SEC Filing | Carlsmed

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 5, 2026

Carlsmed, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware 001-42756 83-1081863
(State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.)
1800 Aston Ave, Suite 100 Carlsbad, California 92008
(Address of Principal Executive Offices)
Registrant’s Telephone Number, Including Area Code: (760) 766-1923

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, $0.00001 par value per share CARL The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 2.02 Results of Operations and Financial Condition.

On May 5, 2026, Carlsmed, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended March 31, 2026. The full text of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.

The foregoing information in this Item 2.02 (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(a) Exhibits
Exhibit No. Description
99.1* Press Release of Carlsmed, Inc., dated May 5, 2026
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CARLSMED, INC.
Date: May 5, 2026 By: /s/Michael Cordonnier
Michael Cordonnier
Chief Executive Officer and President

EX-99.1

Carlsmed® Reports First Quarter 2026 Financial Results

First quarter 2026 revenue of $16.1 million, representing 58% growth year-over-year
Full year 2026 revenue guidance raised to $72 million to $77 million

CARLSBAD, CALIFORNIA, MAY 5, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) ("Carlsmed" or the "Company"), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today reported financial results for the first quarter ended March 31, 2026.

"We began 2026 with strong momentum, delivering 58% year-over-year revenue growth, publishing meaningful clinical data, and debuting new products to continue to advance our mission of improved patient outcomes and reduced cost of healthcare," said Mike Cordonnier, Chairman and Chief Executive Officer of Carlsmed. "The publication of peer-reviewed data from a retrospective cohort study in Global Spine Journal demonstrates a 74% reduction in revision rates for aprevo®, which represents one of the most significant advancements in reducing reoperations in adult spinal deformity over the past two decades. With our first full commercial quarter for aprevo® Cervical and the launch of our corra™ patient-specific fixation portfolio later this year, we believe we are well positioned for continued growth and innovation throughout 2026."

Recent Business Highlights

First Quarter 2026 Financial Results

2026 Financial Outlook

Non-GAAP Financial Measures

This press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles ("GAAP"), including adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Carlsmed’s financial measures presented in this press release that are calculated and presented in accordance with GAAP.

The Company calculates adjusted EBITDA as net income (loss), as adjusted to exclude, as applicable, (i) net interest income (expense), (ii) income tax expense (benefit), (iii) depreciation expense from property and equipment (iv) amortization expense from long-lived assets, (iv) stock-based compensation expense and (v) change in fair value of warrant liabilities.

This non-GAAP measure is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate financial performance for both strategic and annual operating planning.

The non-GAAP financial measures used by Carlsmed may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Carlsmed’s financial results prepared and reported in accordance with GAAP. This non-GAAP measure should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release.

About Carlsmed

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

CARLSMED, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

Three Months Ended March 31,
2026
Revenue $ 16,116
Cost of sales 3,691
Gross profit 12,425
Operating expenses:
Research and development 5,178
Sales and marketing 10,297
General and administrative 6,226
Total operating expenses 21,701
Loss from operations (9,276)
Other income (expense):
Interest expense (311)
Interest income 891
Change in fair value of warrant liabilities —
Total other income (expense), net 580
Net loss and comprehensive loss (8,696)
Deemed dividend to preferred stockholders —
Net loss attributable to common stockholders $ (8,696)
Net loss per share attributable to common stockholders, basic and diluted $ (0.32)
Weighted-average number of common shares used to compute basic and diluted net loss per share 26,835,841

CARLSMED, INC.

CONDENSED BALANCE SHEETS

(in thousands, except for share and par value amounts)

March 31, 2026 December 31, 2025
Assets
Current assets:
Cash and cash equivalents $ 73,016 $ 85,793
Restricted cash 100 100
Short-term investments 24,000 24,000
Accounts receivable, net of allowances of $2,055 and $1,653, as of March 31, 2026 and December 31, 2025, respectively 12,268 11,362
Inventory 2,063 1,845
Prepaid expenses and other current assets 3,959 3,573
Total current assets 115,406 126,673
Property and equipment, net 1,597 1,487
Operating lease right-of-use assets 1,663 1,826
Other assets 103 134
Total assets $ 118,769 $ 130,120
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 2,952 $ 4,481
Accrued liabilities 3,202 3,287
Accrued compensation 2,785 5,760
Short-term operating lease liabilities 776 752
Total current liabilities 9,715 14,280
Long-term portion of term loan, net 15,364 15,346
Long-term operating lease liabilities 1,115 1,316
Other long-term liabilities 327 309
Total liabilities 26,521 31,251
Stockholders’ equity:
Preferred stock, $0.00001 par value; 10,000,000 shares authorized and zero shares issued and outstanding as of March 31, 2026 and December 31, 2025 — —
Common stock, $0.00001 par value; 600,000,000 shares authorized, 27,232,278 shares issued, and 27,181,501 shares outstanding as of March 31, 2026; 600,000,000 shares authorized, 26,664,243 shares issued, and 26,604,505 shares outstanding as of December 31, 2025 — —
Additional paid-in capital 201,749 199,674
Accumulated deficit (109,501) (100,805)
Total stockholders’ equity 92,248 98,869
Total liabilities and stockholders’ equity $ 118,769 $ 130,120

RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA

Three Months Ended March 31,
2026
Net loss $ (8,696)
Interest (income) expense (580)
Depreciation and amortization 99
EBITDA (9,177)
Stock-based compensation 1,629
Adjusted EBITDA $ (7,548)