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CTSO US Equity

Cytosorbents CorpHealth Care · Surgical & Medical Instruments & Apparatus · CIK 1175151 · FY ends Dec 31
$0.36
-0.00 (-1.11%)
USD · as of 2026-08-19 · marketstack

CTSO · 10-K · period ended 2025-12-31

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filed 2026-03-30 · EDGAR original ↗

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of the results of operations and financial condition for the fiscal years ended December 31, 2025 and 2024 should be read in conjunction with our consolidated financial statements, and the notes to those consolidated financial statements that are included elsewhere in this Report.

Overview

We are a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents’ proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, ECMO, heart-lung machines). CytoSorbents’ technologies are used in a number of broad applications. Specifically, four important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding 2) the removal of inflammatory agents in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis that can lead to massive inflammation, organ failure and patient death 3) the removal of liver toxins that accumulate in acute liver dysfunction or failure and 4) the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.

CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide, with more than 300,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA EUA in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved in the United States.

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In the U.S. and Canada, CytoSorbents is developing the DrugSorb®TM-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures.

The Company continues to actively pursue regulatory approval of DrugSorb-ATR with the U.S. FDA and expects to pursue regulatory approval in Canada with better visibility from the FDA. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. See further discussion in ‘Cardiac Surgery’ below.

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XLTM, HemoDefend-RBCTM, HemoDefend-BGATM, VetResQ®, K+ontrolTM, DrugSorbTM, ContrastSorb, and others. For more information, please visit the Company’s website at www.cytosorbents.com or follow us on Facebook and X.

Summary of Operational and Business Highlights

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Impact of Inflation and Other Issues:

The recent high inflationary environment impacted us in various ways. Due to the competitive labor market and rising inflation, our labor costs have risen significantly in order to attract and retain qualified employees throughout our organization. In addition, we have experienced raw material price increases primarily related to the oil-based chemicals used in the polymer manufacturing process as well as additional requests for higher fuel surcharges from most suppliers. Rising energy costs, including electricity and fossil fuels, have also made it more expensive to support our operations, manufacturing, and commercial activities. We have also experienced increases in our transportation costs; however, we have been able to substantially mitigate these cost increases by implementing bulk shipping methods. Inflationary pressures may continue to impact our product gross margins and other costs in the future.

Results of Operations

Comparison of the year ended December 31, 2025 and 2024

​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

​ ​ For the Year Ended December 31,

​ ​ ​ ​ ​ % of ​ ​ ​ ​ % of

​ ​ ​ ​ Amount ​ ​ ​ Revenue ​ ​ ​ Amount ​ ​ ​ Revenue

​ ​ (in thousands) ​ ​ ​ (in thousands) ​ ​ ​

Operating expenses: ​ ​ ​ ​ ​ ​ ​

Restructuring ​ ​ 510 ​ 1.4 % ​ — ​ — %

Other income (expense): ​ ​ ​ ​ ​ ​ ​

Loss on abandoned patents ​ ​ (559) ​ (1.5) % ​ (334) ​ (0.9) %

Benefit from income taxes ​ ​ 401 ​ 1.1 % ​ 1,691 ​ 4.8 %

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Revenue

For the year ended December 31, 2025, we generated total revenue of approximately $37.1 million as compared to revenues of approximately $35.6 million for the year ended December 31, 2024, an increase of approximately $1.5 million, or 4.1%, and down 0.4% on a constant currency basis. Revenue growth was led by strength in our distributor and strategic partner sales and direct sales outside of Germany, partially offset by lower revenue in our direct German market. The Company began a proactive reorganization and strategic realignment of our German commercial team and sales approach in the first quarter of 2025. We are making progress with this important initiative, and remain confident it will lead to stronger execution and improved performance.

Gross Profit

Gross profit was approximately $26.5 million for the year ended December 31, 2025, an increase of approximately $1.6 million or 6.4%, as compared to gross profit of $24.9 million for the year ended December 31, 2024. Gross margins were 71.5% and 69.9% for the years ended December 31, 2025 and 2024, respectively.

