CVRx, Inc. 10-Q

Item 1. Financial Statements CVRx, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ ​ 2025 ​ 2024 Assets ​ ​ Current assets: ​ ​ Cash and cash equivalents ​ $ 85,124 ​ $ 105,933 Accounts receivable, net of allowances of $ 871 and $ 780 , respectively ​ 8,209 ​ 9,268 Inventory ​ 11,394 ​ 12,107 Prepaid expenses and other current assets ​ 3,163 ​ 2,505 Total current assets ​ 107,890 ​ 129,813 Property and equipment, net ​ 2,446 ​ 2,505 Operating lease right-of-use asset ​ ​ 963 ​ ​ 1,069 Other non-current assets ​ 26 ​ 27 Total assets ​ $ 111,325 ​ $ 133,414 Liabilities and Stockholders’ Equity ​ ​ Current liabilities: ​ ​ Accounts payable ​ $ 3,628 ​ $ 2,582 Accrued expenses ​ 7,590 ​ 8,180 Total current liabilities ​ 11,218 ​ 10,762 Long-term debt ​ ​ 49,453 ​ ​ 49,273 Operating lease liability, non-current portion ​ ​ 730 ​ ​ 877 Other long-term liabilities ​ 1,870 ​ 1,447 Total liabilities ​ 63,271 ​ 62,359 Commitments and contingencies (Note 10) ​ ​ Stockholders’ equity: ​ ​ Common stock, $ 0.01 par value, 200,000,000 authorized as of September 30, 2025 and December 31, 2024; 26,193,733 and 25,324,684 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively ​ 262 ​ 253 Additional paid-in capital ​ 626,714 ​ 608,354 Accumulated deficit ​ ( 578,718 ) ​ ( 537,346 ) Accumulated other comprehensive loss ​ ( 204 ) ​ ( 206 ) Total stockholders’ equity ​ 48,054 ​ 71,055 Total liabilities and stockholders’ equity ​ $ 111,325 ​ $ 133,414 ​ The accompanying notes are an integral part of these condensed consolidated financial statements. ​ 5 Table of Contents CVRx, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended ​ Nine months ended ​ ​ September 30, ​ September 30, ​ ​ 2025 2024 2025 2024 Revenue ​ $ 14,690 ​ $ 13,373 ​ $ 40,627 ​ $ 35,950 Cost of goods sold ​ 1,937 ​ 2,248 ​ 6,112 ​ 5,763 Gross profit ​ 12,753 ​ 11,125 ​ 34,515 ​ 30,187 Operating expenses: ​ ​ ​ ​ Research and development ​ 3,146 ​ 2,504 ​ 8,132 ​ 8,326 Selling, general and administrative ​ 21,875 ​ 21,632 ​ 66,464 ​ 71,077 Total operating expenses ​ 25,021 ​ 24,136 ​ 74,596 ​ 79,403 Loss from operations ​ ( 12,268 ) ​ ( 13,011 ) ​ ( 40,081 ) ​ ( 49,216 ) Interest expense ​ ( 1,480 ) ​ ( 958 ) ​ ( 4,410 ) ​ ( 2,877 ) Other income, net ​ 875 ​ 917 ​ 3,108 ​ 2,905 Loss before income taxes ​ ( 12,873 ) ​ ( 13,052 ) ​ ( 41,383 ) ​ ( 49,188 ) Benefit (provision) for income taxes ​ 3 ​ ( 47 ) ​ 11 ​ ( 126 ) Net loss ​ ( 12,870 ) ​ ( 13,099 ) ​ ( 41,372 ) ​ ( 49,314 ) Cumulative translation adjustment ​ ( 1 ) ​ 2 ​ 2 ​ ( 1 ) Comprehensive loss ​ $ ( 12,871 ) ​ $ ( 13,097 ) ​ $ ( 41,370 ) ​ $ ( 49,315 ) Net loss per share, basic and diluted ​ $ ( 0.49 ) ​ $ ( 0.57 ) ​ $ ( 1.59 ) ​ $ ( 2.25 ) Weighted-average common shares used to compute net loss per share, basic and diluted ​ 26,168,562 ​ 22,783,337 ​ 26,039,718 ​ 21,884,588 ​ The accompanying notes are an integral part of these condensed consolidated financial statements. ​ 6 Table of Contents ​ CVRx, INC. Condensed Consolidated Statements of Stockholders’ Equity (In thousands, except share data) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ other ​ Total ​ ​ Common stock ​ paid-in ​ Accumulated ​ comprehensive ​ stockholders’ ​ Shares ​ Amount capital deficit loss equity Balances as of June 30, 2025 26,145,951 $ 261 ​ $ 623,724 ​ $ ( 565,848 ) ​ $ ( 203 ) ​ $ 57,934 Exercise of stock options 47,782 1 ​ 147 ​ — ​ — ​ 148 Employee stock compensation — — ​ 2,888 ​ — ​ — ​ 2,888 Issuance of common stock ​ — — ​ ​ ( 45 ) ​ ​ — ​ — ​ ( 45 ) Net loss for the three months ended September 30, 2025 — — ​ — ​ ( 12,870 ) ​ — ​ ( 12,870 ) Cumulative translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 1 ) ​ ​ ( 1 ) Balances as of September 30, 2025 26,193,733 $ 262 ​ $ 626,714 ​ $ ( 578,718 ) ​ $ ( 204 ) ​ $ 48,054 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balances as of June 30, 2024 21,712,357 $ 217 ​ $ 568,837 ​ $ ( 513,596 ) ​ $ ( 210 ) ​ $ 55,248 Exercise of stock options ​ 132,526 1 ​ 727 ​ — ​ — ​ 728 Employee stock compensation — — ​ 2,680 ​ — ​ — ​ 2,680 Issuance of common stock ​ 2,358,775 ​ ​ 24 ​ ​ 19,600 ​ ​ — ​ ​ — ​ ​ 19,624 Net loss for the three months ended September 30, 2024 — — ​ — ​ ( 13,099 ) ​ — ​ ( 13,099 ) Cumulative translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ 2 ​ ​ 2 Balances as of September 30, 2024 24,203,658 $ 242 ​ $ 591,844 ​ $ ( 526,695 ) ​ $ ( 208 ) ​ $ 65,183 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ other ​ Total ​ ​ Common stock ​ paid-in ​ Accumulated ​ comprehensive ​ stockholders’ ​ Shares ​ Amount capital deficit loss equity Balances as of December 31, 2024 25,324,684 $ 253 ​ $ 608,354 ​ $ ( 537,346 ) ​ $ ( 206 ) ​ $ 71,055 Exercise of stock options ​ 253,645 3 ​ 594 ​ — ​ — ​ 597 Proceeds from Employee