Cytosorbents Corp 10-K

Item 9A. Controls and Procedures Management’s Evaluation of our Disclosure Controls and Procedures Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, mean controls and other procedures of a company that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company on the reports that it files or submits under the Exchange Act is accumulated and communicated to management, including, our principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures are not designed at a reasonable assurance level and are not effective due to a material weakness, as further described below. Management’s Annual Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) of the Securities Exchange Act of 1934, as amended. Our internal control over financial reporting is a process designed to provide reasonable assurance to our management and board of directors regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes policies and procedures that: (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements, errors or fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected. Also, projections of any evaluations of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of December 31, 2025. Material Weakness in Internal Control Over Financial Reporting A material weakness (as defined in Rule 12b-2 under the Exchange Act) is a deficiency, or combination of deficiencies, in our internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements would not be prevented or detected on a timely basis. Material Weakness — Continuing from Prior Year The Company previously disclosed a material weakness in internal control over financial reporting as of December 31, 2024 in our Annual Report on Form 10-K for the year ended December 31, 2024 related to the accounting for stock-based compensation corresponding to grants of Restricted Stock Units. Specifically, our controls were not effectively designed or operating to ensure that restricted stock unit grants or vesting activities were recorded within the proper accounts and at the proper amounts. As described below, while management has developed and implemented certain remediation actions to address the material weakness, further actions are still ongoing or have not been implemented for a sufficient amount of time to test and conclude on the effectiveness of the remediation actions as of December 31, 2025. Although most of our remediation efforts have been in place and functioning properly for much of the year, in connection with our preparation of our consolidated financial statements as of and for the year ended December 31, 2025, we 44 Table of Contents identified two transactions related to unique RSU vesting events that required adjustment. As a result, the material weakness related to the accounting for stock-based compensation corresponding to Restricted Stock Units continues to be present as of December 31, 2025. Material Weakness — Newly Identified in Current Year During the year ended December 31, 2025, management identified a new material weakness related to the Company’s financial statement consolidation and reporting, as controls over the consolidation and monthly close processes were deemed not to be operating effectively, a determination which is at least partially attributable to the significant volume of manual procedures involved in these processes. Specifically, deficiencies in the review and reconciliation of intercompany balances resulted in (i) losses not being appropriately allocated to the correct jurisdiction when preparing the income tax provision and (ii) foreign currency transaction gains related to an intercompany balance being recorded incorrectly during the fourth quarter of 2025. As a result, net operating losses were not initially reflected properly in the income tax disclosures, and foreign currency transaction gains were materially misstated in the Company’s consolidated financial statements prior to being corrected. Discussion of Remediation Activities Remediation of the identified material weaknesses and strengthening our internal control environment is an identified priority for us and will continue to be a priority in 2026. We are committed to completing the remediation of these material weaknesses as expeditiously as possible and expect these enhancements to be fully implemented during the fiscal year ending December 31, 2026. However, the material weaknesses will not be considered fully remediated until the new controls have been operational for a sufficient period of time and tested to demonstrate their effectiveness. With continued oversight from the Audit Committee, the Company’s management has begun to design and implement changes in processes and controls to remediate the material weaknesses described above. These internal control enhancements include, but are not limited to, the following: Accounting for Stock-Based Compensation Corresponding to Grants of Restricted Stock Units Management intends to continue implementing measures to strengthen our internal control over the accounting for restricted stock unit grant and vesting events. These efforts are intended to ensure accurate and timely reporting in accordance with U.S. GAAP for both interim and annual periods. Key steps in our remediation plan include: - Developing and implementing more robust control procedures to validate that the inputs and assumptions used in stock-based compensation expense calculation models are accurate and reflect proper application of generally accepted accounting principles. - Increasing oversight and review by executive management to ensure the completeness and accuracy of restricted stock unit expense calculations and their corresponding Journal Entries. Financial Statement Consolidation and Reporting Actions to address this material weakness are currently being developed, with the following primary solutions having been identified: - A consolidation tool is currently being implemented, which will eliminate the need for the Company to manually execute the consolidation of its various entities at the end of each period. - A financial close automation tool is also being implemented, which will create automated workflows, approval streams, and checklists for a variety of period-end close procedures (balance sheet reconciliations, etc.). - Period-end analytics and the metrics and variance thresholds applied to those analytics are to be enhanced in order to make them more precise tools for the purpose of identifying potential errors or misstatements. 45 Table of Contents Changes in Internal Control Over Financial Reporting Except as discussed above, there were no changes in the Company’s internal control over financial reporting that occurred during year ended December 31, 2025, that have materially affected, or are reasonably likely to materially affect, its internal control over financial reporting. Notwithstanding the material weaknesses, management has concluded that the consolidated financial statements included elsewhere in this Annual Report present fairly, in all material respects, our financial position, results of operations and cash flows in conformity with GAAP. ​ Item 9B. Other Information. N o n e . ​ Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection. None. ​ 46 Table of Contents PART III Item 10. Directors, Executive Officers and Control Persons. The information required by this Item will be provided in an amendment to this Annual Report on Form 10-K/A. ​ Item 11. Executive Compensation. The information required by this Item will be provided in an amendment to this Annual Report on Form 10-K/A. ​ Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this Item will be provided in an amendment to this Annual Report on Form 10-K/A. ​ Item 13. Certain Relationships and Related Transactions and Director Independence. The information required by this Item will be provided in an amendment to this Annual Report on Form 10-K/A. ​ Item 14. Principal Accounting Fees and Services. The information required by this Item will be provided in an amendment to this Annual Report on Form 10-K/A. ​ ​ 47 Table of Contents PART IV Item 15. Exhibits, Financial Statement Schedules. (a) Financial Statements and Schedules: 1. Financial Statements The following consolidated financial statements and reports of independent registered public accounting firm are included herein: Report of Independent Registered Public Accounting Firm F-2 Consolidated Balance Sheets F-4 Consolidated Statements of Operations and Comprehensive Loss F-5 Consolidated Statements of Changes in Stockholders’ Equity F-6 Consolidated Statements of Cash Flows F-7 Notes to Consolidated Financial Statements F-8 ​ 2. Financial Statement Schedules Not applicable. ​ 48 Table of Contents 3. List of Exhibits Exhibit ​ ​ ​ ​ No. Description 3.1 Second Amended and Restated Certificate of Incorporation, dated June 12, 2019 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 13, 2019) 3.2 Second Amended and Restated Bylaws of CytoSorbents Corporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on May 6, 2024) 4.1 Description of Capital Stock of CytoSorbents Corporation (incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 10, 2022). 4.2 ​ Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 11, 2023). ​ ​ ​ 4.3 ​ Form of Subscription Right Warrant Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 9, 2024). ​ ​ ​ 4.4 ​ Form of Series A Right Warrant Certificate (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 9, 2024). ​ ​ ​ 4.5 ​ Form of Series B Right Warrant Certificate (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 9, 2024). ​ ​ ​ 10.1+ Amended and Restated Employment Agreement, dated as of July 30, 2019, by and between CytoSorbents Medical, Inc. and Phillip P. Chan (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on August 5, 2019) 10.2+ Amended and Restated Employment Agreement, dated as of July 30 2019, by and between CytoSorbents Medical, Inc. and Vincent J. Capponi (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on August 5, 2019) 10.3+ Amended and Restated Employment Agreement, dated as of July 30, 2019, by and between CytoSorbents Medical, Inc. and Kathleen P. Bloch (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on August 5, 2019) 10.4+ ​ Employment Agreement by and between the Company and Efthymios Deliargyris, M.D., dated April 12, 2020 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on April 27, 2020). ​ ​ ​ 10.5+† ​ Consulting Agreement, dated March 31, 2023, by and between the Company and Ms. Kathleen P. Bloch (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on April 6, 2023). ​ ​ ​ 10.6+ ​ Employment Agreement, dated September 18, 2023, by and between the Company and Ms. Kathleen Bloch (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on September 19, 2023). ​ ​ ​ 10.7 ​ Consulting Agreement, dated August 13, 2024, by and between the Company and Kathleen P. Bloch (incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 16, 2024). ​ ​ ​ 10.8+ Employment Agreement, dated August 14, 2024, by and between the Company and Mr. Peter J. Mariani (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 16, 2024). ​ ​ ​ 10.9+ ​ Form of Payment Reduction Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on April 3, 2024). ​ ​ ​ 49 Table of Contents 10.10+ Form of Nonqualified Stock Option Agreement (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on April 3, 2024). ​ ​ ​ 10.11 ​ Restricted Stock Unit Award Agreement (Inducement Award), dated as of August 14, 2024, by and between the Registrant and Peter Mariani (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 16, 2024). ​ ​ ​ 10.12 ​ Nonstatutory Option Award Agreement (Inducement Award), dated as of August 14, 2024, by and between the Registrant and Peter Mariani (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 16, 2024). ​ ​ ​ 10.13 ​ Nonstatutory Option Award Agreement (Inducement Award), dated as of August 14, 2024, by and between the Registrant and Peter Mariani (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 16, 2024). ​ ​ ​ 10.14 Royalty Agreement between Guillermina Vega Montiel and the Registrant dated as of August 11, 2003 (incorporated by reference to Exhibit 10.6 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 31, 2015). ​ ​ ​ 10.15 ​ Assignment and Assumption of Certain Royalty Rights, dated as of November 22, 2022, by and among Robert Shipley Living Trust, ROKK, LLC, and CytoSorbents Medical, Inc (incorporated by reference to Exhibit 10.11 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 9,2023). 