Research and Development Expenses

Our research and development costs were approximately $5.1 million and $7.6 million for the years ended December 31, 2025 and 2024, respectively, a decrease of approximately $2.5 million, or 33.2%. This decrease was driven by a decrease in our clinical trial costs due primarily to the completion of the STAR-T clinical trial, lower grant funded projects, as well as other clinical and product development program reductions.

Selling, General and Administrative Expenses

Our selling, general and administrative expenses were approximately $35.6 million and $33.7 million for the years ended December 31, 2025 and 2024, respectively, an increase of approximately $1.9 million, or 5%. This increase was mainly due to increases in legal, regulatory, financial and consulting costs including costs associated with our 2024 audited financial statements, as well as regulatory filings and initial costs associated with the anticipated approval and commercial launch of DrugSorb-ATR in North America, partially offset by decreases in stock-based compensation expense, and royalty expenses. The decrease in stock-based compensation expense was primarily related to the full vesting of certain stock options in earlier periods and the decrease in royalty expense was the result of the expiration of a 4% royalty in August of 2024.

Restructuring Expenses

During the fourth quarter of 2025, we 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. Our restructuring expenses were $0.5 million for the year ended December 31, 2025. These costs primarily included cash-based severance and related workforce reduction charges of $0.4 million and other non-cash costs of $0.1 million.

Loss From Operations

Our loss from operations (including the impact of the $0.5 million restructuring charge) decreased by 10.4% to approximately $14.7 million, from $16.5 million for the years ended December 31, 2025 and 2024 respectively. This improvement was the result of revenue growth and gross margin improvement.

Interest Expense, Net

For the year ended December 31, 2025, net interest expense was approximately $2.6 million, as compared to $1.4 million for the year ended December 31, 2024. The increase was due to interest incurred on our credit facility for the full year of 2025, which began in the third quarter of 2024. Additionally, we amended our credit facility which increased the principal balance outstanding under the credit facility by $2.5 million effective November 13, 2025.

Gain (Loss) on Foreign Currency Transactions

For the year ended December 31, 2025, the gain on foreign currency transactions was approximately $9.3 million, compared to a loss on foreign currency transactions of approximately $4.2 million for the year ended December 31, 2024. The gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of December 31, 2025, as compared to December 31,

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2024. The exchange rate of the Euro to the U.S. dollar was $1.17 per Euro as of December 31, 2025, as compared to $1.03 per Euro at December 31, 2024. The 2024 loss is directly related to the decrease of the exchange rate of the Euro as of December 31, 2024, as compared to December 31, 2023. The exchange rate of the Euro to the U.S. dollar was $1.03 per Euro as of December 31, 2024, as compared to $1.11 per Euro as of December 31, 2023.

Loss on Abandoned Patents

Loss on abandoned patents was approximately $0.6 million for the year ended December 31, 2025, an increase of approximately $0.2 million or 67.4%, as compared to loss on abandoned patents of $0.3 million for the year ended December 31, 2024.

Benefit from Income Taxes

Our benefit from income taxes was approximately $0.4 million and $1.7 million for the years ended December 31, 2025, and 2024, respectively. This benefit was realized by utilizing the New Jersey Technology Business Tax Certificate Transfer Program whereby the State of New Jersey allows us to sell a portion of our state net operating losses and R&D credits to a third party.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of December 31, 2025, we had current assets of approximately $20.6 million and current liabilities of approximately $9.7 million.

Effective Shelf Registration

We have an effective shelf registration statement dated September 30, 2024 with the SEC which enables us to raise up to $150 million in one or more offerings, through the issuance and sale of any combination of equity securities, debt securities, warrants and units. Approximately $149.7 million of this amount was available as of December 31, 2025. We have also allocated $20 million of our total shelf amount to our ATM facility. At December 31, 2025, approximately $19.4 million was available for use under the ATM facility, subject to certain limitations. For the year ended December 31, 2025, we did not raise any proceeds under the ATM facility.

