CVRx, Inc. 10-K

Item 8. Financial Statements and Supplementary Data Report of Independent Registered Public Accounting Firm Board of Directors and Stockholders CVRx, Inc. ​ Opinion on the financial statements We have audited the accompanying consolidated balance sheets of CVRx, Inc. (a Delaware corporation) and subsidiary (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America. Basis for opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. ​ /s/ GRANT THORNTON LLP ​ We have served as the Company’s auditor since 2016. ​ Minneapolis, Minnesota February 18, 2025 ​ 83 Table of Contents CVRx, INC. Consolidated Balance Sheets (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ 2024 ​ 2023 Assets ​ ​ Current assets: ​ ​ Cash and cash equivalents ​ $ 105,933 ​ $ 90,569 Accounts receivable, net of allowances of $ 780 and $ 508 , respectively ​ 9,268 ​ 7,551 Inventory ​ 12,107 ​ 10,983 Prepaid expenses and other current assets ​ 2,505 ​ 2,987 Total current assets ​ 129,813 ​ 112,090 Property and equipment, net ​ 2,505 ​ 1,763 Operating lease right-of-use asset ​ ​ 1,069 ​ ​ 1,349 Other non-current assets ​ 27 ​ 27 Total assets ​ $ 133,414 ​ $ 115,229 Liabilities and Stockholders’ Equity ​ ​ Current liabilities: ​ ​ Accounts payable ​ $ 2,582 ​ $ 1,884 Accrued expenses ​ 8,180 ​ 5,980 Total current liabilities ​ 10,762 ​ 7,864 Long-term debt ​ ​ 49,273 ​ ​ 29,222 Operating lease liability, non-current portion ​ ​ 877 ​ ​ 1,160 Other long-term liabilities ​ 1,447 ​ 1,036 Total liabilities ​ 62,359 ​ 39,282 Commitments and contingencies (Note 10) ​ ​ Stockholders’ equity: ​ ​ Common stock, $ 0.01 par value, 200,000,000 authorized as of December 31, 2024 and 2023; 25,324,684 and 20,879,199 shares issued and outstanding as of December 31, 2024 and 2023, respectively ​ 253 ​ 209 Additional paid-in capital ​ 608,354 ​ 553,326 Accumulated deficit ​ ( 537,346 ) ​ ( 477,381 ) Accumulated other comprehensive loss ​ ( 206 ) ​ ( 207 ) Total stockholders’ equity ​ 71,055 ​ 75,947 Total liabilities and stockholders’ equity ​ $ 133,414 ​ $ 115,229 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ 84 Table of Contents CVRx, INC. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, ​ 2024 2023 Revenue ​ $ 51,292 ​ $ 39,295 Cost of goods sold ​ 8,334 ​ 6,256 Gross profit ​ 42,958 ​ 33,039 Operating expenses: ​ ​ Research and development ​ 11,131 ​ 11,633 Selling, general and administrative ​ 91,317 ​ 64,509 Total operating expenses ​ 102,448 ​ 76,142 Loss from operations ​ ( 59,490 ) ​ ( 43,103 ) Interest expense ​ ( 4,397 ) ​ ( 1,799 ) Other income, net ​ 3,977 ​ 3,850 Loss before income taxes ​ ( 59,910 ) ​ ( 41,052 ) Provision for income taxes ​ ( 55 ) ​ ( 147 ) Net loss ​ ( 59,965 ) ​ ( 41,199 ) Cumulative translation adjustment ​ 1 ​ — Comprehensive loss ​ $ ( 59,964 ) ​ $ ( 41,199 ) Net loss per share, basic and diluted ​ $ ( 2.65 ) ​ $ ( 1.99 ) Weighted-average common shares used to compute net loss per share, basic and diluted ​ 22,596,229 ​ 20,754,375 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ 85 Table of Contents ​ CVRx, INC. Consolidated Statements of Stockholders’ Equity (In thousands, except share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ ​ other ​ Total ​ ​ Common stock ​ paid-in ​ Accumulated ​ comprehensive ​ stockholders’ ​ Shares ​ Amount capital deficit loss equity Balances as of December 31, 2022 20,663,736 $ 207 ​ $ 545,362 ​ $ ( 436,182 ) ​ $ ( 207 ) ​ $ 109,180 Exercise of stock options ​ 144,187 1 ​ 727 ​ — ​ — ​ 728 Proceeds from Employee Stock Purchase Plan 71,276 ​ ​ 1 ​ ​ 934 ​ ​ — ​ ​ — ​ ​ 935 Employee stock compensation — — ​ 6,303 ​ — ​ — ​ 6,303 Net loss for the year ended December 31, 2023 ​ — — ​ — ​ ( 41,199 ) ​ — ​ ( 41,199 ) Balances as of December 31, 2023 20,879,199 $ 209 ​ $ 553,326 ​ $ ( 477,381 ) ​ $ ( 207 ) ​ $ 75,947 Exercise of stock options ​ 510,669 5 ​ 2,693 ​ — ​ — ​ 2,698 Proceeds from Employee Stock Purchase Plan ​ 79,618 ​ ​ 1 ​ ​ 802 ​ ​ — ​ ​ — ​ ​ 803 Employee stock compensation — — ​ 19,050 ​ — ​ — ​ 19,050 Issuance of common stock, net of costs ​ 3,251,198 ​ ​ 32 ​ ​ 32,489 ​ ​ — ​ ​ — ​ ​ 32,521 Issuance of common stock upon net exercise of common warrants ​ 604,000 ​ ​ 6 ​ ​ ( 6 ) ​ ​ — ​ ​ — ​ ​ — Net loss for the year ended December 31, 2024 — — ​ — ​ ( 59,965 ) ​ — ​ ( 59,965 ) Cumulative translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ 1 ​ ​ 1 Balances as of December 31, 2024 25,324,684 $ 253 ​ $ 608,354 ​ $ ( 537,346 ) ​ $ ( 206 ) ​ $ 71,055 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The accompanying notes are an integral part of these consolidated financial statements. ​ 86 Table of Contents CVRx, INC. Consolidated Statements of Cash Flows (In thousands) ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, ​ ​ 2024 2023 Cash flows from operating activities: ​ ​ Net loss ​ $ ( 59,965 ) ​ $ ( 41,199 ) Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ Stock-based compensation ​ 19,050 ​ 6,303 Depreciation of property and equipment ​ 619 ​ 522 Loss on disposal of equipment ​ ​ — ​ ​ 4 Amortization of deferred financing costs and loan discount ​ 203 ​ 154 Changes in operating assets and liabilities: ​ ​ Accounts receivable ​ ( 1,717 ) ​ ( 2,047 ) Inventory ​ ( 1,124 ) ​ ( 4,026 ) Prepaid expenses and other current assets ​ 531 ​ 1,273 Accounts payable ​ 698 ​ 165 Accrued expenses ​ 2,561 ​ ( 170 ) Net cash used in operating activities ​ ( 39,144 ) ​ ( 39,021 ) Cash flows from investing activities: ​ ​ Purchase of property and equipment ​ ( 1,361 ) ​ ( 591 ) Net cash used in investing activities ​ ( 1,361 ) ​ ( 591 ) Cash flows from financing activities: ​ ​ Proceeds from the exercise of common stock options ​ 2,698 ​ 728 Proceeds from Employee Stock Purchase Plan ​ ​ 803 ​ ​ 935 Proceeds from the issuance of common stock ​ ​ 32,521 ​ ​ — Proceeds from debt financing ​ ​ 20,000 ​ ​ 22,500 Debt financing costs ​ ​ ( 152 ) ​ ​ ( 179 ) Net cash provided by financing activities ​ 55,870 ​ 23,984 Effect of currency exchange on cash and cash equivalents ​ ( 1 ) ​ 3 Net change in cash and cash equivalents ​ 15,364 ​ ( 15,625 ) Cash and cash equivalents at beginning of year ​ 90,569 ​ 106,194 Cash and cash equivalents at end of period ​ $ 105,933 ​ $ 90,569 Supplemental Information: ​ ​ Cash paid for interest ​ $ 3,614 ​ $ 1,396 Cash paid for income taxes ​ — ​ 4 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ 87 Table of Contents CVRx, INC. Notes to Consolidated Financial Statements ​ 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 consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and with the applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of CVRx, Inc., its wholly owned subsidiary, CVRx Switzerland LLC, and its sales branch in Italy, which was closed during 2023. 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 consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the 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 December 31, 2024 and 2023, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of December 31, 2024 and 2023, 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. ​ 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. ​ 88 Table of Contents 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 in consideration of 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 consolidated 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. 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 consolidated 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. 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. 89 Table of Contents Recent accounting pronouncements In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires public companies to disclose for each reportable segment the significant expense categories and amounts for such expenses. ASU 2023-07 became effective for us for annual periods beginning December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024. Accordingly, we have expanded our financial statement disclosures in order to comply with the guidance. ​ 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 ended December 31, 2025. ​ 3. Selected balance sheet information Inventory consists of the following at: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, (in thousands) ​ 2024 ​ 2023 Raw material ​ $ 6,857 ​ $ 4,714 Work-in-process ​ 353 ​ 654 Finished goods ​ 4,897 ​ 5,615 ​ ​ $ 12,107 ​ $ 10,983 ​ Property and equipment, net consists of the following at: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, (in thousands) ​ 2024 ​ 2023 Office furniture and equipment ​ $ 512 ​ $ 402 Lab equipment ​ 3,144 ​ 2,721 Computer equipment and software ​ 994 ​ 776 Leasehold improvements ​ 542 ​ 98 Capital equipment in process ​ 720 ​ 554 ​ ​ 5,912 ​ 4,551 Less: Accumulated depreciation and amortization ​ 3,407 ​ 2,788 ​ ​ $ 2,505 ​ $ 1,763 ​ ​ 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 $ 0.6 million and $ 0.5 million for the years ended December 31, 2024 and 2023, respectively. 