10.16 Stipulated Order and Settlement Agreement between Bro-Tech Corporation, dated as of August 7, 2006, by and between Bio-Tech Corporation, and Purolite International Ltd., and MedaSorb Corporation (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on September 8, 2006) 10.17† Distribution Agreement between Biocon Biologics Limited and the Registrant dated as of September 20, 2013 (incorporated by reference to Exhibit 10.8 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 31, 2015). 10.18† First Amendment to the Distribution Agreement between Biocon Biologics Limited and the Registrant, dated October 30, 2014 (incorporated by reference to Exhibit 10.9 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 31, 2015). 10.19+ CytoSorbents Corporation 2006 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed on July 6, 2006) ​ ​ ​ 10.20+ Amendment No. 1 to the CytoSorbents Corporation 2006 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s registration statement on Form S-8 filed with the SEC on November 4, 2014). 10.21 ​ Amended and Restated CytoSorbents Corporation 2014 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-8 filed with the SEC on August 26, 2019). ​ ​ ​ 10.22 Amended and Restated Loan and Security Agreement, dated as of March 29, 2018, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on April 4, 2018) 10.23 First Amendment to Amended and Restated Loan and Security Agreement, dated as of July 30, 2019, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on August 5, 2019) 10.24 ​ Third Amendment to Amended and Restated Loan and Security Agreement, dated as of December 4, 2020, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 10, 2020). ​ ​ ​ 50 Table of Contents 10.25 Fourth Amendment to the Amended and Restated Loan and Security Agreement, dated as of January 19, 2022, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on January 20, 2022). ​ ​ ​ 10.26 ​ Fifth Amendment to the Amended and Restated Loan and Security Agreement, dated as of December 28, 2022, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 29, 2022). ​ ​ ​ 10.27 ​ Sixth Amendment to the Amended and Restated Loan and Security Agreement, dated as of March 8, 2023, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.30 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 9, 2023). ​ ​ ​ 10.28 ​ Seventh Amendment to the Amended and Restated Loan and Security Agreement, dated as of May 16, 2023, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 1, 2023). ​ ​ ​ 10.29† ​ Loan and Security Agreement, dated as of June 28, 2024, by and among CytoSorbents Corporation, the lenders, and the administrative and collateral agent party thereto (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on July 5, 2024). ​ ​ ​ 10.30† ​ Supplement to the Loan and Security Agreement, dated as of June 28, 2024, by and among CytoSorbents Corporation, the lenders, and the administrative and collateral agent party thereto (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on July 5, 2024). ​ ​ ​ 10.31 ​ Form of Warrant, by and between CytoSorbents Corporation and Avenue Venture Opportunities Fund, LP (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed with the SEC on July 5, 2024). 10.32 ​ Success Fee Letter, dated as of March 29, 2018, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on April 4, 2018). ​ ​ ​ 10.33 Success Fee Letter, dated as of January 19, 2022, by and among CytoSorbents Corporation, CytoSorbents Medical, Inc. and Western Alliance Bank (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on January 20, 2022). ​ ​ ​ 10.34 ​ First Amendment to Loan Documents, dated November 13, 2025, by and among CytoSorbents Corporation, the lenders, and the administrative and collateral agent party thereto (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2025). ​ ​ ​ 10.35 ​ Form of Warrant to Purchase Shares of Stock of CytoSorbents Corporation by and between the Company and Avenue Venture Opportunities Fund, L.P., dated November 13, 2025 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2025). ​ ​ ​ 10.36 ​ Form of Warrant to Purchase Shares of Stock of CytoSorbents Corporation by and between the Company and Avenue Venture Opportunities Fund II, L.P. dated November 13, 2025 (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2025). 10.37† Exclusive Distribution Agreement, dated as of September 26, 2014, by and between CytoSorbents Europe GmbH and Aferetica s.r.l. (incorporated by reference to Exhibit 10.23 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 7, 2019). 10.38† Amendment to Exclusive Distribution Agreement, dated December 15, 2014, by and between CytoSorbents Europe GmbH and Aferetica s.r.l (incorporated by reference to Exhibit 10.24 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 7, 2019). ​ ​ ​ 51 Table of Contents 10.39 ​ Open Market Sale Agreement SM, dated as of December 30, 2021, by and between CytoSorbents Corporation and Jefferies LLC (incorporated by reference from Exhibit 1.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 30, 2021). ​ ​ ​ 10.40 ​ Marketing Agreement, dated as of August 1, 2022, by and between CytoSorbents Corporation and Fresenius Medical Care Deutschlancd GmbH (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on November 3, 2022). 10.41 ​ Lease, dated as of March 26, 2021, by and between 300 CR LLC and CytoSorbents Medical, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on March 31, 2021). ​ ​ ​ 10.42† ​ Securities Purchase Agreement, dated as of December 11, 2023, by and among CytoSorbents Corporation and the investors party thereto (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 11, 2023). ​ ​ ​ 19.1 ​ Insider Trading Policy. ​ ​ ​ 21.1* ​ List of Subsidiaries. ​ ​ ​ 23.1* Consent of WithumSmith+Brown, PC. 24.1* ​ Power of Attorney ​ ​ ​ 31.1* Certification of the Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 31.2* Certification of the Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 32.1* Certification of the Chief Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2* Certification of the Chief Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 97 ​ Compensation Recoupment Policy (incorporated by reference to Exhibit 97 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 15, 2024). ​ ​ ​ 101 The following materials from CytoSorbents Form 10-K for the fiscal year ended December 31, 2025, formatted in Extensible Business Reporting Language (XBRL): (1) Consolidated Balance Sheets at December 31, 2025 and December 31, 2024, (iii) Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025, and 2024, (iii) Consolidated Statements of Changes in Stockholders’ Equity/(Deficit) for the years ended December 31, 2025, and 2024, (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024, and (v) Notes to the Consolidated Financial Statements. ​ ​ ​ 104 ​ Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) * Filed or furnished herewith. + Management contract or compensatory plan or arrangement of the Registrant required to be filed as an exhibit to this Annual Report. † Confidential treatment has been requested for certain portions of this exhibit. The confidential portions of this exhibit have been omitted and filed separately with Securities and Exchange Commission. In accordance with SEC Release 33-8238, Exhibits 32.1 and 32.2 are being furnished and not filed. ​ 52 Table of Contents Item 16. Form 10-K Summary. None. ​ 53 Table of Contents SIGNATURES In accordance with Section 13 or 15(d) of the Exchange Act, CytoSorbents Corporation has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on this 29th day of March, 2026. CYTOSORBENTS CORPORATION By: /s/ Dr. Phillip P. Chan Dr. Phillip P. Chan Chief Executive Officer ​ Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature ​ ​ ​ Title ​ ​ ​ Date /s/ Dr. Phillip P. Chan Chief Executive Officer (Principal March 29, 2026 Dr. Phillip P. Chan Executive Officer) and Director ​ ​ /s/ Peter J. Mariani Chief Financial Officer March 29, 2026 Peter J. Mariani (Principal Financial and Accounting Officer) ​ ​ /s/ Michael G. Bator Chairman of the Board March 29, 2026 Michael G. Bator ​ ​ /s/ Alan D. Sobel Director March 29, 2026 Alan D. Sobel ​ ​ /s/ Edward R. Jones Director March 29, 2026 Edward R. Jones ​ ​ /s/Jiny Kim Director March 29, 2026 Jiny Kim ​ ​ ​ 54 Table of Contents FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm F-2 Consolidated Balance Sheets at December 31, 2025 and 2024 F-4 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025, and 2024 F-5 Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025, and 2024 F-6 Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024 F-7 Notes to Consolidated Financial Statements F-8 ​ ​ ​ F-1 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of CytoSorbents Corporation: Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of CytoSorbents Corporation (the “Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of CytoSorbents Corporation as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years in the period ended December 31, 2025 and 2024, in conformity with accounting principles generally accepted in the United States of America. Substantial Doubt Regarding Going Concern The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the entity has suffered recurring losses from operations, has experienced negative cash flows from operations, and has an accumulated deficit, which raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These consolidated financial statements are the responsibility of the entity’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to CytoSorbents Corporation in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. CytoSorbents Corporation is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matters The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate. F-2 Table of Contents Accounting For Warrants Associated with January 2025 Rights Offering Description of the Matter The Company issued warrants in connection with the January 2025 Rights Offering. The accounting for the issuance of these warrants involves evaluation of complex accounting guidance to be performed by management as it relates to determining the accounting classification of the warrants. It also involved management’s estimates and judgements in determining the fair value of the warrants. This matter was identified as a critical audit matter due to the complexity in accounting for the warrants and the potential significant impact of these conclusions to the Company’s consolidated financial statements and related disclosures. How We Addressed the Matter in Our Audit Our principal audit procedures performed to address this critical audit matter included the following: · Reviewed the executed Rights Offering and associated warrant agreements. · Reviewed management’s technical accounting memo evaluating the terms and conditions of the warrant agreements to determine the