季報
季度報告
10-Q
2026-08-06
CVRx第二季收入增16%至1570萬美元 美國市場升21% 淨虧損收窄
AI 繁中摘要
📊 CVRx, Inc. 已提交截至 2026 年 6 月 30 日止季度的 10-Q 季報。公司主打產品為 Barostim 神經調節裝置,用於治療心臟衰竭(HFrEF)及抗藥性高血壓。
業績重點(未經審核)
- 第二季收入為 1,570.5 萬美元,按年增長 16%;上半年收入 3,047.4 萬美元,按年增長約 17.5%。
- 美國市場第二季收入 1,477.5 萬美元,增長 21%,期內銷售單位 466 個,去年同期為 391 個;活躍植入中心增至 258 間(去年同期 240 間),美國銷售區域增至 56 個。
- 歐洲市場第二季收入 93 萬美元,下跌 31%,銷售單位由 61 個減至 40 個。
- 毛利率由 84% 改善至 87%,主要受惠於單位成本下降及製造效率提升。
- 淨虧損第二季為 1,404.4 萬美元,略優於去年同期的 1,473.6 萬美元;每股虧損 0.53 美元,去年同期為 0.57 美元。
- 上半年淨虧損 2,716.4 萬美元,較去年同期的 2,850.2 萬美元有所收窄。
財務狀況
- 截至 2026 年 6 月 30 日,現金及現金等價物為 6,458.6 萬美元,較去年底的 7,570.8 萬美元下降,反映營運持續燒錢。
- 公司於 2026 年 1 月修訂貸款協議,貸款額度增加至 1 億美元,到期日延至 2031 年,並額外提取 1,000
展開英文正文
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Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________________ FORM 10-Q __________________________________________________________________ (Mark One) xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2026 or oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-40545 __________________________________________________________________ CVRx, Inc. (Exact name of registrant as specified in its charter) __________________________________________________________________ Delaware 41-1983744 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 9201 West Broadway Avenue Suite 650 Minneapolis, MN 55445 (Address of Principal Executive Offices) (763) 416-2840 (Registrant’s telephone number) __________________________________________________________________ Securities registered pursuant to Section 12(b) of the Act: Title of each classTrading Symbol(s)Name of each exchange on which registered Common stock, par value $0.01 per share CVRX The Nasdaq Global Select Market 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. Yes x No o 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). Yes x No o Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated fileroAccelerated filero Non-accelerated filerxSmaller reporting companyxEmerging growth companyx If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x As of July 30, 2026, there were 26,641,597 shares of the registrant’s common stock, par value $0.01 per share outstanding. Table of Contents TABLE OF CONTENTS Page Part I Financial Information Item 1. Financial Statements 5 Condensed Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025 (Unaudited) 5 Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2026 and 2025 (Unaudited) 6 Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2026 and 2025 (Unaudited) 7 Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 and 2025 (Unaudited) 8 Notes to Condensed Consolidated Financial Statements (Unaudited) 9 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 20 Item 3. Quantitative and Qualitative Disclosures About Market Risk 30 Item 4. Controls and Procedures 30 Part II Other Information Item 1. Legal Proceedings 31 Item 1A. Risk Factors 31 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 31 Item 3. Defaults Upon Senior Securities 31 Item 4. Mine Safety Disclosures 31 Item 5. Other Information 31 Item 6. Exhibits 32 Exhibit Index Signatures 2 Table of Contents CVRx, Inc. Quarterly Report on Form 10-Q For the quarterly period ended June 30, 2026 Cautionary Note on Forward-Looking Statements This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements, including statements regarding our future results of operations and financial position, business strategy, financial results and financial position, clinical trial results, prospective products, product approvals, research and development costs, timing and likelihood of success, and the plans and objectives of management for future operations. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, the important factors discussed in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, which are summarized below. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Summary Risk Factors Our business is subject to numerous risks and uncertainties, including those described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as updated in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. You should carefully consider these risks and uncertainties when investing in our common stock. The principal risks and uncertainties affecting our business include, but are not limited to, the following: •we have a history of significant losses, which we expect to continue, and we may not be able to achieve or sustain profitability; •our principal stockholders, management, and directors (one of whom is affiliated with one of our principal stockholders) own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval; •we have a limited history operating as a commercial