Cytosorbents Corp 10-Q

Item 1. Financial Statements. CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ December 31, ​ ​ 2025 ​ 2024 ​ (unaudited) ​ ASSETS ​ ​ ​ Current Assets: ​ ​ ​ Cash and cash equivalents ​ $ 7,536 ​ $ 3,280 Restricted cash, current ​ ​ — ​ ​ 5,000 Accounts receivable, net of allowances of $ 134 and $ 158 as of September 30, 2025 and December 31, 2024, respectively ​ 7,427 ​ 7,320 Inventories ​ 4,002 ​ 2,733 Prepaid expenses and other current assets ​ 2,348 ​ 3,271 Total current assets ​ 21,313 ​ 21,604 ​ ​ ​ ​ ​ Property and equipment - net ​ 8,193 ​ 9,002 Restricted cash ​ ​ 1,522 ​ ​ 1,484 Right-of-use asset ​ ​ 11,075 ​ ​ 11,511 Other assets ​ 3,647 ​ 3,771 Total assets ​ $ 45,750 ​ $ 47,372 ​ ​ ​ ​ LIABILITIES AND STOCKHOLDERS’ EQUITY ​ ​ Current Liabilities: ​ ​ Accounts payable ​ $ 3,035 ​ $ 3,340 Accrued expenses and other current liabilities ​ ​ 6,559 ​ ​ 6,032 Lease liability – current portion ​ ​ 518 ​ ​ 453 Total current liabilities ​ 10,112 ​ 9,825 Lease liability, net of current portion ​ ​ 12,051 ​ ​ 12,444 Long-term debt ​ ​ 14,567 ​ ​ 13,996 Total liabilities ​ 36,730 ​ 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 September 30, 2025 and December 31, 2024 ​ ​ — ​ ​ — Common Stock, par value $ 0.001 , 100,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 62,794,305 and 54,830,146 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively ​ 63 ​ 55 Additional paid-in capital ​ 319,511 ​ 310,809 Accumulated other comprehensive income (loss) ​ ( 3,844 ) ​ 4,252 Accumulated deficit ​ ( 306,710 ) ​ ( 304,009 ) Total stockholders’ equity ​ 9,020 ​ 11,107 Total liabilities and stockholders’ equity ​ $ 45,750 ​ $ 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 September 30, ​ Nine Months Ended September 30, ​ 2025 2024 2025 2024 ​ (Unaudited) (Unaudited) (Unaudited) (Unaudited) Revenue $ 9,485 $ 8,613 $ 27,829 $ 26,444 Cost of goods sold ​ 2,819 ​ ​ 3,357 ​ ​ 8,142 ​ ​ 7,812 Gross profit ​ 6,666 ​ ​ 5,256 ​ ​ 19,687 ​ ​ 18,632 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating expenses ​ ​ ​ ​ ​ ​ ​ ​ Research and development, net of grant income ​ 918 ​ 1,826 ​ ​ 3,842 ​ ​ 5,592 Selling, general and administrative ​ 8,610 ​ 8,260 ​ ​ 26,209 ​ ​ 26,097 Total operating expenses ​ 9,528 ​ 10,086 ​ ​ 30,051 ​ ​ 31,689 Loss from operations ​ ( 2,862 ) ​ ( 4,830 ) ​ ​ ( 10,364 ) ​ ​ ( 13,057 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other income (expense) ​ ​ ​ ​ ​ ​ ​ ​ Interest expense, net ​ ( 645 ) ​ ( 588 ) ​ ​ ( 1,866 ) ​ ​ ( 775 ) Gain (loss) on foreign currency transactions ​ ​ ( 64 ) ​ ​ 2,650 ​ ​ 9,128 ​ ​ 680 Total other income (expense), net ​ ( 709 ) ​ 2,062 ​ ​ 7,262 ​ ​ ( 95 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ Loss before benefit from income taxes ​ ​ ( 3,571 ) ​ ​ ( 2,768 ) ​ ​ ( 3,102 ) ​ ​ ( 13,152 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Benefit from income taxes ​ ​ 401 ​ ​ — ​ ​ 401 ​ ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 3,170 ) ​ $ ( 2,768 ) ​ $ ( 2,701 ) ​ $ ( 13,152 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Basic and diluted net loss per common share ​ $ ( 0.05 ) ​ $ ( 0.05 ) ​ $ ( 0.04 ) ​ $ ( 0.24 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average Shares of Common Stock Outstanding ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Basic and diluted ​ 62,753,959 ​ ​ 54,453,006 ​ ​ 62,038,902 ​ ​ 54,340,583 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other comprehensive income (loss): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Foreign currency translation adjustment, net of tax ​ 116 ​ ​ ( 2,330 ) ​ ​ ( 8,096 ) ​ ​ ( 686 ) Comprehensive loss ​ $ ( 3,054 ) ​ $ ( 5,098 ) ​ $ ( 10,797 ) ​ $ ( 13,838 ) ​ 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 June 30, 2025 (unaudited) ​ 62,610,376 ​ $ 63 ​ $ 319,023 ​ $ ( 3,960 ) ​ $ ( 303,540 ) ​ $ 11,586 Stock-based compensation ​ 183,929 ​ ​ — ​ ​ 488 ​ ​ — ​ ​ — ​ ​ 488 Foreign translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ 116 ​ ​ — ​ ​ 116 Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 3,170 ) ​ ​ ( 3,170 ) Balance at September 30, 2025 (unaudited) ​ 62,794,305 ​ $ 63 ​ $ 319,511 ​ $ ( 3,844 ) ​ $ ( 306,710 ) ​ $ 9,020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2024 ​ 54,830,146 ​ $ 55 ​ $ 310,809 ​ $ 4,252 ​ $ ( 304,009 ) ​ $ 11,107 Stock-based compensation 297,160 ​ ​ 1 ​ ​ 1,878 ​ ​ — ​ ​ — ​ ​ 1,879 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 — ​ ​ — ​ ​ — ​ ​ ( 8,096 ) ​ ​ — ​ ​ ( 8,096 ) Net loss — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 2,701 ) ​ ​ ( 2,701 ) Balance as of September 30, 2025 (unaudited) 62,794,305 ​ $ 63 ​ $ 319,511 ​ $ ( 3,844 ) ​ $ ( 306,710 ) ​ $ 9,020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ Shares Par Value Capital Income Deficit Equity Balance as of June 30, 2024 (unaudited) ​ 54,306,415 ​ $ 54 ​ $ 308,874 ​ $ 2,173 ​ $ ( 293,674 ) ​ $ 17,427 Stock-based compensation ​ — ​ ​ — ​ ​ 891 ​ ​ — ​ ​ — ​ ​ 891 Foreign translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ ( 2,330 ) ​ ​ — ​ ​ ( 2,330 ) ATM activation fees ​ — ​ ​ — ​ ​ ( 41 ) ​ ​ — ​ ​ — ​ ​ ( 41 ) Issuance of restricted stock units ​ 194,198 ​ ​ — ​ ​ 204 ​ ​ — ​ ​ — ​ ​ 204 Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 2,768 ) ​ ​ ( 2,768 ) Balance at September 30, 2024 (unaudited) ​ 54,500,613 ​ $ 54 ​ $ 309,928 ​ $ ( 157 ) ​ $ ( 296,442 ) ​ $ 13,383 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2023 ​ 54,240,265 ​ $ 54 ​ $ 306,187 ​ $ 529 ​ $ ( 283,290 ) ​ $ 23,480 Stock-based compensation — ​ ​ — ​ ​ 2,840 ​ ​ — ​ ​ — ​ ​ 2,840 Foreign currency translation adjustment — ​ ​ — ​ ​ — ​ ​ ( 686 ) ​ ​ — ​ ​ ( 686 ) Issuance of common stock offerings, net of fees ​ 53,290 ​ ​ — ​ ​ 12 ​ ​ — ​ ​ — ​ ​ 12 Warrants issued in connection with long-term debt ​ — ​ ​ — ​ ​ 691 ​ ​ — ​ ​ — ​ ​ 691 Issuance of restricted stock units ​ 207,058 ​ ​ — ​ ​ 198 ​ ​ — ​ ​ — ​ ​ 198 Net loss — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 13,152 ) ​ ​ ( 13,152 ) Balance as of September 30, 2024 (unaudited) 54,500,613 ​ $ 54 ​ $ 309,928 ​ $ ( 157 ) ​ $ ( 296,442 ) ​ $ 13,383 ​ See accompanying notes to condensed consolidated financial statements. ​ 5 Table of Contents CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine ​ Nine ​ ​ Months Ended ​ Months Ended ​ ​ September 30, ​ September 30, ​ ​ 2025 ​ 2024 Cash flows from operating activities ​ ​ ​ ​ Net loss ​ $ ( 2,701 ) ​ $ ( 13,152 ) Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ ​ ​ ​ Accrued final fee ​ ​ — ​ ​ 111 Amortization of debt discount ​ ​ 571 ​ ​ 132 Amortization of loan costs ​ ​ — ​ ​ 58 Depreciation and amortization ​ ​ 1,137 ​ 1,181 Amortization of right-of-use asset ​ ​ 109 ​ ​ 138 Write-off of patent cost ​ ​ 176 ​ 313 Write-off of inventory ​ ​ 253 ​ ​ — Bad debt expense ​ ​ 17 ​ ​ 107 Stock-based compensation ​ ​ 1,879 ​ ​ 2,840 Foreign currency transaction gains ​ ​ ( 9,128 ) ​ ( 680 ) Changes in operating assets and liabilities ​ ​ ​ ​ ​ Accounts receivable ​ ​ 560 ​ ( 629 ) Inventories ​ ​ ( 1,247 ) ​ 153 Prepaid expenses and other current assets ​ ​ 989 ​ 505 Other assets ​ ​ — ​ 2 Accounts payable and accrued expenses ​ ​ ( 167 ) ​ ( 3,166 ) Net cash used in operating activities ​ ​ ( 7,552 ) ​ ( 12,087 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from investing activities ​ ​ ​ ​ Purchases of property and equipment ​ ​ ( 56 ) ​ ( 215 ) Payments for patent costs ​ ​ ( 68 ) ​ ( 330 ) Net cash used in investing activities ​ ​ ( 124 ) ​ ( 545 ) 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 ​ ​ — ​ ( 698 ) Equity contributions - net of fees incurred ​ ​ — ​ ​ 12 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 ​ ​ 9,164 Effect of exchange rates on cash ​ ​ 139 ​ 21 Net change in cash, cash equivalents, and restricted cash ​ ​ ( 706 ) ​ ( 3,447 ) ​ ​ ​ ​ ​ ​ ​ Cash, cash equivalents, and restricted cash at beginning of year ​ ​ 9,764 ​ 15,615 Cash, cash equivalents, and restricted cash – end of period ​ $ 9,058 ​ $ 12,168 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of cash flow information ​ ​ ​ ​ ​ Cash paid for interest ​ $ 1,535 ​ $ 772 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of non-cash financing activities ​ ​ ​ ​ ​ Warrants issued in connection with long-term debt ​ $ — ​ $ 691 ​ See accompanying notes to condensed consolidated financial statements. ​ 6 Table of Contents CYTOSORBENTS CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER 30, 2025 (Unaudited) 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 September 30, 2025 and December 31, 2024, and for the three and nine months ended September 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 nine months ended September 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 year, 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 September 30, 2025, the Company had approximately $ 9.1 million in cash, including approximately $ 7.6 million in unrestricted cash and cash equivalents and $ 1.5 million of non-current restricted cash. These cash and restricted cash balances considered with the Company’s historical cash used in operations, notwithstanding the Company’s Strategic Workforce and Cost Reduction Plan and the impact of the Amended Loan and Security Agreement both of which were announced on November 13, 2025 (see Note 10, “Subsequent Events”) raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying condensed consolidated financial statements are issued. 