appropriate classification of the instruments. · Utilized personnel with specialized knowledge and skills in technical accounting to assist in: (i) evaluating the terms of the warrants in relation to the relevant accounting literature, and (ii) assessing the appropriateness of conclusions reached by the Company. · Utilized personnel with specialized knowledge and skills in valuation to assist in: (i) reviewing the valuation provided by management’s valuation specialist. /s/ WithumSmith+Brown, PC We have served as CytoSorbents Corporation’s auditor since 2004. East Brunswick, New Jersey March 29, 2026 PCAOB ID Number 100 ​ ​ ​ F-3 Table of Contents CYTOSORBENTS CORPORATION CONSOLIDATED BALANCE SHEETS (in thousands, except share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ At December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ASSETS ​ ​ ​ ​ ​ Current Assets: ​ ​ ​ ​ ​ Cash and cash equivalents ​ $ 6,249 ​ $ 3,280 Restricted cash, current ​ ​ — ​ ​ 5,000 Accounts receivable, net of allowances of $ 164 and $ 158 at December 31, 2025 and 2024, respectively ​ 7,550 ​ 7,320 Inventories - net ​ 5,281 ​ 2,733 Prepaid expenses and other current assets ​ 1,554 ​ 3,271 Total current assets ​ 20,634 ​ 21,604 ​ ​ ​ ​ ​ Property and equipment - net ​ 7,823 ​ 9,002 Restricted cash ​ ​ 1,522 ​ ​ 1,484 Right-of-use asset ​ ​ 10,924 ​ ​ 11,511 Patents - net ​ ​ 3,226 ​ ​ 3,721 Other assets ​ 53 ​ 50 Total Assets ​ $ 44,182 ​ $ 47,372 ​ ​ ​ ​ ​ LIABILITIES AND STOCKHOLDERS’ EQUITY ​ ​ ​ ​ Current Liabilities: ​ ​ ​ ​ Accounts payable ​ $ 2,869 ​ $ 3,340 Accrued expenses and other current liabilities ​ 6,299 ​ 6,032 Lease liability – current portion ​ ​ 541 ​ ​ 453 Total current liabilities ​ 9,709 ​ 9,825 Lease liability, net of current portion ​ ​ 11,903 ​ ​ 12,444 Long-term debt, net of debt discount ​ 16,667 ​ 13,996 Total Liabilities ​ 38,279 ​ 36,265 ​ ​ ​ ​ ​ Commitments and Contingencies ​ ​ ​ ​ Stockholders’ Equity: ​ ​ ​ ​ Preferred Stock, Par Value $ 0.001 , 5,000,000 shares authorized; no shares issued and outstanding at December 31, 2025 and 2024 ​ ​ — ​ ​ — Common Stock, Par Value $ 0.001 , 100,000,000 shares authorized; and 62,804,305 and 54,830,146 shares issued and outstanding at December 31, 2025 and 2024, respectively ​ 63 ​ 55 Additional paid-in capital ​ 321,024 ​ ​ 310,809 Accumulated other comprehensive income (loss) ​ ( 2,977 ) ​ ​ 4,252 Accumulated deficit ​ ( 312,207 ) ​ ​ ( 304,009 ) Total Stockholders’ Equity ​ 5,903 ​ ​ 11,107 Total Liabilities and Stockholders’ Equity ​ $ 44,182 ​ $ 47,372 ​ The Notes to Consolidated Financial Statements are an integral part of these statements. ​ F-4 Table of Contents CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ Year ended ​ ​ December 31, ​ December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Revenue, net ​ $ 37,063 ​ $ 35,595 Cost of goods sold ​ ​ 10,572 ​ ​ 10,708 Gross profit ​ ​ 26,491 ​ ​ 24,887 Operating expenses: ​ ​ ​ ​ ​ Research and development, net of grant income ​ ​ 5,085 ​ ​ 7,607 Selling, general and administrative ​ ​ 35,645 ​ ​ 33,732 Restructuring ​ ​ 510 ​ ​ — Total operating expenses ​ ​ 41,240 ​ ​ 41,339 Loss from operations ​ ​ ( 14,749 ) ​ ​ ( 16,452 ) Other income (expense): ​ ​ ​ ​ ​ Interest expense, net ​ ​ ( 2,612 ) ​ ​ ( 1,399 ) Gain (loss) on foreign currency transactions ​ ​ 9,321 ​ ​ ( 4,225 ) Loss on abandoned patents ​ ​ ( 559 ) ​ ​ ( 334 ) Total other income (expense), net ​ ​ 6,150 ​ ​ ( 5,958 ) ​ ​ ​ ​ ​ ​ Loss before benefit from income taxes ​ ​ ( 8,599 ) ​ ​ ( 22,410 ) ​ ​ ​ ​ ​ ​ ​ Benefit from income taxes ​ 401 ​ ​ 1,691 ​ ​ ​ ​ ​ Net loss ​ $ ( 8,198 ) ​ $ ( 20,719 ) ​ ​ ​ ​ ​ ​ ​ Basic and diluted net loss per common share ​ $ ( 0.13 ) ​ $ ( 0.38 ) ​ ​ ​ ​ ​ ​ ​ Weighted average number of shares of common stock outstanding ​ ​ 62,231,771 ​ ​ 54,434,609 ​ ​ ​ ​ ​ ​ ​ Comprehensive loss: ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 8,198 ) ​ $ ( 20,719 ) Other comprehensive income (loss): ​ ​ ​ ​ ​ ​ Foreign currency translation adjustment, net of tax ​ ​ ( 7,229 ) ​ ​ 3,723 Comprehensive loss ​ $ ( 15,427 ) ​ $ ( 16,996 ) ​ The Notes to Consolidated Financial Statements are an integral part of these statements. ​ F-5 Table of Contents CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (in thousands, except share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ ​ ​ ​ Shares ​ ​ ​ Par value ​ ​ ​ Capital ​ ​ ​ Income (Loss) ​ ​ ​ Deficit ​ ​ ​ Equity ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2023 54,240,265 ​ $ 54 ​ $ 306,187 ​ $ 529 ​ $ ( 283,290 ) ​ $ 23,480 Stock-based compensation — ​ — ​ 3,760 ​ — ​ — ​ 3,760 Issuance of common stock offerings, net of fees incurred ​ 382,823 ​ ​ 1 ​ ​ 178 ​ ​ — ​ ​ — ​ ​ 179 Common stock issued upon vesting of restricted stock units, less shares withheld to cover taxes ​ 207,058 ​ ​ — ​ ​ ( 7 ) ​ ​ — ​ ​ — ​ ​ ( 7 ) Issuance of warrants ​ — ​ ​ — ​ ​ 691 ​ ​ — ​ ​ — ​ ​ 691 Foreign currency translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ 3,723 ​ ​ — ​ ​ 3,723 Net loss — ​ — ​ — ​ — ​ ( 20,719 ) ​ ( 20,719 ) Balance at December 31, 2024 54,830,146 ​ 55 ​ 310,809 ​ 4,252 ​ ( 304,009 ) ​ 11,107 Stock-based compensation ​ — ​ ​ — ​ ​ 2,765 ​ ​ — ​ ​ — ​ ​ 2,765 Common stock issued upon vesting of restricted stock units, less shares withheld to cover taxes ​ 295,510 ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — Shares issued for exercise of stock options ​ 11,650 ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — 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 ​ 2 ​ 1,437 ​ — ​ — ​ 1,439 Issuance of warrants — ​ — ​ 627 ​ — ​ — ​ 627 Foreign currency translation adjustment ​ — ​ ​ — ​ ​ — ​ ​ ( 7,229 ) ​ ​ — ​ ​ ( 7,229 ) Net loss — ​ — ​ — ​ — ​ ( 8,198 ) ​ ( 8,198 ) Balance at December 31, 2025 62,804,305 ​ $ 63 ​ $ 321,024 ​ $ ( 2,977 ) ​ $ ( 312,207 ) ​ $ 5,903 ​ The Notes to Consolidated Financial Statements are an integral part of these statements. ​ F-6 Table of Contents CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended ​ ​ ​ Year ended ​ ​ December 31, ​ December 31, ​ ​ 2025 ​ 2024 Cash flows from operating activities: ​ ​ ​ ​ ​ Net loss ​ $ ( 8,198 ) ​ $ ( 20,719 ) Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ ​ ​ Accrued final fee ​ ​ — ​ ​ 111 Amortization of debt discount ​ ​ 820 ​ ​ 265 Amortization of loan costs ​ ​ — ​ ​ 116 Amortization of patents ​ ​ 262 ​ ​ 235 Depreciation and amortization ​ 1,234 ​ ​ 1,335 Amortization of right-of-use asset ​ ​ 135 ​ ​ 174 Write off of inventory ​ ​ 253 ​ ​ — Bad debt expense ​ 40 ​ ​ 115 Loss on abandoned patents ​ 559 ​ ​ 334 Write off of fixed assets ​ ​ 104 ​ ​ — Foreign currency transaction (gains) losses ​ ( 9,321 ) ​ ​ 4,225 Stock-based compensation ​ ​ 2,765 ​ ​ 3,760 Changes in operating assets and liabilities: ​ ​ ​ ​ Grants and accounts receivable ​ 423 ​ ​ ( 1,720 ) Inventories ​ ( 2,540 ) ​ ​ 500 Prepaid expenses and other current assets ​ 1,791 ​ ​ ( 1,352 ) Other assets ​ 2 ​ ​ 1 Accounts payable and accrued expenses ​ ( 706 ) ​ ​ ( 1,808 ) Net cash used in operating activities ​ ( 12,377 ) ​ ​ ( 14,428 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from investing activities: ​ ​ ​ ​ Purchases of property and equipment ​ ( 164 ) ​ ​ ( 284 ) Disposal of property and equipment ​ ​ 76 ​ ​ — Patent costs ​ ( 327 ) ​ ​ ( 385 ) Net cash used in investing activities ​ ( 415 ) ​ ​ ( 669 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from financing activities: ​ ​ ​ ​ Proceeds from long-term debt ​ 2,478 ​ 15,000 Repayment of long-term debt ​ — ​ ( 5,000 ) Payment of final fee ​ ​ — ​ ​ ( 150 ) Payment of loan costs ​ ​ — ​ ​ ( 698 ) Proceeds from rights offering, net ​ 5,392 ​ — Cash for exercise of warrants, net ​ ​ 1,439 ​ ​ — Equity contributions - net of fees incurred ​ — ​ ​ 179 Net cash provided by financing activities ​ 9,309 ​ ​ 9,331 Effect of exchange rates on cash ​ 1,490 ​ ​ ( 85 ) Net change in cash, cash equivalents, and restricted cash ​ ( 1,993 ) ​ ​ ( 5,851 ) ​ ​ ​ ​ ​ ​ ​ Cash, cash equivalents, and restricted cash at beginning of year ​ 9,764 ​ ​ 15,615 Cash, cash equivalents, and restricted cash at end of year ​ $ 7,771 ​ $ 9,764 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of cash flow information: ​ ​ ​ ​ Cash paid during the year for interest ​ $ 2,082 ​ $ 1,290 ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of non-cash financing activities: ​ ​ ​ ​ Warrants issued in connection with modification of long-term debt ​ $ 627 ​ $ 691 Capital expenditures included in accounts payable ​ $ — ​ $ 8 Settlement of accrued bonuses with restricted stock units ​ $ — ​ $ 198 ​ The Notes to Consolidated Financial Statements are an integral part of these statements. ​ F-7 Table of Contents CYTOSORBENTS CORPORATION Notes to Consolidated Financial Statements December 31, 2025 1. PRINCIPAL BUSINESS ACTIVITY Nature of Business 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, its wholly-owned Indian subsidiary, CytoSorbents India Private Limited, based in Kasavanahalli, India, and its wholly-owned Dubai entity, CytoSorbents MEA FZCO, based in CommerCity, Dubai, conducts sales and marketing related operations for the CytoSorb device outside of the United States. Going Concern As of December 31, 2025, the Company’s total cash and cash equivalents and restricted cash was approximately $ 7.8 million, with $ 1.5 million classified as restricted, and $ 6.3 million as unrestricted and available to fund operations. 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 (see Note 12, “Restructuring”) and the impact of the Amended Loan and Security Agreement (see Note 5, “Long - Term Debt”) raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying 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 would allow for the opportunity to receive Tranche 2b of the Amended Avenue Capital Commitment by December 31, 2026, and receive an additional 6-month extension of the interest-only period on the credit facility. Additional sources of liquidity available to the Company include the 2024 Shelf (see Note 9, Stockholders’ Equity), 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. 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 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. ​ ​ 2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Consolidation and Foreign Currency Translation The accompanying consolidated financial statements include the results of CytoSorbents Corporation (the “Parent”), CytoSorbents Medical Inc., its wholly owned operating subsidiary (the “Subsidiary”), and CytoSorbents Europe GmbH, its wholly owned European subsidiary (the “European Subsidiary”). In addition, the consolidated financial statements include CytoSorbents Switzerland, CytoSorbents Poland Sp. z.o.o., CytoSorbents Medical UK Limited, and CytoSorbents France SAS, the 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. These entities are collectively referred to as the “Company”. 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 transaction gains and losses are included in other income (loss), net in the consolidated statements of operations and comprehensive loss. F-8 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 (“CODM”) is the Company’s Chief Executive Officer (“CEO”). 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 in Note 11, Segment Information) 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. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The Company’s restricted includes amounts held as collateral for a letter of credit with Bridge Bank, securing the College Road facility lease. The following table provides a reconciliation of cash, cash equivalents, and restricted cash to amounts shown in the consolidated balance sheets and consolidated statements of cash flows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ (amounts, in thousands) Cash and cash equivalents ​ $ 6,249 ​ $ 3,280 Restricted cash, current ​ ​ — ​ ​ 5,000 Restricted cash ​ 1,522 ​ 1,484 Total cash, cash equivalents and restricted cash ​ $ 7,771 ​ $ 9,764 ​ Accounts Receivable (Net of Allowance for Credit Losses) Trade accounts receivable consist of amounts due from direct customers, distributors and agencies of the U.S. government and are presented at net realizable value. At each balance sheet date, the Company estimates an expected allowance for credit losses inherent in the Company’s accounts receivable portfolio based on historical experience, specific allowances for known troubled accounts, and other available evidence. In addition, also at each reporting date, this estimate is updated to reflect any changes in credit risk since the receivable was initially recorded. This estimate is calculated on a pooled basis where similar risk characteristics exist. The Company has identified the following portfolio segments: direct customers, distributors/strategic partners and the U.S. government. A fixed reserve percentage for each pool is derived from a review of the Company’s historical losses in relation to the total pool. This estimate is adjusted quarterly for management’s assessment of current conditions, reasonable and supportable forecasts regarding future events, and any other factors deemed relevant by the Company. The Company believes historical loss information is a reasonable starting point in which to calculate the expected allowance for credit losses as the Company’s portfolio segments have remained constant over the Company’s historical evaluation period. The Company writes off receivables when there is information that indicates the debtor is facing significant financial difficulty and there is no possibility of recovery. If any recoveries are made from any accounts previously written off, they are recognized as an offset to credit loss expense in the year of recovery. The total amount of write-offs was immaterial to the financial statements as a whole for the years ended December 31, 2025 and 2024. The allowance for credit losses reflects accounts receivable balances that are written off when management determines they are uncollectible. The allowance for credit losses is measured on a collective (pool) basis when similar risk characteristics exist, and measures the allowance for credit losses using the following methods: Direct Customers—The Company measures expected credit losses on direct customer receivables using an aging methodology. The risk of loss for direct customer receivables is low based on the Company’s historical experience. The estimate of expected credit losses considers historical credit loss information that is adjusted for current conditions and supportable forecasts. F-9 Table of Contents Distributors/Strategic Partners—The Company measures expected credit losses on distributor receivables using an individual reserve methodology. The risk of loss in this portfolio is low based on the Company’s historical experience. The estimate of expected credit losses considers the past payment history of each distributor. U.S. Government- These receivables are related to the Company’s government grants. The Company measures expected credit losses on these receivables using an individual reserve methodology. The risk of loss in this portfolio is very low based on the Company’s historical experience, as these receivables are supported by approved grant award contracts. Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined based upon standard cost, which approximates actual cost, using a first-in first-out (“FIFO”) basis. Devices used in clinical trials or for research and development purposes are removed from inventory and charged to research and development expenses at the time of their use. Donated devices are removed from inventory and charged to selling, general and administrative expenses. The Company regularly reviews inventory quantities on hand and records inventory reserves for excess, obsolete, expired, and slow moving inventory based upon historical usage, product shelf life, forecasted demand, regulatory considerations, and other relevant factors. Inventory that is determined to be obsolete or expired is written off in the period such determination is made. Property and Equipment Property and equipment are recorded at cost less accumulated depreciation. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the lesser of their economic useful lives or the term of the related leases. Gains and losses on depreciable assets retired or sold are recognized in the statements of operations in the year of disposal. Repairs and maintenance expenditures are expensed as incurred. Patents Legal costs incurred to establish patents are capitalized. When patents are issued, capitalized costs are amortized on the straight-line method over the related patent term. In the event a patent is abandoned, the net book value of the patent is written off. Impairment or Disposal of Long-Lived Assets The Company assesses the impairment of patents and other long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. Leases The Company accounts for leases in accordance with FASB Accounting Standards Update (“ASU”) 2016-02, Leases, Topic 842 (“ASC 842”). Operating lease ROU assets and operating lease liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term. The Company determines if a contract contains a lease at the inception date and determines the lease classification, recognition, and measurement at commencement date. ROU assets also include adjustments related to prepaid or deferred lease payments. As the Company’s leases do not provide an implicit rate, the Company uses the incremental borrowing rate based on the information available at lease commencement date in determining the present value of lease payments. Options to extend a lease are included in the lease term when it is reasonably certain that the Company will exercise such options. Certain of the Company’s lease agreements include provisions for the Company to pay the lessor for common area maintenance, real estate taxes, and insurance, which the Company accounts for as variable lease costs. Revenue Recognition The Company recognizes revenue in an amount that reflects the consideration to which the Company expects to be entitled in exchange for goods or services transferred to its customers. To do this, the Company applies the following five-step model, to determine this amount: (i) identify the contract with a customer: (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when, or as, the Company satisfies the performance obligation. F-10 Table of Contents Revenue is typically recognized when the Company ships its products to its direct customers and distributors/strategic partners. The amount of revenue recognized reflects the consideration the Company expects to be entitled to receive in exchange for the products shipped or the services provided under their grant contracts. The Company’s contracts with its direct customers are generally in the form of a purchase order. The Company has formal written contracts with each of its distributors/strategic partners that define their respective territories and minimum purchase commitments which must be met in order to maintain exclusivity in their territory. Distributors/strategic partner customers also submit purchase orders with each order that define the terms of shipment and transaction price. The performance obligations in contracts with direct customers and distributors/strategic partners are for the shipment of the CytoSorb device and related accessory parts. The price charged is based on the Company’s price list for the CytoSorb device and related accessory parts for both direct customers and distributor/strategic partners. The Company does not permit returns for product sales. The Company also provides for certain rebates and discounts to direct customers for sales of its product that are earned based upon sales volume. These amounts, which are earned based on calendar year sales volume, are recorded as a reduction of sales as earned. The transaction price for the performance obligation is based on the purchase orders received for both direct customers and on the type of contract and are outlined in each contract. The Company satisfies its performance obligation to direct customers and distributors/strategic partners generally upon shipment of the products. Research and Development, Net of Grant Income All research and development costs, payments to laboratories, research consultants and costs related to clinical trials and studies are expensed when incurred. Currently, accounting for grants does not fall under ASC 606, as the grantor will not benefit directly from the Company’s expansion or product development, and no products or services are transferred to the grantor. The Company records grant income, net of expenses, as a reduction of research and development expenses. Refer to the “Effect of Recent Accounting Pronouncements” section below for additional information. Advertising Expenses Advertising costs are charged to activities when incurred. Advertising expense amounted to approximately $ 0.3 million, in both 2025 and 2024, and is included in selling, general, and administrative expenses in the consolidated statements of operations and comprehensive loss. Income Taxes Income taxes are accounted for under the asset and liability method prescribed by accounting standards for accounting for income taxes. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized. Under Section 382 of the Internal Revenue Code, the net operating losses generated prior to the previously completed reverse merger may be limited due to the change in ownership. Additionally, net operating losses generated subsequent to the reverse merger may be limited in the event of changes in ownership. The Company follows the accounting standards associated with uncertain tax provisions. The Company had unrecognized tax benefits of $ 2.1 million and $ 2.2 million as of December 31, 2025 and 2024, respectively. 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 tax carryforwards and Research and Development credits to an industrial company. F-11 Table of Contents CytoSorbents Europe GmbH, CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp. z.o.o., CytoSorbents UK Limited, CytoSorbents Medical UK Limited, CytoSorbents France SAS, CytoSorbents India Private Limited, and CytoSorbents MEA FZCO file an annual corporate tax return, a VAT return and a trade tax return in Germany, Switzerland, Poland, the United Kingdom, France, India, and Dubai, respectively. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the balance sheet, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates. The valuation of options and warrants granted, allowance for credit losses and recoverability of patents are significant estimates in these consolidated financial statements. 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 account 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 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 are from product sales in Germany. See Note 3, “Revenue” for further information relating to the Company’s revenue. The Company does not have any significant concentration of risk with respect to any one particular supplier. As of December 31, 2025, one distributor accounted for approximately 17 % of the Company’s outstanding accounts receivable. As of December 31, 2024, one distributor accounted for approximately 19 % of the Company’s outstanding accounts receivable. For the year ended December 31, 2025, no distributor or direct customer accounted for more than 10 % of the Company’s revenue. For the year ended December 31, 2024, one distributor accounted for approximately 11 % of the Company’s revenue. Fair Value of Financial Instruments The carrying values of cash and cash equivalents, restricted cash, accounts receivable, prepaid expense and other current assets, right-of-use assets, accounts payable and accrued expenses, lease liability – current portion, other current liabilities, and lease liability, net of current portion approximate their fair values due to their short-term nature. Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480 and ASC 815 “Derivatives and Hedging” (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of equity at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as liabilities at their initial fair value on the date of issuance, and each balance sheet date thereafter. The Company estimates the fair value of warrants using the Black-Scholes option pricing model or the Monte Carlo pricing model. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The warrants issued upon the closing of the Company’s December 13, 2023, offering, the closing of the Company’s June 2024 debt financing, the rights offering on January 10, 2025, and the execution of the debt amendment on November 13, 2025 all met the criteria for equity classification under ASC 815. Accordingly, these warrants have been classified as equity as of December 31, 2025 and December 31, 2024. F-12 Table of Contents Stock-Based Compensation The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, including stock options, restricted shares (“RSUs”), based on estimated fair values at the award grant date. The fair value of stock-based awards is amortized over the vesting period of the award using a straight-line method. Stock-based compensation expense for awards with performance conditions is recognized when it is probable that the performance condition will be achieved and is then recognized over the requisite service period. Any changes in the probability assessment are accounted for as a cumulative adjustment to the current period compensation cost. To estimate the fair value of an award, the Company uses the Black-Scholes option pricing model. This model requires inputs such as expected life, expected volatility, expected dividend yield of stock and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. While estimates of expected life and volatility are derived primarily from the Company’s historical data, the risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected life assumption. The Company accounts for forfeitures in the period they occur. The Company also follows the guidance of accounting standards for accounting for equity instruments that are issued to non-employees for acquiring, or in conjunction with selling, goods or services for equity instruments issued to consultants. Net Loss per Common Share Net income or loss per common share is calculated as basic net income or loss per share and diluted net income per share, in the case of recognizing net income. 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 computation of diluted net loss per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings. The following table presents the calculation of net loss per share: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years Ended December 31, ​ ​ 2025 ​ ​ ​ 2024 Basic and Diluted: ​ (amounts, in thousands, except share and per share data) Numerator: ​ ​ ​ ​ Net loss ​ $ ( 8,198 ) ​ $ ( 20,719 ) Denominator: ​ ​ ​ ​ Basic and diluted weighted average common shares outstanding ​ 62,231,771 ​ 54,434,609 ​ ​ ​ ​ ​ ​ ​ Basic and diluted earnings per common share ​ $ ( 0.13 ) ​ $ ( 0.38 ) ​ The following table presents the potentially dilutive shares that were excluded from the computation of diluted net loss per share of common stock attributable to common stockholders, because their effect was anti-dilutive: ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Stock options outstanding 10,988,604 12,341,914 Warrants for common stock 5,780,701 4,352,130 RSUs* 3,529,301 3,450,836 Convertible securities 2,105,263 2,105,263 * Total number of RSUs include 2,754,000 units with a Change in Control-Based performance condition. ​ F-13 Table of Contents Shipping and Handling Costs The cost of shipping products to customers and distributors is typically borne by the customer or distributor. The Company records shipping and handling costs in cost of goods sold. Total freight costs amounted to approximately $ 0.5 and $ 0.4 million for the years ended December 31, 2025 and 2024, respectively. Effect of Recent Accounting Pronouncements In December 2023, the FASB issued ASU No. 2023-09 entitled “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This ASU provides guidance related to additional disclosures related to income taxes. The updated guidance is effective for public entities for fiscal years beginning after December 15, 2024. The Company implemented the updated guidance as of January 1, 2025 using a prospective method. This ASU resulted in additional disclosures in the Company’s consolidated financial statements related to income taxes in 2025. Refer to Note 7, Income Taxes, for additional information. In December 2025, the FASB issued ASU No. 2025-10 entitled “Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities.” This ASU provides guidance related to business entities that receive a government grant. The updated guidance requires grants related to income presented separately under a general heading such as other income or as a deduction from the related expense and is effective for annual reporting periods beginning after December 15, 2028. The Company has early adopted this guidance and records grant income, net of expenses, as a reduction of research and development expenses for the years ended December 31, 2025 and 2024. Recent Accounting Pronouncements Not Yet Effective In November 2024, the FASB issued ASU 2024-03 entitled, “Income Statement- Reporting Comprehensive Income- Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses.” This ASU requires public business entities (“PBEs”) to disclose, in interim and annual reporting periods, additional information about certain expenses in the notes to the financial statements, including disclosing the amounts of purchases of inventory, employee compensation, depreciation, and intangible asset amortization in each relevant expense caption. It also requires PBEs to disclose a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively and to disclose the total amount of selling expenses, and in the annual reporting periods, an entity’s definition of selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, with early adoption permitted. The Company is currently evaluating the disclosure requirements of this standard and the impact on its consolidated financial statements. In July 2025, the FASB issued ASU 2025-05 entitled, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets.” This ASU provides all entities with a practical expedient when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under Topic 606. In developing reasonable and supportable forecasts as part of estimating expected credit losses, all entities may elect a practical expedient that assumes that current conditions as of the balance sheet date do not change for the remaining life of the asset. The amendments are effective for annual reporting periods beginning after December 15, 2025 and interim reporting periods within those annual reporting periods. The Company is currently evaluating this standard and its impact on its consolidated financial statements. Reclassifications Certain amounts included in prior year financial statements have been reclassified to conform to the current year presentation. These reclassifications did not have a material impact on the Company’s previously reported financial statements. ​ ​ F-14 Table of Contents 3. REVENUE The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ ​ ​ ​ Direct ​ ​ ​ Strategic Partners ​ ​ ​ Total ​ ​ (amounts, in thousands) Product revenue: ​ ​ ​ ​ ​ ​ United States ​ $ 249 ​ $ — ​ $ 249 Germany ​ 11,751 ​ ​ — ​ ​ 11,751 All other countries ​ 8,603 ​ 16,460 ​ 25,063 ​ ​ ​ ​ ​ ​ ​ Product revenue ​ $ 20,603 ​ $ 16,460 ​ $ 37,063 ​ The following table disaggregates the Company’s revenue by customer type and geographic area for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Distributors/ ​ ​ ​ ​ ​ ​ ​ Direct ​ ​ ​ Strategic Partners ​ ​ ​ Total ​ ​ (amounts, in thousands) Product revenue: ​ ​ ​ ​ ​ ​ United States ​ $ 115 ​ $ 36 ​ $ 151 Germany ​ 13,050 ​ ​ — ​ ​ 13,050 All other countries ​ 7,616 ​ ​ 14,778 ​ ​ 22,394 ​ ​ ​ ​ ​ ​ ​ ​ ​ Product revenue ​ $ 20,781 ​ $ 14,814 ​ $ 35,595 ​ 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. CytoSorb is not yet approved for commercial sale in the United States. The Company’s U.S. sales relate to its VetResQ related products for emergency and critical care in animals. Direct sales outside the United States relate to sales to hospitals located in Germany, Switzerland, Austria, Belgium, Luxembourg, Poland, the Netherlands, Sweden, Denmark, Norway, India, Dubai, and the United Kingdom and others. 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. Distributor and strategic partner sales make up the remaining product sales. These distributors are located in various countries throughout the world. The Company has a formal written contract with each distributor/strategic partner. These contracts have terms ranging from 1 - 5 years in length, with three years being the typical term. 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/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. F-15 Table of Contents The following table provides information about receivables and contract liabilities from contracts with customers: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2025 ​ ​ ​ December 31, 2024 ​ ​ (amounts in thousands) Contract receivables, which are included in accounts receivable ​ $ 7,125 ​ $ 5,582 Contract liabilities, which are included in accrued expenses and other current liabilities ​ $ 182 ​ $ 596 ​ Contract receivables represent unconditional rights to consideration for goods delivered or services performed under contracts with customers, including purchase orders. These amounts, which are included in accounts receivable on the consolidated balance sheets, were approximately $ 7.1 million, $ 5.6 million, and $ 5.3 million at December 31, 2025, 2024, and 2023, respectively. Contract liabilities, which are included in accrued expenses and other current liabilities on the 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 at December 31, 2025, 2024, and 2023, and deferred grant liability related to the billing on fixed price government contracts in excess of costs incurred $ 0 , $ 0.4 million, and $ 1.4 million of deferred grant liability at December 31, 2025, 2024, and 2023 respectively. ​ 4. BALANCE SHEET COMPONENTS Inventories - net The Company had the following major classes of inventory: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ ​ (amounts in thousands) Raw Materials ​ $ 751 ​ $ 570 Work in Process ​ 1,014 ​ 503 Finished Goods ​ 3,528 ​ 1,660 Inventories ​ $ 5,293 ​ $ 2,733 Less reserve ​ ​ ( 12 ) ​ ​ — Inventories – net ​ $ 5,281 ​ $ 2,733 ​ Property and equipment - net ​ The Company’s Property and equipment - net, consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31 ​ Depreciation ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Period ​ ​ (amounts in thousands) ​ ​ Furniture and fixtures ​ $ 1,532 ​ $ 1,454 7 years Equipment and computers ​ 5,129 ​ 5,491 3 to 7 years Leasehold