Cytosorbents Corp 10-Q

Item 1. Financial Statements. CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, ​ December 31, ​ ​ 2025 ​ 2024 ​ (unaudited) ​ ASSETS ​ ​ ​ Current Assets: ​ ​ ​ Cash and cash equivalents ​ $ 10,204 ​ $ 3,280 Restricted cash, current ​ ​ — ​ ​ 5,000 Grants and accounts receivable, net of allowances of $ 140 and $ 158 as of June 30, 2025 and December 31, 2024, respectively ​ 7,743 ​ 7,320 Inventories ​ 3,710 ​ 2,733 Prepaid expenses and other current assets ​ 1,330 ​ 3,271 Total current assets ​ 22,987 ​ 21,604 ​ ​ ​ ​ ​ Property and equipment - net ​ 8,466 ​ 9,002 Restricted cash ​ ​ 1,522 ​ ​ 1,484 Right-of-use asset ​ ​ 11,223 ​ ​ 11,511 Other assets ​ 3,792 ​ 3,771 Total assets ​ $ 47,990 ​ $ 47,372 ​ ​ ​ ​ LIABILITIES AND STOCKHOLDERS’ EQUITY ​ ​ Current Liabilities: ​ ​ Accounts payable ​ $ 3,394 ​ $ 3,340 Accrued expenses and other current liabilities ​ ​ 5,953 ​ ​ 6,032 Lease liability – current portion ​ ​ 495 ​ ​ 453 Total current liabilities ​ 9,842 ​ 9,825 Lease liability, net of current portion ​ ​ 12,185 ​ ​ 12,444 Long-term debt ​ ​ 14,377 ​ ​ 13,996 Total liabilities ​ 36,404 ​ 36,265 ​ ​ ​ Commitments and Contingencies ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stockholders’ equity ​ ​ Preferred Stock, par value $ 0.001 , 5,000,000 shares authorized; no shares issued and outstanding as of June 30, 2025 and December 31, 2024 ​ ​ — ​ ​ — Common Stock, par value $ 0.001 , 100,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 62,610,376 and 54,830,146 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively ​ 63 ​ 55 Additional paid-in capital ​ 319,023 ​ 310,809 Accumulated other comprehensive income (loss) ​ ( 3,960 ) ​ 4,252 Accumulated deficit ​ ( 303,540 ) ​ ( 304,009 ) Total stockholders’ equity ​ 11,586 ​ 11,107 Total liabilities and stockholders’ equity ​ $ 47,990 ​ $ 47,372 ​ See accompanying notes to condensed consolidated financial statements ​ 3 Table of Contents CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (in thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended June 30, ​ Six Months Ended June 30, ​ 2025 2024 2025 2024 Revenue ​ $ 9,617 ​ $ 8,842 ​ $ 18,344 ​ $ 17,831 Cost of goods sold ​ ​ 2,803 ​ $ 2,339 ​ ​ 5,323 ​ ​ 4,455 Gross profit ​ 6,814 ​ 6,503 ​ ​ 13,021 ​ ​ 13,376 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating expenses ​ ​ ​ ​ ​ ​ ​ ​ Research and development, net of grant income ​ 1,262 ​ 1,519 ​ ​ 2,924 ​ ​ 3,766 Selling, general and administrative ​ 9,167 ​ 8,554 ​ ​ 17,599 ​ ​ 17,837 Total operating expenses ​ 10,429 ​ 10,073 ​ ​ 20,523 ​ ​ 21,603 Loss from operations ​ ( 3,615 ) ​ ( 3,570 ) ​ ​ ( 7,502 ) ​ ​ ( 8,227 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other income (expense) ​ ​ ​ ​ ​ ​ ​ ​ Interest expense, net ​ ( 616 ) ​ ( 180 ) ​ ​ ( 1,221 ) ​ ​ ( 187 ) Gain (loss) on foreign currency transactions ​ ​ 6,178 ​ ​ ( 544 ) ​ ​ 9,192 ​ ​ ( 1,970 ) Total other income (expense), net ​ 5,562 ​ ( 724 ) ​ ​ 7,971 ​ ​ ( 2,157 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ Net income (loss) attributable to common stockholders ​ $ 1,947 ​ $ ( 4,294 ) ​ $ 469 ​ $ ( 10,384 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Basic net income (loss) per common share ​ $ 0.03 ​ $ ( 0.08 ) ​ $ 0.01 ​ $ ( 0.19 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Diluted net income (loss) per common share ​ $ 0.03 ​ $ ( 0.08 ) ​ $ 0.01 ​ $ ( 0.19 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average Shares of Common Stock Outstanding ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Basic ​ 62,608,598 ​ ​ 54,306,041 ​ ​ 61,675,447 ​ ​ 54,284,416 Diluted ​ ​ 67,166,377 ​ ​ 54,306,041 ​ ​ 66,255,298 ​ ​ 54,284,416 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other comprehensive income (loss): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Foreign currency translation adjustment, net of tax ​ ( 5,476 ) ​ ​ 421 ​ ​ ( 8,212 ) ​ ​ 1,644 Comprehensive loss ​ $ ( 3,529 ) ​ $ ( 3,873 ) ​ $ ( 7,743 ) ​ $ ( 8,740 ) ​ See accompanying notes to condensed consolidated financial statements. ​ 4 Table of Contents CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (UNAUDITED) (in thousands, except share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ Shares Par value Capital Income (Loss) Deficit Equity Balance as of March 31, 2025 (unaudited) ​ 62,529,466 ​ $ 63 ​ $ 318,452 ​ $ 1,516 ​ $ ( 305,487 ) ​ $ 14,544 Stock-based compensation ​ 80,910 ​ ​ — ​ ​ 571 ​ ​ — ​ ​ — ​ ​ 571 Foreign translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ ( 5,476 ) ​ ​ — ​ ​ ( 5,476 ) Net income ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ 1,947 ​ ​ 1,947 Balance at June 30, 2025 (unaudited) ​ 62,610,376 ​ $ 63 ​ $ 319,023 ​ $ ( 3,960 ) ​ $ ( 303,540 ) ​ $ 11,586 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2024 ​ 54,830,146 ​ $ 55 ​ $ 310,809 ​ $ 4,252 ​ $ ( 304,009 ) ​ $ 11,107 Stock-based compensation 113,231 ​ ​ 1 ​ ​ 1,390 ​ ​ — ​ ​ — ​ ​ 1,391 Issuance of common stock and warrants from rights offerings, net of fees incurred ​ 6,249,791 ​ ​ 6 ​ ​ 5,386 ​ ​ — ​ ​ — ​ ​ 5,392 Issuance of common stock from exercise of warrants ​ 1,417,208 ​ ​ 1 ​ ​ 1,438 ​ ​ — ​ ​ — ​ ​ 1,439 Foreign translation adjustment — ​ ​ — ​ ​ — ​ ​ ( 8,212 ) ​ ​ — ​ ​ ( 8,212 ) Net income — ​ ​ — ​ ​ — ​ ​ — ​ ​ 469 ​ ​ 469 Balance as of June 30, 2025 (unaudited) 62,610,376 ​ $ 63 ​ $ 319,023 ​ $ ( 3,960 ) ​ $ ( 303,540 ) ​ $ 11,586 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ Shares Par value Capital Income Deficit Equity Balance as of March 31, 2024 (unaudited) ​ 54,293,555 ​ $ 54 ​ $ 307,200 ​ $ 1,752 ​ $ ( 289,380 ) ​ $ 19,626 Stock-based compensation ​ — ​ ​ — ​ ​ 989 ​ ​ — ​ ​ — ​ ​ 989 Warrants issued in connection with long-term debt ​ — ​ ​ — ​ ​ 691 ​ ​ — ​ ​ — ​ ​ 691 Foreign translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ 421 ​ ​ — ​ ​ 421 Issuance of restricted stock options ​ 12,860 ​ ​ — ​ ​ ( 6 ) ​ ​ — ​ ​ — ​ ​ ( 6 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 4,294 ) ​ ​ ( 4,294 ) Balance at June 30, 2024 (unaudited) ​ 54,306,415 ​ $ 54 ​ $ 308,874 ​ $ 2,173 ​ $ ( 293,674 ) ​ $ 17,427 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2023 ​ 54,240,265 ​ $ 54 ​ $ 306,187 ​ $ 529 ​ $ ( 283,290 ) ​ $ 23,480 Stock-based compensation — ​ ​ — ​ ​ 1,949 ​ ​ — ​ ​ — ​ ​ 1,949 Warrants issued in connection with long-term debt ​ — ​ ​ — ​ ​ 691 ​ ​ — ​ ​ — ​ ​ 691 Foreign translation adjustment — ​ ​ — ​ ​ — ​ ​ 1,644 ​ ​ — ​ ​ 1,644 Issuance of common stock offerings, net of fees ​ 53,290 ​ ​ — ​ ​ 53 ​ ​ — ​ ​ — ​ ​ 53 Issuance of restricted stock units ​ 12,860 ​ ​ — ​ ​ ( 6 ) ​ ​ — ​ ​ — ​ ​ ( 6 ) Net loss — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 10,384 ) ​ ​ ( 10,384 ) Balance as of June 30, 2024 (unaudited) 54,306,415 ​ $ 54 ​ $ 308,874 ​ $ 2,173 ​ $ ( 293,674 ) ​ $ 17,427 ​ See accompanying notes to condensed consolidated financial