Stock Purchase Plan ​ 71,942 ​ ​ — ​ ​ 360 ​ ​ — ​ ​ — ​ ​ 360 Employee stock compensation — — ​ 8,259 ​ — ​ — ​ 8,259 Issuance of common stock ​ 543,462 ​ ​ 6 ​ ​ 9,147 ​ ​ — ​ ​ — ​ ​ 9,153 Net loss for the nine months ended September 30, 2025 — — ​ — ​ ( 41,372 ) ​ — ​ ( 41,372 ) Cumulative translation adjustment — — ​ — ​ — ​ 2 ​ 2 Balances as of September 30, 2025 26,193,733 $ 262 ​ $ 626,714 ​ $ ( 578,718 ) ​ $ ( 204 ) ​ $ 48,054 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balances as of December 31, 2023 20,879,199 $ 209 ​ $ 553,326 ​ $ ( 477,381 ) ​ $ ( 207 ) ​ $ 75,947 Exercise of stock options ​ 298,513 ​ ​ 3 ​ ​ 1,607 ​ ​ — ​ ​ — ​ ​ 1,610 Proceeds from Employee Stock Purchase Plan ​ 39,807 ​ ​ — ​ ​ 406 ​ ​ — ​ ​ — ​ ​ 406 Employee stock compensation — — ​ 16,365 ​ — ​ — ​ 16,365 Issuance of common stock ​ 2,382,139 ​ ​ 24 ​ ​ 20,146 ​ ​ — ​ ​ — ​ ​ 20,170 Issuance of common stock upon net exercise of common warrants ​ 604,000 ​ ​ 6 ​ ​ ( 6 ) ​ ​ — ​ ​ — ​ ​ — Net loss for the nine months ended September 30, 2024 — — ​ ​ — ​ ( 49,314 ) ​ — ​ ( 49,314 ) Cumulative translation adjustment — — ​ — ​ — ​ ( 1 ) ​ ( 1 ) Balances as of September 30, 2024 24,203,658 $ 242 ​ $ 591,844 ​ $ ( 526,695 ) ​ $ ( 208 ) ​ $ 65,183 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The accompanying notes are an integral part of these condensed consolidated financial statements. ​ 7 Table of Contents CVRx, INC. Condensed Consolidated Statements of Cash Flows (In thousands) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ Nine months ended ​ ​ September 30, ​ ​ 2025 2024 Cash flows from operating activities: ​ ​ Net loss ​ $ ( 41,372 ) ​ $ ( 49,314 ) Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ Stock-based compensation ​ 8,259 ​ 16,365 Depreciation of property and equipment ​ 571 ​ 441 Amortization of deferred financing costs and loan discount ​ 180 ​ 142 Changes in operating assets and liabilities: ​ ​ Accounts receivable ​ 1,059 ​ ( 1,482 ) Inventory ​ 713 ​ ( 909 ) Prepaid expenses and other current assets ​ ( 639 ) ​ 242 Accounts payable ​ 1,046 ​ 1,392 Accrued expenses ​ ( 229 ) ​ 1,987 Net cash used in operating activities ​ ( 30,412 ) ​ ( 31,136 ) Cash flows from investing activities: ​ ​ Purchase of property and equipment ​ ( 512 ) ​ ( 1,309 ) Net cash used in investing activities ​ ( 512 ) ​ ( 1,309 ) Cash flows from financing activities: ​ ​ Proceeds from the exercise of common stock options ​ 597 ​ 1,610 Proceeds from Employee Stock Purchase Plan ​ ​ 360 ​ ​ 406 Proceeds from the issuance of common stock ​ ​ 9,153 ​ ​ 20,170 Proceeds from debt financing ​ ​ — ​ ​ 20,000 Debt financing costs ​ ​ — ​ ​ ( 150 ) Net cash provided by financing activities ​ 10,110 ​ 42,036 Effect of currency exchange on cash and cash equivalents ​ 5 ​ 1 Net change in cash and cash equivalents ​ ( 20,809 ) ​ 9,592 Cash and cash equivalents at beginning of period ​ 105,933 ​ 90,569 Cash and cash equivalents at end of period ​ $ 85,124 ​ $ 100,161 Supplemental Information: ​ ​ Cash paid for interest ​ $ 3,816 ​ $ 2,456 Cash paid for income taxes ​ $ — ​ $ — ​ The accompanying notes are an integral part of these condensed consolidated financial statements. ​ 8 Table of Contents CVRx, INC. Notes to Condensed Consolidated Financial Statements (Unaudited) 1. Business organization CVRx, Inc. (the “Company”) was incorporated in Delaware and is headquartered in Minneapolis, Minnesota. The Company has developed and is marketing a medical device, Barostim, for heart failure (“HF”) and resistant hypertension. The Company is focused on the sale of its product in the U.S. and Europe. Management expects that operating losses and negative cash flows from operations could continue in the foreseeable future. There is no assurance that the Company will generate sufficient product sales to produce positive earnings or cash flows. 2. Summary of significant accounting policies Statement presentation and basis of consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) applicable to interim financial statements. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the Company’s statements of financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole or any other future period. The condensed consolidated financial statements include the accounts of CVRx, Inc. and its wholly owned subsidiary, CVRx Switzerland LLC. All intercompany balances and transactions have been eliminated in consolidation. JOBS Act accounting election We are an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As a result, we have elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. Use of estimates Preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. Cash and cash equivalents Cash and cash equivalents include highly liquid investments with an original maturity of three months or less. As of September 30, 2025 and December 31, 2024, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of September 30, 2025 and December 31, 2024, a majority of our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits are likely in excess of insured limits. 