Loan and Security Agreement

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 $15.0 million (“Tranche 1”), consisted of $10.0 million which was available to the Company on the Closing Date and $5.0 million constituted restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved: (i) the FDA 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 $3.0 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 $3.0 million and $5.0 million. The second tranche (“Tranche 2”) consisted of $5.0 million, which would have been 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%). 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 achieved for the trailing six month period ended June 30, 2026, at least $25 million of revenue, (the Interest only Milestone as defined in the Loan), the Interest only Period 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 November 13, 2025, the Company and Avenue Capital Group entered into 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 provided an extension of the interest only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027. The Company will have access to an additional aggregate $2.5 million (“Tranche 2b”) from Avenue Capital Group and also 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 prior to December 31, 2026. Tranche 2a and Tranche 2b, in the aggregate,

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replace Tranche 2 of the Avenue Capital Commitment. The Amended Loan and Security Agreement requires that the Company maintain certain operating cash burn targets (as defined in the Amended Loan and Security Agreement) prior to FDA approval of DrugSorb-ATR.

Under the terms of the Amended Loan and Security Agreement, we 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.

For further discussion regarding the Loan Agreement please see Note 5, Long Term Debt, to our Consolidated Financial Statements, included elsewhere in this Annual Report on Form 10-K.

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 with an expiration date of February 24, 2025, and one Series B Right Warrant to purchase one share of common stock with an expiration date of April 10, 2025. Up to an additional 6.25 million shares of common stock may have been issued upon exercise of the Right Warrants. Proceeds from the closing of the subscription period satisfied a debt covenant which allowed for $5 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use. 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). 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 5-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.

Technology Business Tax Certificate Transfer Program

In April 2025, we further supplemented our cash balance with the receipt of $1.7 million from the sale of our 2023 and amended 2022 Net Operating Loss (NOL) and R&D tax credits from the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority (NJEDA).

Resource Allocation and Path to Cash-Flow Profitability

We proactively manage our resources with a focus on driving commercial success, investing in key areas such as our regulatory submissions of DrugSorb-ATR to the FDA and Health Canada and the development of clinical data. We have instituted and continue to maintain tight control over expenditures and have lowered our spending over the past year. Further, on November 13, 2025, the Company announced it initiated a Strategic Workforce and Cost Reduction Plan to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. This initiative followed 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%, reduced and realigned operating and production expenses, and now expects that the Company will reach operating cash flow break-even in the second half of 2026. The Company recorded a charge of $0.5 million that includes severance and other cash and non-cash charges related to the restructuring.

As of December 31, 2025, we have approximately $7.8 million in cash (a non-GAAP measure), including approximately $6.3 million in unrestricted cash and cash equivalents, and $1.5 million of non-current restricted cash which may not be sufficient to fund the Company’s operations beyond the next twelve months from the issuance of these consolidated financial statements. These cash and restricted cash balances considered with our historical cash used in operations, notwithstanding our Strategic Workforce and Cost Reduction Plan and the impact of the Amended Loan and Security Agreement, 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.

Our expected future capital requirements may depend on many factors, including expanding our 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 Credit Facility, and receive an additional 6-month extension of the interest-only period on the credit facility. Additional sources of liquidity available to us include the 2024 Shelf, other public or private equity offerings, debt financing or from other sources. The sale

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of additional equity may result in dilution to our shareholders. There is no assurance that we will be able to secure funding on terms acceptable to us, or at all. Although the Company has taken actions to achieve cash flow breakeven, if it does not achieve this goal, the potential increased need for capital could also make it more difficult to obtain funding through either equity or debt. Should additional capital not become available to us as needed, we 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.

On September 16, 2025, the Company announced that it would file a new De Novo application for DrugSorb-ATR with the FDA. This decision followed an appeal meeting and decision by the FDA to uphold its previous denial of the Company’s original DrugSorb-ATR application, but affirmed that there were no safety related issues with the device, and requested additional information to support the Company’s desired label indication. As part of the resubmission process, the Company filed a pre-submission meeting request with supporting documentation to the FDA on November 7, 2025. The Company conducted a formal pre-submission meeting with the FDA in late January 2026 and continues to engage with the FDA to clarify and confirm the requirements for the new De Novo submission. The interactive discussions regarding the information to be included in the new submission are ongoing, and the Company expects to provide an update of the anticipated timing for the new submission once these interactive discussions with the FDA on the final requirements are complete. Following the new De Novo submission, a regulatory decision would be expected following a typical 150-day review process but may be accelerated or extended depending on interactive discussions with the FDA related to submission questions.

