サイトソーベンツの四半期報告

September 30, 2025

December 31, 2024

(amounts, in thousands)

Total assets

0001175151--12-312025Q3falsehttp://fasb.org/us-gaap/2025#UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMemberhttp://fasb.org/us-gaap/2025#UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMemberP0YP0YP0YP0Yhttp://fasb.org/us-gaap/2025#PrimeRateMemberP5DP5DP5DP3MP6Y0001175151srt:MinimumMemberctso:SeriesBRightWarrantsMemberus-gaap:MeasurementInputExercisePriceMember2025-01-100001175151srt:MinimumMemberctso:SeriesaRightWarrantsMemberus-gaap:MeasurementInputExercisePriceMember2025-01-100001175151srt:MaximumMemberctso:SeriesBRightWarrantsMemberus-gaap:MeasurementInputExercisePriceMember2025-01-100001175151srt:MaximumMemberctso:SeriesaRightWarrantsMemberus-gaap:MeasurementInputExercisePriceMember2025-01-100001175151ctso:SeriesBRightWarrantsMemberus-gaap:MeasurementInputSharePriceMember2025-01-100001175151ctso:SeriesBRightWarrantsMemberus-gaap:MeasurementInputRiskFreeInterestRateMember2025-01-100001175151ctso:SeriesBRightWarrantsMemberus-gaap:MeasurementInputPriceVolatilityMember2025-01-100001175151ctso:SeriesBRightWarrantsMemberus-gaap:MeasurementInputExpectedDividendRateMember2025-01-100001175151ctso:SeriesaRightWarrantsMemberus-gaap:MeasurementInputSharePriceMember2025-01-100001175151ctso:SeriesaRightWarrantsMemberus-gaap:MeasurementInputRiskFreeInterestRateMember2025-01-100001175151ctso:SeriesaRightWarrantsMemberus-gaap:MeasurementInputPriceVolatilityMember2025-01-100001175151ctso:SeriesaRightWarrantsMemberus-gaap:MeasurementInputExpectedDividendRateMember2025-01-100001175151us-gaap:AdditionalPaidInCapitalMember2025-07-012025-09-300001175151us-gaap:CommonStockMember2025-07-012025-09-300001175151us-gaap:CommonStockMember2024-07-012024-09-300001175151us-gaap:CommonStockMember2024-01-012024-09-300001175151us-gaap:RetainedEarningsMember2025-09-300001175151us-gaap:AdditionalPaidInCapitalMember2025-09-300001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-09-300001175151us-gaap:RetainedEarningsMember2025-06-300001175151us-gaap:AdditionalPaidInCapitalMember2025-06-300001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-06-3000011751512025-06-300001175151us-gaap:RetainedEarningsMember2024-12-310001175151us-gaap:AdditionalPaidInCapitalMember2024-12-310001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-12-310001175151us-gaap:RetainedEarningsMember2024-09-300001175151us-gaap:AdditionalPaidInCapitalMember2024-09-300001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-09-300001175151us-gaap:RetainedEarningsMember2024-06-300001175151us-gaap:AdditionalPaidInCapitalMember2024-06-300001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-06-3000011751512024-06-300001175151us-gaap:RetainedEarningsMember2023-12-310001175151us-gaap:AdditionalPaidInCapitalMember2023-12-310001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-12-310001175151us-gaap:CommonStockMember2025-09-300001175151us-gaap:CommonStockMember2025-06-300001175151us-gaap:CommonStockMember2024-12-310001175151us-gaap:CommonStockMember2024-09-300001175151us-gaap:CommonStockMember2024-06-300001175151us-gaap:CommonStockMember2023-12-310001175151ctso:ExercisePriceRangeOneMember2025-01-012025-09-3000011751512024-01-012024-12-310001175151ctso:OtherRsuMember2025-09-300001175151ctso:ControlBasedRsusMember2025-09-300001175151ctso:OtherRsuMember2024-12-310001175151ctso:ControlBasedRsusMember2024-12-310001175151ctso:OtherRsuMember2025-01-012025-09-300001175151ctso:ControlBasedRsusMember2025-01-012025-09-300001175151us-gaap:SellingGeneralAndAdministrativeExpensesMember2025-07-012025-09-300001175151us-gaap:RestrictedStockUnitsRSUMember2025-07-012025-09-300001175151us-gaap:EmployeeStockOptionMember2025-07-012025-09-300001175151us-gaap:CostOfSalesMember2025-07-012025-09-300001175151ctso:ResearchAndDevelopmentNetOfGrantIncomeMember2025-07-012025-09-300001175151us-gaap:SellingGeneralAndAdministrativeExpensesMember2025-01-012025-09-300001175151us-gaap:RestrictedStockUnitsRSUMember2025-01-012025-09-300001175151us-gaap:EmployeeStockOptionMember2025-01-012025-09-300001175151us-gaap:CostOfSalesMember2025-01-012025-09-300001175151ctso:ResearchAndDevelopmentNetOfGrantIncomeMember2025-01-012025-09-300001175151us-gaap:SellingGeneralAndAdministrativeExpensesMember2024-07-012024-09-300001175151us-gaap:RestrictedStockUnitsRSUMember2024-07-012024-09-300001175151us-gaap:EmployeeStockOptionMember2024-07-012024-09-300001175151us-gaap:CostOfSalesMember2024-07-012024-09-300001175151us-gaap:SellingGeneralAndAdministrativeExpensesMember2024-01-012024-09-300001175151us-gaap:RestrictedStockUnitsRSUMember2024-01-012024-09-300001175151us-gaap:EmployeeStockOptionMember2024-01-012024-09-300001175151us-gaap:CostOfSalesMember2024-01-012024-09-300001175151us-gaap:RoyaltyAgreementsMember2025-07-012025-09-300001175151us-gaap:RoyaltyAgreementsMember2025-01-012025-09-300001175151us-gaap:RoyaltyAgreementsMember2024-07-012024-09-300001175151us-gaap:RoyaltyAgreementsMember2024-01-012024-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2025-07-012025-09-300001175151ctso:DirectMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2025-07-012025-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:US2025-07-012025-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:DE2025-07-012025-09-300001175151us-gaap:ProductMemberctso:AllOtherCountriesMember2025-07-012025-09-300001175151us-gaap:ProductMembercountry:US2025-07-012025-09-300001175151us-gaap:ProductMembercountry:DE2025-07-012025-09-300001175151ctso:DistributorsAndStrategicPartnersMember2025-07-012025-09-300001175151ctso:DirectMember2025-07-012025-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2025-01-012025-09-300001175151ctso:DirectMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2025-01-012025-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:US2025-01-012025-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:DE2025-01-012025-09-300001175151us-gaap:ProductMemberctso:AllOtherCountriesMember2025-01-012025-09-300001175151us-gaap:ProductMembercountry:US2025-01-012025-09-300001175151us-gaap:ProductMembercountry:DE2025-01-012025-09-300001175151ctso:DistributorsAndStrategicPartnersMember2025-01-012025-09-300001175151ctso:DirectMember2025-01-012025-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2024-07-012024-09-300001175151ctso:DirectMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2024-07-012024-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:US2024-07-012024-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:DE2024-07-012024-09-300001175151us-gaap:ProductMemberctso:AllOtherCountriesMember2024-07-012024-09-300001175151us-gaap:ProductMembercountry:US2024-07-012024-09-300001175151us-gaap:ProductMembercountry:DE2024-07-012024-09-300001175151ctso:DistributorsAndStrategicPartnersMember2024-07-012024-09-300001175151ctso:DirectMember2024-07-012024-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2024-01-012024-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:ProductMembercountry:US2024-01-012024-09-300001175151ctso:DirectMemberus-gaap:ProductMemberctso:AllOtherCountriesMember2024-01-012024-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:US2024-01-012024-09-300001175151ctso:DirectMemberus-gaap:ProductMembercountry:DE2024-01-012024-09-300001175151us-gaap:ProductMemberctso:AllOtherCountriesMember2024-01-012024-09-300001175151us-gaap:ProductMembercountry:US2024-01-012024-09-300001175151us-gaap:ProductMembercountry:DE2024-01-012024-09-300001175151ctso:DistributorsAndStrategicPartnersMember2024-01-012024-09-300001175151ctso:DirectMember2024-01-012024-09-300001175151srt:MaximumMemberctso:StrategicWorkforceAndCostReductionPlanMemberus-gaap:SubsequentEventMember2025-11-132025-11-130001175151ctso:StrategicWorkforceAndCostReductionPlanMemberus-gaap:SubsequentEventMember2025-11-132025-11-130001175151ctso:LoanAndSecurityAgreementMember2024-10-220001175151srt:MinimumMemberus-gaap:ComputerEquipmentMember2025-09-300001175151srt:MaximumMemberus-gaap:ComputerEquipmentMember2025-09-300001175151srt:MinimumMemberus-gaap:ComputerEquipmentMember2024-12-310001175151srt:MaximumMemberus-gaap:ComputerEquipmentMember2024-12-310001175151us-gaap:LeaseholdImprovementsMember2025-09-300001175151us-gaap:FurnitureAndFixturesMember2025-09-300001175151us-gaap:ComputerEquipmentMember2025-09-300001175151us-gaap:LeaseholdImprovementsMember2024-12-310001175151us-gaap:FurnitureAndFixturesMember2024-12-310001175151us-gaap:ComputerEquipmentMember2024-12-310001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-07-012025-09-300001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2025-01-012025-09-300001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-07-012024-09-300001175151us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-01-012024-09-300001175151us-gaap:RetainedEarningsMember2025-07-012025-09-300001175151us-gaap:RetainedEarningsMember2025-01-012025-09-300001175151us-gaap:RetainedEarningsMember2024-07-012024-09-300001175151us-gaap:RetainedEarningsMember2024-01-012024-09-300001175151ctso:TwoThousandAndTwentyTwoSuccessFeeLetterMemberctso:ThirdTrancheMember2025-09-300001175151ctso:TwoThousandAndTwentyTwoSuccessFeeLetterMemberctso:SecondTrancheMember2025-09-300001175151ctso:TwoThousandAndTwentyTwoSuccessFeeLetterMemberctso:FirstTrancheMember2025-09-300001175151srt:MinimumMember2025-09-300001175151srt:MaximumMember2025-09-300001175151ctso:FiniteLivedIntangibleAssetsPatentsIssuedMember2025-09-300001175151ctso:FiniteLivedIntangibleAssetsPatentApplicationsPendingMember2025-09-300001175151ctso:FiniteLivedIntangibleAssetsPatentsIssuedMember2024-12-310001175151ctso:FiniteLivedIntangibleAssetsPatentApplicationsPendingMember2024-12-310001175151ctso:LoanAndSecurityAgreementTrancheOneMember2024-06-280001175151ctso:LoanAndSecurityAgreementMember2025-01-012025-09-300001175151us-gaap:CargoAndFreightMember2025-07-012025-09-300001175151us-gaap:CargoAndFreightMember2025-01-012025-09-300001175151us-gaap:CargoAndFreightMember2024-07-012024-09-300001175151us-gaap:CargoAndFreightMember2024-01-012024-09-300001175151us-gaap:ProductMember2025-09-300001175151us-gaap:GrantMember2025-09-300001175151us-gaap:ProductMember2024-12-310001175151us-gaap:GrantMember2024-12-310001175151ctso:SeriesBRightWarrantsMember2025-01-100001175151ctso:SeriesaRightWarrantsMember2025-01-100001175151srt:MinimumMemberctso:SeriesBRightWarrantsMember2025-01-100001175151srt:MinimumMemberctso:SeriesaRightWarrantsMember2025-01-100001175151srt:MaximumMemberctso:SeriesBRightWarrantsMember2025-01-100001175151srt:MaximumMemberctso:SeriesaRightWarrantsMember2025-01-1000011751512023-12-1300011751512024-09-3000011751512023-12-310001175151ctso:StockOptionsAndWarrantsAndRestrictedStockUnitsMember2025-07-012025-09-300001175151ctso:StockOptionsAndWarrantsAndRestrictedStockUnitsMember2025-01-012025-09-300001175151us-gaap:AdditionalPaidInCapitalMember2024-07-012024-09-3000011751512025-11-100001175151ctso:SeriesBRightWarrantsMember2025-06-112025-06-110001175151srt:MinimumMember2025-01-012025-09-300001175151srt:MaximumMember2025-01-012025-09-300001175151us-gaap:AdditionalPaidInCapitalMember2025-01-012025-09-300001175151us-gaap:AdditionalPaidInCapitalMember2024-01-012024-09-300001175151us-gaap:CommonStockMember2025-01-012025-09-3000011751512025-07-012025-09-3000011751512024-07-012024-09-300001175151srt:MinimumMemberctso:LoanAndSecurityAgreementMember2024-06-280001175151srt:MaximumMemberctso:LoanAndSecurityAgreementMember2024-06-280001175151ctso:SeriesaRightWarrantsMember2025-02-240001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:RevenueFromContractWithCustomerMemberus-gaap:CustomerConcentrationRiskMember2025-07-012025-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:RevenueFromContractWithCustomerMemberus-gaap:CustomerConcentrationRiskMember2025-01-012025-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMember2025-01-012025-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:RevenueFromContractWithCustomerMemberus-gaap:CustomerConcentrationRiskMember2024-07-012024-09-300001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMember2024-01-012024-12-310001175151ctso:DistributorsAndStrategicPartnersMemberus-gaap:RevenueFromContractWithCustomerMemberus-gaap:CustomerConcentrationRiskMember2024-01-012024-09-300001175151ctso:TwoThousandAndTwentyTwoSuccessFeeLetterMemberctso:ThirdTrancheMember2025-01-012025-09-300001175151ctso:TwoThousandAndTwentyTwoSuccessFeeLetterMemberctso:SecondTrancheMember2025-01-012025-09-300001175151ctso:TwoThousandAndTwentyTwoSuccessFeeLetterMemberctso:FirstTrancheMember2025-01-012025-09-3000011751512025-02-242025-02-240001175151srt:ScenarioForecastMember2026-04-012026-06-3000011751512014-06-012014-06-300001175151srt:MinimumMemberctso:LoanAndSecurityAgreementMember2025-09-300001175151srt:MaximumMemberctso:LoanAndSecurityAgreementMember2025-09-300001175151ctso:LoanAndSecurityAgreementTrancheTwoMember2024-06-280001175151ctso:LoanAndSecurityAgreementMember2024-06-282024-06-280001175151ctso:LoanAndSecurityAgreementMember2025-09-300001175151ctso:AvenuePartnersMemberus-gaap:SubsequentEventMember2025-11-130001175151ctso:JefferiesLlcAndB.RileyFbrIncMemberctso:ScenarioOneNoLimitationRelatingToMarketCapitalizationMember2021-12-302021-12-3000011751512025-01-1000011751512024-06-282024-06-2800011751512025-01-102025-01-100001175151ctso:SeriesBRightWarrantsMember2025-01-102025-01-100001175151ctso:SeriesaRightWarrantsMember2025-01-102025-01-100001175151ctso:LoanAndSecurityAgreementMember2024-06-2800011751512025-02-240001175151ctso:SingleReportableSegmentMember2025-09-300001175151ctso:SingleReportableSegmentMember2024-12-3100011751512025-01-012025-09-3000011751512024-07-260001175151ctso:SingleReportableSegmentMember2025-07-012025-09-300001175151ctso:SingleReportableSegmentMember2025-01-012025-09-300001175151ctso:SingleReportableSegmentMember2024-07-012024-09-300001175151ctso:SingleReportableSegmentMember2024-01-012024-09-3000011751512024-01-012024-09-3000011751512025-09-3000011751512024-12-31iso4217:USDxbrli:sharesctso:Dxbrli:pureiso4217:USDxbrli:sharesctso:Distributorctso:itemctso:segment

Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: 001-36792

CYTOSORBENTS CORPORATION

(Exact name of registrant as specified in its charter)

Delaware		98-0373793
(State or other jurisdiction of		(I.R.S. Employer Identification No.)
incorporation or organization)

305 College Road East
Princeton, New Jersey		08540
(Address of principal executive offices)		(Zip Code)

(732) 329-8885

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value per share	CTSO	Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☑ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☑	Smaller reporting company	☑
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☑ No

As of November 10, 2025, there were 62,804,305 shares of the issuer’s common stock, $0.001 par value per share (the “Common Stock”), outstanding.

Table of Contents

CytoSorbents Corporation

FORM 10-Q

TABLE OF CONTENTS


		Page
PART I. FINANCIAL INFORMATION

Item 1. Financial Statements		3

Condensed Consolidated Balance Sheets as of September 30, 2025 (unaudited) and December 31, 2024		3
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2025 and 2024 (unaudited)		4
Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Nine Months Ended September 30, 2025 and 2024 (unaudited)		5
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024 (unaudited)		6

Notes to Condensed Consolidated Financial Statements (unaudited)		7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		25

Item 3. Quantitative and Qualitative Disclosures About Market Risk		32

Item 4. Controls and Procedures		33

PART II. OTHER INFORMATION

Item 1. Legal Proceedings		35

Item 1A. Risk Factors		35

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds		37

Item 3. Defaults Upon Senior Securities		37

Item 4. Mine Safety Disclosures		37

Item 5. Other Information		37

Item 6. Exhibits		38

Signatures		39

This Report includes our trademarks and trade names, such as “CytoSorb,” “CytoSorb XL,” “ECOS-300CY,” “BetaSorb,” “ContrastSorb,” “DrugSorb,” “HemoDefend-RBC,” “HemoDefend-BGA, “K+ontrol” and “VetResQ,” which are protected under applicable intellectual property laws and are the property of CytoSorbents Corporation and its subsidiaries. This Report also contains the trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this Report may appear without the ™, ®, or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by these other parties.

Table of Contents

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements.

CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)


	September 30,		December 31,
	2025		2024
	(unaudited)
ASSETS
Current Assets:
Cash and cash equivalents	$	7,536	$	3,280
Restricted cash, current		—		5,000
Accounts receivable, net of allowances of $134 and $158 as of September 30, 2025 and December 31, 2024, respectively		7,427		7,320
Inventories		4,002		2,733
Prepaid expenses and other current assets		2,348		3,271
Total current assets		21,313		21,604

Property and equipment - net		8,193		9,002
Restricted cash		1,522		1,484
Right-of-use asset		11,075		11,511
Other assets		3,647		3,771
Total assets	$	45,750	$	47,372

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$	3,035	$	3,340
Accrued expenses and other current liabilities		6,559		6,032
Lease liability – current portion		518		453
Total current liabilities		10,112		9,825
Lease liability, net of current portion		12,051		12,444
Long-term debt		14,567		13,996
Total liabilities		36,730		36,265

Commitments and Contingencies

Stockholders’ equity
Preferred Stock, par value $0.001, 5,000,000 shares authorized; no shares issued and outstanding as of September 30, 2025 and December 31, 2024		—		—
Common Stock, par value $0.001, 100,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 62,794,305 and 54,830,146 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		63		55
Additional paid-in capital		319,511		310,809
Accumulated other comprehensive income (loss)		(3,844)		4,252
Accumulated deficit		(306,710)		(304,009)
Total stockholders’ equity		9,020		11,107
Total liabilities and stockholders’ equity	$	45,750	$	47,372

See accompanying notes to condensed consolidated financial statements

Table of Contents

CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)

(in thousands, except share and per share data)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
	(Unaudited)		(Unaudited)		(Unaudited)		(Unaudited)
Revenue	$	9,485	$	8,613	$	27,829	$	26,444
Cost of goods sold		2,819		3,357		8,142		7,812
Gross profit		6,666		5,256		19,687		18,632

Operating expenses
Research and development, net of grant income		918		1,826		3,842		5,592
Selling, general and administrative		8,610		8,260		26,209		26,097
Total operating expenses		9,528		10,086		30,051		31,689
Loss from operations		(2,862)		(4,830)		(10,364)		(13,057)

Other income (expense)
Interest expense, net		(645)		(588)		(1,866)		(775)
Gain (loss) on foreign currency transactions		(64)		2,650		9,128		680
Total other income (expense), net		(709)		2,062		7,262		(95)

Loss before benefit from income taxes		(3,571)		(2,768)		(3,102)		(13,152)

Benefit from income taxes		401		—		401		—

Net loss	$	(3,170)	$	(2,768)	$	(2,701)	$	(13,152)

Basic and diluted net loss per common share	$	(0.05)	$	(0.05)	$	(0.04)	$	(0.24)

Weighted Average Shares of Common Stock Outstanding
Basic and diluted		62,753,959		54,453,006		62,038,902		54,340,583

Other comprehensive income (loss):
Foreign currency translation adjustment, net of tax		116		(2,330)		(8,096)		(686)
Comprehensive loss	$	(3,054)	$	(5,098)	$	(10,797)	$	(13,838)

See accompanying notes to condensed consolidated financial statements.