statements. ​ 5 Table of Contents CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Six ​ Six ​ ​ Months Ended ​ Months Ended ​ ​ June 30, ​ June 30, ​ ​ 2025 ​ 2024 Cash flows from operating activities ​ ​ ​ ​ Net income (loss) attributable to common stockholders ​ $ 469 ​ $ ( 10,384 ) Adjustments to reconcile net income (loss) attributable to common stockholders to net cash used in operating activities: ​ ​ ​ ​ ​ Accrued final fee ​ ​ — ​ ​ 111 Amortization of debt discount ​ ​ 381 ​ ​ — Depreciation and amortization ​ ​ 773 ​ 798 Amortization of right-of-use asset ​ ​ 72 ​ ​ 92 Write-off of patent cost ​ ​ — ​ 250 Write-off of inventory ​ ​ 253 ​ ​ — Bad debt expense ​ ​ 9 ​ ​ 29 Stock-based compensation ​ ​ 1,391 ​ ​ 1,949 Foreign currency transaction (gains) losses ​ ​ ( 9,192 ) ​ 1,970 Changes in operating assets and liabilities ​ ​ ​ ​ ​ Grants and accounts receivable ​ ​ 257 ​ ( 1,952 ) Inventories ​ ​ ( 925 ) ​ ( 1,030 ) Prepaid expenses and other current assets ​ ​ 1,897 ​ 574 Other assets ​ ​ — ​ 1 Accounts payable and accrued expenses ​ ​ ( 360 ) ​ ( 2,032 ) Net cash used in operating activities ​ ​ ( 4,975 ) ​ ( 9,624 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from investing activities ​ ​ ​ ​ Purchases of property and equipment ​ ​ ( 39 ) ​ ( 63 ) Payments for patent costs ​ ​ ( 140 ) ​ ( 183 ) Net cash used in investing activities ​ ​ ( 179 ) ​ ( 246 ) Cash flows from financing activities ​ ​ ​ ​ Proceeds from long-term debt ​ ​ — ​ ​ 15,000 Repayment of long-term debt ​ ​ — ​ ( 5,000 ) Payment of final fee ​ ​ — ​ ​ ( 150 ) Payment of loan costs ​ ​ — ​ ( 640 ) Equity contributions - net of fees incurred ​ ​ — ​ ​ 53 Proceeds from exercise of common stock warrants ​ ​ 1,439 ​ ​ — Proceeds from rights offering, net of fees incurred ​ ​ 5,392 ​ ​ — Net cash provided by financing activities ​ ​ 6,831 ​ ​ 9,263 Effect of exchange rates on cash ​ ​ 285 ​ ( 64 ) Net change in cash, cash equivalents, and restricted cash ​ ​ 1,962 ​ ( 671 ) ​ ​ ​ ​ ​ ​ ​ Cash, cash equivalents, and restricted cash at beginning of year ​ ​ 9,764 ​ 15,615 Cash, cash equivalents, and restricted cash – end of period ​ $ 11,726 ​ $ 14,944 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of cash flow information ​ ​ ​ ​ ​ Cash paid for interest ​ $ 1,018 ​ $ 538 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of non-cash financing activities ​ ​ ​ ​ ​ Warrants issued in connection with long-term debt ​ $ 556 ​ $ 691 ​ ​ ​ ​ ​ ​ ​ ​ See accompanying notes to condensed consolidated financial statements. ​ 6 Table of Contents CYTOSORBENTS CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2025 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION CytoSorbents Corporation (the “Company”) is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. The Company, through its subsidiary CytoSorbents Medical, Inc. based in New Jersey, is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, based in Berlin, Germany, conducts sales and marketing related operations for the CytoSorb device outside of the United States. The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of June 30, 2025 and December 31, 2024, and for the three and six months ended June 30, 2025 and 2024. The Company’s condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and therefore, do not include all information and footnotes necessary for a fair presentation of consolidated financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2024, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments, for a fair presentation of the Company’s consolidated financial position and results of operations for the interim periods presented. Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The results for the three and six months ended June 2025 and 2024, are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period. Beginning in the current quarter, the Company presents amounts in thousands unless otherwise stated. Prior periods have been adjusted accordingly for consistent presentation. Certain prior year amounts in the footnotes have been reclassified to conform to the current year presentation. As of June 30, 2025, the Company’s total cash and cash equivalents and restricted cash was approximately $ 11.7 million, with $ 1.5 million classified as restricted, and $ 10.2 million as unrestricted and available to fund operations, which raises substantial doubt about the Company’s ability to continue as a going concern. The Company’s expected future capital requirements may depend on many factors including expanding the Company’s customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb-ATR in the U.S. and Canada, which regulatory decisions are expected in 2025, and the related opportunity to receive Tranche 2 of Avenue Capital Commitment (see Note 6. Long-Term Debt) by December 31, 2025 and extend the principal re-payment terms of the facility beginning in the third quarter of 2026. Additional sources of liquidity available to the Company include the 2024 Shelf (as defined in Note 4, Common Stock, Stock-Based Compensation and Warrants), other public or private equity offerings, debt financings or from other sources. The sale of additional equity may result in dilution to shareholders. There is no assurance that the Company will be able to secure funding on terms acceptable, or at all. The increasing need for capital could also make it more difficult to obtain funding through either equity or debt. Should additional capital not become available as needed, the Company may be required to take certain actions, such as slowing sales and marketing expansion, delaying further regulatory approvals, or reducing headcount. As a result of these additional uncertainties, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates available financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors. ​ ​ 7 Table of Contents 2. SIGNIFICANT ACCOUNTING POLICIES There have been no material changes to significant accounting policies disclosed in the Company’s consolidated financial statements from the Annual Report on Form 10-K for the year ended December 31, 2024. Basis of Consolidation and Foreign Currency Translation The condensed consolidated financial statements include the accounts of CytoSorbents Corporation and its wholly owned subsidiaries, CytoSorbents Medical, Inc. and CytoSorbents Europe GmbH. In addition, the consolidated financial statements include CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp. z.o.o., CytoSorbents Medical UK Limited and CytoSorbents France SAS, wholly owned subsidiaries of CytoSorbents Europe GmbH, and CytoSorbents UK Limited and CytoSorbents India Private Limited, wholly-owned subsidiaries of CytoSorbents Medical, Inc. All significant intercompany transactions and balances have been eliminated in consolidation. Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recorded in cumulative translation adjustment, a component of accumulated other comprehensive income. Foreign currency transactions gains and losses are included in other income (loss), net in the consolidated statements of operations and other comprehensive loss. Impairment or Disposal of Long-Lived Assets During the six months ended June 30, 2025, the Company did not record any impairment charges. During the six months ended June 30, 2024, the Company recorded impairment charges of approximately $ 0.3 million, related to the impairment of certain issued patents and pending patent applications in certain specific jurisdictions and the abandonment of certain pending patent application costs in the ordinary course of business. This charge is included in selling, general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss. Income Taxes The Company has no t recorded income tax expense or income tax benefit for the six months ended June 30, 2025 and 2024 due to the generation of net operating losses, the benefits of which have been fully reserved. Deferred income taxes are accounted for using the balance sheet approach, which requires recognition of deferred tax assets and liabilities for the expected future consequences of temporary differences between the financial reporting basis and the tax basis of assets and liabilities. A valuation allowance is provided when it is more likely than not that a deferred tax asset will not be realized. A full valuation allowance has been established on the deferred tax asset as it is more likely than not that a future tax benefit will not be realized. In addition, future utilization of the available net operating loss carryforward may be limited under Internal Revenue Code Section 382 as a result of changes in ownership. The Company follows accounting standards associated with uncertain tax positions. The Company had no unrecognized tax benefits as of June 30, 2025 and December 31, 2024. The Company is accounting for an uncertain tax position of approximately $ 2.2 million as of December 31, 2024. The Company files tax returns in the U.S. federal and state jurisdictions. The Company utilizes the Technology Business Tax Certificate Transfer Program to sell a portion of its New Jersey Net Operating Loss carryforwards to an industrial company. Concentration of Credit Risk The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation (“FDIC”). Through the IntraFi Network, the Company maintains an Insured Cash Sweep account whereby all cash held in the Company’s money market accounts is swept daily in increments of less than the FDIC insurance limit and deposited in a number of IntraFi’s network of 3,000 financial institutions. This arrangement provides FDIC insurance coverage for all of the cash balances held in the money market accounts, which represents all of the cash and cash equivalents held at Bridge Bank. This arrangement excludes the restricted cash balances. Management monitors the soundness of these institutions in an effort to minimize its collection risk of these balances. 8 Table of Contents A significant portion of the Company’s revenues is from product sales in Germany. Substantially all of the Company’s grant and other income is from government agencies in the United States. As of June 30, 2025, no distributor or direct customers accounted for more than 10 % of the Company’s outstanding grants and accounts receivable. As of December 31, 2024, one distributor accounted for approximately 19 % of outstanding grants and accounts receivable. For the three and six months ended June 30, 2025 and 2024, no distributor or direct customers accounted for more than 10 % of the Company’s total revenue. Shipping and Handling Costs Total freight costs amounted to approximately $ 0.2 million and $ 0.1 million for the three months ended June 30, 2025 and 2024, respectively, and $ 0.3 million and $ 0.2 million for the six months ended June 30, 2025 and 2024, respectively. ​ 3. BALANCE SHEET COMPONENTS Inventories The Company had the following major classes of inventories: ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Raw materials ​ $ 491 ​ $ 570 Work in process ​ 782 ​ 503 Finished goods ​ 2,437 ​ 1,660 Inventories ​ $ 3,710 ​ $ 2,733 ​ Property and equipment, net The Company’s property and equipment consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Depreciation/ ​ ​ ​ ​ ​ ​ ​ ​ Amortization ​ June 30, 2025 December 31, 2024 Period ​ ​ (amounts, in thousands) ​ ​ Furniture and fixtures ​ $ 1,599 ​ $ 1,454 7 years Equipment and computers ​ 5,557 ​ 5,491 3 to 7 years Leasehold improvements ​ 6,308 ​ 6,283 Lesser of term of lease or estimated useful life ​ ​ 13,464 ​ 13,228 ​ ​ Less accumulated depreciation and amortization ​ 4,998 ​ 4,226 Property and equipment, net ​ $ 8,466 ​ $ 9,002 ​ Depreciation expense for the six months ended June 30, 2025 and 2024 amounted to $ 0.6 million and $ 0.8 million, respectively. Other assets Other assets consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Patent applications pending ​ $ 1,722 ​ $ 1,612 Patents issued ​ 3,391 ​ 3,391 Less accumulated amortization of patents issued ​ ( 1,374 ) ​ ( 1,255 ) Patents, net ​ 3,739 ​ 3,748 Other ​ 53 ​ 23 Other assets ​ $ 3,792 ​ $ 3,771 ​ 9 Table of Contents Patent amortization expenses amounted to $ 0.1 million for the six months ended June 30, 2025 and 2024. Patent amortization expense for the next five years and thereafter is scheduled as follows: ​ ​ ​ ​ ​ ​ ​ (amounts, in thousands) Remainder of 2025 $ 97 2026 ​ 257 2027 ​ 251 2028 ​ 238 2029 ​ 238 Thereafter ​ 936 Scheduled amortization of patents issued ​ $ 2,017 ​ Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Accrued salaries and commissions ​ $ 3,397 ​ $ 3,076 Clinical studies ​ 567 ​ 590 Deferred revenue ​ 361 ​ 419 Professional fees ​ ​ 356 ​ ​ 773 Royalties ​ ​ 287 ​ ​ 275 Goods received not invoiced ​ ​ 20 ​ ​ 87 Other ​ 965 ​ 812 Accrued expenses and other current liabilities ​ $ 5,953 ​ $ 6,032 ​ ​ 4. COMMON STOCK, STOCK-BASED COMPENSATION AND WARRANTS Common Stock Rights Offering On January 10, 2025, the Company closed the subscription period of its previously announced rights offering (the “Rights Offering”), raising aggregate gross proceeds of $ 6.25 million ($ 5.4 million net of fees) from the sale of all 6.25 million Units reserved for the Rights Offering. Participants in the Rights Offering received Units, each Unit comprising of one share of common stock of the Company, one Series A Right Warrant to purchase one share of common stock, and one Series B Right Warrant to purchase one share of common stock (collectively, the “Rights Warrants”). Up to an additional 6.25 million shares of common stock may be issued upon exercise of the Right Warrants. Once the 6.25 million shares of common stock reserved for the Right Warrants are issued, the remaining outstanding and unexercised Right Warrants will expire worthless. The Series A Right Warrants and the Series B Right Warrants expired