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. which decision is now expected in mid-2026 and the related opportunity to receive Tranche 2 (b) of the Amended Avenue Capital Commitment by December 31, 2026. Additional sources of liquidity available to the Company include the 2024 Shelf, other public or private equity offerings, debt financing 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. Although the Company has taken actions to achieve cash flow breakeven, if it does not achieve this goal, the potential 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. 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 other 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, CytoSorbents India Private Limited, CytoSorbents Medical Canada, Inc., and CytoSorbents MEA FZCO, 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 (loss). Foreign currency transactions gains and losses are included in other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. Impairment or Disposal of Long-Lived Assets During the three months ended September 30, 2025 and 2024, the Company recorded impairment charges of approximately $ 0.2 million and $ 0.1 million respectively, and during the nine months ended September 30, 2025 and 2024, the Company recorded impairment charges of approximately $ 0.2 million and $ 0.3 million, respectively, 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 recorded an income tax benefit of $ 0.4 million for the three and nine months ended September 30, 2025. This benefit was realized by utilizing the New Jersey Technology Business Tax Certificate Program (the “Program”) whereby the State of New Jersey allows the Company to sell a portion of its state net operating losses and research and development (“R&D”) credits to a third party. The Company received $ 1.7 million from the Program in April of 2025 resulting from the sale of 2023 and amended 2022 net operating losses and R&D credits. The Company anticipates receiving the current benefit of $ 0.4 million in the second quarter of 2026. The Company has no t recorded income tax expense or income tax benefit for the three and nine months ended September 30, 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 September 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. 8 Table of Contents 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”) up to a $250,000 limit. At times, cash balances may exceed the maximum coverage provided by the FDIC on insured depositor accounts. 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. 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. A significant portion of the Company’s revenues is from product sales in Germany. As of September 30, 2025, two distributors accounted for approximately 28 % of the Company’s outstanding accounts receivable. As of December 31, 2024, one distributor accounted for approximately 19 % of outstanding accounts receivable. For the nine months ended September 30, 2025, no distributor or direct customers accounted for more than 10 % of the Company’s revenue. For the nine months ended September 30, 2024, one distributor accounted for approximately 10 % of the Company’s revenue. For the three months ended September 30, 2025, one distributor accounted for approximately 10 % of the Company’s revenue. For the three months ended September 30, 2024, no distributor or direct customers accounted for more than 10 % of the Company’s revenue. Shipping and Handling Costs Total freight costs amounted to approximately $ 0.1 million for each of the three months ended September 30, 2025 and 2024, and $ 0.4 million and $ 0.3 million for the nine months ended September 30, 2025 and 2024, respectively. ​ 3. BALANCE SHEET COMPONENTS Inventories The Company had the following major classes of inventories: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Raw materials ​ $ 565 ​ $ 570 Work in process ​ 1,130 ​ 503 Finished goods ​ 2,307 ​ 1,660 Inventories ​ $ 4,002 ​ $ 2,733 ​ Property and equipment, net The Company’s property and equipment consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Depreciation/ ​ ​ ​ ​ ​ ​ ​ ​ Amortization ​ September 30, 2025 December 31, 2024 Period ​ ​ (amounts, in thousands) ​ ​ Furniture and fixtures ​ $ 1,612 ​ $ 1,454 7 years Equipment and computers ​ 5,562 ​ 5,491 3 to 7 years Leasehold improvements ​ 6,308 ​ 6,283 Lesser of term of lease or estimated useful life ​ ​ 13,482 ​ 13,228 ​ ​ Less accumulated depreciation and amortization ​ 5,289 ​ 4,226 Property and equipment, net ​ $ 8,193 ​ $ 9,002 ​ Depreciation expense for the nine months ended September 30, 2025 and 2024 amounted to $ 0.9 million and $ 1.0 million, respectively. Depreciation expense for each of the three months ended September 30, 2025 and 2024 amounted to $ 0.3 million. 9 Table of Contents Other assets Other assets consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Patent applications pending ​ $ 1,539 ​ $ 1,612 Patents issued ​ 3,501 ​ 3,391 Less accumulated amortization of patents issued ​ ( 1,448 ) ​ ( 1,255 ) Patents, net ​ 3,592 ​ 3,748 Other ​ 55 ​ 23 Other assets ​ $ 3,647 ​ $ 3,771 ​ Patent amortization expenses amounted to $ 0.2 million each for the nine months ended September 30, 2025 and 2024. Patent amortization expense amounted to $ 0.1 million each for the three months ended September 30, 2025 and 2024. Patent amortization expense for the next five years and thereafter is scheduled as follows: ​ ​ ​ ​ ​ ​ ​ (amounts, in thousands) Remainder of 2025 $ 66 2026 ​ 258 2027 ​ 253 2028 ​ 240 2029 ​ 240 Thereafter ​ 996 Scheduled amortization of patents issued ​ $ 2,053 ​ Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Accrued salaries and commissions ​ $ 3,464 ​ $ 3,076 Clinical studies ​ 594 ​ 590 Deferred revenue and contract liabilities ​ 403 ​ 596 Professional fees ​ ​ 738 ​ ​ 773 Royalties ​ ​ 282 ​ ​ 275 Goods received not invoiced ​ ​ 6 ​ ​ 87 Accrued operating expenses ​ 1,072 ​ 635 Accrued expenses and other current liabilities ​ $ 6,559 ​ $ 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. Management and the Board of Directors of the Company are estimated to have 10 Table of Contents subscribed for approximately 450,000 of the total Units prior to any pro rata adjustment. Subscribers of basic subscription rights in the Rights Offering were allocated Units based upon their pro-rata share of 6.25 million Units. 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 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 satisfied a debt covenant which allowed 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 five -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 five -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 required additional investment separate from the purchase of the Units. 6.25 million shares of common stock were reserved for exercise of the Right Warrants. 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. ​ 11 Table of Contents 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 September 30, Stock-based compensation expense by category ​ 2025 ​ 2024 ​ ​ (amounts, in thousands) Cost of goods sold ​ $ 29 ​ $ 48 Research and development, net of grant income ​ 83 ​ — Selling, general and administrative ​ 376 ​ ​ 843 Total stock-based compensation expense ​ $ 488 ​ $ 891 ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine Months Ended September 30, Stock-based compensation expense by category ​ 2025 2024 ​ ​ (amounts, in thousands) Cost of goods sold ​ $ 114 ​ $ 48 Research and development, net of grant income ​ ​ 330 ​ ​ — Selling, general and administrative ​ 1,435 ​ 2,792 Total stock-based compensation expense ​ $ 1,879 ​ $ 2,840 ​ For the nine months ended September 30, 2025 and 2024, approximately $ 1.5 million and $ 2.3 million of stock-based compensation expense relates to stock options, respectively, and approximately $ 0.4 million and $ 0.5 million relates to RSUs, respectively. For the three months ended September 30, 2025 and 2024, approximately $ 0.4 million and $ 0.8 million of stock-based compensation expense relates to stock options, respectively, and approximately $ 0.1 million relates to RSUs for each period. ​ Stock-options The summary of the stock option activity for the nine months ended September 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 787,000 ​ ​ 1.00 — Exercised ​ ( 11,650 ) ​ ​ 0.96 ​ — Forfeited ( 110,985 ) ​ ​ 2.09 — Expired ( 255,552 ) ​ ​ 6.15 — Outstanding, September 30, 2025 12,750,720 ​ $ 3.36 6.37 ​ The Company estimated the fair value of stock options granted during the nine months ended September 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 - 81.7 % Expected term* ​ 6.3 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. ​ 12 Table of Contents The intrinsic value is calculated as the difference between the market value of the shares as of September 30, 2025 of $ 0.93 and the exercise price of the shares. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Options Outstanding ​ ​ Number ​ Weighted ​ Weighted ​ Aggregate Range of ​ Outstanding at ​ Average ​ Average ​ Intrinsic Exercise ​ September 30, ​ Exercise ​ Remaining ​ Value Price 2025 Price Life (Years) (in thousands) $ 0.82 - $ 13.20 12,750,720 ​ $ 3.36 ​ 6.37 ​ $ 4 ​ ​ ​ ​ ​ ​ ​ ​ Options Exercisable Number ​ Weighted ​ Aggregate Exercisable at ​ Average ​ Intrinsic September 30, ​ Exercise ​ Value 2025 Price (in thousands) 8,767,055 ​ $ 4.14 ​ $ 2 ​ The summary of the status of the Company’s non-vested options for the nine months ended September 30, 2025, is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Exercise ​ Shares Price Non-vested, December 31, 2024 6,234,550 ​ $ 1.09 Granted 787,000 ​ $ 1.00 Forfeited ( 110,985 ) ​ $ 2.09 Vested ( 2,926,891 ) ​ $ 1.55 Non-vested, September 30, 2025 3,983,674 ​ $ 1.63 ​ As of September 30, 2025, the Company had approximately $ 2.1 million of total unrecognized compensation cost related to stock options which will, on average, be amortized over approximately 18 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 vest upon a Change in Control of the Company, as defined in the Amended and Restated CytoSorbents Corporation 2014 Long-Term Incentive Plan, or upon certain life events. The following table is a summary of these restricted stock units: ​ ​ ​ ​ ​ ​ Total ​ ​ (amounts in thousands, except share data) Outstanding, December 31, 2024 2,809,500 Granted 121,500 Vested ​ ( 35,000 ) Forfeited ( 49,000 ) Outstanding, September 30, 2025 2,847,000 ​ 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 nine months ended September 30, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ Shares Fair Value Non-vested, January 1, 2025 641,335 ​ $ 1.31 Granted ​ 498,800 ​ ​ 1.01 Vested ( 264,835 ) ​ ​ 1.81 Unvested shares forfeited ​ ( 65,000 ) ​ ​ 0.96 Non-vested, September 30, 2025 810,300 ​ $ 0.99 ​ As of September 30, 2025, the remaining weighted average vesting period for restricted stock awards subject to vesting was 26 months and the remaining unrecognized restricted stock unit compensation expense was $ 0.6 million. ​ Warrants related to the December 2023 equity offering and June 2024 Loan and Security Agreement As of September 30, 2025, the Company had 4,352,130 warrants outstanding. Of this amount, 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 September 30, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ Direct Strategic Partners Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ United States ​ $ 28 ​ $ — ​ $ 28 Germany ​ 2,899 ​ — ​ 2,899 All other countries ​ 2,246 ​ 4,312 ​ 6,558 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue ​ $ 5,173 ​ $ 4,312 ​ $ 9,485 ​ The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ Direct Strategic Partners Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ ​ ​ ​ United States ​ $ 21 ​ $ — ​ $ 21 Germany ​ 3,181 ​ — ​ 3,181 All other countries ​ 1,937 ​ 3,474 ​ 5,411 Revenue ​ $ 5,139 ​ $ 3,474 ​ $ 8,613 ​ 14 Table of Contents The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ Direct Strategic Partners Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ United States ​ $ 152 ​ $ — ​ $ 152 Germany ​ 9,050 ​ ​ — ​ ​ 9,050 All other countries ​ 6,344 ​ ​ 12,283 ​ ​ 18,627 Revenue ​ $ 15,546 ​ $ 12,283 ​ $ 27,829 ​ The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ Direct Strategic Partners Total ​ ​ (amounts, in thousands) Revenue: ​ ​ ​ United States ​ $ 63 ​ $ 36 ​ $ 99 Germany ​ 9,497 ​ ​ — ​ ​ 9,497 All other countries ​ 5,362 ​ ​ 11,486 ​ ​ 16,848 Revenue ​ $ 14,922 ​ $ 11,522 ​ $ 26,444 ​ ​ 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, estimated at the time of sale. 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2025 December 31, 2024 ​ (amounts in thousands) Contract receivables ​ $ 5,997 ​ $ 4,427 Contract liabilities ​ $ 403 ​ $ 596 ​ Contract receivables, which are included in accounts receivable on the condensed consolidated balance sheets, represent balances due from product sales to direct and distributor customers amounting to $ 6.0 million and $ 4.2 million as of September 30, 2025 and December 31, 2024, respectively, and billed and unbilled amounts due on government contracts amounting to $ 0.0 million and $ 0.2 million as of September 30, 2025 and December 31, 2024, respectively. 