 24, 2025, we completed our IPO, in which we issued and sold 6,700,000 shares of our common stock, at a price to the public of $15.00 per share. The net proceeds to the Company from the IPO were approximately $88.1 million, after deducting underwriting fees and offering costs.
The net proceeds from our IPO have been used and will be used, together with our existing cash and cash equivalents: (i) to support the commercialization of the aprevo Technology Platform and expand and improve our product offerings, including approximately $25 million to support our increased sales and marketing efforts and approximately $46 million to fund our research and development activities to advance the aprevo Technology Platform, including the continued development of the aprevo Technology Platform for use in cervical spine fusion surgeries, and (ii) the remainder for working capital and general corporate purposes.
There has been no material change in the intended use of proceeds from our IPO as described in our IPO Prospectus.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Rule 10b5-1 Trading Arrangements
During the fiscal quarter ended September 30, 2025, none of our directors or officers
34
Item 6. Exhibits.
Exhibit Number |
|
Description |
3.1 |
|
|
3.2 |
|
|
10.1 |
|
|
10.2 |
|
|
10.3 |
|
|
10.4 |
|
|
31.1* |
|
|
31.2* |
|
|
32.1** |
|
|
32.2** |
|
|
101.INS* |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104* |
|
Cover page formatted as Inline XBRL and contained in Exhibit 101 |
* Filed herewith.
** Furnished herewith.
35
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.
|
|
CARLSMED, INC. |
|
|
|
|
|
Date: November 6, 2025 |
|
By: |
/s/Michael Cordonnier |
|
|
|
Michael Cordonnier |
|
|
|
Chief Executive Officer and President |
|
|
|
(Principal Executive Officer) |
|
|
|
|
Date: November 6, 2025 |
|
By: |
/s/ Leonard Greenstein |
|
|
|
Leonard Greenstein |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial Officer) |
36
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael Cordonnier, certify that:
Date: November 6, 2025 |
|
By: |
/s/ Michael Cordonnier |
|
|
|
Michael Cordonnier |
|
|
|
Chief Executive Officer and President (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Leonard Greenstein, certify that:
Date: November 6, 2025 |
|
By: |
/s/ Leonard Greenstein |
|
|
|
Leonard Greenstein |
|
|
|
Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Carlsmed, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: November 6, 2025 |
|
By: |
/s/ Michael Cordonnier |
|
|
|
Michael Cordonnier |
|
|
|
Chief Executive Officer and President (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Carlsmed, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: November 6, 2025 |
|
By: |
/s/ Leonard Greenstein |
|
|
|
Leonard Greenstein |
|
|
|
Chief Financial Officer (Principal Financial Officer) |