Table of Contents

CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (UNAUDITED)

(in thousands, except share data)


						Accumulated
				Additional		Other
	Common Stock			Paid-In		Comprehensive		Accumulated		Stockholders’
	Shares	Par Value		Capital		Income (Loss)		Deficit		Equity
Balance as of June 30, 2025 (unaudited)	62,610,376	$	63	$	319,023	$	(3,960)	$	(303,540)	$	11,586
Stock-based compensation	183,929		—		488		—		—		488
Foreign translation adjustment	—		—		—		116		—		116
Net loss	—		—		—		—		(3,170)		(3,170)
Balance at September 30, 2025 (unaudited)	62,794,305	$	63	$	319,511	$	(3,844)	$	(306,710)	$	9,020

Balance at December 31, 2024	54,830,146	$	55	$	310,809	$	4,252	$	(304,009)	$	11,107
Stock-based compensation	297,160		1		1,878		—		—		1,879
Issuance of common stock and warrants from rights offerings, net of fees incurred	6,249,791		6		5,386		—		—		5,392
Issuance of common stock from exercise of warrants	1,417,208		1		1,438		—		—		1,439
Foreign translation adjustment	—		—		—		(8,096)		—		(8,096)
Net loss	—		—		—		—		(2,701)		(2,701)
Balance as of September 30, 2025 (unaudited)	62,794,305	$	63	$	319,511	$	(3,844)	$	(306,710)	$	9,020


						Accumulated
				Additional		Other
	Common Stock			Paid-In		Comprehensive		Accumulated		Stockholders’
	Shares	Par Value		Capital		Income		Deficit		Equity
Balance as of June 30, 2024 (unaudited)	54,306,415	$	54	$	308,874	$	2,173	$	(293,674)	$	17,427
Stock-based compensation	—		—		891		—		—		891
Foreign translation adjustment	—		—		—		(2,330)		—		(2,330)
ATM activation fees	—		—		(41)		—		—		(41)
Issuance of restricted stock units	194,198		—		204		—		—		204
Net loss	—		—		—		—		(2,768)		(2,768)
Balance at September 30, 2024 (unaudited)	54,500,613	$	54	$	309,928	$	(157)	$	(296,442)	$	13,383

Balance at December 31, 2023	54,240,265	$	54	$	306,187	$	529	$	(283,290)	$	23,480
Stock-based compensation	—		—		2,840		—		—		2,840
Foreign currency translation adjustment	—		—		—		(686)		—		(686)
Issuance of common stock offerings, net of fees	53,290		—		12		—		—		12
Warrants issued in connection with long-term debt	—		—		691		—		—		691
Issuance of restricted stock units	207,058		—		198		—		—		198
Net loss	—		—		—		—		(13,152)		(13,152)
Balance as of September 30, 2024 (unaudited)	54,500,613	$	54	$	309,928	$	(157)	$	(296,442)	$	13,383

See accompanying notes to condensed consolidated financial statements.

Table of Contents

CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(in thousands)


	Nine		Nine
	Months Ended		Months Ended
	September 30,		September 30,
	2025		2024
Cash flows from operating activities
Net loss	$	(2,701)	$	(13,152)
Adjustments to reconcile net loss to net cash used in operating activities:
Accrued final fee		—		111
Amortization of debt discount		571		132
Amortization of loan costs		—		58
Depreciation and amortization		1,137		1,181
Amortization of right-of-use asset		109		138
Write-off of patent cost		176		313
Write-off of inventory		253		—
Bad debt expense		17		107
Stock-based compensation		1,879		2,840
Foreign currency transaction gains		(9,128)		(680)
Changes in operating assets and liabilities
Accounts receivable		560		(629)
Inventories		(1,247)		153
Prepaid expenses and other current assets		989		505
Other assets		—		2
Accounts payable and accrued expenses		(167)		(3,166)
Net cash used in operating activities		(7,552)		(12,087)

Cash flows from investing activities
Purchases of property and equipment		(56)		(215)
Payments for patent costs		(68)		(330)
Net cash used in investing activities		(124)		(545)
Cash flows from financing activities
Proceeds from long-term debt		—		15,000
Repayment of long-term debt		—		(5,000)
Payment of final fee		—		(150)
Payment of loan costs		—		(698)
Equity contributions - net of fees incurred		—		12
Proceeds from exercise of common stock warrants		1,439		—
Proceeds from rights offering, net of fees incurred		5,392		—
Net cash provided by financing activities		6,831		9,164
Effect of exchange rates on cash		139		21
Net change in cash, cash equivalents, and restricted cash		(706)		(3,447)

Cash, cash equivalents, and restricted cash at beginning of year		9,764		15,615
Cash, cash equivalents, and restricted cash – end of period	$	9,058	$	12,168

Supplemental disclosure of cash flow information
Cash paid for interest	$	1,535	$	772

Supplemental disclosure of non-cash financing activities
Warrants issued in connection with long-term debt	$	—	$	691

See accompanying notes to condensed consolidated financial statements.

Table of Contents

CYTOSORBENTS CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2025

(Unaudited)

NATURE OF BUSINESS AND BASIS OF PRESENTATION

CytoSorbents Corporation (the “Company”) is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. The Company, through its subsidiary CytoSorbents Medical, Inc. based in New Jersey, is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, based in Berlin, Germany, conducts sales and marketing related operations for the CytoSorb device outside of the United States.

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of September 30, 2025 and December 31, 2024, and for the three and nine months ended September 30, 2025 and 2024. The Company’s condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and therefore, do not include all information and footnotes necessary for a fair presentation of consolidated financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2024, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments, for a fair presentation of the Company’s consolidated financial position and results of operations for the interim periods presented. Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The results for the three and nine months ended September 2025 and 2024, are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period. Beginning in the current year, the Company presents amounts in thousands unless otherwise stated. Prior periods have been adjusted accordingly for consistent presentation. Certain prior year amounts in the footnotes have been reclassified to conform to the current year presentation.

As of September 30, 2025, the Company had approximately $9.1 million in cash, including approximately $7.6 million in unrestricted cash and cash equivalents and $1.5 million of non-current restricted cash. These cash and restricted cash balances considered with the Company’s historical cash used in operations, notwithstanding the Company’s Strategic Workforce and Cost Reduction Plan and the impact of the Amended Loan and Security Agreement both of which were announced on November 13, 2025 (see Note 10, “Subsequent Events”) raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying condensed consolidated financial statements are issued.

The Company’s expected future capital requirements may depend on many factors, including expanding the Company’s customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb™-ATR, in the U.S. which decision is now expected in mid-2026 and the related opportunity to receive Tranche 2 (b) of the Amended Avenue Capital Commitment by December 31, 2026. Additional sources of liquidity available to the Company include the 2024 Shelf, other public or private equity offerings, debt financing or from other sources. The sale of additional equity may result in dilution to shareholders. There is no assurance that the Company will be able to secure funding on terms acceptable, or at all. Although the Company has taken actions to achieve cash flow breakeven, if it does not achieve this goal, the potential need for capital could also make it more difficult to obtain funding through either equity or debt. Should additional capital not become available as needed, the Company may be required to take certain actions, such as slowing sales and marketing expansion, delaying further regulatory approvals, or reducing headcount. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates other financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors.

Table of Contents

SIGNIFICANT ACCOUNTING POLICIES

There have been no material changes to significant accounting policies disclosed in the Company’s consolidated financial statements from the Annual Report on Form 10-K for the year ended December 31, 2024.

Basis of Consolidation and Foreign Currency Translation

The condensed consolidated financial statements include the accounts of CytoSorbents Corporation and its wholly owned subsidiaries, CytoSorbents Medical, Inc. and CytoSorbents Europe GmbH. In addition, the consolidated financial statements include CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp. z.o.o., CytoSorbents Medical UK Limited and CytoSorbents France SAS, wholly owned subsidiaries of CytoSorbents Europe GmbH, and CytoSorbents UK Limited, CytoSorbents India Private Limited, CytoSorbents Medical Canada, Inc., and CytoSorbents MEA FZCO, wholly owned subsidiaries of CytoSorbents Medical, Inc. All significant intercompany transactions and balances have been eliminated in consolidation.

Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recorded in cumulative translation adjustment, a component of accumulated other comprehensive income (loss). Foreign currency transactions gains and losses are included in other income (expense), net in the condensed consolidated statements of operations and comprehensive loss.

Impairment or Disposal of Long-Lived Assets

During the three months ended September 30, 2025 and 2024, the Company recorded impairment charges of approximately $0.2 million and $0.1 million respectively, and during the nine months ended September 30, 2025 and 2024, the Company recorded impairment charges of approximately $0.2 million and $0.3 million, respectively, related to the impairment of certain issued patents and pending patent applications in certain specific jurisdictions and the abandonment of certain pending patent application costs in the ordinary course of business. This charge is included in selling, general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.