Loan and Security Agreement

On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group. Avenue Capital Group agreed to loan the Company up to an aggregate of $20 million, to be disbursed in two tranches: (1) one tranche of $15 million (“Tranche 1”), of which $10 million is available to the Company on the Closing Date and $5 million which remained classified as restricted cash through January 10, 2025, when it was released from its restriction as the following conditions were met: (i) the FDA has accepted Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company has received a minimum of $3 million in net proceeds from the sale of its equity securities after the Closing Date. A second tranche of up to $5 million, may be disbursed at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company receives FDA marketing approval of its DrugSorb-ATR application (“Tranche 2” and together with Tranche 1, the “Avenue Capital Commitment”). All unpaid principal and accrued and unpaid interest shall be due and payable in full by the maturity date. If the 2nd tranche is fully funded by December 2025, the maturity date is January 1, 2028; otherwise, the maturity date is July 1, 2027. Commencing on August 1, 2024, the Company shall make monthly interest only payments during the initial 25-month period following the Closing Date, followed by equal monthly installments through the maturity date consisting of principal plus accrued and unpaid interest.

On November 13, 2025, we and Avenue Capital Group entered into the First Amendment to Loan Documents (the “Amended Loan and Security Agreement”), amending our Loan and Security Agreement, dated June 28, 2024, as supplemented. The Amended Loan and Security Agreement provides for access to an additional aggregate $2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and for the extension of the interest only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027. We will have access to an additional aggregate $2.5 million (“Tranche 2b”) from Avenue Capital Group, subject to FDA approval of DrugSorb-ATR, between January 1, 2026 and December 31, 2026. Tranche 2a and Tranche 2b, in the aggregate, replace Tranche 2 of the Loan. The Amended Loan and Security Agreement requires that we maintain certain operating cash burn targets (as defined) prior to FDA approval of DrugSorb-ATR and provides for a further six-month extension of the interest only period to the July 1, 2027 maturity date upon FDA approval of DrugSorb-ATR.

Under the terms of the Amended Loan and Security Agreement, we 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.

On October 22, 2024, the Company announced that the FDA had accepted its application of for DrugSorb-ATR, which was one of the two conditions required by the restricted cash debt covenant. Proceeds from the Rights Offering on January 10, 2025 satisfied the second condition of the debt covenant which now allows for the $5.0 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use.

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The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and will additionally be used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment shall bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent (5.00%) or (B) thirteen and one-half percent (13.50)%.

For further discussion regarding the Loan Agreement please see Note 5, Long Term Debt, to our Consolidated Financial Statements, included elsewhere in this Annual Report on Form 10-K.

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 with an expiration date of February 24, 2025, and one Series B Right Warrant to purchase one share of common stock with an expiration date of April 10, 2025. Up to an additional 6.25 million shares of common stock may be issued upon exercise of the Right Warrants. Proceeds from the closing of the subscription period satisfy a debt covenant which allowed for $5 million of restricted cash on the Company’s consolidated balance sheets to now become unrestricted, and available for use. 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). 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 5-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.

Critical Accounting Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. We believe the following critical accounting estimates have significant effect in the preparation of our consolidated financial statements.

Uncertain tax positions and valuation allowances:

The Company records income tax expense and related liabilities based on estimates of amounts expected to be taxable or deductible in tax returns filed in various jurisdictions. These tax returns are subject to examination by taxing authorities, which may occur several years after the date of the financial statements. During such examinations, disputes may arise regarding the timing or validity of certain items, including the recognition of taxable income or deductions, and the resolution of these matters may take an extended period of time.