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 September 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 $ 0.2 million and $ 0.4 million as of September 30, 2025 and December 31, 2024, respectively. 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 under one reportable business segment for which segment disclosure is consistent with the management decision making process that determines the allocation of resources and the measuring of performance. The Company operates as one reportable segment. Consisting of one 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. 17 Table of Contents 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 Nine Months Ended ​ ​ September 30, ​ September 30, ​ 2025 2024 2025 2024 ​ (amounts, in thousands) ​ Revenue ​ $ 9,485 ​ $ 8,613 ​ $ 27,829 ​ $ 26,444 ​ Gross profit ​ $ 6,666 ​ $ 5,256 ​ $ 19,687 ​ $ 18,632 ​ Gross margin ​ 70 % 61 % 71 % 70 % Total operating expenses ​ $ 9,528 ​ $ 10,086 ​ $ 30,051 ​ $ 31,689 ​ Loss from operations ​ $ ( 2,862 ) ​ $ ( 4,830 ) ​ $ ( 10,364 ) ​ $ ( 13,057 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ EBITDA and Adjusted EBITDA (both non-GAAP measures): ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 3,170 ) ​ $ ( 2,768 ) ​ $ ( 2,701 ) ​ $ ( 13,152 ) ​ Interest expense, net ​ 645 ​ 588 ​ 1,866 ​ 775 ​ Benefit from income taxes ​ ( 401 ) ​ — ​ ( 401 ) ​ — ​ Depreciation and amortization expense ​ 364 ​ 383 ​ 1,137 ​ 1,181 ​ Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure ​ ( 2,562 ) ​ ( 1,797 ) ​ ( 99 ) ​ ( 11,196 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stock-based compensation ​ 488 ​ 891 ​ 1,879 ​ 2,840 ​ Loss (gain) on foreign currency transactions ​ ​ 64 ​ ( 2,650 ) ​ ​ ( 9,128 ) ​ ( 680 ) ​ Adjusted EBITDA, a non-GAAP measure ​ $ ( 2,010 ) ​ $ ( 3,556 ) ​ $ ( 7,348 ) ​ $ ( 9,036 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Adjusted net loss, a non-GAAP measure: ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 3,170 ) ​ $ ( 2,768 ) ​ $ ( 2,701 ) ​ $ ( 13,152 ) ​ Stock-based compensation ​ 488 ​ 891 ​ 1,879 ​ 2,840 ​ Loss (gain) on foreign currency transactions ​ ​ 64 ​ ​ ( 2,650 ) ​ ​ ( 9,128 ) ​ ​ ( 680 ) ​ Adjusted net loss, a non-GAAP measure ​ $ ( 2,618 ) ​ $ ( 4,527 ) ​ $ ( 9,950 ) ​ $ ( 10,992 ) ​ Total cash used in operating and investing activities ​ $ ( 2,522 ) ​ $ ( 2,762 ) ​ $ ( 7,676 ) ​ $ ( 12,632 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2025 December 31, 2024 ​ ​ (amounts, in thousands) Total assets ​ $ 45,750 ​ $ 47,372 ​ 18 Table of Contents Significant expense categories regularly provided to the CODM consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Nine Months Ended ​ ​ September 30, ​ September 30, ​ 2025 2024 2025 2024 ​ ​ (amounts, in thousands) Research and development: ​ ​ ​ ​ ​ ​ ​ ​ Clinical expenses ​ $ 719 ​ $ 936 ​ $ 2,510 ​ $ 3,499 Other research and development expenses ​ 199 ​ 890 ​ 1,332 ​ 2,093 Total research and development ​ $ 918 ​ $ 1,826 ​ $ 3,842 ​ $ 5,592 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Selling, general and administrative ​ ​ ​ ​ ​ Royalty expense ​ $ 285 ​ $ 354 ​ $ 826 ​ $ 1,594 Stock-based compensation ​ 376 ​ 843 ​ 1,435 ​ 2,792 Legal, financial and consulting ​ 1,061 ​ 824 ​ 3,063 ​ 2,325 Other general and administrative ​ 6,888 ​ 6,239 ​ 20,885 ​ 19,386 Total selling, general and administrative ​ $ 8,610 ​ $ 8,260 ​ $ 26,209 ​ $ 26,097 ​ 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 and $ 0.2 million for the nine months ended September 30, 2025 and 2024, respectively. 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 (the “Avenue Capital Commitment”), to be disbursed in two tranches. The first tranche of $ 15 million (“Tranche 1”), consists of $ 10 million which 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. The second tranche (“Tranche 2”) consists of $ 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. 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. On November 13, 2025, the interest only period was extended from July 1, 2026 to December 31, 2026, and the terms surrounding the access to Tranche 2 were amended. Refer to Note 10, Subsequent Events, for additional information. 