90 Table of Contents Accrued expenses consist of the following at: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, (in thousands) ​ 2024 ​ 2023 Bonuses ​ $ 3,621 ​ $ 3,335 401(k) employer match ​ ​ 1,106 ​ ​ — Paid time off ​ 947 ​ 770 Customer rebates ​ ​ 592 ​ ​ 411 Accrued interest payable ​ ​ 437 ​ ​ 220 Operating lease liability, current portion ​ ​ 282 ​ ​ 231 Clinical trial and other professional fees ​ ​ 182 ​ ​ 277 Taxes ​ ​ 135 ​ ​ 125 Other ​ 878 ​ 611 ​ ​ $ 8,180 ​ $ 5,980 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 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. On the closing date, we borrowed the minimum amount of $ 7.5 million under the Loan Agreement. On March 10, 2023, we borrowed the $ 7.5 million remaining under the first tranche of the Loan Agreement. On December 15, 2023, we borrowed an additional $ 15.0 million under the second tranche of the Loan Agreement. On September 30, 2024, we borrowed the remaining $ 20.0 million under the third and final tranche of the Loan Agreement. The Loan Agreement initially requires interest only payments through November 2027, followed by three monthly principal and interest payments. A final payment of $ 2.3 million, equal to 4.5 % of the original borrowed principal, is due in January 2028. The term loans advanced pursuant to the Loan Agreement (collectively, 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 December 31, 2024. ​ 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: ​ ​ ​ ​ ​ ​ December 31, (in thousands) ​ 2024 2025 $ — 2026 ​ — 2027 ​ 33,333 2028 ​ 16,667 ​ ​ 50,000 Less: Unamortized debt costs and discounts ​ ( 727 ) Long-term debt ​ $ 49,273 ​ ​ ​ 91 Table of Contents 5. Leases We lease 31,505 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. The term on this expanded property is for 57 consecutive months that 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 consolidated balance sheets: ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, (in thousands) ​ 2024 ​ 2023 Right-of-use assets: ​ ​ ​ ​ ​ ​ Operating lease right-of-use asset ​ $ 1,069 ​ $ 1,349 Operating lease liabilities: ​ ​ ​ ​ ​ ​ Accrued expenses ​ ​ 282 ​ ​ 231 Operating lease liability, non-current portion ​ ​ 877 ​ ​ 1,160 Total operating lease liabilities ​ $ 1,159 ​ $ 1,391 ​ Maturities of our lease liability for our operating lease are as follows as of December 31, 2024: ​ ​ ​ ​ ​ ​ ​ December 31, (in thousands) ​ 2024 2025 ​ $ 350 2026 ​ ​ 362 2027 ​ ​ 374 2028 ​ ​ 223 Total undiscounted lease payments ​ ​ 1,309 Less: imputed interest ​ ​ ( 150 ) Present value of lease liability ​ $ 1,159 ​ As of December 31, 2024, the remaining lease term was 3.7 years, and the weighted average discount rate was 6.7 %. The operating cash outflows from our operating lease were $ 0.5 million and $ 0.4 million for the years ended December 31, 2024 and 2023, respectively. 6. Stockholders’ equity We had common stock warrants exercisable for 103,349 shares of common stock upon conversion at a weighted average exercise price of $ 12.92 per share and 716,131 shares of common stock upon conversion at a weighted average exercise price of $ 2.39 per share outstanding at December 31 2024 and 2023, respectively. Johnson & Johnson Innovation – JJDC, Inc. had common stock warrants exercisable for 92 Table of Contents 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 year ended December 31, 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 3,251,198 shares of common stock for gross proceeds of $ 33.8 million under the ATM offering during the year ended December 31, 2024. We have remaining capacity to issue and sell up to approximately $ 16.2 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 1,043,959 shares being reserved for issuance under the 2021 Plan as of January 1, 2024. 