on February 24, 2025 and June 10, 2025, respectively. The warrants do not have a redemption feature and are classified as equity instruments. A fair value of approximately $ 0.3 million and approximately $ 0.1 million has been allocated to the Series A Right Warrant and the Series B Right Warrant, respectively, and recorded within additional paid-in capital. The warrants were valued on the date of issuance using the Monte Carlo pricing model with the following assumptions: ​ 10 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ Series A Right Warrant Series B Right Warrant ​ Common Stock Price as of Issuance Date ​ $ 0.94 ​ $ 0.94 ​ Risk-Free Rate ​ ​ 4.31 % 4.27 % Dividend Rate ​ ​ 0.00 % 0.00 % Volatility ​ ​ 88.90 % 97.19 % Minimum Exercise Price ​ $ 1.00 ​ $ 2.00 ​ Maximum Exercise Price ​ $ 2.00 ​ $ 4.00 ​ Formula for Exercise Price ​ ​ 90 % of the 5-day volume weighted average stock price as of the exercise date rounded down to the nearest cent, not to fall outside the range of the maximum and minimum exercise prices. ​ ​ Proceeds from the closing of the subscription period satisfy a debt covenant which allows for $ 5.0 million of restricted cash on the Company’s condensed consolidated balance sheets to become unrestricted, and available for use. The Right Warrants were exercisable commencing on their date of issuance and the exercise price is equal to (i) in the case of the Series A Right Warrants, 90 % of the 5 -day volume weighted average price of Common Stock over the last five -trading days prior to the expiration date of the Series A Right Warrants on February 24, 2025, rounded down to the nearest whole cent but (x) not lower than $ 1.00 and (y) not higher than $ 2.00 , and (ii) in the case of the Series B Right Warrants, 90 % of the 5 -day volume weighted average price of Common Stock over the last five -trading days prior to the extended expiration date of the Series B Right Warrants on June 10, 2025, rounded down to the nearest whole cent but (x) not lower than $ 2.00 and (y) not higher than $ 4.00 . Exercise of the Right Warrants require additional investment separate from the purchase of the Units. 6.25 million shares of common stock have been reserved for exercise of the Right Warrants, after which any remaining unexercised Right Warrants will immediately expire worthless. The Right Warrants were transferable until expiration. On February 24, 2025, approximately 1.4 million Series A Right Warrants were exercised by holders, including members of management and the Board of Directors, at an exercise price of $ 1.13 per warrant, providing an additional $ 1.6 million in aggregate gross proceeds ($ 1.4 million net of fees). All of the remaining 4.85 million Series A Right Warrants expired on February 24, 2025. On April 4, 2025, the Board of Directors extended the expiration date of the Series B Right Warrants from April 10, 2025 to June 10, 2025. On June 11, 2025, the five - day volume weighted average price of Common Stock over the last five - trading days prior to June 10, 2025 was lower than the minimum required price of $ 2.00 and, as a result, the Series B Right Warrants issued in connection with the previously announced Rights Offering expired worthless pursuant to their terms. Shelf Registration On July 26, 2024, the Company filed a registration statement on Form S-3 with the Securities and Exchange Commission (the “2024 Shelf”), which enables the Company to offer and sell in one or more offerings, any combination of common stock, preferred stock, senior or subordinated debt securities, warrants and units, up to a total dollar amount of $ 150 million. On September 26, 2024, the Company filed Amendment No. 1 to Form S-3 with the Securities and Exchange Commission (the “SEC”). The 2024 Shelf was declared effective by the SEC on September 30, 2024. Because the Company’s market capitalization is less than $ 75 million, it will be subject to baby shelf rules which limit the amount of securities sales the Company can make to one-third of its public market float over a 12-month period. Stock-Based Compensation The following non-cash stock-based compensation expense, which relates to stock options and restricted stock units (“RSUs”), is included in each of the respective line items in the Company’s condensed consolidated statements of operations and comprehensive loss: ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended June 30, Stock-based compensation expense by category ​ 2025 ​ 2024 ​ ​ (amounts, in thousands) Cost of goods sold ​ $ 32 ​ $ — Research and development, net of grant income ​ 110 ​ — Selling, general and administrative ​ 429 ​ ​ 989 11 Table of Contents Total stock-based compensation expense ​ $ 571 ​ $ 989 ​ ​ ​ ​ ​ ​ ​ ​ ​ Six Months Ended June 30, Stock-based compensation expense by category ​ 2025 2024 ​ ​ (amounts, in thousands) Cost of goods sold ​ $ 88 ​ $ — Research and development, net of grant income ​ ​ 247 ​ ​ — Selling, general and administrative ​ 1,056 ​ 1,949 Total stock-based compensation expense ​ $ 1,391 ​ $ 1,949 ​ For the six months ended June 30, 2025 and 2024, approximately $ 1.1 and $ 1.5 million of stock-based compensation expense relates to stock options, and approximately $ 0.3 and $ 0.4 million relates to RSUs, respectively. For the three months ended June 30, 2025 and 2024, approximately $ 0.4 and $ 0.8 million of stock-based compensation expense relates to stock options, and approximately $ 0.1 and $ 0.2 million relates to RSUs, respectively. ​ Stock-options The summary of the stock option activity for the six months ended June 30, 2025, is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Weighted ​ Average ​ ​ ​ ​ Average ​ Remaining ​ ​ ​ ​ Exercise Price ​ Contractual ​ Shares per Share Life (Years) Outstanding, December 31, 2024 12,341,907 ​ $ 3.55 ​ 6.81 Granted 144,500 ​ ​ 1.02 — Forfeited ( 97,514 ) ​ ​ 2.17 — Expired ( 187,177 ) ​ ​ 6.64 — Outstanding, June 30, 2025 12,201,716 ​ $ 3.48 6.41 ​ The Company estimated the fair value of stock options granted during the six months ended June 30, 2025 using a Black-Scholes pricing model, which used the following inputs: ​ ​ ​ ​ ​ ​ Exercise price (per share) ​ $ 0.82 - $ 1.30 ​ Expected volatility ​ 80.7 % Expected term* ​ 6.2 years ​ Risk-free rate ​ 3.89 % - 4.40 % Dividends ​ 0 % ​ *The expected term of the options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term. The simplified method is used as the Company’s employee exercise history may not be indicative for estimating future exercises. In addition, the Company recognizes forfeitures as they occur. ​ The intrinsic value is calculated as the difference between the market value of the shares as of June 30, 2025 of $ 1.28 and the exercise price of the shares. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Options Outstanding ​ ​ Number ​ Weighted ​ Weighted ​ Aggregate Range of ​ Outstanding at ​ Average ​ Average ​ Intrinsic Exercise ​ June 30, ​ Exercise ​ Remaining ​ Value Price 2025 Price Life (Years) (in thousands) $ 0.82 - $ 13.20 12,201,716 ​ $ 3.48 ​ 6.41 ​ $ 1,064 12 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ Options Exercisable Number ​ Weighted ​ Aggregate Exercisable at ​ Average ​ Intrinsic June 30, ​ Exercise ​ Value 2025 Price (in thousands) 8,249,409 ​ $ 4.24 ​ $ 702 ​ The summary of the status of the Company’s non-vested options for the six months ended June 30, 2025, is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ Shares Fair Value ​ ​ ​ ​ ​ ​ Non-vested, December 31, 2024 6,234,550 ​ $ 1.09 Granted 144,500 ​ $ 1.02 Forfeited ( 97,514 ) ​ $ 2.17 Vested ( 2,329,220 ) ​ $ 0.80 Non-vested, June 30, 2025 3,952,316 ​ $ 1.24 ​ As of June 30, 2025, the Company had approximately $ 2.2 million of total unrecognized compensation cost related to stock options which will, on average, be amortized over approximately 17 months . Change in Control-Based RSUs The Board of Directors has granted restricted stock units to members of the Board of Directors, to the Company’s executive officers, and to employees of the Company. These restricted stock units will only vest upon a Change in Control of the Company, as defined in the Amended and Restated CytoSorbents Corporation 2014 Long-Term Incentive Plan. The following table is a summary of these restricted stock units: ​ ​ ​ ​ ​ ​ ​ ​ ​ Total ​ Intrinsic Value ​ ​ (amounts in thousands, except share data) Outstanding, December 31, 2024 2,809,500 $ 2,557 Granted 97,500 ​ — Vested ​ ( 35,000 ) ​ ​ — Forfeited ( 39,500 ) ​ — Outstanding, June 30, 2025 2,832,500 ​ $ 3,626 ​ Due to the uncertainty over whether these restricted stock units will vest, which will only happen upon a Change in Control, no charges for these restricted stock units have ever been recorded in the Company’s condensed consolidated statements of operations and comprehensive loss. 13 Table of Contents Other RSU Awards The following table outlines the restricted stock unit activity for the six months ended June 30, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ Shares Fair Value Non-vested, January 1, 2025 641,335 ​ $ 1.31 Granted ​ 110,000 ​ ​ 1.04 Vested ( 139,000 ) ​ ​ 0.96 Unvested shares forfeited ​ ( 65,000 ) ​ ​ 0.96 Non-vested, June 30, 2025 547,335 ​ $ 1.39 ​ As of June 30, 2025, the remaining weighted average vesting period for restricted stock awards subject to vesting was 28 months and the remaining unrecognized restricted stock unit compensation expense was $ 0.4 million. ​ Warrants related to the December 2023 equity offering and June 2024 Loan and Security Agreement As of June 30, 2025, the Company had 4,352,130 warrants outstanding. 2,706,561 warrants outstanding are related to the Company’s December 13, 2023 offering, and these warrants are immediately cash exercisable at an exercise price of $ 2.00 per share and expire on December 13, 2028. Another 1,645,569 warrants were issued on June 28, 2024 in connection with the closing of the Company’s Loan and Security Agreement with Avenue Capital Group (see Note 6. Long-Term Debt). These warrants have an exercise price of $ 0.79 and expire on June 30, 2029. The number of warrants is fixed; however, the exercise price may be adjusted down if the Company raises equity (excluding sales of equity utilizing the Company’s at-the-market equity facility) at a share price that is lower than $ 0.79 . These warrants can be exercised into common stock. 5. REVENUE AND SEGMENT INFORMATION The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended June 30, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ ​ Direct ​ Strategic Partners ​ Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ United States ​ $ 61 ​ $ — ​ $ 61 Germany ​ 3,355 ​ — ​ 3,355 All other countries ​ 2,208 ​ 3,993 ​ 6,201 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue ​ $ 5,624 ​ $ 3,993 ​ $ 9,617 ​ The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended June 30, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ ​ Direct ​ Strategic Partners ​ Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ ​ ​ ​ United States ​ $ 20 ​ $ 18 ​ $ 38 Germany ​ 2,779 ​ — ​ 2,779 All other countries ​ 1,674 ​ 4,351 ​ 6,025 Revenue ​ $ 4,473 ​ $ 4,369 ​ $ 8,842 ​ 14 Table of Contents The following table disaggregates the Company’s revenue by customer type and geographic area for the six months ended June 30, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ Direct Strategic Partners Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ United States ​ $ 124 ​ $ — ​ $ 124 Germany ​ 6,151 ​ ​ — ​ ​ 6,151 All other countries ​ 4,098 ​ ​ 7,971 ​ ​ 12,069 ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue ​ $ 10,373 ​ $ 7,971 ​ $ 18,344 ​ The following table disaggregates the Company’s revenue by customer type and geographic area for the six months ended June 30, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ Direct Strategic Partners Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ United States ​ $ 42 ​ $ 36 ​ $ 78 Germany ​ 6,316 ​ ​ — ​ ​ 6,316 All other countries ​ 3,424 ​ ​ 8,013 ​ ​ 11,437 Revenue ​ $ 9,782 ​ $ 8,049 ​ $ 17,831 ​ ​ 15 Table of Contents CytoSorb Sales The Company sells its CytoSorb device using both its own sales force (direct sales) and through the use of distributors and/or strategic partners. The majority of sales of the device are outside the United States, as CytoSorb is not yet approved for commercial sale in the United States. However, in April 2020, the Company was granted Emergency Use Authorization (“EUA”) of CytoSorb for use in critically-ill patients infected with COVID-19 with imminent or confirmed respiratory failure by the United States Food and Drug Administration (the “FDA”). Direct sales outside the United States relate to sales to hospitals located in Germany, Switzerland, Austria, Poland, the Netherlands and the United Kingdom. Direct sales are fulfilled from the Company’s warehouse facility in Berlin, Germany. There are no formal sales contracts with any direct customers relating to product price or minimum purchase requirements. However, there are agreements in place with certain direct customers that provide for either free of charge product or rebate credits based upon achieving minimum purchase levels. The Company records the value of these items earned as a reduction of revenue. These customers submit purchase orders and the order is fulfilled and shipped directly to the customer. Prices to all direct customers are based on a standard price list based on the packaged quantity (6 packs versus 12 packs). Distributor and strategic partner sales make up the remaining product sales. These distributors are located in various countries throughout the world. In general, the Company has formal written contracts with each of its distributors and strategic partners. These contracts have terms ranging from 1 - 5 years in length, with