improvements ​ 6,308 ​ 6,283 Lesser of term of lease or estimated useful life ​ ​ 12,969 ​ 13,228 ​ Less accumulated depreciation ​ ( 5,146 ) ​ ( 4,226 ) ​ Property and Equipment, Net ​ $ 7,823 ​ $ 9,002 ​ ​ Depreciation expense for the years ended December 31, 2025 and 2024, amounted to $ 1.2 million and $ 1.3 million, respectively. F-16 Table of Contents Patents - net ​ Patents consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ (amounts in thousands) Patent applications pending ​ $ 1,356 ​ $ 1,585 Patents issued ​ ​ 3,298 ​ ​ 3,391 Less accumulated amortization of patents issued ​ ( 1,428 ) ​ ( 1,255 ) Patents - net ​ 3,226 ​ 3,721 ​ Patent amortization expense amounted to $ 0.3 million, and $ 0.2 million for the years ended December 31, 2025 and 2024, respectively. During the years ended December 31, 2025 and 2024, the Company wrote-off patent costs of approximately $ 0.6 million and $ 0.3 million, respectively, related to the abandonment 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. ​ Patent amortization expense for the next five years and thereafter is scheduled as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ (amounts, in thousands) 2026 ​ $ 245 2027 ​ 240 2028 ​ 227 2029 ​ 227 2030 ​ 227 Thereafter ​ ​ 704 Scheduled amortization of patents issued ​ $ 1,870 ​ Accrued expenses and other current liabilities ​ Accrued expenses and other current liabilities consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ ​ (amounts, in thousands) Accrued salaries and commissions ​ $ 3,413 ​ $ 3,076 Professional fees ​ ​ 856 ​ ​ 773 Clinical studies ​ 522 ​ 590 Deferred revenue ​ 182 ​ 596 Royalties ​ ​ 271 ​ ​ 275 Goods received not invoiced ​ ​ 150 ​ ​ 87 Other ​ 905 ​ 635 Accrued expenses and other current liabilities ​ $ 6,299 ​ $ 6,032 ​ ​ ​ 5. LONG-TERM DEBT Loan and Security Agreement June 28, 2024 Loan: On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with 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”) consisted of $ 10 million, which was available to the Company on the Closing Date and $ 5 million constituted restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved: (i) the United States Food and Drug Administration (the “FDA”) has accepted the Company’s application for review with respect to its DrugSorb-ATR De Novo 510(k) and (ii) the Company 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”) consisted of $ 5 million, which would have been F-17 Table of Contents disbursed at the Company’s request between July 1, 2025 and December 31, 2025, if the Company received FDA marketing approval of its DrugSorb-ATR application, which it did not. The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and were additionally used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment 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 )%. 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 28, 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 ASC 815. The loan required 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 had drawn the full amount of Tranche 2 by December 31, 2025, and achieves for the trailing six-month period ended June 30, 2025, at least $ 25 million of revenue, (the Interest only Milestone as defined in the Loan), the Interest only Period would have been 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 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 allowed for the $ 5 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use. 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 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 Collateral Agent. November 13, 2025 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 funded an additional aggregate $ 2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and extended 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 and receive a further six-month extension of the interest only period to the July 1, 2027 maturity date, 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 revenue and certain operating cash burn targets prior to FDA approval of DrugSorb-ATR. 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 December 31, 2025, the Company was in compliance with these covenants. The Company evaluated the amendment in accordance with applicable accounting guidance and determined that the amendment should be accounted for as a debt modification. As a result of the debt amendment, there were no write-offs of existing unamortized deferred financing costs. The Company recorded new deferred financing costs of approximately $ 0.6 million related to the F-18 Table of Contents fair value of warrants issued in connection with the debt amendment. The Company incurred approximately $ 0.1 million of third-party costs which were recorded as other expenses related to financing. The Company’s obligations under the Amended Loan and Security Agreement are joint and several (see June 28, 2024 Loan for obligation under original loan agreement). 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. Debt Discounts Related to Avenue Capital Group Agreements In connection with the long-term debt transactions, the Company recorded the following discounts: ​ ​ ​ ​ ​ ​ ​ ​ ​ (amounts, in thousands) Fair value of warrants issued to Avenue Capital Group - 2024 ​ $ 690 Fair value of warrants issued to Avenue Capital Group - 2025 ​ ​ 627 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 ​ $ 2,915 ​ 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. The Company’s obligations under the Amended 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. Long - term debt as of December 31, 2025, and 2024 consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, 2025 ​ ​ As of December 31, 2024 ​ ​ ​ ​ (amounts in thousands) Principal amount ​ ​ ​ $ 17,500 ​ ​ ​ ​ 15,000 Plus: final payment upon maturity ​ ​ 900 ​ ​ 900 Less unamortized debt discount ​ ( 1,733 ) ​ ​ ( 1,904 ) Subtotal ​ 16,667 ​ ​ 13,996 Less current maturities ​ — ​ ​ — Long-term debt net of current maturities ​ $ 16,667 ​ ​ 13,996 ​ As of December 31, 2025, principal payments of long-term debt, including the final payment, are due as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ (amounts, in thousands) 2026 ​ $ — 2027 ​ 18,400 Total ​ $ 18,400 ​ Bridge Bank On June 28, 2024, concurrent with the closing of the Avenue Capital Group financing discussed above, the Company paid off its existing outstanding debt with Bridge Bank. F-19 Table of Contents As of December 31, 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 Bridge 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 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 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 the 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. Prior to repayment of the loan on June 28, 2024, the Company had drawn the first tranche of the loan and would be subject to total success fees of less than $ 0.1 million if the stock price exceeds $ 8.00 for five consecutive trading days prior to December 27, 2027. The Company did no t draw down the second or third tranche prior to repayment of the loan. The termination date of the 2022 Success Fee Letter is December 27, 2027. ​ ​ ​ 6. 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 December 31, 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 operating leases is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the year ended December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ (amounts, in thousands) Cash paid in connection with operating leases ​ $ 1,696 ​ $ 1,684 ​ Supplemental balance sheet information related to operating leases is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ 2024 ​ ​ ​ ​ (amounts, in thousands) ​ Right-of-use asset ​ $ 10,924 ​ $ 11,511 ​ Lease liability – current portion ​ $ 541 ​ ​ 453 ​ Lease liability – net of current portion ​ 11,903 ​ ​ 12,444 ​ Total lease liability ​ $ 12,444 ​ $ 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the year ended December 31, ​ ​ ​ ​ 2025 ​ 2024 ​ ​ (amounts, in thousands) Operating lease cost ​ $ 1,743 ​ ​ ​ $ 1,701 Variable lease cost ​ 510 ​ 499 Total lease cost ​ $ 2,253 ​ $ 2,200 ​ F-20 Table of Contents As of December 31, 2025, the maturities of the lease liabilities are as follows: ​ ​ ​ ​ ​ 2026 ​ ​ ​ $ 1,736 2027 ​ 1,777 2028 ​ 1,819 2029 ​ 1,863 2030 ​ 1,907 Thereafter ​ 11,643 Future operating lease payments ​ ​ 20,745 Imputed interest ​ ​ ( 8,301 ) Total lease liability ​ $ 12,444 ​ ​ 7. INCOME TAXES In December 2023, FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. The Company adopted ASU 2023-09 for the annual period beginning January 1, 2025, using a prospective transition method in accordance with ASC 740-10-65-9. Accordingly, the Company has presented the enhanced income tax disclosures, including disaggregated effective tax rate reconciliation and disaggregated income taxes paid, beginning with the year ended December 31, 2025, and has not restated prior-period comparative disclosures. The adoption of ASU 2023-09 affected only the Company’s income tax disclosures and did not have a material impact on its consolidated financial position, results of operations, or cash flows. The Company’s consolidated loss before income taxes for the years ended December 31, 2025 and 2024 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ (amounts, in thousands) Domestic ​ $ ( 9,608 ) ​ $ ( 11,723 ) Foreign ​ 1,009 ​ ( 10,687 ) Total ​ $ ( 8,599 ) ​ $ ( 22,410 ) ​ F-21 Table of Contents The benefit for income taxes consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ (amounts, in thousands) Current: ​ ​ ​ ​ ​ ​ Federal ​ $ — ​ $ — State Tax, including sale of New Jersey losses & credits ​ ​ 401 ​ ​ 1,691 Foreign tax provision ​ — ​ — Total current ​ ​ 401 ​ ​ 1,691 ​ ​ ​ ​ ​ ​ ​ Deferred ​ ​ ​ ​ ​ ​ Federal ​ ​ — ​ ​ — State Tax, including sale of New Jersey losses & credits ​ ​ — ​ ​ — Foreign tax provision ​ ​ — ​ ​ — Total deferred ​ ​ — ​ ​ — ​ ​ ​ ​ ​ ​ ​ Total income tax provision (benefit) ​ ​ ​ ​ ​ ​ Federal ​ ​ — ​ ​ — State Tax, including sale of New Jersey losses & credits ​ ​ 401 ​ ​ 1,691 Foreign tax provision ​ ​ — ​ ​ — Total ​ $ 401 ​ $ 1,691 ​ Income taxes paid (net of refunds received) for the years ended December 31, 2025 and 2024, consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ ​ ​ ​ 2024 ​ ​ (amounts, in thousands) Federal ​ $ — ​ ​ ​ State ​ ( 1,712 ) ​ ​ ( 881 ) Foreign ​ — ​ ​ ​ Total ​ $ ( 1,712 ) ​ ​ ( 881 ) ​ The Company has deemed any foreign earnings will be indefinitely reinvested. Currently, foreign operations have resulted in an accumulated deficit. The Company will continue to analyze their stance if their circumstances change in the future. As of December 31, 2025, the Company had federal net operating loss (“NOL”) carry forwards of $ 118.8 million, state NOL carry forwards of $ 11.8 million, and foreign NOL carry forwards of $ 68.0 million which are available to reduce future taxable income. Any unutilized NOL carry forwards will begin to expire at various dates starting in 2026 and some may be carried indefinitely. As of December 31, 2025 and 2024, the Company had Federal and state research and development tax credit carryforwards of $ 2.1 million and $ 2.2 million (net of uncertain tax benefits), respectively, available to reduce future tax liabilities which will begin to expire at various dates starting in 2026. The federal NOL carryforwards of $ 47.6 million, if not utilized, will expire between 2026 and 2038. The federal NOL carryforwards of $ 71.2 million generated since 2018 are subject to an 80% limitation on taxable income , do not expire and will carry forward indefinitely. The NOL carry forwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. The NOLs