Income Taxes

The Company recorded an income tax benefit of $0.4 million for the three and nine months ended September 30, 2025. This benefit was realized by utilizing the New Jersey Technology Business Tax Certificate Program (the “Program”) whereby the State of New Jersey allows the Company to sell a portion of its state net operating losses and research and development (“R&D”) credits to a third party. The Company received $1.7 million from the Program in April of 2025 resulting from the sale of 2023 and amended 2022 net operating losses and R&D credits. The Company anticipates receiving the current benefit of $0.4 million in the second quarter of 2026. The Company has not recorded income tax expense or income tax benefit for the three and nine months ended September 30, 2024 due to the generation of net operating losses, the benefits of which have been fully reserved.

Deferred income taxes are accounted for using the balance sheet approach, which requires recognition of deferred tax assets and liabilities for the expected future consequences of temporary differences between the financial reporting basis and the tax basis of assets and liabilities. A valuation allowance is provided when it is more likely than not that a deferred tax asset will not be realized. A full valuation allowance has been established on the deferred tax asset as it is more likely than not that a future tax benefit will not be realized. In addition, future utilization of the available net operating loss carryforward may be limited under Internal Revenue Code Section 382 as a result of changes in ownership.

The Company follows accounting standards associated with uncertain tax positions. The Company had no unrecognized tax benefits as of September 30, 2025 and December 31, 2024. The Company is accounting for an uncertain tax position of approximately $2.2 million as of December 31, 2024. The Company files tax returns in the U.S. federal and state jurisdictions.

Table of Contents

Concentration of Credit Risk

The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation (“FDIC”) up to a $250,000 limit. At times, cash balances may exceed the maximum coverage provided by the FDIC on insured depositor accounts. Through the IntraFi Network, the Company maintains an Insured Cash Sweep account whereby all cash held in the Company’s money market accounts is swept daily in increments of less than the FDIC insurance limit and deposited in a number of IntraFi’s network of 3,000 financial institutions. This arrangement provides FDIC insurance coverage for all of the cash balances held in the money market accounts. This arrangement excludes the restricted cash balances. Management monitors the soundness of these institutions in an effort to minimize its collection risk of these balances.

A significant portion of the Company’s revenues is from product sales in Germany.

As of September 30, 2025, two distributors accounted for approximately 28% of the Company’s outstanding accounts receivable. As of December 31, 2024, one distributor accounted for approximately 19% of outstanding accounts receivable. For the nine months ended September 30, 2025, no distributor or direct customers accounted for more than 10% of the Company’s revenue. For the nine months ended September 30, 2024, one distributor accounted for approximately 10% of the Company’s revenue. For the three months ended September 30, 2025, one distributor accounted for approximately 10% of the Company’s revenue. For the three months ended September 30, 2024, no distributor or direct customers accounted for more than 10% of the Company’s revenue.

Shipping and Handling Costs

Total freight costs amounted to approximately $0.1 million for each of the three months ended September 30, 2025 and 2024, and $0.4 million and $0.3 million for the nine months ended September 30, 2025 and 2024, respectively.

BALANCE SHEET COMPONENTS

Inventories

The Company had the following major classes of inventories:


	September 30, 2025		December 31, 2024

	(amounts, in thousands)
Raw materials	$	565	$	570
Work in process		1,130		503
Finished goods		2,307		1,660
Inventories	$	4,002	$	2,733

Property and equipment, net

The Company’s property and equipment consist of the following:


					Depreciation/
					Amortization
	September 30, 2025		December 31, 2024		Period

	(amounts, in thousands)
Furniture and fixtures	$	1,612	$	1,454	7 years
Equipment and computers		5,562		5,491	3 to 7 years
Leasehold improvements		6,308		6,283	Lesser of term of lease or estimated useful life
		13,482		13,228
Less accumulated depreciation and amortization		5,289		4,226
Property and equipment, net	$	8,193	$	9,002

Depreciation expense for the nine months ended September 30, 2025 and 2024 amounted to $0.9 million and $1.0 million, respectively. Depreciation expense for each of the three months ended September 30, 2025 and 2024 amounted to $0.3 million.

Table of Contents

Other assets

Other assets consist of the following:


	September 30, 2025		December 31, 2024

	(amounts, in thousands)
Patent applications pending	$	1,539	$	1,612
Patents issued		3,501		3,391
Less accumulated amortization of patents issued		(1,448)		(1,255)
Patents, net		3,592		3,748
Other		55		23
Other assets	$	3,647	$	3,771

Patent amortization expenses amounted to $0.2 million each for the nine months ended September 30, 2025 and 2024. Patent amortization expense amounted to $0.1 million each for the three months ended September 30, 2025 and 2024.

Patent amortization expense for the next five years and thereafter is scheduled as follows:


	(amounts, in thousands)
Remainder of 2025	$	66
2026		258
2027		253
2028		240
2029		240
Thereafter		996
Scheduled amortization of patents issued	$	2,053

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following:


	September 30, 2025		December 31, 2024

	(amounts, in thousands)
Accrued salaries and commissions	$	3,464	$	3,076
Clinical studies		594		590
Deferred revenue and contract liabilities		403		596
Professional fees		738		773
Royalties		282		275
Goods received not invoiced		6		87
Accrued operating expenses		1,072		635
Accrued expenses and other current liabilities	$	6,559	$	6,032

COMMON STOCK, STOCK-BASED COMPENSATION AND WARRANTS

Common Stock

Rights Offering

Table of Contents

Subscribers of basic subscription rights in the Rights Offering were allocated Units based upon their pro-rata share of 6.25 million Units. The Series A Right Warrants and the Series B Right Warrants expired on February 24, 2025 and June 10, 2025, respectively. The warrants do not have a redemption feature and are classified as equity instruments. A fair value of approximately $0.3 million and approximately $0.1 million has been allocated to the Series A Right Warrant and the Series B Right Warrant, respectively, and recorded within additional paid-in capital. The warrants were valued on the date of issuance using the Monte Carlo pricing model with the following assumptions:


	Series A Right Warrant			Series B Right Warrant
Common Stock Price as of Issuance Date	$	0.94		$	0.94
Risk-Free Rate		4.31	%		4.27	%
Dividend Rate		0.00	%		0.00	%
Volatility		88.90	%		97.19	%
Minimum Exercise Price	$	1.00		$	2.00
Maximum Exercise Price	$	2.00		$	4.00
Formula for Exercise Price		90% of the 5-day volume weighted average stock price as of the exercise date rounded down to the nearest cent, not to fall outside the range of the maximum and minimum exercise prices.

Proceeds from the closing of the subscription period satisfied a debt covenant which allowed for $5.0 million of restricted cash on the Company’s condensed consolidated balance sheets to become unrestricted, and available for use.

The Right Warrants were exercisable commencing on their date of issuance and the exercise price is equal to (i) in the case of the Series A Right Warrants, 90% of the five-day volume weighted average price of Common Stock over the last five trading days prior to the expiration date of the Series A Right Warrants on February 24, 2025, rounded down to the nearest whole cent but (x) not lower than $1.00 and (y) not higher than $2.00, and (ii) in the case of the Series B Right Warrants, 90% of the five-day volume weighted average price of Common Stock over the last five trading days prior to the extended expiration date of the Series B Right Warrants on June 10, 2025, rounded down to the nearest whole cent but (x) not lower than $2.00 and (y) not higher than $4.00.

Exercise of the Right Warrants required additional investment separate from the purchase of the Units. 6.25 million shares of common stock were reserved for exercise of the Right Warrants. The Right Warrants were transferable until expiration.

On February 24, 2025, approximately 1.4 million Series A Right Warrants were exercised by holders, including members of management and the Board of Directors, at an exercise price of $1.13 per warrant, providing an additional $1.6 million in aggregate gross proceeds ($1.4 million net of fees). All of the remaining 4.85 million Series A Right Warrants expired on February 24, 2025. On April 4, 2025, the Board of Directors extended the expiration date of the Series B Right Warrants from April 10, 2025 to June 10, 2025. On June 11, 2025, the five-day volume weighted average price of Common Stock over the last five - trading days prior to June 10, 2025 was lower than the minimum required price of $2.00 and, as a result, the Series B Right Warrants issued in connection with the previously announced Rights Offering expired worthless pursuant to their terms.

Shelf Registration

On July 26, 2024, the Company filed a registration statement on Form S-3 with the Securities and Exchange Commission (the “2024 Shelf”), which enables the Company to offer and sell in one or more offerings, any combination of common stock, preferred stock, senior or subordinated debt securities, warrants and units, up to a total dollar amount of $150 million. On September 26, 2024, the Company filed Amendment No. 1 to Form S-3 with the Securities and Exchange Commission (the “SEC”). The 2024 Shelf was declared effective by the SEC on September 30, 2024. Because the Company’s market capitalization is less than $75 million, it will be subject to baby shelf rules which limit the amount of securities sales the Company can make to one-third of its public market float over a 12-month period.

Table of Contents

Stock-Based Compensation

The following non-cash stock-based compensation expense, which relates to stock options and restricted stock units (“RSUs”), is included in each of the respective line items in the Company’s condensed consolidated statements of operations and comprehensive loss:


	Three Months Ended September 30,
Stock-based compensation expense by category	2025		2024

	(amounts, in thousands)
Cost of goods sold	$	29	$	48
Research and development, net of grant income		83		—
Selling, general and administrative		376		843
Total stock-based compensation expense	$	488	$	891


	Nine Months Ended September 30,
Stock-based compensation expense by category	2025		2024

	(amounts, in thousands)
Cost of goods sold	$	114	$	48
Research and development, net of grant income		330		—
Selling, general and administrative		1,435		2,792
Total stock-based compensation expense	$	1,879	$	2,840

For the nine months ended September 30, 2025 and 2024, approximately $1.5 million and $2.3 million of stock-based compensation expense relates to stock options, respectively, and approximately $0.4 million and $0.5 million relates to RSUs, respectively. For the three months ended September 30, 2025 and 2024, approximately $0.4 million and $0.8 million of stock-based compensation expense relates to stock options, respectively, and approximately $0.1 million relates to RSUs for each period.