three years being the typical term. When a contract is not in place, the Company will ship product based upon the terms of an accepted purchase order. In addition, certain distributors are eligible for volume discount pricing if their unit sales are in excess of the base amount in the contract. Most distributor’s/strategic partner’s contracts have minimum annual purchase requirements in order to maintain exclusivity in their respective territories. There is no additional consideration or monetary penalty that would be required to be paid to CytoSorbents if a distributor does not meet the minimum purchase commitments included in the contract; however, at the discretion of the Company, the distributor may lose its exclusive rights in the territory if such commitments are not met. In summary, the contracts the Company has with customers are the distributor/strategic partner contracts related to CytoSorb product sales, agreements with direct customers related to free-of-charge product and credit rebates based upon achieving minimum purchase levels. The Company does not currently incur any outside third-party incremental costs to obtain any of these contracts. The following table provides information about receivables and contract liabilities from contracts with customers: ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, 2025 December 31, 2024 ​ (amounts in thousands) Contract receivables ​ $ 6,637 ​ $ 4,427 Contract liabilities ​ $ 521 ​ $ 596 ​ Contract receivables, which are included in grants and accounts receivable on the condensed consolidated balance sheets, represent balances due from product sales to direct and distributor customers amounting to $ 6.4 million and $ 4.2 million as of June 30, 2025 and December 31, 2024, respectively, and billed and unbilled amounts due on government contracts amounting to $ 0.2 million each as of June 30, 2025 and December 31, 2024. Contract liabilities, which are included in accrued expenses and other current liabilities on the condensed consolidated balance sheets, represent the value of free of charge goods and credit rebates earned in accordance with the terms of certain direct customer agreements, which amounted to $ 0.2 million each as of June 30, 2025 and December 31, 2024, and deferred grant liability related to the billing on fixed price government contracts in excess of costs incurred, which amounted to $ 0.4 million each as of June 30, 2025 and December 31, 2024. 16 Table of Contents Segment Information The Company operates and manages its business as one reportable segment and one operating segment, which is the business of developing, testing and selling blood purification medical devices. The Company’s chief operating decision maker, or CODM, is the Company’s Chief Executive Officer. The CODM assesses performance of the segment and decides how to allocate resources based on revenue growth, gross margin, operating expenses, adjusted net loss, adjusted EBITDA (as defined below) and cash burn (cash used in operating and investing activities) derived from the Company’s consolidated results of operations and cash flows and total assets of the segment. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. All material long-lived assets are located in New Jersey, United States and Berlin, Germany. Long-lived assets consist of property and equipment, net and operating lease right-of-use assets. Factors used in determining the reportable segment include the nature of the Company’s operations, the organizational and reporting structure and the type of information reviewed by the CODM to allocate resources and evaluate financial performance. The Company operates as one reportable operating segment. Consisting of one reportable operating segment, the components presented in the condensed consolidated statements of operations and comprehensive loss also present the components of the Company’s single operating segment. The CODM uses financial metrics to evaluate the Company’s spending and monitor budget versus actual results. The monitoring of budgeted versus actual results is used in assessing performance of the segment and in establishing resource allocation across the organization. The financial metrics used by the CODM in evaluating the Company’s spending and monitoring budget versus actual results are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended Six Months Ended ​ ​ June 30, ​ June 30, ​ 2025 2024 2025 2024 ​ (amounts, in thousands) ​ Revenue ​ $ 9,617 ​ $ 8,842 ​ $ 18,344 ​ $ 17,831 ​ Gross profit ​ $ 6,814 ​ $ 6,503 ​ $ 13,021 ​ $ 13,376 ​ Gross margin ​ 71 % 74 % 71 % 75 % Total operating expenses ​ $ 10,429 ​ $ 10,073 ​ $ 20,523 ​ $ 21,603 ​ Loss from operations ​ $ ( 3,615 ) ​ $ ( 3,570 ) ​ $ ( 7,502 ) ​ $ ( 8,227 ) ​ EBITDA and Adjusted EBITDA (both non-GAAP measures): ​ ​ ​ ​ ​ ​ ​ ​ ​ Net income (loss) attributable to common stockholders ​ $ 1,947 ​ $ ( 4,294 ) ​ $ 469 ​ $ ( 10,384 ) ​ Interest expense, net ​ 616 ​ 180 ​ 1,221 ​ 187 ​ Depreciation and amortization expense ​ 404 ​ 401 ​ 773 ​ 798 ​ Income (loss) before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure ​ 2,967 ​ ( 3,713 ) ​ 2,463 ​ ( 9,399 ) ​ Stock-based compensation ​ 571 ​ 989 ​ 1,391 ​ 1,949 ​ Loss (gain) on foreign currency transactions ​ ​ ( 6,178 ) ​ 544 ​ ​ ( 9,192 ) ​ 1,970 ​ Adjusted EBITDA, a non-GAAP measure ​ $ ( 2,640 ) ​ $ ( 2,180 ) ​ $ ( 5,338 ) ​ $ ( 5,480 ) ​ Adjusted net loss, a non-GAAP measure: ​ ​ ​ ​ ​ ​ ​ ​ ​ Net income (loss) attributable to common stockholders ​ $ 1,947 ​ $ ( 4,294 ) ​ $ 469 ​ $ ( 10,384 ) ​ Stock-based compensation ​ 571 ​ 989 ​ 1,391 ​ 1,949 ​ Loss (gain) on foreign currency transactions ​ ​ ( 6,178 ) ​ ​ 544 ​ ​ ( 9,192 ) ​ ​ 1,970 ​ Adjusted net loss, a non-GAAP measure ​ $ ( 3,660 ) ​ $ ( 2,761 ) ​ $ ( 7,332 ) ​ $ ( 6,465 ) ​ Total cash used in operating and investing activities ​ $ ( 1,642 ) ​ $ ( 4,913 ) ​ $ ( 5,154 ) ​ $ ( 9,870 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Total assets ​ $ 47,990 ​ $ 47,372 ​ 17 Table of Contents Significant expense categories regularly provided to the CODM consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Six Months Ended ​ ​ June 30, ​ June 30, ​ 2025 2024 2025 2024 ​ ​ (amounts, in thousands) Research and development: ​ ​ ​ ​ ​ ​ ​ ​ Clinical expenses ​ $ 812 ​ $ 936 ​ $ 1,791 ​ $ 2,563 Other research and development expenses ​ 450 ​ 583 ​ 1,133 ​ 1,203 Total research and development ​ $ 1,262 ​ $ 1,519 ​ $ 2,924 ​ $ 3,766 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Selling, general and administrative ​ ​ ​ ​ ​ Royalty expense ​ $ 286 ​ $ 528 ​ $ 544 ​ $ 1,240 Stock-based compensation ​ 429 ​ 989 ​ 1,056 ​ 1,949 Legal, financial and consulting ​ 1,364 ​ 820 ​ 2,002 ​ 1,501 Other general and administrative ​ 7,088 ​ 6,217 ​ 13,997 ​ 13,147 Total selling, general and administrative ​ $ 9,167 ​ $ 8,554 ​ $ 17,599 ​ $ 17,837 ​ Amounts presented within research and development expenses in the table above are inclusive of stock-based compensation expense. Refer to Note 4, Common Stock, Stock-Based Compensation and Warrants, for additional information. Capital expenditures of the segment totaled $ 0.1 million for each of the six months ended June 30, 2025 and 2024. 