19 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 Final fee ​ ​ 900 Debt issuance cost ​ 498 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 ​ $ 2,288 ​ 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 September 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 September 30, 2025, long-term debt, after giving consideration to the extension of the interest only period provided by the Amended Loan and Security Agreement from July 1, 2026 to December 31, 2026 (see Note 10, “Subsequent Events”), consists of the following: ​ ​ ​ ​ ​ ​ (amounts, in thousands) Principal amount $ 15,000 Plus: final payment upon maturity ​ ​ 900 Less unamortized debt discount ​ ​ ( 1,333 ) Long-term debt ​ 14,567 ​ As of September 30, 2025, after giving consideration to the extension of the interest only period provided by the Amended Loan and Security Agreement from July 1, 2026 to December 31, 2026, (see Note 10, “Subsequent Events”) principal payments of long-term debt are due as follows: ​ ​ ​ ​ ​ ​ (amounts, in thousands) 2026 $ — 2027 ​ 15,900 Total ​ $ 15,900 ​ 20 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, a division of Western Alliance Bank (the “Bank”). As of September 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 Company 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 Company’s previously outstanding term loan with the Bank(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”). the Company may pay the Success Fee in cash or in shares of common stock, at the Company’s sole discretion. The right of the Bank to receive the Success Fees and the obligation of the Company 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, at times, party to various royalty and license agreements that require the payment of royalty fees. Royalty expense amounted to approximately $ 0.8 million and $ 1.6 million for the nine months ended September 30, 2025, and 2024, respectively. Royalty expense amounted to approximately $ 0.3 million and $ 0.4 million for the three months ended September 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 and $ 0.4 million for the nine months ended September 30, 2025 and 2024, respectively. Matching contributions amounted to approximately $ 0.1 million and $ 0.2 million for the three months ended September 30, 2025 and 2024, respectively. ​ 21 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 September 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): ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ 2025 2024 ​ ​ (amounts, in thousands) Cash paid in connection with the operating leases ​ $ 1,264 ​ $ 1,235 ​ Supplemental balance sheet information related to operating leases is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, ​ December 31, ​ ​ 2025 2024 ​ ​ ​ (amounts, in thousands) ​ Right-of-use asset ​ $ 11,075 ​ $ 11,511 ​ Lease liability - current portion ​ $ 518 ​ $ 453 ​ Lease liability - net of current portion ​ ​ 12,051 ​ ​ 12,444 ​ Total lease liability ​ $ 12,569 ​ $ 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 September 30, ​ ​ 2025 2024 ​ ​ (amounts, in thousands) Operating lease cost ​ $ 440 ​ $ 409 Variable lease cost ​ ​ 207 ​ ​ 156 Total lease cost ​ $ 647 ​ $ 565 ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine Months Ended September 30, ​ ​ 2025 2024 ​ ​ (amounts, in thousands) Operating lease cost ​ $ 1,288 ​ $ 1,297 Variable lease cost ​ ​ 356 ​ ​ 360 Total lease cost ​ $ 1,644 ​ $ 1,657 ​ As of September 30, 2025, the maturities of the operating lease liability are as follows: ​ ​ ​ ​ Remainder of 2025 $ 431 2026 ​ 1,736 2027 ​ 1,777 2028 ​ 1,819 2029 ​ 1,863 Thereafter ​ 13,550 Future operating lease payments ​ ​ 21,176 Imputed interest ​ ​ ( 8,607 ) Total operating lease liability ​ $ 12,569 ​ 22 Table of Contents ​ 9. NET LOSS PER SHARE Basic loss per share and diluted loss per share for the three and nine months ended September 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; (iv) if the RSUs with service and performance conditions were considered contingently issuable; (v) if outstanding warrants were exercised; and (vi) if convertible debt was converted to common stock. The following table summarizes earnings per share calculations: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Nine Months Ended ​ ​ September 30, ​ September 30, ​ 2025 2024 2025 2024 ​ ​ (amounts, in thousands, except share and per share data) Basic and diluted earnings per common share: ​ ​ ​ ​ Net loss ​ $ ( 3,170 ) ​ $ ( 2,768 ) ​ $ ( 2,701 ) ​ $ ( 13,152 ) Basic and diluted weighted average common shares outstanding ​ 62,753,959 ​ 54,453,006 ​ 62,038,902 ​ 54,340,583 Basic and diluted earnings per common share ​ $ ( 0.05 ) ​ $ ( 0.05 ) ​ $ ( 0.04 ) ​ $ ( 0.24 ) ​ 