Stock-options

The summary of the stock option activity for the nine months ended September 30, 2025, is as follows:


				Weighted
		Weighted		Average
		Average		Remaining
		Exercise Price		Contractual
	Shares	per Share		Life (Years)
Outstanding, December 31, 2024	12,341,907	$	3.55	6.81
Granted	787,000		1.00	—
Exercised	(11,650)		0.96	—
Forfeited	(110,985)		2.09	—
Expired	(255,552)		6.15	—
Outstanding, September 30, 2025	12,750,720	$	3.36	6.37

The Company estimated the fair value of stock options granted during the nine months ended September 30, 2025 using a Black-Scholes pricing model, which used the following inputs:


Exercise price (per share)	$	0.82 - $1.30
Expected volatility		80.7 - 81.7	%
Expected term*		6.3 years
Risk-free rate		3.89% - 4.40	%
Dividends		0	%

*The expected term of the options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term. The simplified method is used as the Company’s employee exercise history may not be indicative for estimating future exercises. In addition, the Company recognizes forfeitures as they occur.

Table of Contents

The intrinsic value is calculated as the difference between the market value of the shares as of September 30, 2025 of $0.93 and the exercise price of the shares.


Options Outstanding
	Number	Weighted		Weighted	Aggregate
Range of	Outstanding at	Average		Average	Intrinsic
Exercise	September 30,	Exercise		Remaining	Value
Price	2025	Price		Life (Years)	(in thousands)
$0.82 - $13.20	12,750,720	$	3.36	6.37	$	4


Options Exercisable
Number	Weighted		Aggregate
Exercisable at	Average		Intrinsic
September 30,	Exercise		Value
2025	Price		(in thousands)
8,767,055	$	4.14	$	2

The summary of the status of the Company’s non-vested options for the nine months ended September 30, 2025, is as follows:


		Weighted
		Average
		Exercise
	Shares	Price
Non-vested, December 31, 2024	6,234,550	$	1.09
Granted	787,000	$	1.00
Forfeited	(110,985)	$	2.09
Vested	(2,926,891)	$	1.55
Non-vested, September 30, 2025	3,983,674	$	1.63

As of September 30, 2025, the Company had approximately $2.1 million of total unrecognized compensation cost related to stock options which will, on average, be amortized over approximately 18 months.

Change in Control-Based RSUs

The Board of Directors has granted restricted stock units to members of the Board of Directors, to the Company’s executive officers, and to employees of the Company. These restricted stock units will vest upon a Change in Control of the Company, as defined in the Amended and Restated CytoSorbents Corporation 2014 Long-Term Incentive Plan, or upon certain life events.

The following table is a summary of these restricted stock units:


		Total
		(amounts in thousands, except share data)
Outstanding, December 31, 2024		2,809,500
Granted		121,500
Vested		(35,000)
Forfeited		(49,000)
Outstanding, September 30, 2025		2,847,000

Due to the uncertainty over whether these restricted stock units will vest, which will only happen upon a Change in Control, no charges for these restricted stock units have ever been recorded in the Company’s condensed consolidated statements of operations and comprehensive loss.

Table of Contents

Other RSU Awards

The following table outlines the restricted stock unit activity for the nine months ended September 30, 2025:


		Weighted
		Average
		Grant Date
	Shares	Fair Value
Non-vested, January 1, 2025	641,335	$	1.31
Granted	498,800		1.01
Vested	(264,835)		1.81
Unvested shares forfeited	(65,000)		0.96
Non-vested, September 30, 2025	810,300	$	0.99

As of September 30, 2025, the remaining weighted average vesting period for restricted stock awards subject to vesting was 26 months and the remaining unrecognized restricted stock unit compensation expense was $0.6 million.

Warrants related to the December 2023 equity offering and June 2024 Loan and Security Agreement

As of September 30, 2025, the Company had 4,352,130 warrants outstanding. Of this amount, 2,706,561 warrants outstanding are related to the Company’s December 13, 2023 offering, and these warrants are immediately cash exercisable at an exercise price of $2.00 per share and expire on December 13, 2028. Another 1,645,569 warrants were issued on June 28, 2024 in connection with the closing of the Company’s Loan and Security Agreement with Avenue Capital Group (see Note 6. Long-Term Debt). These warrants have an exercise price of $0.79 and expire on June 30, 2029. The number of warrants is fixed; however, the exercise price may be adjusted down if the Company raises equity (excluding sales of equity utilizing the Company’s at-the-market equity facility) at a share price that is lower than $0.79. These warrants can be exercised into common stock.

REVENUE AND SEGMENT INFORMATION

The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2025:


			Distributors/
	Direct		Strategic Partners		Total

	(amounts, in thousands)
Revenue:
United States	$	28	$	—	$	28
Germany		2,899		—		2,899
All other countries		2,246		4,312		6,558

Revenue	$	5,173	$	4,312	$	9,485

The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended September 30, 2024:


			Distributors/
	Direct		Strategic Partners		Total

	(amounts, in thousands)
Revenue:
United States	$	21	$	—	$	21
Germany		3,181		—		3,181
All other countries		1,937		3,474		5,411
Revenue	$	5,139	$	3,474	$	8,613

Table of Contents

The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2025:



			Distributors/
	Direct		Strategic Partners		Total

	(amounts, in thousands)
Revenue:
United States	$	152	$	—	$	152
Germany		9,050		—		9,050
All other countries		6,344		12,283		18,627
Revenue	$	15,546	$	12,283	$	27,829

The following table disaggregates the Company’s revenue by customer type and geographic area for the nine months ended September 30, 2024:



			Distributors/
	Direct		Strategic Partners		Total

	(amounts, in thousands)
Revenue:
United States	$	63	$	36	$	99
Germany		9,497		—		9,497
All other countries		5,362		11,486		16,848
Revenue	$	14,922	$	11,522	$	26,444

Table of Contents

CytoSorb Sales

The Company sells its CytoSorb device using both its own sales force (direct sales) and through the use of distributors and/or strategic partners. The majority of sales of the device are outside the United States, as CytoSorb is not yet approved for commercial sale in the United States. However, in April 2020, the Company was granted Emergency Use Authorization (“EUA”) of CytoSorb for use in critically-ill patients infected with COVID-19 with imminent or confirmed respiratory failure by the United States Food and Drug Administration (the “FDA”). Direct sales outside the United States relate to sales to hospitals located in Germany, Switzerland, Austria, Poland, the Netherlands and the United Kingdom. Direct sales are fulfilled from the Company’s warehouse facility in Berlin, Germany. There are no formal sales contracts with any direct customers relating to product price or minimum purchase requirements. However, there are agreements in place with certain direct customers that provide for either free of charge product or rebate credits based upon achieving minimum purchase levels. The Company records the value of these items earned as a reduction of revenue, estimated at the time of sale. These customers submit purchase orders and the order is fulfilled and shipped directly to the customer. Prices to all direct customers are based on a standard price list based on the packaged quantity (6 packs versus 12 packs).

Distributor and strategic partner sales make up the remaining product sales. These distributors are located in various countries throughout the world. In general, the Company has formal written contracts with each of its distributors and strategic partners. These contracts have terms ranging from 1-5 years in length, with three years being the typical term. When a contract is not in place, the Company will ship product based upon the terms of an accepted purchase order. In addition, certain distributors are eligible for volume discount pricing if their unit sales are in excess of the base amount in the contract.

Most distributor’s/strategic partner’s contracts have minimum annual purchase requirements in order to maintain exclusivity in their respective territories.

There is no additional consideration or monetary penalty that would be required to be paid to CytoSorbents if a distributor does not meet the minimum purchase commitments included in the contract; however, at the discretion of the Company, the distributor may lose its exclusive rights in the territory if such commitments are not met.

In summary, the contracts the Company has with customers are the distributor/strategic partner contracts related to CytoSorb product sales, agreements with direct customers related to free-of-charge product and credit rebates based upon achieving minimum purchase levels. The Company does not currently incur any outside third-party incremental costs to obtain any of these contracts.

The following table provides information about receivables and contract liabilities from contracts with customers:


	September 30, 2025		December 31, 2024

	(amounts in thousands)
Contract receivables	$	5,997	$	4,427
Contract liabilities	$	403	$	596

Contract receivables, which are included in accounts receivable on the condensed consolidated balance sheets, represent balances due from product sales to direct and distributor customers amounting to $6.0 million and $4.2 million as of September 30, 2025 and December 31, 2024, respectively, and billed and unbilled amounts due on government contracts amounting to $0.0 million and $0.2 million as of September 30, 2025 and December 31, 2024, respectively.

Contract liabilities, which are included in accrued expenses and other current liabilities on the condensed consolidated balance sheets, represent the value of free of charge goods and credit rebates earned in accordance with the terms of certain direct customer agreements, which amounted to $0.2 million each as of September 30, 2025 and December 31, 2024, and deferred grant liability related to the billing on fixed price government contracts in excess of costs incurred, which amounted to $0.2 million and $0.4 million as of September 30, 2025 and December 31, 2024, respectively.

Table of Contents

Segment Information

The Company operates and manages its business as one reportable segment and one operating segment, which is the business of developing, testing and selling blood purification medical devices. The Company’s chief operating decision maker, or CODM, is the Company’s Chief Executive Officer. The CODM assesses performance of the segment and decides how to allocate resources based on revenue growth, gross margin, operating expenses, adjusted net loss, adjusted EBITDA (as defined below) and cash burn (cash used in operating and investing activities) derived from the Company’s consolidated results of operations and cash flows and total assets of the segment.

The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. All material long-lived assets are located in New Jersey, United States and Berlin, Germany. Long-lived assets consist of property and equipment, net and operating lease right-of-use assets.

Factors used in determining the reportable segment include the nature of the Company’s operations, the organizational and reporting structure and the type of information reviewed by the CODM to allocate resources and evaluate financial performance.