9 Table of Contents Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. Customer credit terms are established prior to shipment with the standard generally being net 30 days. We evaluate the collectability of our accounts receivable based on known collection risks and historical experience. In circumstances where we are aware of a specific customer's inability to meet its financial obligations to us, we record a specific allowance for bad debts against amounts due to reduce the carrying amount of accounts receivable to the amount we reasonably believe will be collected. ​ Inventory Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. We regularly review inventory quantities based on actual loss experiences, projected future demand and remaining shelf life to record a provision for excess and obsolete inventory when appropriate. Leases Operating leases are included in operating lease right-of-use (“ROU”) asset, accrued expenses, and operating lease liability – non-current portion in our balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. We used the incremental borrowing rate based on information readily available at the time of recognition to determine the present value of the lease payments. The determination of our incremental borrowing rate requires management judgement based on information available at lease commencement. Revenue recognition We sell our products primarily through a direct sales force and to a lesser extent through a combination of sales agents and independent distributors. Our revenue consists primarily of the sale of our Barostim, which consists of two implantable components: a pulse generator and a stimulation lead. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services it transfers to the customer. We recognize net revenue on product sales, adjusted for any applicable estimates of variable consideration, when the customer obtains control of our product, which generally occurs at a point in time upon delivery based on the contractual shipping terms of a contract. Our contracts have a single performance obligation, and our payment terms with customers are generally between 30 and 90 days. Variable consideration related to certain customer rebates is estimated based on the amounts expected to be paid under the agreement with the customer. 10 Table of Contents Stock-Based Compensation We recognize equity-based compensation expense for awards of equity instruments to employees and non-employees based on the grant date fair value of those awards in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all equity-based compensation awards to employees and non-employee directors, including grants of restricted shares and stock options, to be recognized as expense in the statements of operations and comprehensive loss based on their grant date fair values. We estimate the grant date fair value of stock options using the Black-Scholes option pricing model, and the fair value of restricted stock units (“RSUs”) is equal to the closing price of our common stock on the grant date. We account for forfeitures as they occur. We expense the fair value of our equity-based compensation awards granted to employees on a straight-line basis over the associated service period, which is generally the period in which the related services are received. ​ Recent accounting pronouncements In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires public business entities to disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. This ASU will be effective for our annual period ending December 31, 2025. We are evaluating the impact of this new guidance on our income tax disclosures. ​ 3. Selected balance sheet information Inventory consists of the following at: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, (in thousands) ​ 2025 ​ 2024 Raw material ​ $ 8,123 ​ $ 6,857 Work-in-process ​ 139 ​ 353 Finished goods ​ 3,132 ​ 4,897 ​ ​ $ 11,394 ​ $ 12,107 ​ Property and equipment, net consists of the following at: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, (in thousands) ​ 2025 ​ 2024 Office furniture and equipment ​ $ 512 ​ $ 512 Lab equipment ​ 3,625 ​ 3,144 Computer equipment and software ​ 1,173 ​ 994 Leasehold improvements ​ 802 ​ 542 Capital equipment in process ​ 312 ​ 720 ​ ​ 6,424 ​ 5,912 Less: Accumulated depreciation and amortization ​ 3,978 ​ 3,407 ​ ​ $ 2,446 ​ $ 2,505 ​ Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally three to five years . Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or the term of the lease. Depreciation expense was $ 194,000 and $ 169,000 for the three months ended September 30, 2025 and 2024, respectively, and $ 571,000 and $ 441,000 for the nine months ended September 30, 2025 and 2024, respectively. ​ 11 Table of Contents Accrued expenses consist of the following at: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, (in thousands) ​ 2025 ​ 2024 Bonuses ​ $ 3,523 ​ $ 3,621 401(k) match ​ ​ 915 ​ ​ 1,106 Paid time off ​ ​ 799 ​ ​ 947 Customer rebates ​ ​ 446 ​ ​ 592 Accrued interest payable ​ ​ 413 ​ ​ 437 Operating lease liability, current portion ​ ​ 342 ​ ​ 282 Employee stock purchase plan ​ ​ 288 ​ ​ 121 Taxes ​ ​ 131 ​ ​ 135 Clinical trial and other professional fees ​ ​ 122 ​ ​ 182 Other ​ 611 ​ 757 ​ ​ $ 7,590 ​ $ 8,180 ​ ​ ​ ​ 4. Debt Innovatus Loan Agreement On October 31, 2022, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Innovatus Life Sciences Fund I, LP, as the collateral agent and a lender, allowing us to borrow, subject to our achievement of certain milestones, up to a total of $ 50.0 million in a series of term loans (collectively, the “Term Loans”). W e had $ 50.0 million in outstanding Term Loans under the Loan Agreement as of September 30, 2025. The Loan Agreement initially requires interest only payments through November 2027, followed by three monthly principal and interest payments, of which a principal payment of $ 16.7 million is due in December 2027 and two principal payments of $ 16.7 million each are due in January 2028. A final payment of $ 2.3 million, equal to 4.5 % of the funded amount, is due in January 2028. The Term Loans bear interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime rate and (ii) 5.50 %; plus (b) 2.65 %. The Term Loans are secured by substantially all of our personal property. A performance covenant took effect upon the third tranche funding, requiring that we achieve 50 % of the trailing twelve months revenue target set in the Board-approved revenue plan in effect for such period. The Loan Agreement requires the payment of certain penalties if the Term Loans are paid off prior to maturity for any reason, including pursuant to an acceleration clause, and includes various restrictive covenants, including a restriction on the payment of dividends or making other distributions or payments on our capital stock, subject to limited exceptions. We were in compliance with these covenants as of September 30, 2025. ​ In connection with the Loan Agreement, we recorded $ 1.1 million of debt issuance costs and discounts as a reduction of long-term debt. ​ The annual principal maturities of debt under the Loan Agreement are as follows: ​ ​ ​ ​ ​ ​ September 30, (in thousands) ​ 2025 2025 $ — 2026 ​ — 2027 ​ ​ 16,667 2028 ​ ​ 33,333 ​ ​ 50,000 Less: Unamortized debt costs and discounts ​ ( 547 ) Long-term debt ​ $ 49,453 ​ ​ ​ ​ 12 Table of Contents 5. Leases We lease 35,183 square feet of office space in Minneapolis, Minnesota, which houses our principal executive offices and our manufacturing facility. We lease this space under an operating lease agreement that commenced December 1, 2008, which has been amended to expand the leased space and extend the term of the lease, which expires August 31, 2028. Most recently, on May 20, 2025, we expanded our existing office space with an additional 3,678 square feet of property adjacent to our principal executive offices and our manufacturing facility. The term on this expanded property is for 39 consecutive months and runs concurrently with the term on the existing lease. We intend to add new facilities as we grow, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations. Our operating lease agreement includes an option to renew for one additional period of three years . The exercise of the lease renewal option is at our sole discretion and was not included in the lease term for the calculation of the ROU asset and lease liability, as it is not reasonably certain of exercise. In addition to base rent, we also pay our proportionate share of operating expenses, as defined in the lease. These payments are made monthly and are adjusted annually to reflect actual charges incurred for operating expenses, such as common area maintenance, taxes, and insurance. The following table presents the lease balances within the condensed consolidated balance sheets: ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ December 31, (in thousands) ​ 2025 ​ 2024 Right-of-use assets: ​ ​ ​ ​ ​ ​ Operating lease right-of-use asset ​ $ 963 ​ $ 1,069 Operating lease liabilities: ​ ​ ​ ​ ​ ​ Accrued expenses ​ ​ 342 ​ ​ 282 Operating lease liability, non-current portion ​ ​ 730 ​ ​ 877 Total operating lease liabilities ​ $ 1,072 ​ $ 1,159 ​ Maturities of our lease liability for our operating