company and are highly dependent on a single product, Barostim, and the failure to increase market acceptance in the U.S. for Barostim would negatively impact our business, liquidity, and results of operations; •we have limited commercial sales experience marketing and selling Barostim, and if we are unable to continue to maintain and grow sales and marketing capabilities, we will be unable to generate sustained and increasing product revenue; •we must continue to demonstrate to physicians and patients the merits of Barostim; 3 Table of Contents •if third-party payers do not provide adequate coverage and reimbursement for the use of Barostim, our revenue will be negatively impacted; •our industry is highly competitive; if our competitors, many of which are large, well-established companies with substantially greater resources than us and have a long history of competing in the heart failure market, are better able to develop and market products that are safer, more effective, less costly, easier to use, or otherwise more attractive than Barostim, our business will be adversely impacted; •if we fail to receive access to hospitals, our sales may decrease; •we are dependent upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers, making us vulnerable to supply shortages, loss or degradation in performance of the suppliers, price fluctuations, and ongoing supply chain disruptions, which could harm our business; •manufacturing risks may adversely affect our ability to manufacture our product and could reduce our gross margin and profitability; •our clinical studies may not produce results necessary to support regulatory clearance or approval, and could produce negative or inconclusive results; •a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide could adversely affect our business; •we may face product liability claims that could be costly, divert management’s attention and harm our reputation; •we may in the future become involved in lawsuits to protect or enforce our intellectual property or defend ourselves against intellectual property disputes, which could be expensive, time consuming and ultimately unsuccessful, and could result in the diversion of significant resources, thereby hindering our ability to effectively commercialize our existing or future products; •if we fail to retain our key executives or recruit and hire new employees, our operations and financial results may be adversely affected while we attract other highly qualified personnel; and •we will continue to obtain long-term clinical data regarding the safety and effectiveness of our products, which could impact future adoption and regulatory approvals. 4 Table of Contents PART I —FINANCIAL INFORMATION Item 1. Financial Statements CVRx, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) June 30, 2026December 31, 2025 Assets Current assets: Cash and cash equivalents$64,586 $75,708 Accounts receivable, net of allowances of $869 and $871, respectively 9,401 10,665 Inventory13,028 12,205 Prepaid expenses and other current assets2,473 3,069 Total current assets89,488 101,647 Property and equipment, net2,061 2,243 Operating lease right-of-use asset708 878 Other non-current assets26 26 Total assets$92,283 $104,794 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$3,874 $3,833 Accrued expenses7,250 9,484 Total current liabilities11,124 13,317 Long-term debt58,571 49,514 Operating lease liability, non-current portion448 638 Other long-term liabilities2,187 2,001 Total liabilities72,330 65,470 Commitments and contingencies (Note 10) Stockholders’ equity: Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2026 and December 31, 2025; 26,641,597 and 26,311,607 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 266 263 Additional paid-in capital637,707 629,916 Accumulated deficit(617,816)(590,652) Accumulated other comprehensive loss(204)(203) Total stockholders’ equity19,953 39,324 Total liabilities and stockholders’ equity$92,283 $104,794 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 June 30,Six months ended June 30, 2026202520262025 Revenue$15,705 $13,589 $30,474 $25,937 Cost of goods sold1,981 2,139 3,869 4,175 Gross profit13,724 11,450 26,605 21,762 Operating expenses: Research and development3,130 2,469 6,214 4,986 Selling, general and administrative23,617 23,357 45,575 44,589 Total operating expenses26,747 25,826 51,789 49,575 Loss from operations(13,023)(14,376)(25,184)(27,813) Interest expense(1,578)(1,473)(3,129)(2,930) Other income, net560 1,110 1,153 2,233 Loss before income taxes(14,041)(14,739)(27,160)(28,510) Benefit (provision) for income taxes(3)3 (4)8 Net loss(14,044)(14,736)(27,164)(28,502) Cumulative translation