The Company operates under one reportable business segment for which segment disclosure is consistent with the management decision making process that determines the allocation of resources and the measuring of performance.

The Company operates as one reportable segment. Consisting of one operating segment, the components presented in the condensed consolidated statements of operations and comprehensive loss also present the components of the Company’s single operating segment.

Table of Contents

The CODM uses financial metrics to evaluate the Company’s spending and monitor budget versus actual results. The monitoring of budgeted versus actual results is used in assessing performance of the segment and in establishing resource allocation across the organization. The financial metrics used by the CODM in evaluating the Company’s spending and monitoring budget versus actual results are as follows:


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2025			2024			2025			2024

	(amounts, in thousands)
Revenue	$	9,485		$	8,613		$	27,829		$	26,444
Gross profit	$	6,666		$	5,256		$	19,687		$	18,632
Gross margin		70	%		61	%		71	%		70	%
Total operating expenses	$	9,528		$	10,086		$	30,051		$	31,689
Loss from operations	$	(2,862)		$	(4,830)		$	(10,364)		$	(13,057)

EBITDA and Adjusted EBITDA (both non-GAAP measures):
Net loss	$	(3,170)		$	(2,768)		$	(2,701)		$	(13,152)
Interest expense, net		645			588			1,866			775
Benefit from income taxes		(401)			—			(401)			—
Depreciation and amortization expense		364			383			1,137			1,181
Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure		(2,562)			(1,797)			(99)			(11,196)

Stock-based compensation		488			891			1,879			2,840
Loss (gain) on foreign currency transactions		64			(2,650)			(9,128)			(680)
Adjusted EBITDA, a non-GAAP measure	$	(2,010)		$	(3,556)		$	(7,348)		$	(9,036)

Adjusted net loss, a non-GAAP measure:
Net loss	$	(3,170)		$	(2,768)		$	(2,701)		$	(13,152)
Stock-based compensation		488			891			1,879			2,840
Loss (gain) on foreign currency transactions		64			(2,650)			(9,128)			(680)
Adjusted net loss, a non-GAAP measure	$	(2,618)		$	(4,527)		$	(9,950)		$	(10,992)
Total cash used in operating and investing activities	$	(2,522)		$	(2,762)		$	(7,676)		$	(12,632)

Table of Contents

Significant expense categories regularly provided to the CODM consist of the following:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024

	(amounts, in thousands)
Research and development:
Clinical expenses	$	719	$	936	$	2,510	$	3,499
Other research and development expenses		199		890		1,332		2,093
Total research and development	$	918	$	1,826	$	3,842	$	5,592

Selling, general and administrative
Royalty expense	$	285	$	354	$	826	$	1,594
Stock-based compensation		376		843		1,435		2,792
Legal, financial and consulting		1,061		824		3,063		2,325
Other general and administrative		6,888		6,239		20,885		19,386
Total selling, general and administrative	$	8,610	$	8,260	$	26,209	$	26,097

Amounts presented within research and development expenses in the table above are inclusive of stock-based compensation expense. Refer to Note 4, Common Stock, Stock-Based Compensation and Warrants, for additional information. Capital expenditures of the segment totaled $0.1 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively.

LONG-TERM DEBT

Avenue Capital Group

On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group (“Loan”). Avenue Capital Group agreed to loan the Company up to an aggregate of $20 million (the “Avenue Capital Commitment”), to be disbursed in two tranches. The first tranche of $15 million (“Tranche 1”), consists of $10 million which was available to the Company on the Closing Date and $5 million constitutes restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved: (i) the FDA has accepted Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company has received a minimum of $3 million in net proceeds from the sale of its equity securities after the Closing Date. The restriction was released on a dollar-for-dollar basis for equity raised between $3 million and $5 million. The second tranche (“Tranche 2”) consists of $5 million, which may be disbursed at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company receives FDA marketing approval of its DrugSorb-ATR application. The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and will additionally be used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment shall bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent (5.00%) or (B) thirteen and one-half percent (13.50%).

On October 22, 2024, the Company announced that the FDA had accepted its application of DrugSorb-ATR, which was one of the two conditions required by the restricted cash debt covenant. Proceeds from the Rights Offering on January 10, 2025 satisfied the second condition of the debt covenant which now allows for the $5 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use.

The loan requires interest-only payments for the first 24 months through July 1, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity, on July 1, 2027; provided, however that if the Company draws the full amount of Tranche 2 by December 31, 2025, and achieves for the trailing six month period ended June 30, 2026, at least $25 million of revenue, (the Interest only Milestone as defined in the Loan), the Interest only Period will be extended by six months to January 1, 2027, followed by equal monthly installments of principal plus accrued and unpaid interest through January 1, 2028. On November 13, 2025, the interest only period was extended from July 1, 2026 to December 31, 2026, and the terms surrounding the access to Tranche 2 were amended. Refer to Note 10, Subsequent Events, for additional information.

Table of Contents

As of the Closing Date, the Company recorded the following discounts:


	(amounts, in thousands)
Fair value of warrants issued to Avenue Capital Group	$	690
Final fee		900
Debt issuance cost		498
Commitment fee paid on the Closing Date (1% of the Avenue Capital Group commitment)		200
Total discounts recorded at inception against Avenue Capital Group Long-Term Debt	$	2,288

The Company amortizes debt discounts as interest expense using the interest method through the maturity date. The loan and security agreement included a final payment upon maturity of $0.9 million. The Company accretes the final payment as interest expense using the interest method through the maturity date.

Upon a prepayment, the Company would incur a fee ranging from 1% to 3% of the outstanding principal, depending on the time of payment in relation to the maturity date.

The Loan and Security Agreement includes customary loan conditions, company representations and warranties, company affirmative covenants and company negative covenants for secured transactions of this type. As of September 30, 2025, the Company was in compliance with these covenants.

As additional consideration for the Commitment, on June 28, 2024, the Company also issued Avenue Capital Group with warrants with a fair value of $0.7 million to purchase an aggregate of 1,645,569 shares of the Company’s common stock for cash at the exercise price of $0.79, which expire on June 30, 2029. The number of warrants is fixed; however, the exercise price may be adjusted down if the Company raises equity (excluding sales of equity utilizing the Company’s at-the-market equity facility) at a share price that is lower than $0.79. These warrants meet the criteria for equity classification under Accounting Standards Codification 815.

The Lenders were also granted the right while the Commitment is outstanding to convert up to an aggregate amount of $2 million of the principal amount of the outstanding Growth Capital Loans into the Company’s common stock at a fixed conversion price of 120% of the Closing Price (as defined in the warrant) or $0.95 per share (the “Conversion Option”).

The Company’s obligations under the Loan and Security Agreement are joint and several. The obligations under the Loan and Security Agreement are secured by a first priority security interest in favor of the Lenders with respect to the Company’s Shares (as defined in the Loan and Security Agreement) and the Company’s Collateral (as defined in the Loan and Security Agreement), which includes the Company’s intellectual property, pursuant to that certain Intellectual Property Security Agreement, dated as of June 28, 2024, by and between the Company and the Administrative and Collateral Agent.

As of September 30, 2025, long-term debt, after giving consideration to the extension of the interest only period provided by the Amended Loan and Security Agreement from July 1, 2026 to December 31, 2026 (see Note 10, “Subsequent Events”), consists of the following:


	(amounts, in thousands)
Principal amount	$	15,000
Plus: final payment upon maturity		900
Less unamortized debt discount		(1,333)
Long-term debt		14,567

As of September 30, 2025, after giving consideration to the extension of the interest only period provided by the Amended Loan and Security Agreement from July 1, 2026 to December 31, 2026, (see Note 10, “Subsequent Events”) principal payments of long-term debt are due as follows:


	(amounts, in thousands)
2026	$	—
2027		15,900
Total	$	15,900

Table of Contents

Bridge Bank

On June 28, 2024, concurrent with the closing of the Avenue Capital Group financing discussed above, the Company paid off its previously outstanding debt with Bridge Bank, a division of Western Alliance Bank (the “Bank”).

As of September 30, 2025, the following commitments survive after the termination of the Bridge Bank Amended and Restated Loan and Security Agreement and related amendments:

2022 Success Fee Letter

Pursuant to the 2022 Success Fee Letter, the Company will pay to the Bank a success fee equal to (i) 1% of $5 million if the Company draws down the first tranche of the Company’s previously outstanding term loan with the Bank(the “Term C Loan”) and is payable only if the Company’s stock price equals or exceeds $8 for five consecutive trading days; (ii) 1.5% of $5 million if the Company draws down the second tranche of the Term C Loan and is payable only if the Company’s stock price equals or exceeds $10 for five consecutive trading days; and (iii) 2% of $5.0 million if the Company draws down the third tranche of the Term C Loan and is payable only if the Company’s stock price equals or exceeds $12 for five consecutive trading days (together, the “Success Fee”). the Company may pay the Success Fee in cash or in shares of common stock, at the Company’s sole discretion. The right of the Bank to receive the Success Fees and the obligation of the Company to pay the Success Fees hereunder shall terminate on the date that is fifth anniversary of the funding date of the last Term C Loans made but shall survive the termination of the Loan Agreement and any prepayment of the Term C Loans. The termination date of the 2022 Success Fee Letter is December 27, 2027.

COMMITMENTS AND CONTINGENCIES

Litigation

The Company is, from time to time, subject to claims and litigation arising in the ordinary course of business. The Company intends to defend vigorously against any future claims and litigation.

Royalty Agreements

The Company is, at times, party to various royalty and license agreements that require the payment of royalty fees. Royalty expense amounted to approximately $0.8 million and $1.6 million for the nine months ended September 30, 2025, and 2024, respectively. Royalty expense amounted to approximately $0.3 million and $0.4 million for the three months ended September 30, 2025, and 2024, respectively. Royalty expense is included in selling, general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.