The Company evaluates uncertain tax positions related to income taxes in accordance with FIN 48, which establishes the recognition threshold and measurement guidance for financial statement recognition of tax positions taken or expected to be taken in a tax return. Under this guidance, the Company assesses whether the tax position is more likely than not to be sustained upon examination by the relevant taxing authority based on the technical merits of the position. For positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement. For positions that do not meet this threshold, no tax benefit is recognized in the financial statements.

The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. In addition, the Company offsets liabilities for unrecognized tax benefits against deferred tax assets associated with net operating loss or tax credit carryforwards when the uncertain tax position would be settled for the presumed amount at the balance sheet date.

The Company also evaluates its deferred tax assets and records a valuation allowance to reduce these assets to the amount that is more likely than not to be realized. In assessing the need for a valuation allowance, the Company considers available positive and negative evidence, including expectations of future taxable income. If the Company determines that it will be able to realize deferred tax assets in excess of the amount currently recorded, an adjustment would be made to increase income in the period such determination is made. Conversely, if the Company determines that it will not be able to realize all or a portion of its deferred tax assets, the deferred

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tax asset would be reduced and the resulting adjustment would be recognized as an expense in the period of determination. Either determination could have a material impact on the Company’s financial statements.

Fair Value of Warrants

The Company issues warrants in connection with certain financing transactions. The fair value of these warrants is estimated using the Black-Scholes option pricing model or the Monte Carlo pricing model, which requires management to make significant estimates and assumptions regarding inputs that are not directly observable in the market. These estimates include, among other things, the expected volatility of the Company’s common stock, the expected term of the warrants, the risk-free interest rate, and the expected dividend yield.

Expected volatility is generally based on the historical volatility of the Company’s common stock and, when appropriate, comparable publicly traded companies. The expected term represents the period of time the warrants are expected to remain outstanding, which may differ from the contractual term depending on the specific features of the warrants. The risk-free interest rate is based on the yields of U.S. Treasury securities with maturities consistent with the expected term of the warrants, and the dividend yield is based on the Company’s historical and expected dividend policy.

Because the valuation relies on significant assumptions, changes in these inputs could materially affect the estimated fair value of the warrants and the related amounts recorded in the Company’s financial statements. If the warrants are classified as liabilities, the Company remeasures the fair value of the warrants at each reporting date, and changes in fair value are recognized in the consolidated statements of operations. Accordingly, fluctuations in the underlying assumptions used in the valuation model, particularly expected volatility and the Company’s stock price, may result in significant non-cash gains or losses in future periods.

Management believes the assumptions used in estimating the fair value of the warrants are reasonable; however, actual results and future changes in these assumptions could differ materially from those estimates and could have a material impact on the Company’s financial statements.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.

Item 8. Financial Statements and Supplementary Data.

Our Consolidated Financial Statements and notes thereto are included elsewhere in this Annual Report on Form 10-K and incorporated herein by reference. See Item 15 of Part IV.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

None.

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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

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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:

Financial Statement Consolidation and Reporting

Actions to address this material weakness are currently being developed, with the following primary solutions having been identified:

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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.

None.

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection.

None.

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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.

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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.

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3. List of Exhibits

Exhibit ​ ​ ​ ​

No. Description

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

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​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

50

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​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

​ ​ ​

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​ ​ ​

​ ​ ​

​ ​ ​

19.1 ​ Insider Trading Policy.

​ ​ ​

21.1* ​ List of Subsidiaries.

​ ​ ​

23.1* Consent of WithumSmith+Brown, PC.

24.1* ​ Power of Attorney

​ ​ ​

​ ​ ​

​ ​ ​

* Filed or furnished herewith.

In accordance with SEC Release 33-8238, Exhibits 32.1 and 32.2 are being furnished and not filed.

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Item 16. Form 10-K Summary.

None.

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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

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FINANCIAL STATEMENTS

Page

Report of Independent Registered Public Accounting Firm F-2

Consolidated Balance Sheets at December 31, 2025 and 2024 F-4

Notes to Consolidated Financial Statements F-8

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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.

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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.