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 made under the 2001 Plan following the adoption of the 2021 Plan. As of December 31, 2024, there were 1,142,918 shares available for future issuance under the 2021 Plan. Options are granted at exercise prices not less than the fair market value (as determined by the Board of Directors) 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. 93 Table of Contents 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, 2022 ​ 3,756,835 ​ $ 8.28 ​ ​ $ 36,616 Granted ​ 1,161,926 ​ $ 14.20 ​ ​ ​ ​ Cancelled / Forfeited ​ ( 285,729 ) ​ $ 10.52 ​ ​ ​ ​ Exercised ​ ( 144,187 ) ​ $ 5.05 ​ ​ ​ ​ Balance as of December 31, 2023 4,488,845 ​ $ 9.77 ​ $ 97,266 Granted 3,237,758 ​ $ 12.77 ​ ​ Cancelled / Forfeited ( 1,665,515 ) ​ $ 10.16 ​ ​ Exercised ( 510,669 ) ​ $ 5.28 ​ ​ Balance as of December 31, 2024 5,550,419 ​ $ 11.81 ​ ​ $ 18,771 Options exercisable as of December 31, 2024 2,854,762 ​ $ 9.24 ​ ​ $ 13,390 ​ As of December 31, 2024, stock options outstanding included 4,402 options that were not granted under the 2001 Plan or the 2021 Plan. For options outstanding as of December 31, 2024, the weighted average remaining contractual life was 7.0 years. For options exercisable as of December 31, 2024, the weighted average remaining contractual life was 5.5 years. 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 208,791 shares being reserved for issuance under the ESPP as of January 1, 2024. 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 l ower 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 year ended December 31, 2024, 79,618 shares of common stock were purchased under the ESPP for $ 0.8 million of employee contributions. As of December 31, 2024, there were 632,807 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. 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 the offering period for ESPP purchase rights. The amount of stock-based compensation expense recognized for stock option 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. 94 Table of Contents 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 years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ ​ 2024 ​ 2023 ​ Weighted average fair value of options granted $ 10.31 ​ ​ $ 10.65 ​ Expected term (in years) — non-officer employees ​ 5.0 to 6.1 ​ ​ ​ 5.5 to 6.1 ​ Expected term (in years) — officer employees ​ 2.5 to 6.1 ​ ​ ​ 2.5 to 6.1 ​ Expected volatility ​ 87.7 % to 98.9 % ​ ​ 77.2 % to 79.6 % Expected dividend yield ​ — % ​ ​ — % Risk-free interest rate ​ 3.67 % to 4.71 % ​ ​ 3.40 % to 4.89 % ​ 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 years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ ​ ​ 2024 ​ ​ 2023 ​ Weighted average fair value per ESPP purchase right $ 5.23 ​ ​ $ 5.64 ​ Expected term (in years)  ​ 0.5 ​ ​ ​ 0.5 ​ Expected volatility ​ 74.0 % to 96.9 % ​ ​ 76.2 % to 84.6 % Expected dividend yield ​ — % ​ ​ — % Risk-free interest rate ​ 5.24 % to 5.37 % ​ ​ 4.77 % to 5.53 % ​ 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: ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, (in thousands) ​ 2024 ​ 2023 Stock options ​ $ 18,633 ​ $ 5,901 Employee Stock Purchase Plan ​ ​ 417 ​ ​ 402 Total stock-based compensation expense ​ $ 19,050 ​ $ 6,303 ​ ​ ​ ​ ​ ​ ​ Selling, general & administrative ​ $ 17,746 ​ $ 5,073 Research & development ​ ​ 1,174 ​ 1,152 Cost of goods sold ​ ​ 130 ​ 78 ​ ​ $ 19,050 ​ $ 6,303 ​ As of December 31, 2024, unrecognized compensation expense related to unvested stock-based compensation arrangements was $ 26.5 million. As of December 31, 2024, the related weighted average period over which the expense is expected to be recognized is approximately 2.7 years. 95 Table of Contents 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 year ended December 31, 2024. 