401(k) Plan

Employees are eligible to participate in the Company’s 401(k) plan on the first day of the calendar quarter following three full months of employment. Participants may defer up to 100% of their eligible compensation subject to certain Internal Revenue Code limitations. Matching contributions amounted to $0.2 million and $0.4 million for the nine months ended September 30, 2025 and 2024, respectively. Matching contributions amounted to approximately $0.1 million and $0.2 million for the three months ended September 30, 2025 and 2024, respectively.

Table of Contents

LEASES

The Company has operating leases that primarily relate to operating facilities in both the United States and Germany. The Company leases its operating facilities under operating lease arrangements with varying expiration dates through March 2037. As of September 30, 2025, the remaining lease term of the Company’s operating leases ranges from six to twelve years.

Supplemental statement of operations and cash flows related to the operating lease liability is as follows (excluding variable payments and expenses):

Supplemental balance sheet information related to operating leases is as follows:


	September 30,			December 31,
	2025			2024

	(amounts, in thousands)
Right-of-use asset	$	11,075		$	11,511
Lease liability - current portion	$	518		$	453
Lease liability - net of current portion		12,051			12,444
Total lease liability	$	12,569		$	12,897
Weighted average discount rate		9.8	%		9.8	%
Weighted average remaining lease term		11.4 years			11.7 years

Lease Expense

The components of lease expense were as follows:


	Three Months Ended September 30,
	2025		2024

	(amounts, in thousands)
Operating lease cost	$	440	$	409
Variable lease cost		207		156
Total lease cost	$	647	$	565


	Nine Months Ended September 30,
	2025		2024

	(amounts, in thousands)
Operating lease cost	$	1,288	$	1,297
Variable lease cost		356		360
Total lease cost	$	1,644	$	1,657

As of September 30, 2025, the maturities of the operating lease liability are as follows:


Remainder of 2025	$	431
2026		1,736
2027		1,777
2028		1,819
2029		1,863
Thereafter		13,550
Future operating lease payments		21,176
Imputed interest		(8,607)
Total operating lease liability	$	12,569

Table of Contents

NET LOSS PER SHARE

Basic loss per share and diluted loss per share for the three and nine months ended September 30, 2025 and 2024 have been computed by dividing the net loss for each respective period by the weighted average number of shares outstanding during that period.

Net income per common share is calculated as basic net income per share and diluted net income per share. Basic net income per share excludes dilution and is computed by dividing net income by the weighted average number of common shares outstanding for the period. Diluted net income per share is computed in the same manner as basic net income after assuming issuance of common stock for all potentially dilutive equivalent shares, which includes the potential dilution that could occur: (i) if the RSUs with service conditions were fully vested (using the treasury stock method); (ii) if all of the Company’s outstanding stock options that are in-the-money were exercised (using the treasury stock method); (iii) if the RSUs with service and market conditions were considered contingently issuable; (iv) if the RSUs with service and performance conditions were considered contingently issuable; (v) if outstanding warrants were exercised; and (vi) if convertible debt was converted to common stock.

The following table summarizes earnings per share calculations:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2025		2024		2025		2024

	(amounts, in thousands, except share and per share data)
Basic and diluted earnings per common share:
Net loss	$	(3,170)	$	(2,768)	$	(2,701)	$	(13,152)
Basic and diluted weighted average common shares outstanding		62,753,959		54,453,006		62,038,902		54,340,583
Basic and diluted earnings per common share	$	(0.05)	$	(0.05)	$	(0.04)	$	(0.24)

Certain stock options and restricted stock units are not included in the diluted earnings per share calculation when the effect would be anti-dilutive. The number of anti-dilutive shares were 11,264,903 and 11,387,763 for the three and nine months ended September 30, 2025, respectively.

10.

SUBSEQUENT EVENTS

Management has evaluated subsequent events through the date of issuance of these condensed consolidated financial statements and has determined that there are no subsequent events outside the ordinary scope of business that require adjustment to, or disclosure in, the condensed consolidated financial statements.

Amended Loan and Security Agreement

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

Under the terms of the Amended Loan and Security Agreement, the Company issued additional warrants to Avenue Capital Group to purchase 1,428,571 shares of the Company’s common stock for cash at the exercise price of $0.70, which expire on November 13, 2030. The number of warrants and exercise price are fixed.

Table of Contents

Workforce and Cost Reduction Plan

On November 13, 2025, the Company announced it initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. This initiative follows a comprehensive review of the Company’s cost structure and operating model. As part of the strategic plan, the Company reduced its workforce by approximately 10%, and reduced and realigned operating and production expenses. The Company expects to record a charge of up to $0.9 million that will include severance and other cash and non-cash charges related to the restructuring. The estimated costs that the Company expects to incur, and the timing thereof, are subject to a number of assumptions, and actual amounts may differ materially.

Continued Listing Requirements Notification

On October 2, 2025, the Company was notified by the Nasdaq Stock Market LLC (“Nasdaq”) that the Company was not in compliance with the Nasdaq’s continued listing requirements relating to the minimum average closing price per share of the Company’s common stock, because the average closing price of the Company’s common stock over a consecutive 30 trading-day period was below $1.00 per share (the “Minimum Bid Price Requirement”). The notice does not result in the immediate delisting of the Company’s common stock from the Nasdaq.

The Company has timely notified the Nasdaq of its intent to regain compliance with the minimum price condition within a 180-day cure period provided by Nasdaq rules, or until March 31, 2026 (the “Compliance Date”). The Company can regain compliance at any time within the cure period if, the closing bid price of the Company’s common stock meets or exceeds $1.00 per common share for a minimum of 10 consecutive business days prior to the Compliance Date, unless the Nasdaq staff exercises its discretion to require the Company to meet the Minimum Bid Price Requirement for a longer period pursuant to applicable Nasdaq rules. If the Company fails to regain compliance with the Nasdaq’s minimum price condition by the end of the cure period, the Company would be eligible for an additional compliance period of 180 days provided it presents an acceptable plan to Nasdaq to regain compliance.

The Company intends to actively monitor the closing bid price of its common stock and will consider its options to regain compliance with the Minimum Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq listing standards. If the Company is unable to regain compliance with the Minimum Bid Price Requirement, the Company’s common stock will be subject to the Nasdaq’s suspension and delisting procedures.

During this time, the Company’s common stock will continue to be listed on the Nasdaq, subject to its compliance with other Nasdaq continued listing requirements. However, there can be no assurance about the Company’s ability to regain compliance with the Nasdaq’s minimum price condition within the applicable cure periods.

Table of Contents

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Cautionary Notes Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, or this Report, contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. Forward-looking statements discuss matters that are not historical facts. Because they discuss future events or conditions, forward-looking statements may include words such as “anticipate,” “believe,” “estimate,” “intend,” “could,” “should,” “would,” “may,” “seek,” “plan,” “might,” “will,” “expect,” “predict,” “project,” “forecast,” “potential,” “continue,” negatives thereof or similar expressions. These forward-looking statements are found at various places throughout this Report and include information concerning possible or assumed future results of our operations; business strategies; future cash flows; financing plans; plans and objectives of management; any other statements regarding future operations, future cash needs, business plans and future financial results, and any other statements that are not historical facts. Unless otherwise indicated, the terms “CytoSorbents,” “Company,” “we,” “us” and “our” refer to CytoSorbents Corporation.

From time to time, forward-looking statements also are included in our other periodic reports on Forms 10-K and 8-K, in our press releases, in our presentations, on our website and in other materials released to the public. Any or all of the forward-looking statements included in this Report and in any other reports or public statements made by us are not guarantees of future performance and may turn out to be inaccurate. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors. Many of those factors are outside of our control and could cause actual results to differ materially from the results expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of the applicable Report or public statement. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report or public statement and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report.

Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise. For discussion of factors that we believe could cause our actual results to differ materially from expected and historical results see “Item 1A - Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

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, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents’ technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses include, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure 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 nearly 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.

Table of Contents

In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-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 U.S. Food and Drug Administration (“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 is actively pursuing regulatory approval of DrugSorb-ATR with the FDA and will pursue regulatory approval with Health Canada with better visibility from the FDA. DrugSorb-ATR is not yet granted or approved in either the U.S. or Canada.

Upon approval, the Company expects to rapidly commercialize DrugSorb-ATR in the U.S. and Canada to address this large unmet medical need, with an initial estimated total addressable market of $300 million today to over $1 billion over time as we pursue additional indications for DrugSorb-ATR to remove additional classes of blood thinners and expansion of the antithrombotic removal application beyond cardiac surgery and across other surgical specialties. We believe that DrugSorb-ATR has the potential to become an “all-in-one” countermeasure for these agents.

Our executive offices are located at 305 College Road East, Princeton, New Jersey 08540, and our telephone number is (732) 329-8885. Our website address is http://www.cytosorbents.com. We have included our website address as an inactive textual reference only. We make available free of charge through our website our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material, or furnish it to the SEC. We also similarly make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10% stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons. We are not including the information contained at http://www.cytosorbents.com, or at any other website address, as part of, or incorporating it by reference into, this Quarterly Report on Form 10-Q.

Summary of Operational and Recent Business Highlights

●

Total revenue was $27.8 million for the nine months ended September 30, 2025, an increase of $1.4 million, or 5.2%, compared to the prior year.

●

Gross profit was $19.7 million for the nine months ended September 30, 2025, an increase of $1.1 million, or 5.7%, compared to the prior year. Gross margin was 71% for the nine months ended September 30, 2025, compared to 71% in the prior year.

●

Our loss from operations improved by 20.6% to approximately $10.4 million, from $13.1 million for the nine months ended September 30, 2025, and 2024, respectively. This improvement was driven by a 5.2% increase in total revenue and a 5.2% reduction in total operating expense year over year.

●

We strengthened our balance sheet with the completion of a shareholder Rights Offering in January 2025 that provided $5.4 million net proceeds, and then added another $1.4 million net proceeds with the exercise of the Series A Right Warrant in February 2025.

●

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).

●

On May 22, 2025, a new contemporary real-world data analysis was presented at EuroPCR, highlighting the intraoperative use of the Company’s technology to significantly reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not completed the recommended drug washout period. (Storey, R.F., et al. Early CABG with intraoperative hemadsorption in patients on ticagrelor. Cardiovascular Revascularization Medicine.) The information in this data analysis are referenced for general information only and are not incorporated by reference into this Report.