adjustment— 3 — 3 Comprehensive loss$(14,044)$(14,733)$(27,164)$(28,499) Net loss per share, basic and diluted$(0.53)$(0.57)$(1.03)$(1.10) Weighted-average common shares used to compute net loss per share, basic and diluted26,515,44226,071,31626,435,95825,974,229 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) Common stockAdditional paid-in capitalAccumulated deficitAccumulated other comprehensive lossTotal stockholders’ equity SharesAmount Balances as of March 31, 202626,428,767 $264 $632,820 $(603,772)$(203)$29,109 Exercise of stock options6,381 — 35 — — 35 Employee stock compensation— — 3,665 — — 3,665 Proceeds from Employee Stock Purchase Plan102,808 1 449 — — 450 Vesting of restricted stock units1,487 — — — — — Issuance of common stock102,154 1 738 — — 739 Net loss for the three months ended June 30, 2026— — — (14,044)— (14,044) Cumulative translation adjustment— — — — (1)(1) Balances as of June 30, 202626,641,597 $266 $637,707 $(617,816)$(204)$19,953 Balances as of March 31, 202526,051,992 $261 $620,416 $(551,112)$(205)$69,360 Exercise of stock options22,017 — 32 — — 32 Proceeds from Employee Stock Purchase Plan71,942 — 360 — — 360 Employee stock compensation— — 2,916 — — 2,916 Net loss for the three months ended June 30, 2025— — — (14,736)— (14,736) Cumulative translation adjustment— — — — 2 2 Balances as of June 30, 202526,145,951 $261 $623,724 $(565,848)$(203)$57,934 Common stockAdditional paid-in capitalAccumulated deficitAccumulated other comprehensive lossTotal stockholders’ equity SharesAmount Balances as of December 31, 202526,311,607 $263 $629,916 $(590,652)$(203)$39,324 Exercise of stock options42,881 — 67 — — 67 Proceeds from Employee Stock Purchase Plan102,808 1 449 — — 450 Employee stock compensation— — 6,581 — — 6,581 Vesting of restricted stock units82,147 1 (1)— — — Issuance of common stock102,154 1 695 — — 696 Net loss for the six months ended June 30, 2026— — — (27,164)— (27,164) Cumulative translation adjustment— — — — (1)(1) Balances as of June 30, 202626,641,597 $266 $637,707 $(617,816)$(204)$19,953 Balances as of December 31, 202425,324,684 $253 $608,354 $(537,346)$(206)$71,055 Exercise of stock options205,863 2 447 — — 449 Proceeds from Employee Stock Purchase Plan71,942 — 360 — — 360 Employee stock compensation— — 5,371 — — 5,371 Issuance of common stock543,462 6 9,192 — — 9,198 Net loss for the six months ended June 30, 2025— — — (28,502)— (28,502) Cumulative translation adjustment— — — — 3 3 Balances as of June 30, 202526,145,951 $261 $623,724 $(565,848)$(203)$57,934 The accompanying notes are an integral part of these condensed consolidated financial statements. 7 Table of Contents CVRx, INC. Condensed Consolidated Statements of Cash Flows (In thousands) (Unaudited) Six months ended June 30, 20262025 Cash flows from operating activities: Net loss$(27,164)$(28,502) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation6,581 5,371 Depreciation of property and equipment414 377 Loss on disposal of equipment1 — Amortization of deferred financing costs and loan discount167 119 Changes in operating assets and liabilities: Accounts receivable1,264 2,115 Inventory(823)387 Prepaid expenses and other current assets596 271 Accounts payable41 450 Accrued expenses(2,067)(1,291) Net cash used in operating activities(20,990)(20,703) Cash flows from investing activities: Purchase of property and equipment(234)(217) Net cash used in investing activities(234)(217) Cash flows from financing activities: Proceeds from the exercise of common stock options68 449 Proceeds from Employee Stock Purchase Plan449 360 Proceeds from the issuance of common stock696 9,198 Proceeds from debt financing10,000 — Debt financing costs(1,110)— Net cash provided by financing activities10,103 10,007 Effect of currency exchange on cash and cash equivalents(1)5 Net change in cash and cash equivalents(11,122)(10,908) Cash and cash equivalents at beginning of period75,708 105,933 Cash and cash equivalents at end of period$64,586 $95,025 Supplemental Information: Cash paid for interest$2,715 $2,537 Cash paid for income taxes$— $— 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 June 30, 2026 and December 31, 2025, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of June 30, 2026 and December 31, 2025, a majority of our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits were in excess of insured limits. 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 9 Table of Contents 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 judgment 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. 