may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Section 382 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. In addition to the new provisions enacted under the Tax Cuts and Jobs Act, this could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will generally be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has not determined whether such a change has occurred and accordingly, the utilization of the net operating loss carryforwards may be subject to certain limitations. F-22 Table of Contents Sale of NOLs The Company may be eligible, from time to time, to receive cash from the sale of its Net Operating Losses and R&D tax credits under the State of New Jersey Technology Business Tax Certificate Transfer Program. As of December 31, 2025, the Company has accrued a receivable $ 0.4 million from the approved sale of the 2024 state NOL and research and development credits. The Company expects to collect this receivable in the first half of 2026. The principal components of the Company’s deferred tax assets and liabilities are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2025 ​ 2024 ​ ​ (amounts, in thousands) Current and long term deferred tax assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Federal NOL ​ $ 24,947 ​ $ 21,693 Foreign NOL ​ ​ 20,003 ​ ​ 17,164 NJ NOL ​ ​ 837 ​ ​ 459 Net operating loss carryforward ​ ​ 45,787 ​ ​ 39,316 Stock Options ​ 590 ​ 483 Federal R&D Credit ​ ​ 2,104 ​ ​ 2,224 Research and development credit carryforward ​ 2,104 ​ 2,224 Other ​ ​ 353 ​ ​ 458 Charitable Contributions ​ ​ 6 ​ ​ 6 Accruals and others ​ 359 ​ 464 §174(b) research & experimental ​ 3,138 ​ 5,486 §163(j) business interest expense ​ ​ 835 ​ ​ 255 Lease Liability ​ 3,498 ​ 3,625 Gross deferred tax assets ​ ​ 56,311 ​ ​ 51,853 Less valuation allowance ​ ( 52,852 ) ​ ( 48,268 ) ​ ​ ​ 3,459 ​ ​ 3,585 Deferred tax liability: ​ ​ ​ ​ Fixed Assets ​ ( 388 ) ​ ( 349 ) Right of Use Asset ​ ( 3,071 ) ​ ( 3,236 ) Net deferred tax assets ​ $ — ​ $ — ​ In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based on this assessment, management has established a full valuation allowance against all of the deferred tax assets for each period because it is more likely than not that all of the deferred tax assets will not be realized. The changes in valuation allowance for the years ended December 31, 2025 and 2024 were $ 4.6 million and $ 2.9 million, respectively. F-23 Table of Contents A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows for the year ended December 31 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ $ ​ ​ ​ % Federal statutory rate ​ $ ( 1,806 ) 21.0 % State and local income taxes, net of federal income tax effect ​ ( 318 ) 3.7 ​ Foreign tax effects ​ ​ ​ ​ ​ ​ Germany ​ ​ ​ ​ ​ ​ Foreign rate differential ​ ( 466 ) 5.4 ​ Foreign-exchange tax effects ​ ( 2,060 ) 24.0 ​ Change in valuation allowance ​ 3,117 ( 36.3 ) ​ Foreign deferred tax adjustments ​ 494 ( 5.7 ) ​ Other foreign jurisdictions ​ 173 ( 2.0 ) ​ Total foreign tax effects ​ 1,258 ( 14.6 ) ​ Tax credits ​ ​ ​ ​ ​ ​ Research and development tax credits ​ 240 ( 2.8 ) ​ Changes in valuation allowance ​ 1,509 ( 17.5 ) ​ Nontaxable or nondeductible items ​ ​ ​ ​ Incentive stock options ​ 151 ( 1.8 ) ​ Restricted stock units shortfall ​ 136 ( 1.6 ) ​ Deferred true-ups ​ ( 348 ) 4.1 ​ Expiring Federal NOL ​ 362 ( 4.2 ) ​ Other ​ 5 ( 0.1 ) ​ Total nontaxable or nondeductible items ​ 306 ( 3.6 ) ​ Changes in unrecognized tax benefits ​ ​ ​ ​ Federal R&D credit ​ ( 120 ) 1.4 ​ Other ​ ​ ​ ​ ​ ​ Consolidation and intercompany eliminations ​ ​ ( 1,470 ) ​ 17.1 ​ ​ ​ ​ ​ ​ ​ ​ Effective income tax rate ​ $ ( 401 ) 4.7 % ​ For the year ended December 31, 2025, state income taxes in New Jersey comprise the state and local income taxes, net of federal income tax effect category . A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows for the year ended December 31 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ 2024 ​ ​ ​ Federal statutory rate 21.0 % State taxes, net of federal benefit 2.6 Foreign rate differential 3.1 Permanent items ( 3.6 ) Other rate change and true-up 0.3 NJ NOL and R&D credit write-off ​ ( 8.4 ) ​ True up of foreign NOLs ​ ( 4.2 ) ​ NJ Amended NOL ​ 1.8 ​ Uncertain tax positions ​ ( 0.6 ) ​ Change in valuation allowance ( 13.1 ) R&D credit 1.1 Sale of 2023 NJ R&D & NOL 7.6 Other ​ — ​ Effective income tax rate 7.6 % ​ F-24 Table of Contents A reconciliation of the unrecognized tax benefit balances is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ (amounts, in thousands) Balance at beginning of the year ​ $ 2,224 ​ $ 2,113 Increase for tax positions of prior years ​ ( 120 ) ​ ( 9 ) Increase for tax positions in current year ​ — ​ 120 Balance at end of the year ​ $ 2,104 ​ $ 2,224 ​ The Company and its subsidiaries file income tax returns in the U.S. federal jurisdiction and New Jersey. With few exceptions, we are no longer subject to U.S. federal, state and local, or non-U.S. income tax examinations by tax authorities for years before 2020, although NOL carryforwards and tax credit carryforwards from any year are subject to examination and adjustment for at least three years following the year in which they are fully utilized. As of December 31, 2025, no significant adjustments have been proposed relative to our tax positions. For year ended December 31, 2025, there are no interest and penalties relating to our uncertain tax positions. The Company is accounting for an uncertain tax position of approximately $ 2.1 million and $ 2.2 million as of December 31, 2025 and 2024, respectively. ​ 8. 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. On March 5, 2024, a former employee filed a complaint against us in the Superior Court of New Jersey, Law Division, Mercer County, alleging retaliatory termination in breach of the New Jersey Conscientious Employee Protection Act (“CEPA”). Following further discussion, the parties agree there was a professional misunderstanding between them and have amicably resolved the litigation. Royalty Agreement The Company is, at times, party to various royalty and license agreements that require the payment of royalty fees. Currently the Company records royalty expense of 3 % on sales of Covered Products, under the ROKK, LLC Royalty Contract. Royalty expense amounted to approximately $ 1.1 million and $ 1.9 million for the years ended December 31, 2025 and 2024, respectively. Royalty expense is included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. The decrease in royalty fees in 2025 was the result of the expiration of a 4 % royalty in August of 2024, net of increases in revenue applicable to royalty agreements. 401 (k) Plan In June 2014, the Company formed the CytoSorbents 401(k) Plan. The plan is a defined contribution plan as described in section 401(k) of the Internal Revenue Code (“IRC”) covering substantially all full-time employees. Employees are eligible to participate in the 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 IRC limitations. Effective January 1, 2021, the Company changed its matching contribution to 100 % of the participants contribution up to three percent of compensation plus 50 % of the participants contribution over three percent of compensation up to a maximum of five percent of compensation. Matching contributions amounted to $ 0.3 million and $ 0.4 million for the years ended December 31, 2025 and 2024, respectively. ​ F-25 Table of Contents 9. STOCKHOLDERS’ EQUITY Preferred Stock In June 2019, the Company amended and restated its Certificate of Incorporation. The amended and restated certificate of incorporation authorizes the issuance of up to 5,000,000 shares of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board of Directors. Common Stock For the years ended December 31, 2025 and 2024, issuance of common stock offerings, net of fees incurred were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the year ended December 31, 2025 ​ ​ For the year ended December 31, 2024 ​ ​ ​ ​ Shares Issued ​ ​ ​ Proceeds, Net of Fees ​ ​ Shares Issued ​ ​ ​ Proceeds, Net of Fees January 10, 2025 Offering ​ 6,249,791 ​ $ 5,392 ​ ​ — ​ $ — Series A Rights Warrants ​ 1,417,208 ​ ​ 1,439 ​ ​ ​ ​ ​ ​ Open Market Sale Agreement with Jefferies LLC ​ — ​ ​ — ​ ​ 383 ​ ​ 179 ​ ​ 7,666,999 ​ $ 6,831 ​ ​ 383 ​ $ 179 ​ Shelf Registration On July 26, 2024, the Company filed a registration statement on Form S-3 with the SEC (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 the Form S-3 with 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. Open Market Sale Agreement with Jefferies LLC On December 30, 2021, the Company entered into an Open Market Sale Agreement (the “Sale Agreement”) with Jefferies LLC (the “Agent”), pursuant to which the Company may sell, from time to time, at its option, shares of the Company’s common stock having an aggregate offering price of up to $ 25 million through the Agent, as the Company’s sales agent. However, as a result of limitations related to the Company’s market capitalization discussed above, the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to approximately $ 19.7 million from time to time through the Agent. If the Company’s public float increases above $75 million, the Company may sell additional amounts under the Sales Agreement. All shares of the Company’s common stock offered and sold, or to be offered and sold under the Sale Agreement will be issued and sold pursuant to the Company’s 2024 Shelf by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, in block transactions or if specified by the Company, in privately negotiated transactions. Subject to the terms of the Sales Agreement, the Agent is required to use its commercially reasonable efforts consistent with their normal sales and trading practices to sell the shares of the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company is required to pay the Agent a commission of up to 3.0 % of the gross proceeds from the sale of the shares of the Company’s common stock sold thereunder, if any. F-26 Table of Contents January 10, 2025 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 were available for issue upon exercise of the Right Warrants. Once the 6.25 million shares of common stock reserved for the Right Warrants were issued, the remaining outstanding and unexercised Right Warrants would have expired worthless. Management and the Board of Directors of the Company 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 ​ ​ ​ Series B Right ​ ​ ​ Warrant ​ ​ ​ 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 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 transferrable 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. ​ F-27 Table of Contents 10. STOCK-BASED COMPENSATION Stock Option Plans As of December 31, 2025, the Company had two Long Term Incentive Plans (the “2014 Plan” and the “2006 Plan”, collectively, the “Plans”)) to attract, retain, and provide incentives to employees, officers, directors, and consultants. The Plans generally provide for the granting of stock, stock options, stock appreciation rights, restricted shares, or any combination of the foregoing to eligible participants. In June 2024, the Company amended and restated CytoSorbents Corporation 2014 Long-term Incentive Plan (the “Plan”). The amended and restated Plan increased the number of shares to be reserved and authorized for issuance under the Plan by 7,500,000 shares to 20,900,000 shares of the Company’s Common Stock. A total of 20,900,000 and 2,400,000 shares of common stock are reserved for issuance under the 2014 Plan and the 2006 Plan, respectively. As of December 31, 2024, there were approximately 8.7 million shares of common stock remaining for issuance under the Plans. As of December 31, 2025, there were approximately 9.7 million shares of common stock remaining for issuance under the Plans. Total stock-based compensation expense for the year ended December 31, 2025 amounted to $ 2.8 million, of which $ 1.9 million and $ 0.9 million were for stock options and restricted stock units, respectively. Total stock-based compensation expense for the year ended December 31, 2024 amounted to $ 3.8 million, of which $ 3.2 million and $ 0.6 million were for stock options and restricted stock units, respectively. These amounts are included in selling, general, and administrative expenses on the consolidated statements of operations and comprehensive loss. 