lease are as follows as of September 30, 2025: ​ ​ ​ ​ ​ ​ ​ September 30, (in thousands) ​ 2025 2025 ​ ​ 101 2026 ​ ​ 410 2027 ​ ​ 424 2028 ​ ​ 253 Total undiscounted lease payments ​ ​ 1,188 Less: imputed interest ​ ​ ( 116 ) Present value of lease liability ​ $ 1,072 ​ As of September 30, 2025, the remaining lease term was 2.9 years, and the weighted average discount rate was 7.1 %. The operating cash outflows from our operating lease were $ 0.5 million and $ 0.4 million for the nine months ended September 30, 2025 and 2024. ​ 13 Table of Contents 6 . Stockholders’ equity Common Stock Warrants We had common stock warrants exercisable for 102,718 shares of common stock upon conversion at a weighted average exercise price of $ 12.66 per share outstanding and 103,349 shares of common stock upon conversion at a weighted average exercise price of $ 12.92 per share outstanding at September 30, 2025 and December 31, 2024, respectively. Johnson & Johnson Innovation – JJDC, Inc. had common stock warrants exercisable for 607,725 shares of our common stock with an exercise price of $ 0.16 per share that were all exercised through a net exercise transaction for 604,000 shares of common stock during the nine months ended September 30, 2024. At-the-Market (“ATM”) Offering In January 2024, we commenced an ATM offering, which allows us to issue and sell shares of our common stock having an aggregate offering price of up to $ 50.0 million . We issued 543,462 shares of common stock for gross proceeds of $ 9.5 million under the ATM offering during the nine months ended September 30, 2025. On November 4, 2025, we and the agent mutually agreed to terminate the Equity Distribution Agreement for the ATM, effective on November 6, 2025. In connection with the filing of this Quarterly Report on Form 10-Q, we expect to file a new registration statement on Form S-3 to replace our existing registration statement on Form S-3 that is scheduled to expire on November 15, 2025 and subsequently enter into a new sales agreement to permit continued ATM offering activity in the future. ​ 7. Stock-based compensation Summary of plans and activity In June 2001, our Board of Directors and stockholders established the 2001 Stock Incentive Award Plan (“2001 Plan”). Under the 2001 Plan, as amended, 2,674,749 shares of common stock had been reserved for the issuance of incentive stock options granted to employees, non-employee directors, consultants, or independent contractors. Options granted under the 2001 Plan have vesting terms that range from the date of grant to four years and expire within a maximum term of 10 years from the grant date. In 2021, our Board of Directors and stockholders established the 2021 Equity Incentive Plan (“2021 Plan”). The number of shares of common stock initially reserved for issuance under the 2021 Plan was 1,854,490 newly reserved shares in addition to the 600,737 shares that remained available for issuance under the 2001 Plan. The shares available for issuance under the 2021 Plan automatically increase on the first day of each year, commencing January 1, 2022, and ending on (and including) January 1, 2031, in an amount equal to 5 % of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase, or such lesser number of shares as determined by the Board of Directors. The annual increase resulted in an additional 1,266,234 shares being reserved for issuance under the 2021 Plan as of January 1, 2025. The 2021 Plan provides for the issuance of stock options, stock appreciation rights, restricted stock awards, stock unit awards and other stock-based awards and cash incentive awards to employees, consultants and non-employee directors of the Company and its subsidiaries. Awards granted under the 2021 Plan will have such vesting schedules and other terms as determined by the Compensation Committee and stock options and stock appreciation rights have a maximum term of 10 years from the grant date. No further awards can be granted under the 2001 Plan following the adoption of the 2021 Plan. As of September 30, 2025, there were 1,407,814 shares available for future issuance under the 2021 Plan. Stock Options Options are granted at exercise prices not less than the fair market value of our common stock on the date of grant. Prior to our initial public offering (the “IPO”), the fair market value of our common stock was determined 14 Table of Contents by our Board of Directors, and following our IPO, the fair market value of our common stock is based on the closing price of our common stock on the date of grant. ​ During the years 2008 through the IPO, the Board of Directors authorized the grant of stock options for the purchase of shares of common stock to the employers of certain non-employee directors. The options were not granted under