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”) and performance stock units (“PSUs”) are 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 for stock options and RSUs, and the performance period and any additional service period based on the probability of achieving the performance objectives for PSUs. 10 Table of Contents Recent accounting pronouncements In November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments require public business entities to provide enhanced disclosures related to the disaggregation of income statement expenses, including additional quantitative and qualitative information about the nature of expenses presented within relevant expense captions. The guidance is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. We have not yet adopted ASU 2024-03 and are in the process of evaluating the impact of the guidance on our consolidated financial statements. While the amendments will require additional disclosures and may require changes to internal data aggregation and reporting processes, we do not expect adoption to have a material impact on its results of operations, financial position, or cash flows. 3. Selected balance sheet information Inventory consists of the following at: (in thousands)June 30, 2026December 31, 2025 Raw material$9,366 $8,628 Work-in-process356 473 Finished goods3,306 3,104 $13,028 $12,205 Property and equipment, net consists of the following at: (in thousands)June 30, 2026December 31, 2025 Office furniture and equipment$399 $512 Lab equipment2,679 3,533 Computer equipment and software1,021 1,194 Leasehold improvements827 827 Capital equipment in process428 325 5,354 6,391 Less: Accumulated depreciation and amortization3,293 4,148 $2,061 $2,243 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 $0.2 million for each of the three months ended June 30, 2026 and 2025, and $0.4 million for each of the six months ended June 30, 2026 and 2025, respectively. 11 Table of Contents Accrued expenses consist of the following at: (in thousands)June 30, 2026December 31, 2025 Bonuses$3,806 $5,200 401(k) match756 1,136 Accrued interest payable463 403 Customer rebates398 801 Operating lease liability, current portion371 352 Paid time off346 630 Clinical trial and other professional fees188 116 Taxes53 93 Other869 753 $7,250 $9,484 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”). On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the term loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones, and the maturity date was extended to 2031. In connection with the Amendment, we borrowed an additional $10.0 million under the Loan Agreement. We had $60.0 million in outstanding Term Loans under the Loan Agreement as of June 30, 2026. The Term Loans require interest only payments through December 2029, followed by monthly principal and interest payments. A final payment of $2.7 million, equal to 4.5% of the original borrowed principal amount, is due in May 2031. 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) 6.75%; plus (b) 2.65%, which margin will decrease to 2% after we achieve a positive adjusted EBITDA for two consecutive quarters. 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 June 30, 2026. In connection with the Loan Agreement, we recorded $2.2 million of debt issuance costs and discounts as a reduction of long-term debt. 12 Table of Contents The annual principal maturities of debt under the Loan Agreement are as follows: (in thousands)June 30, 2026 2026$— 2027— 2028— 2029— 203041,250 Thereafter18,750 60,000 Less: Unamortized debt costs and discounts(1,429) Long-term debt$58,571 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 and was scheduled to expire August 31, 2024. On April 21, 2023, we extended the operating lease for our office space in Minneapolis, Minnesota for an additional 49 consecutive months through August 31, 2028. On November 7, 2023, we expanded our existing office space with the addition of 7,615 square feet of property adjacent to our principal executive offices and our manufacturing facility. On May 20, 2025, we further increased our office space by leasing an additional 3,678 square feet of the contiguous property. The term on this expanded property is for 40 consecutive months, which will run 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: (in thousands)June 30, 2026December 31, 2025 Right-of-use assets: Operating lease right-of-use asset$708 $878 Operating lease liabilities: Accrued expenses371 352 Operating lease liability, non-current portion448 638 Total operating lease liabilities $819 $990 13 Table of Contents Maturities of our lease liability for our operating lease are as follows as of June 30, 2026: (in thousands)June 30, 2026 2026$207 2027424 2028253 Total undiscounted lease payments884 Less: imputed interest(65) Present value of lease liability$819 As of June 30, 2026, the remaining lease term was 2.2 years, and the weighted average discount rate was 7.1%. The operating cash outflows from our operating lease were $0.3 million for each of the six months ended June 30, 2026 and 2025. 