6. LONG-TERM DEBT Avenue Capital Group On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group (“Loan”). Avenue Capital Group agreed to loan the Company up to an aggregate of $ 20 million, to be disbursed in two tranches: (1) one tranche of $ 15 million (“Tranche 1”), of which $ 10 million was available to the Company on the Closing Date and $ 5 million constitutes restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved: (i) the FDA has accepted Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company has received a minimum of $ 3 million in net proceeds from the sale of its equity securities after the Closing Date. The restriction was released on a dollar-for-dollar basis for equity raised between $ 3 million and $ 5 million and (2) a second tranche of up to $ 5 million, which may be disbursed at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company receives FDA marketing approval of its DrugSorb-ATR application (“Tranche 2” and together with Tranche 1, the “Avenue Capital Commitment”). The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and will additionally be used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment shall bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent ( 5.00 %) or (B) thirteen and one-half percent ( 13.50 %). On October 22, 2024, the Company announced that the FDA had accepted its application of DrugSorb-ATR, which was one of the two conditions required by the restricted cash debt covenant. Proceeds from the Rights Offering on January 10, 2025 satisfied the second condition of the debt covenant which now allows for the $ 5 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use. The loan requires interest-only payments for the first 24 months through July 1, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity, on July 1, 2027; provided, however that if the Company draws the full amount of Tranche 2 by December 31, 2025, and achieves for the trailing six month period ended June 30, 2026, at least $ 25 million of revenue, (the Interest only Milestone as defined in the Loan), the Interest only Period will be extended by six months to January 1, 2027, followed by equal monthly installments of principal plus accrued and unpaid interest through January 1, 2028. 18 Table of Contents As of the Closing Date, the Company recorded the following discounts: ​ ​ ​ ​ ​ ​ ​ (amounts, in thousands) Fair value of warrants issued to Avenue Capital Group $ 690 Debt issuance cost ​ 640 Commitment fee paid on the Closing Date ( 1 % of the Avenue Capital Group commitment) ​ 200 Total discounts recorded at inception against Avenue Capital Group Long-Term Debt ​ $ 1,530 ​ The Company amortizes debt discounts as interest expense using the interest method through the maturity date. The loan and security agreement included a final payment upon maturity of $ 0.9 million. The Company accretes the final payment as interest expense using the interest method through the maturity date. Upon a prepayment, the Company would incur a fee ranging from 1 % to 3 % of the outstanding principal, depending on the time of payment in relation to the maturity date. The Loan and Security Agreement includes customary loan conditions, company representations and warranties, company affirmative covenants and company negative covenants for secured transactions of this type. As of June 30, 2025, the Company was in compliance with these covenants. As additional consideration for the Commitment, on June 28, 2024, the Company also issued Avenue Capital Group with warrants with a fair value of $ 0.7 million to purchase an aggregate of 1,645,569 shares of the Company’s common stock for cash at the exercise price of $ 0.79 , which expire on June 30, 2029. The number of warrants is fixed; however, the exercise price may be adjusted down if the Company raises equity (excluding sales of equity utilizing the Company’s at-the-market equity facility) at a share price that is lower than $ 0.79 . These warrants meet the criteria for equity classification under Accounting Standards Codification 815. The Lenders were also granted the right while the Commitment is outstanding to convert up to an aggregate amount of $ 2 million of the principal amount of the outstanding Growth Capital Loans into the Company’s common stock at a fixed conversion price of 120 % of the Closing Price (as defined in the warrant) or $ 0.95 per share (the “Conversion Option”). The Company’s obligations under the Loan and Security Agreement are joint and several. The obligations under the Loan and Security Agreement are secured by a first priority security interest in favor of the Lenders with respect to the Company’s Shares (as defined in the Loan and Security Agreement) and the Company’s Collateral (as defined in the Loan and Security Agreement), which includes the Company’s intellectual property, pursuant to that certain Intellectual Property Security Agreement, dated as of June 28, 2024, by and between the Company and the Administrative and Collateral Agent. ​ As of June 30, 2025, long-term debt consists of the following: ​ ​ ​ ​ ​ ​ (amounts, in thousands) Principal amount $ 15,000 Plus: final payment upon maturity ​ ​ 900 Less unamortized debt discount ​ ​ ( 1,523 ) Subtotal ​ 14,377 Less current maturities ​ — Long-term debt ​ $ 14,377 ​ As of June 30, 2025, principal payments of long-term debt are due as follows: ​ ​ ​ ​ ​ ​ (amounts, in thousands) 2026 $ 6,250 2027 ​ 8,750 Total ​ $ 15,000 ​ 19 Table of Contents Bridge Bank On June 28, 2024, concurrent with the closing of the Avenue Capital Group financing discussed above, the Company paid off its previously outstanding debt with Bridge Bank. As of June 30, 2025, the following commitments survive after the termination of the Bridge Bank Amended and Restated Loan and Security Agreement and related amendments: 2022 Success Fee Letter Pursuant to the 2022 Success Fee Letter, the Borrower will pay to the Bank a success fee equal to (i) 1 % of $ 5 million if the Company draws down the first tranche of the Term C Loan and is payable only if the Company’s stock price equals or exceeds $ 8 for five consecutive trading days; (ii) 1.5 % of $ 5 million if the Company draws down the second tranche of the Term C Loan and is payable only if the Company’s stock price equals or exceeds $ 10 for five consecutive trading days; and (iii) 2 % of $ 5.0 million if the Company draws down the third tranche of the Term C Loan and is payable only if the Company’s stock price equals or exceeds $ 12 for five consecutive trading days (together, the “Success Fee”). Borrower may pay the Success Fee in cash or in shares of