the 2001 Plan or the 2021 Plan, but terms are substantially the same as our standard form of option agreement for non-employee directors as they have an exercise price not less than the fair market value on the grant date and vest over 48 months from the date of grant. The following is a summary of stock option activity: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Number ​ Average ​ Aggregate ​ ​ of ​ Exercise ​ Intrinsic ​ ​ Options ​ Price ​ Value ​ ​ ​ ​ ​ ​ (in thousands) Balance as of December 31, 2024 5,550,419 ​ $ 11.81 ​ $ ​ 18,771 Granted 1,020,722 ​ 11.62 ​ ​ Cancelled / Forfeited ( 371,022 ) ​ 14.89 ​ ​ Exercised ( 253,645 ) ​ 2.35 ​ ​ Balance as of September 30, 2025 5,946,474 ​ $ 11.99 ​ $ ​ 4,213 Options exercisable as of September 30, 2025 3,585,400 ​ $ 11.09 ​ $ ​ 3,820 ​ As of September 30, 2025, stock options outstanding included 4,402 options that were not granted under the 2001 Plan or the 2021 Plan. For options outstanding as of September 30, 2025, the weighted average remaining contractual life was 6.8 years. For options exercisable as of September 30, 2025, the weighted average remaining contractual life was 5.6 years. As of September 30, 2025, unrecognized compensation expense related to unvested stock-based compensation arrangements for stock options was $ 20.8 million. As of September 30, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 2.6 years. Restricted Stock Units RSUs are share awards that entitle the holder to receive freely tradable shares of our common stock upon vesting. The RSUs cannot be transferred and the awards are subject to forfeiture if the holder’s service terminates prior to vesting other than for death, disability, or other qualifying terminations. The following is a summary of RSU activity: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Number ​ Average ​ Aggregate ​ ​ of ​ Grant Date ​ Intrinsic ​ ​ RSUs ​ Fair Value ​ Value ​ ​ ​ ​ ​ ​ (in thousands) Unvested Balance as of December 31, 2024 — ​ $ — ​ $ ​ — Granted 359,828 ​ 12.56 ​ ​ Vested — ​ — ​ ​ Cancelled / Forfeited ( 8,190 ) ​ 12.96 ​ ​ Unvested Balance as of September 30, 2025 351,638 ​ $ 12.55 ​ $ ​ 2,838 ​ The aggregate intrinsic value of unvested RSUs is based on our closing stock price on the last trading day of the period. No RSUs were vested as of September 30, 2025. As of September 30, 2025, the unrecognized compensation expense related to unvested stock-based compensation arrangements for RSUs was $ 3.8 15 Table of Contents million. As of September 30, 2025, the related weighted average period over which the expense is expected to be recognized is approximately 3.4 years. Employee Stock Purchase Plan Our Board of Directors and stockholders also established an Employee Stock Purchase Plan (the “ESPP”). The number of shares of common stock initially reserved for issuance under the ESPP was 278,170 . The shares available for issuance under the ESPP automatically increase on the first day of each year, commencing January 1, 2022, and ending on (and including) January 1, 2031, in an amount equal to 1 % of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase, or such lesser number of shares as determined by the Board of Directors. The annual increase resulted in an additional 253,246 shares being reserved for issuance under the ESPP as of January 1, 2025. The ESPP permits certain of our U.S. employees to purchase shares of our common stock at a price per share not less than 85 % of the lower of (i) the closing market price per share of our common stock on the first day of the applicable purchase period or (ii) the closing market price per share of our common stock on the purchase date at the end of the applicable six-month purchase period. For the nine months ended September 30, 2025, 71,942 shares of common stock were purchased under the ESPP for $ 0.4 million of employee contributions. As of September 30, 2025, there were 814,111 shares available for issuance under the ESPP. Stock-based compensation expense We use the Black-Scholes option pricing model to determine the fair value of stock options and ESPP purchase rights on the grant date. The fair value of RSUs is determined based on the closing stock price of our common stock on the grant date. We measure stock-based compensation expense based on the grant date fair value of the award and recognize compensation expense over the requisite service period, which is generally the vesting period for stock options and RSUs, and the offering period for ESPP purchase rights. The amount of stock-based compensation expense recognized for stock option and RSU awards during a period is based on the portion of the awards that are ultimately expected to vest. The amount of stock-based compensation expense recognized for ESPP purchase rights