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 11,264,903 and 11,387,763 for the three and nine months ended September 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. Amended Loan and Security Agreement On November 13, 2025, the Company and Avenue Capital Group entered into the First Amendment to Loan Documents (the “Amended Loan and Security Agreement”), amending the Company’s Loan and Security Agreement, dated June 28, 2024, as supplemented. The Amended Loan and Security Agreement provides for access to an additional aggregate $ 2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and for the extension of the interest only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027. The Company will have access to an additional aggregate $ 2.5 million (“Tranche 2b”) from Avenue Capital Group, subject to FDA approval of DrugSorb-ATR, between January 1, 2026 and December 31, 2026. Tranche 2a and Tranche 2b, in the aggregate, replace Tranche 2 of the Loan. The Amended Loan and Security Agreement requires that the Company maintain certain operating cash burn targets (as defined) prior to FDA approval of DrugSorb-ATR and provides for a further six-month extension of the interest only period to the July 1, 2027 maturity date upon FDA approval of DrugSorb-ATR. Under the terms of the Amended Loan and Security Agreement, the Company issued additional warrants to Avenue Capital Group to purchase 1,428,571 shares of the Company’s common stock for cash at the exercise price of $ 0.70 , which expire on November 13, 2030. The number of warrants and exercise price are fixed. 23 Table of Contents Workforce and Cost Reduction Plan On November 13, 2025, the Company announced it initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. This initiative follows a comprehensive review of the Company’s cost structure and operating model. As part of the strategic plan, the Company reduced its workforce by approximately 10 %, and reduced and realigned operating and production expenses. The Company expects to record a charge of up to $ 0.9 million that will include severance and other cash and non-cash charges related to the restructuring. The estimated costs that the Company expects to incur, and the timing thereof, are subject to a number of assumptions, and actual amounts may differ materially. Continued Listing Requirements Notification On October 2, 2025, the Company was notified by the Nasdaq Stock Market LLC (“Nasdaq”) that the Company was not in compliance with the Nasdaq’s continued listing requirements relating to the minimum average closing price per share of the Company’s common stock, because the average closing price of the Company’s common stock over a consecutive 30 trading-day period was below $1.00 per share (the “Minimum Bid Price Requirement”). The notice does not result in the immediate delisting of the Company’s common stock from the Nasdaq. The Company has timely notified the Nasdaq of its intent to regain compliance with the minimum price condition within a 180-day cure period provided by Nasdaq rules, or until March 31, 2026 (the “Compliance Date”). The Company can regain compliance at any time within the cure period if, the closing bid price of the Company’s common stock meets or exceeds $1.00 per common share for a minimum of 10 consecutive business days prior to the Compliance Date, unless the Nasdaq staff exercises its discretion to require the Company to meet the Minimum Bid Price Requirement for a longer period pursuant to applicable Nasdaq rules. If the Company fails to regain compliance with the Nasdaq’s minimum price condition by the end of the cure period, the Company would be eligible for an additional compliance period of 180 days provided it presents an acceptable plan to Nasdaq to regain compliance. The Company intends to actively monitor the closing bid price of its common stock and will consider its options to regain compliance with the Minimum Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq listing standards. If the Company is unable to regain compliance with the Minimum Bid Price Requirement, the Company’s common stock will be subject to the Nasdaq’s suspension and delisting procedures. During this time, the Company’s common stock will continue to be listed on the Nasdaq, subject to its compliance with other Nasdaq continued listing requirements. However, there can be no assurance about the Company’s ability to regain compliance with the Nasdaq’s minimum price condition within the applicable cure periods. ​ 24 Table of Contents