common stock, at Borrower’s sole discretion. The right of Bank to receive the Success Fees and the obligation of the Borrower to pay the Success Fees hereunder shall terminate on the date that is fifth anniversary of the funding date of the last Term C Loans made but shall survive the termination of the Loan Agreement and any prepayment of the Term C Loans. The termination date of the 2022 Success Fee Letter is December 27, 2027. ​ 7. COMMITMENTS AND CONTINGENCIES Litigation The Company is, from time to time, subject to claims and litigation arising in the ordinary course of business. The Company intends to defend vigorously against any future claims and litigation. Royalty Agreements The Company is party to various royalty and license agreements that require the payment of royalty fees. Royalty expense amounted to approximately $ 0.5 million and $ 1.2 million for the six months ended June 30, 2025, and 2024, respectively. Royalty expense amounted to approximately $ 0.3 million and $ 0.5 million for the three months ended June 30, 2025, and 2024, respectively. Royalty expense is included in selling, general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss. 401(k) Plan ​ Employees are eligible to participate in the Company’s 401(k) plan on the first day of the calendar quarter following three full months of employment. Participants may defer up to 100 % of their eligible compensation subject to certain Internal Revenue Code limitations. Matching contributions amounted to $ 0.2 million for each of the six months ended June 30, 2025 and 2024. Matching contributions amounted to approximately $ 0.1 million for each of the three months ended June 30, 2025 and 2024. ​ 20 Table of Contents 8. LEASES The Company has operating leases that primarily relate to operating facilities in both the United States and Germany. The Company leases its operating facilities under operating lease arrangements with varying expiration dates through March 2037. As of June 30, 2025, the remaining lease term of the Company’s operating leases ranges from six to twelve years . Supplemental statement of operations and cash flows related to the operating lease liability is as follows (excluding variable payments and expenses): ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, ​ 2025 2024 ​ ​ (amounts, in thousands) Cash paid in connection with the operating leases ​ $ 843 ​ $ 566 ​ Supplemental balance sheet information related to operating leases is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, ​ December 31, ​ ​ 2025 2024 ​ ​ ​ (amounts, in thousands) ​ Right-of-use asset ​ $ 11,223 ​ $ 11,511 ​ Lease liability - current portion ​ $ 495 ​ $ 453 ​ Lease liability - net of current portion ​ ​ 12,185 ​ ​ 12,444 ​ Total lease liability ​ $ 12,680 ​ $ 12,897 ​ Weighted average discount rate ​ 9.8 % ​ 9.8 % Weighted average remaining lease term ​ ​ 11.4 years ​ ​ 11.7 years ​ ​ Lease Expense The components of lease expense were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended June 30, ​ ​ 2025 2024 ​ ​ (amounts, in thousands) Operating lease cost ​ $ 408 ​ $ 423 Variable lease cost ​ $ 52 ​ $ 117 Total lease cost ​ $ 460 ​ $ 540 ​ ​ ​ ​ ​ ​ ​ ​ ​ Six Months Ended June 30, ​ ​ 2025 2024 ​ ​ (amounts, in thousands) Operating lease cost ​ $ 845 ​ $ 888 Variable lease cost ​ $ 149 ​ $ 204 Total lease cost ​ $ 994 ​ $ 1,092 ​ As of June 30, 2025, the maturities of the operating lease liability are as follows: ​ ​ ​ ​ Remainder of 2025 $ 853 2026 ​ 1,736 2027 ​ 1,777 2028 ​ 1,819 2029 ​ 1,863 Thereafter ​ 13,550 Future operating lease payments ​ ​ 21,598 Imputed interest ​ ​ ( 8,918 ) Total operating lease liability ​ $ 12,680 ​ 21 Table of Contents ​ 9. NET INCOME (LOSS) PER SHARE Basic loss per share and diluted loss per share for the three and six months ended June 30, 2025 and 2024 have been computed by dividing the net loss for each respective period by the weighted average number of shares outstanding during that period. Net income per common share is calculated as basic net income per share and diluted net income per share. Basic net income per share excludes dilution and is computed by dividing net income by the weighted average number of common shares outstanding for the period. Diluted net income per share is computed in the same manner as basic net income after assuming issuance of common stock for all potentially dilutive equivalent shares, which includes the potential dilution that could occur: (i) if the RSUs with service conditions were fully vested (using the treasury stock method); (ii) if all of the Company’s outstanding stock options that are in-the-money were exercised (using the treasury stock method); (iii) if the RSUs with service and market conditions were considered contingently issuable; and (iv) if the RSUs with service and performance conditions were considered contingently issuable. The following table summarizes earnings per share calculations: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Six Months Ended ​ ​ June 30, ​ June 30, ​ 2025 2024 2025 2024 ​ ​ (amounts, in thousands, except share and per share data) Basic earnings per common share: ​ ​ ​ ​ Net income (loss) attributable to common stockholders ​ $ 1,947 ​ $ ( 4,294 ) ​ $ 469 ​ $ ( 10,384 ) Basic weighted average common shares outstanding ​ 62,608,598 ​ 54,306,041 ​ 61,675,447 ​ 54,284,416 Basic earnings per common share ​ $ 0.03 ​ $ ( 0.08 ) ​ $ 0.01 ​ $ ( 0.19 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Diluted earnings per common share ​ ​ ​ ​ Net income (loss) attributable to common stockholders ​ 1,947 ​ ( 4,294 ) ​ 469 ​ ( 10,384 ) Basic weighted average common shares outstanding ​ 62,608,598 ​ 54,306,041 ​ 61,675,447 ​ 54,284,416 Effect of dilutive securities ​ 4,557,779 ​ — ​ 4,579,851 ​ — Diluted weighted average common shares outstanding ​ 67,166,377 ​ 54,306,041 ​ 66,255,298 ​ 54,284,416 Diluted earnings per common share ​ $ 0.03 ​ $ ( 0.08 ) ​ $ 0.01 ​ $ ( 0.19 ) ​ Certain stock options and restricted stock units are not included in the diluted earnings per share calculation when the effect would be anti-dilutive. The number of anti-dilutive shares were 10,819,609 and 10,820,859 for the three and six months ended June 30, 2025, respectively. ​ 10. SUBSEQUENT EVENTS ​ Management has evaluated subsequent events through the date of issuance of these condensed consolidated financial statements and has determined that there are no subsequent events outside the ordinary scope of business that require adjustment to, or disclosure in, the condensed consolidated financial statements. ​ On July 4, 2025, the One Big Beautiful Bill Act was signed into law in the U.S. The Company is currently evaluating the provisions of the bill and any potential impacts on its financial position and operations, but does not anticipate any material impacts to its financial statements for the year ending December 31, 2025. ​ ​ 22 Table of Contents