8. Income taxes As of December 31, 2024 and 2023, a valuation allowance was recorded against all deferred tax assets due to our cumulative net loss position. The components of our provision for income taxes are as follows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, (in thousands) ​ ​ 2024 ​ 2023 Current ​ ​ ​ ​ ​ ​ Federal and state ​ $ — ​ $ — Foreign ​ 55 ​ 147 Total provision for income taxes ​ $ 55 ​ $ 147 ​ The reconciliation of taxes at the federal statutory rate to our provision for income taxes are as follows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, ​ ​ ​ 2024 ​ 2023 Tax at federal statutory rate ​ ​ 21.0 % ​ 21.0 % Permanent differences ​ ​ ( 4.2 ) ​ ​ ( 4.3 ) ​ Research and development ("R&D") tax credit ​ ​ 0.8 ​ ​ 1.4 ​ Uncertain tax position ​ ​ ( 0.1 ) ​ ​ ( 0.3 ) ​ State, net of federal benefit ​ ​ 2.0 ​ ​ 2.6 ​ Deferred rate change ​ ​ ( 0.3 ) ​ ​ 0.4 ​ Change in valuation allowance ​ ( 19.3 ) ​ ( 21.2 ) ​ Total ​ ​ ( 0.1 ) % ​ ( 0.4 ) % ​ ​ ​ ​ ​ ​ ​ ​ ​ 96 Table of Contents Significant components of net deferred tax assets were as follows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, (in thousands) ​ ​ 2024 ​ 2023 Deferred tax assets ​ ​ ​ ​ ​ ​ Net operating loss carryforwards ​ $ 98,329 ​ $ 89,173 R&D tax credits ​ ​ 10,147 ​ ​ 9,664 Capitalized R&D expenses ​ ​ 8,015 ​ ​ 8,963 Non-qualified stock options ​ ​ 4,482 ​ ​ 1,473 Start-up costs ​ ​ 452 ​ ​ 680 Accrued vacation ​ ​ 227 ​ ​ 179 Other ​ ​ 450 ​ ​ 420 Total deferred tax assets ​ ​ 122,102 ​ ​ 110,552 Valuation allowance ​ ​ ( 122,102 ) ​ ​ ( 110,552 ) Net deferred tax assets ​ $ — ​ $ — ​ 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. The changes to our gross unrecognized tax benefits were as follows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, (in thousands) ​ ​ 2024 ​ 2023 Gross unrecognized tax benefits at beginning of year ​ $ 2,221 ​ $ 2,046 Gross increases: ​ ​ ​ ​ ​ ​ Prior year tax positions ​ ​ — ​ ​ 12 Current year tax positions ​ ​ 182 ​ ​ 185 Gross decreases: ​ ​ ​ ​ ​ ​ Prior year tax positions ​ ​ ( 57 ) ​ ​ ( 22 ) Gross unrecognized tax benefits at end of year ​ $ 2,346 ​ $ 2,221 ​ All of these unrecognized tax benefits, if recognized, would impact the effective tax rate before taking consideration of the valuation allowance. The amount of unrecognized tax benefits subjected to the valuation allowance was $ 1.8 million and $ 1.7 million for the years ended December 31, 2024 and 2023, respectively. We recognized a nominal amount and approximately $ 0.1 million of interest or penalties for each of the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and 2023, total accrued interest and penalties were both $ 0.5 million. We recognize accrued interest and penalties related to unrecognized tax positions as a component of income tax expense. We do not expect a significant change in the amount of unrecognized tax benefits in the next year. ​ We are subject to U.S. federal income tax as well as income tax of multiple state and foreign jurisdictions. Tax years from 2005 through present remain open for audit under the applicable statute of limitations due to 97 Table of Contents the carryover of the unused NOLs and tax credit carryforwards. We do not have any tax audits or other proceedings pending. 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): ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, ​ ​ ​ 2024 ​ 2023 Numerator: ​ ​ ​ ​ Net loss ​ ​ $ ( 59,965 ) ​ $ ( 41,199 ) Denominator: ​ ​ ​ Weighted average common shares outstanding — basic and diluted ​ ​ 22,596,229 ​ 20,754,375 Net loss per share attributable to common stockholders — basic and diluted ​ ​ $ ( 2.65 ) ​ $ ( 1.99 ) ​ Our potentially dilutive securities, which include stock options 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: ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2024 2023 Options to purchase common stock 5,550,419 4,488,845 Warrants to purchase common stock ​ 103,349 ​ 716,131 ​ 5,653,768 5,204,976 ​ ​ ​ 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 December 31, 2024 or December 31, 2023. 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 $ 1.1 million and $ 0 for the years ended December 31, 2024 and 2023, respectively. 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 98 Table of Contents 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 consolidated statements of operations and comprehensive loss in this Annual Report on Form 10-K. 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ December 31, (in thousands) ​ 2024 2023 U.S. ​ $ 47,167 ​ $ 35,111 Germany ​ 3,460 ​ 3,690 Other countries ​ 665 ​ 494 ​ ​ $ 51,292 ​ $ 39,295 ​ As of December 31, 2024 and 2023, long-lived assets were located primarily in the U.S. ​ ​ 99 Table of Contents Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.