6. Stockholders’ equity Common Stock Warrants We had common stock warrants exercisable for 47,408 shares of common stock upon conversion at a weighted average exercise price of $12.66 per share outstanding and 102,718 shares of common stock upon conversion at a weighted average exercise price of $12.66 per share outstanding at June 30, 2026 and December 31, 2025, respectively. At-the-Market (“ATM”) Offering We issued 543,462 shares of common stock for gross proceeds of $9.5 million under the ATM offering during the year ended December 31, 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. On January 12, 2026, we entered into an Open Market Sale AgreementSM (the “Sale Agreement”) with Jefferies LLC, as agent. Pursuant to the terms of the Sale Agreement, we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price up to $50.0 million in an ATM offering, to or through the agent. We issued 102,154 shares of common stock for gross proceeds of $0.8 million under the ATM offering during the six months ended June 30, 2026. We have remaining capacity to issue and sell up to approximately $49.2 million of additional shares of common stock under this ATM offering. 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 1,315,580 shares being reserved for issuance under the 2021 Plan as of January 1, 2026. The 2021 Plan provides for the issuance of stock options, stock appreciation rights, 14 Table of Contents 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 June 30, 2026, there were 463,119 shares available for future issuance under the 2021 Plan, based on awards outstanding and reserved at target levels for PSUs. In connection with the PSUs granted during 2026, we evaluated the number of shares that could be issued assuming maximum achievement of the applicable performance conditions. If PSUs are reserved at the maximum payout level, the number of shares subject to outstanding awards could exceed the shares available under the plan as of June 30, 2026. We expect that we will have sufficient shares available for issuance under the 2021 Plan to satisfy these awards as a result of future automatic annual increases pursuant to the terms of the plan prior to the end of the performance period. 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 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: Number of OptionsWeighted Average Exercise PriceAggregate Intrinsic Value (in thousands) Balance as of December 31, 20255,834,448$11.96 $2,459 Granted1,217,4447.83 Cancelled / Forfeited(241,342)13.63 Exercised(42,881)1.58 Balance as of June 30, 20266,767,669$11.23 $620 Options exercisable as of June 30, 20264,181,115$11.48 $620 As of June 30, 2026, stock options outstanding included 4,363 options that were not granted under the 2001 Plan or the 2021 Plan. For options outstanding as of June 30, 2026, the weighted average remaining contractual life was 6.8 years. For options exercisable as of June 30, 2026, the weighted average remaining contractual life was 5.5 years. As of June 30, 2026, unrecognized compensation expense related to unvested stock-based compensation arrangements for stock options was $20.1 million. As of June 30, 2026, the related weighted average period over which the expense is expected to be recognized is approximately 2.7 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. 15 Table of Contents The following is a summary of RSU activity: Number of RSUsWeighted Average Grant Date Fair ValueAggregate Intrinsic Value (in thousands) Unvested Balance as of December 31, 2025383,268$12.11 $2,721 Granted743,4307.76 Vested(82,147)12.84 Cancelled / Forfeited(22,020)10.28 Unvested Balance as of June 30, 20261,022,531$8.92 $5,256 The aggregate intrinsic value of unvested RSUs is based on our closing stock price on the last trading day of the period. 82,147 RSUs were vested as of June 30, 2026. As of June 30, 2026, the unrecognized compensation expense related to unvested stock-based compensation arrangements for RSUs was $8.3 million. As of June 30, 2026, the related weighted average period over which the expense is expected to be recognized is approximately 3.3 years. Performance Stock Units We grant PSUs to officers and key employees. The number of PSUs that will ultimately be earned is based on our performance relative to pre-established performance goals for the respective performance period. The expense is recorded on a straight-line basis ove