/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

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CYTOSORBENTS CORPORATION

CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

​ ​ ​ ​ ​ ​ ​

​ ​ At December 31,

ASSETS ​ ​ ​ ​ ​

Current Assets: ​ ​ ​ ​ ​

Cash and cash equivalents ​ $ 6,249 ​ $ 3,280

Restricted cash, current ​ ​ — ​ ​ 5,000

Prepaid expenses and other current assets ​ 1,554 ​ 3,271

​ ​ ​ ​ ​

Property and equipment - net ​ 7,823 ​ 9,002

Other assets ​ 53 ​ 50

​ ​ ​ ​ ​

LIABILITIES AND STOCKHOLDERS’ EQUITY ​ ​ ​ ​

Current Liabilities: ​ ​ ​ ​

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

​ ​ ​ ​ ​

Commitments and Contingencies ​ ​ ​ ​

Stockholders’ Equity: ​ ​ ​ ​

Accumulated other comprehensive income (loss) ​ (2,977) ​ ​ 4,252

Total Liabilities and Stockholders’ Equity ​ $ 44,182 ​ $ 47,372

The Notes to Consolidated Financial Statements are an integral part of these statements.

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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,

Operating expenses: ​ ​ ​ ​ ​

Research and development, net of grant income ​ ​ 5,085 ​ ​ 7,607

Selling, general and administrative ​ ​ 35,645 ​ ​ 33,732

Restructuring ​ ​ 510 ​ ​ —

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

​ ​ ​ ​ ​

​ ​ ​ ​ ​ ​ ​

Basic and diluted net loss per common share ​ $ (0.13) ​ $ (0.38)

​ ​ ​ ​ ​ ​ ​

​ ​ ​ ​ ​ ​ ​

Comprehensive loss: ​ ​ ​ ​ ​ ​

Other comprehensive income (loss): ​ ​ ​ ​ ​ ​

Foreign currency translation adjustment, net of tax ​ ​ (7,229) ​ ​ 3,723

The Notes to Consolidated Financial Statements are an integral part of these statements.

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CYTOSORBENTS CORPORATION

CONSOLIDATED STATEMENTS OF CHANGES IN

STOCKHOLDERS’ EQUITY

(in thousands, except share data)

​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​

​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ ​ ​

​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’

​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

Stock-based compensation — ​ — ​ 3,760 ​ — ​ — ​ 3,760

Issuance of warrants ​ — ​ ​ — ​ ​ 691 ​ ​ — ​ ​ — ​ ​ 691

Stock-based compensation ​ — ​ ​ — ​ ​ 2,765 ​ ​ — ​ ​ — ​ ​ 2,765

Issuance of warrants — ​ — ​ 627 ​ — ​ — ​ 627

Net loss — ​ — ​ — ​ — ​ (8,198) ​ (8,198)

The Notes to Consolidated Financial Statements are an integral part of these statements.

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CYTOSORBENTS CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

​ ​ ​ ​ ​ ​ ​

​ ​ ​ ​ Year ended ​ ​ ​ Year ended

​ ​ December 31, ​ December 31,

Cash flows from 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)

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 ​ ​ —

Net cash used in investing activities ​ (415) ​ ​ (669)

​ ​ ​ ​ ​ ​ ​

Cash flows from financing activities: ​ ​ ​ ​

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 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: ​ ​ ​ ​

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.

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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.

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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,

​ ​ (amounts, in thousands)

Cash and cash equivalents ​ $ 6,249 ​ $ 3,280

Restricted cash, current ​ ​ — ​ ​ 5,000

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.

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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.

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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.

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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.

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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,

Basic and Diluted: ​ (amounts, in thousands, except share and per share data)

Numerator: ​ ​ ​ ​

Denominator: ​ ​ ​ ​

​ ​ ​ ​ ​ ​ ​

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,

* Total number of RSUs include 2,754,000 units with a Change in Control-Based performance condition.

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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.

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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

Source: SEC EDGAR (public domain) · 10-K for the period ended 2025-12-31, filed 2026-03-30 · accession 0001104659-26-036451

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