during a period is based on the estimated purchase rights as of the grant date. We account for forfeitures as they occur. The following table provides the weighted average fair value of options granted to employees and the related assumptions used in the Black-Scholes option pricing model for the nine months ended September 30, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ ​ ​ ​ 2025 ​ ​ 2024 Weighted average fair value of options granted $ 9.21 ​ ​ $ 10.31 ​ Expected term (in years) — non-officer employees ​ 5.5 to 6.1 ​ ​ ​ 5.0 to 6.1 ​ Expected term (in years) — officer employees ​ 6.1 ​ ​ ​ 2.5 to 6.1 ​ Expected volatility ​ 95.0 % to 103.1 % ​ ​ 87.7 % to 98.6 % Expected dividend yield ​ — % ​ ​ — % Risk-free interest rate ​ 3.92 % to 4.47 % ​ ​ 3.67 % to 4.71 % ​ ​ 16 Table of Contents The following table provides the weighted average fair value of ESPP purchase rights and the related assumptions used in the Black-Scholes option pricing model for the nine months ended September 30, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ ​ ​ ​ 2025 ​ ​ 2024 ​ Weighted average fair value per ESPP purchase right $ 5.05 ​ ​ $ 7.60 ​ Expected term (in years)  ​ 0.5 ​ ​ ​ 0.5 ​ Expected volatility ​ 112.3 % to 133.4 % ​ ​ 74.0 % to 96.9 % Expected dividend yield ​ — % ​ ​ — % Risk-free interest rate ​ 4.25 % to 4.29 % ​ ​ 5.24 % to 5.37 % ​ We review these assumptions on a periodic basis and adjust them, as necessary. We utilize the simplified method to develop the estimate of the expected term for stock option awards and ESPP purchase rights. The expected volatility is based upon our historical stock price. The expected dividend yield is assumed to be zero , as we have never paid dividends and have no current plans to do so. The risk-free interest rate is based on the yield on U.S. Treasury securities for a period approximating the expected term of the options being valued. The following table presents the components and classification of stock-based compensation expense for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended ​ Nine months ended ​ September 30, September 30, (in thousands) ​ 2025 ​ 2024 ​ 2025 ​ 2024 Options ​ $ 2,459 ​ $ 2,550 ​ $ 7,269 ​ $ 16,063 RSUs ​ ​ 159 ​ ​ — ​ ​ 363 ​ ​ — Employee Stock Purchase Plan ​ ​ 270 ​ ​ 130 ​ ​ 627 ​ ​ 302 Total stock-based compensation expense ​ $ 2,888 ​ $ 2,680 ​ $ 8,259 ​ $ 16,365 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Selling, general & administrative ​ $ 2,534 ​ $ 2,379 ​ $ 7,399 ​ $ 15,412 Research & development ​ ​ 306 ​ 267 ​ ​ 741 ​ 855 Cost of goods sold ​ ​ 48 ​ 34 ​ ​ 119 ​ 98 ​ ​ $ 2,888 ​ $ 2,680 ​ $ 8,259 ​ $ 16,365 ​ On January 30, 2024, we amended the terms and conditions of certain stock option award agreements granted under the 2001 Plan and 2021 Plan between us and our former Chief Executive Officer in connection with his retirement, which occurred on February 11, 2024. The option agreements were amended to provide that, if not already vested at the time of termination of his employment due to retirement, the options will continue to vest on the previously scheduled vesting dates following his retirement, subject to his compliance with certain covenants. Additionally, the option agreements were modified so that the options may be exercised, to the extent vested, by our former Chief Executive Officer until the earlier of (a) five years following his retirement date, or (b) the applicable option expiration date. The modification of these option awards resulted in an additional $ 8.4 million of non-cash stock-based compensation expense recognized during the nine months ended September 30, 2024. 8. Income taxes As of September 30, 2025 and December 31, 2024, a valuation allowance was recorded against all deferred tax assets due to our cumulative net loss position. Benefit for income taxes for the three months ended September 30, 2025 was $ 3,000 and provision for income taxes for the three months ended September 30, 2024 was $ 47,000 . Benefit for income taxes for the nine months ended September 30, 2025 was $ 11,000 and provision for income taxes for the nine months ended September 30, 2024 was $ 126,000 . 17 Table of Contents As of December 31, 2024, we had federal and state net operating loss carryforwards (“NOLs”) of approximately $ 429.7 million and $ 8.1 million, respectively. The federal NOLs began expiring in 2021 and the state NOLs began expiring in 2020. As of December 31, 2024, we had federal and state tax credit carryforwards of approximately $ 10.2 million and $ 1.7 million, respectively. The federal tax credit carryforwards began expiring in 2021 and the state tax credits will begin expiring in 2028. Utilization of NOLs may be subject to an annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions. We have not performed a detailed analysis to determine whether an ownership change has occurred. Such a change of ownership would limit our utilization of the NOLs and could be triggered by subsequent sales of securities by us or our stockholders. On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant tax-related provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework, and the restoration of favorable tax treatment for certain business provisions, including the capitalization of certain R&D costs. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We are currently evaluating the potential impact of the OBBBA on our consolidated financial statements and related disclosures. ​ 9. Loss Per Share Basic and diluted net loss per share attributable to common stockholders was calculated for the periods indicated (in thousands, except share and per share data): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended Nine months ended ​ ​ September 30, ​ September 30, ​ ​ 2025 ​ 2024 ​ 2025 ​ 2024 Numerator: ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 12,870 ) ​ $ ( 13,099 ) ​ $ ( 41,372 ) ​ $ ( 49,314 ) Denominator: ​ ​ ​ ​ Weighted average common shares outstanding — basic and diluted ​ 26,168,562 ​ 22,783,337 ​ 26,039,718 ​ 21,884,588 Net loss per share attributable to common stockholders — basic and diluted ​ $ ( 0.49 ) ​ $ ( 0.57 ) ​ $ ( 1.59 ) ​ $ ( 2.25 ) ​ Our potentially dilutive securities, which include stock options, RSUs, and warrants to purchase shares of common stock, have been excluded from the computation of diluted net loss per share attributable to common stockholders, as the effect would be to reduce the net loss per share attributable to common stockholders. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. We excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: ​ ​ ​ ​ ​ ​ ​ Nine months ended ​ ​ September 30, ​ ​ 2025 2024 Options 5,946,474 5,846,377 RSUs ​ 351,638 ​ — Warrants ​ 102,718 ​ 103,349 ​ 6,400,830 5,949,726 ​ ​ ​ ​ ​ 18 Table of Contents 10. Commitments and contingencies From time to time, we may have certain contingent liabilities that arise in the ordinary course of business. We accrue a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual or disclosure as of September 30, 2025 or December 31, 2024. ​ 11. Employee benefit plans We sponsor a voluntary defined-contribution employee retirement plan (the “401(k) plan”) for our U.S. employees. The 401(k) plan provides that each participant may contribute pre-tax or post-tax compensation up to the statutory limit allowable. Under the 401(k) plan, each participant is fully vested in his or her deferred salary contributions when contributed. Beginning January 1, 2024, we adopted a policy to match a portion of employee contributions for all qualified employees participating in the 401(k) plan. We recorded an expense for matching contributions of $ 0.3 million for each of the three months ended September 30, 2025 and 2024. We recorded an expense for matching contributions of $ 0.9 million for each of the nine months ended September 30, 2025 and 2024. ​ 12. Segment, geographic information, and revenue disaggregation We have determined that we have a single reportable and operating segment structure. We have one business activity and there are no segment managers who are held accountable for operations, operating results, or plans for levels or components below the consolidated unit level. Our chief operating decision maker is our Chief Executive Officer. Our Chief Executive Officer evaluates performance based primarily on revenue in the geographic locations in which the Company operates and consolidated net loss. The Chief Executive Officer reviews financial information presented on a consolidated basis, including consolidated net loss, accompanied by information about revenue by geographic region, for purposes of allocating resources and evaluating financial performance. Further, the financial information on expenses provided to the Chief Executive Officer is presented on a consolidated basis, as reported in the condensed consolidated statements of operations and comprehensive loss in this Quarterly Report on Form 10-Q. We derive all our revenues from sales to customers in Europe and the U.S. The following table provides revenue by country for each location accounting for more than 10% of the total revenue for the periods indicated (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended ​ Nine months ended ​ September 30, ​ September 30, ​ ​ 2025 2024 ​ 2025 2024 U.S. ​ $ 13,493 ​ $ 12,300 ​ $ 36,937 ​ $ 32,808 Other countries ​ 1,197 ​ 1,073 ​ 3,690 ​ 3,142 ​ ​ $ 14,690 ​ $ 13,373 ​ $ 40,627 ​ $ 35,950 ​ As of September 30, 2025 and December 31, 2024, substantially all our long-lived assets were located in the U.S. ​