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 consolidated statements of operations and comprehensive loss: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2025 ​ 2024 Stock-based compensation expense by category ​ (amounts, in thousands) Cost of goods sold ​ ​ ​ $ 140 ​ ​ ​ $ 239 Research and development, net of grant income ​ 388 ​ 691 Selling, general and administrative ​ 2,237 ​ 2,830 Total stock-based compensation expense ​ $ 2,765 ​ $ 3,760 ​ The summary of the stock option activity for the years ended December 31, 2025 and 2024 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Weighted ​ Average ​ ​ ​ ​ Average ​ Remaining ​ ​ ​ ​ Exercise ​ Contractual ​ ​ ​ ​ Shares ​ ​ ​ per Share ​ ​ ​ Life (Years) ​ ​ ​ ​ ​ ​ ​ ​ Outstanding, December 31, 2023 10,548,174 ​ $ 4.49 7.01 Granted 3,982,846 ​ $ 0.97 9.32 Forfeited ( 1,391,897 ) ​ $ 2.24 — Expired ( 797,209 ) ​ $ 5.34 — Outstanding, December 31, 2024 12,341,914 ​ $ 3.55 ​ 6.81 Granted 812,800 ​ $ 1.00 — Forfeited ( 1,780,685 ) ​ $ 1.83 — Expired ( 373,775 ) ​ $ 5.54 — Exercised ( 11,650 ) ​ $ 0.96 — Outstanding, December 31, 2025 10,988,604 ​ $ 3.58 5.98 ​ F-28 Table of Contents The fair value of each stock option was estimated using the Black-Scholes pricing model which takes the following inputs into account. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Grant Date ​ ​ ​ Weighted Average Expected Life ​ ​ ​ Expected ​ ​ ​ ​ ​ ​ ​ Risk Free ​ ​ Exercise Price ​ of the Stock ​ Volatility ​ Expected ​ Interest Rate Year - Ended ​ Range ​ Option* ​ Range ​ Dividends ​ Range ​ December 31, 2024 ​ $ 0.84 - $ 1.19 per share ​ 6.1 years ​ 75.6 % to 80.1 % — % 3.60 % to 4.65 % December 31, 2025 ​ $ 0.70 - $ 1.30 per share ​ 6.3 years ​ 80.7 % to 82.5 % — % 3.66 % to 4.40 % * 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. In addition, the Company recognizes forfeitures as they occur. The intrinsic value is calculated at the difference between the market value as of December 31, 2025 of $ 0.64 and the exercise price of the shares. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Options Outstanding ​ ​ Number ​ Weighted ​ Weighted ​ ​ ​ Range of ​ Outstanding at ​ Average ​ Average ​ Aggregate Exercise ​ December 31, ​ Exercise ​ Remaining ​ Intrinsic Price ​ ​ ​ 2025 ​ ​ ​ Price ​ ​ ​ Life (Years) ​ ​ ​ Value $ 0.70 - $ 13.20 10,988,604 ​ $ 3.58 ​ 5.98 ​ $ — ​ ​ ​ ​ ​ ​ ​ ​ Options Exercisable Number ​ Weighted ​ ​ ​ Exercisable at ​ Average ​ Aggregate December 31, ​ Exercise ​ Intrinsic 2025 ​ ​ ​ Price ​ ​ ​ Value 8,668,132 ​ $ 4.13 ​ $ — ​ The summary of the status of the Company’s non-vested options for the year ended December 31, 2025, is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ ​ ​ ​ Shares ​ ​ ​ Fair Value ​ ​ ​ ​ ​ ​ Non-vested, January 1, 2025 6,234,550 ​ $ 1.09 Granted 812,800 ​ ​ 1.00 Forfeited ( 1,780,685 ) ​ ​ 1.83 Vested ( 2,946,691 ) ​ ​ 1.01 Non-vested, December 31, 2025 2,319,974 ​ $ 1.03 ​ As of December 31, 2025, the Company had approximately $ 1.5 million of total unrecognized compensation cost related to stock options which will, on average, be amortized over 17 months . The summary of the status of the Company’s non-vested options for the year ended December 31, 2024, is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ ​ ​ ​ Shares ​ ​ ​ Fair Value ​ ​ ​ ​ ​ ​ Non-vested, January 1, 2024 5,205,736 ​ $ 1.89 Granted 3,982,846 ​ 0.68 Forfeited ( 1,391,897 ) ​ 1.52 Vested ( 1,562,137 ) ​ 2.26 Non-vested, December 31, 2024 6,234,550 ​ $ 1.09 ​ F-29 Table of Contents As of December 31, 2024, the Company had approximately $ 3.0 million of total unrecognized compensation cost related to stock options which will, on average, be amortized over 32 months . Change in Control-Based Awards of Restricted Stock Units: 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 Company’s 2014 Long-Term Incentive Plan, or upon certain life events. The following table is a summary of the outstanding balance of these restricted stock units at the end of each of the past two calendar years: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ ​ Weighted Average Grant Date Fair Value December 31, 2023 2,823,500 ​ $ 6.31 Granted 2024 ​ 331,250 ​ ​ 0.97 Forfeited 2024 ​ ( 345,250 ) ​ ​ 5.73 December 31, 2024 ​ 2,809,500 ​ $ 5.77 Granted 2025 131,500 ​ 0.98 Vested ​ ( 65,000 ) ​ ​ 7.71 Forfeited 2025 ( 122,000 ) ​ 3.62 December 31, 2025 2,754,000 ​ $ 5.60 ​ Due to the uncertainty over whether these restricted stock units will vest, which will only happen upon a Change in Control, or upon certain life events, the Company will only record expense only upon an actual vesting event. For the year ended December 31, 2025 the Company recorded non-cash charges totaling $ 0.5 million upon the death of two participants holding a total of 65,000 units. Other Restricted Stock Units: The following table outlines the restricted stock unit activity (not related to change in control-based awards) for the year ended December 31, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ ​ ​ ​ Shares ​ ​ ​ Fair Value Non-vested, January 1, 2025 641,336 ​ $ 1.31 Granted 498,800 ​ $ 1.01 Forfeited ( 100,000 ) ​ $ 0.98 Vested ( 264,835 ) ​ $ 1.81 Non-vested, December 31, 2025 775,301 ​ $ 0.99 ​ The following table outlines the restricted stock unit activity for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted ​ ​ ​ ​ Average ​ ​ ​ ​ Grant Date ​ ​ ​ ​ Shares ​ ​ ​ Fair Value Non-vested, January 1, 2024 430,505 ​ $ 3.31 Granted ​ 548,000 ​ $ 0.96 Forfeited ( 40,000 ) ​ $ 3.73 Vested ​ ( 297,169 ) ​ $ 3.23 Non-vested, December 31, 2024 ​ 641,336 ​ $ 1.31 ​ At December 31, 2025 and December 31, 2024, the remaining weighted average vesting period for restricted stock awards subject to vesting was 24 months and 43 months , respectively. The remaining unrecognized restricted stock unit compensation expense was $ 0.5 million at both December 31, 2025 and 2024. F-30 Table of Contents Warrants As of December 31, 2025, the Company had 5,780,701 warrants outstanding. Of this amount, 2,706,561 related to the Company’s December 13, 2023 Offering. 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 Company’s Loan and Security Agreement with Avenue (See Note 5, Long-Term Debt) and these warrants have an exercise price of $ 0.79 and expire on June 28, 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 are exercisable into the Company’s common stock. In connection with 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. ​ ​ 11. 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 (EBITDA, as defined below, adjusted for stock-based compensation, (gain) loss on foreign currency transactions, and restructuring) 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, 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 accounting policies of the segment are the same as those described in Note 2, Basis of Presentation and Summary of Significant Accounting Policies. 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 components presented in the consolidated statements of operations and comprehensive loss also present the components of the Company’s single operating segment. F-31 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ ​ ​ 2025 ​ 2024 ​ ​ ​ ​ ​ (amounts, in thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue ​ $ 37,063 ​ $ 35,595 ​ Gross profit ​ $ 26,491 ​ $ 24,887 ​ Gross margin ​ ​ 71 % 70 % Total operating expenses ​ $ 41,240 ​ $ 41,339 ​ Loss from operations ​ ​ ( 14,749 ) ​ ​ ( 16,452 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ EBITDA and Adjusted EBITDA (both non-GAAP measures): ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 8,198 ) ​ $ ( 20,719 ) ​ Interest expense, net ​ 2,612 ​ 1,399 ​ Benefit from income taxes ​ ​ ( 401 ) ​ ​ ( 1,691 ) ​ Depreciation and amortization expense ​ ​ 1,496 ​ ​ 1,570 ​ Earnings (Loss) before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure ​ ​ ( 4,491 ) ​ ​ ( 19,441 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ Stock-based compensation ​ ​ 2,765 ​ ​ 3,760 ​ (Gain) loss on foreign currency transactions ​ ​ ( 9,321 ) ​ ​ 4,225 ​ Restructuring ​ ​ 510 ​ ​ — ​ Adjusted EBITDA, a non-GAAP measure ​ $ ( 10,537 ) ​ $ ( 11,456 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ Adjusted net loss, a non-GAAP measure: ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 8,198 ) ​ $ ( 20,719 ) ​ Stock-based compensation ​ ​ 2,765 ​ ​ 3,760 ​ Gain (loss) on foreign currency transactions ​ ​ ( 9,321 ) ​ ​ 4,225 ​ Restructuring ​ ​ 510 ​ ​ — ​ Adjusted net loss, a non-GAAP measure ​ $ ( 14,244 ) ​ $ ( 12,734 ) ​ Total cash used in operating and investing activities ​ $ ( 12,749 ) ​ $ ( 15,097 ) ​ Total Assets ​ $ 44,182 ​ $ 47,372 ​ ​ F-32 Table of Contents Significant expense categories regularly provided to the CODM consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ ​ (amounts, in thousands) ​ ​ ​ ​ ​ ​ ​ Research and development, net of grant income: ​ ​ ​ ​ ​ ​ Clinical expenses ​ $ 3,377 ​ $ 4,979 Other research and development expenses ​ 1,708 ​ 2,628 Total research and development, net of grant income ​ $ 5,085 ​ $ 7,607 ​ ​ ​ ​ ​ ​ ​ Selling, general and administrative ​ ​ ​ ​ Royalty expense ​ 1,097 ​ 1,869 Stock-based compensation ​ 2,237 ​ 2,830 Legal, financial and consulting ​ 4,108 ​ 3,179 Other general and administrative ​ 28,203 ​ 25,854 Total selling, general and administrative ​ $ 35,645 ​ $ 33,732 ​ Capital expenditures of the segment totaled $ 0.4 million and $ 0.7 million for the years ended December 31, 2025 and 2024, respectively. ​ 12. RESTRUCTURING Restructuring Plan During the fourth quarter of 2025, the Company 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 Workforce and Cost Reduction Plan, the Company reduced its workforce by approximately 10 %, and reduced and realigned operating and production expenses. The Company recorded a charge of $ 0.5 million that includes severance and other cash and non-cash charges related to restructuring. Restructuring Charges The following table presents the components of restructuring charges. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ (amounts, in thousands) Restructuring ​ ​ ​ ​ Workforce reduction $ 408 $ — Other restructuring costs ​ 102 ​ — Total restructuring ​ $ 510 ​ $ — ​ ​ F-33 Table of Contents The table below sets forth the estimated amount of unpaid restructuring charges as of December 31, 2025 and 2024 included in accrued expenses that are expected to be paid in less than one year. Total additions to unpaid restructuring charges are limited to workforce reductions as the other components of restructuring costs do not require cash payments. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2025 ​ 2024 ​ ​ (amounts, in thousands) Restructuring charges, beginning of the year ​ $ — ​ $ — Additions ​ 408 ​ — Payments ​ ​ ( 111 ) ​ ​ — Restructuring charges unpaid and outstanding, end of year ​ $ 297 ​ $ — ​ 13. SUBSEQUENT EVENTS Management has evaluated subsequent events through the date of issuance of these 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 financial statements. F-34