●

Continued to see real world validation of improved clinical outcomes (reduced serious perioperative bleeding) in cardiac surgery patients on a blood thinner at several global cardiac surgery conferences including EuroPCR, ESCVS, EACTS, and TCT.

Table of Contents

●

On July 31, 2025 the Company highlighted data demonstrating the vital and evolving role of CytoSorb therapy in the treatment of sepsis and septic shock–among the deadliest challenges in critical care medicine. Recent data demonstrate early and intensive use of CytoSorb therapy improves clinical outcomes for patients suffering from these conditions. The Company presented a World Sepsis Day Global Webinar on September 10, 2025 in commemoration of Sepsis Awareness Month and World Sepsis Day. See our Current Report on Form 8-K, filed with the SEC on August 1, 2025, for additional information.

●

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 that upheld its previous denial of the Company’s DrugSorb-ATR De Novo 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. A formal meeting with the FDA is anticipated in either late fourth quarter of 2025, or early 2026 to confirm the requirements for the new De Novo submission, followed by a formal submission in the first quarter of 2026. A regulatory decision is expected in mid-2026 following a typical 150-day review process.

●

Continued to see real world validation of improved clinical outcomes (reduced serious perioperative bleeding) in cardiac surgery patients on a blood thinner at global cardiac surgery conferences including EuroPCR, ESCVS, EACTS and TCT

●

On November 13, 2025, the Company and Avenue Capital Group entered into the First Amendment to Loan Documents (“the Amended Loan and Security Agreement”), amending the Company’s Loan and Security Agreement, dated June 28, 2024, as supplemented. The Amended Loan and Security Agreement provides for access to an additional aggregate $2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and for the extension of the interest only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027. The Company will have access to an additional aggregate $2.5 million (“Tranche 2b”) from Avenue Capital Group, subject to FDA approval of DrugSorb-ATR, between January 1, 2026 and December 31, 2026. Tranche 2a and Tranche 2b, in the aggregate, replace Tranche 2 of the original loan. 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 and also 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.

●

On November 13, 2025, the Company announced it initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. This initiative follows a comprehensive review of the Company’s cost structure and operating model. As part of the Strategic 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 first quarter of 2026. The Company expects to record a charge of up to $0.9 million that will include severance and other cash and non-cash charges related to the restructuring. The estimated costs that the Company expects to incur, and the timing thereof, are subject to a number of assumptions, and actual amounts may differ materially.

Table of Contents

Results of Operations:

Comparison for the three months ended September 30, 2025 and 2024:


	Three Months Ended September 30,
	2025				2024
			% of				% of
	Amount		Revenue		Amount		Revenue
	(in thousands)				(in thousands)
Revenue	$	9,485	100	%	$	8,613	100	%
Cost of goods sold		2,819	29.7			3,357	39.0
Gross profit		6,666	70.3			5,256	61.0
Operating expenses:
Research and development		918	9.7			1,826	21.2
Selling, general and administrative		8,610	90.8			8,260	95.9
Total operating expenses		9,528	100.5			10,086	117.1
Loss from operations		(2,862)	(30.2)			(4,830)	(56.1)
Other income (expense):
Interest expense, net		(645)	(6.8)			(588)	(6.8)
Gain (loss) on foreign currency transactions		(64)	(0.7)			2,650	30.8
Total other income (expense), net		(709)	(7.5)			2,062	23.9
Loss before benefit from income taxes	$	(3,571)	(37.6)	%	$	(2,768)	(32.1)	%

Revenues

For the three months ended September 30, 2025, we generated total revenue of approximately $9.5 million, an increase of approximately $0.9 million, or 10.1%, and 3.8% on a constant currency basis, as compared to revenues of approximately $8.6 million for the three months ended September 30, 2024. 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 steady progress with this important initiative and are tracking to expectations through the third quarter of 2025, and remain confident it will lead to stronger execution and improved performance in Germany and our financial results overall into next year.

Gross Profit

Gross profit was approximately $6.7 million for the three months ended September 30, 2025, an increase of approximately $1.4 million, or 26.8%, as compared to gross profit of $5.2 million for the three months ended September 30, 2024. Gross margins were 70.3% and 61.0% for the three months ended September 30, 2025 and 2024, respectively. Prior year gross margins were negatively impacted by a planned reduction in units production to rebalance inventory levels, coupled with a short-term manufacturing issue which was resolved in the third quarter of last year and resulted in significantly lower number of CytoSorb devices produced in the quarter.

Research and Development Expenses

Our research and development costs were approximately $0.9 million and $1.8 million for the three months ended September 30, 2025 and 2024, respectively, a decrease of approximately $0.9 million, or 49.7%. This decrease was driven by a decrease in our clinical trial costs due to the completion of the STAR-T clinical trial, the reduction of grant funded projects, and other payroll and project-related cost reductions.

Selling, General and Administrative Expenses

Our selling, general and administrative expenses were approximately $8.6 million and $8.3 million for the three months ended September 30, 2025 and 2024, respectively, an increase of approximately $0.3 million, or 4.2%. The increase is primarily due to costs associated with the regulatory submission and anticipated commercial approval and launch of DrugSorb-ATR in North America, partially offset by lower non-cash stock comp and other compensation costs, and lower royalty expense as a result of the expiration of a 4% royalty in August of 2024.

Table of Contents

Gain (Loss) on Foreign Currency Transactions

For the three months ended September 30, 2025, the loss on foreign currency transactions was approximately $0.1 million, as compared to a gain on foreign currency transactions of approximately $2.7 million for the three months ended September 30, 2024. The loss was directly related to the slight decrease in the spot exchange rate of the Euro to the U.S. dollar as of September 30, 2025 compared to June 30, 2025. The prior year gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of September 30, 2024, to $1.11 per Euro from $1.07 per Euro at June 30, 2024.

Loss From Operations

Our loss from operations decreased by 40.7% to approximately $2.9 million, from $4.8 million for the nine months ended September 30, 2025, and 2024, respectively. This improvement was primarily the result of a 5.5% reduction in operating expenses year over year, and the increase in gross profit.

Comparison for the nine months ended September 30, 2025 and 2024:


	Nine Months Ended September 30,
	2025					2024
			% of				% of
	Amount		Revenue		Amount		Revenue
	(in thousands)				(in thousands)
Revenue	$	27,829	100	%	$	26,444	100	%
Cost of goods sold		8,142	29.3			7,812	29.5
Gross profit		19,687	70.7			18,632	70.5
Operating expenses:
Research and development		3,842	13.8			5,592	21.1
Selling, general and administrative		26,209	94.2			26,097	98.7
Total operating expenses		30,051	108.0			31,689	119.8
Loss from operations		(10,364)	(37.2)			(13,057)	(49.4)
Other income (expense):
Interest expense, net		(1,866)	(6.7)			(775)	(2.9)
Gain (loss) on foreign currency transactions		9,128	32.8			680	2.6
Total other income (expense), net		7,262	26.1			(95)	(0.4)
Loss before benefit from income taxes	$	(3,102)	(11.1)	%	$	(13,152)	(49.7)	%

Revenues

For the nine months ended September 30, 2025, we generated total revenue of approximately $27.8 million, an increase of approximately $1.4 million, or 5.2%, and 2.2% on a constant currency basis, as compared to revenues of approximately $26.4 million for the nine months ended September 30, 2024. Revenue growth was led by strength in our other direct European territories, and distributors and strategic partner sales, and partially offset by a decrease in 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 steady progress with this important initiative and are tracking to expectations through the third quarter of 2025, and remain confident it will lead to stronger execution and improved performance in Germany and our financial results overall into next year.

Gross Profit

Gross profit was approximately $19.7 million for the nine months ended September 30, 2025, an increase of approximately $1.1 million, or 5.7%, as compared to gross profit of $18.6 million for the nine months ended September 30, 2024. Gross margins were 70.7% and 70.5% for the nine months ended September 30, 2025 and 2024, respectively.

Research and Development Expenses

Our research and development costs were approximately $3.8 million and $5.6 million for the nine months ended September 30, 2025 and 2024, respectively, a decrease of approximately $1.8 million, or 31.3%. This decrease was driven by a decrease in our clinical trial costs due to the completion of the STAR-T clinical trial, lower grant funded projects, and other payroll and project-related cost reductions.

Table of Contents

Selling, General and Administrative Expenses

Our selling, general and administrative expenses were approximately $26.2 million and $26.1 for the nine months ended September 30, 2025 and 2024, respectively, an increase of approximately $0.1 million, or 0.4%. 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.

Gain (Loss) on Foreign Currency Transactions

For the nine months ended September 30, 2025, the gain on foreign currency transactions was approximately $9.1 million, as compared to a gain on foreign currency transactions of approximately $0.7 million for the nine months ended September 30, 2024. The gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of September 30, 2025 to $1.17 per Euro from $1.03 per Euro at December 31, 2024. The prior year gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of September 30, 2024, to $1.11 per Euro from $1.10 per Euro at December 31, 2023.

Loss From Operations

Our loss from operations decreased by 20.6% to approximately $10.4 million, from $13.1 million for the nine months ended September 30, 2025, and 2024, respectively. This improvement was primarily the result of a 5.2% reduction in operating expenses year over year, and the increase in gross profit.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of September 30, 2025, we had current assets of approximately $21.3 million and current liabilities of approximately $12.6 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 September 30, 2025. We have also allocated $20 million of our total shelf amount to our ATM facility. At September 30, 2025, approximately $19.4 million was available for use under the ATM facility. During the nine months ended September 30, 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 the Avenue Capital Group (“Loan”). Avenue Capital Group agreed to loan the Company up to an aggregate of $20 million (the “Avenue Capital Commitment”), to be disbursed in two tranches. The first tranche of $15.0 million (“Tranche 1”), consists of $10.0 million which was available to the Company on the Closing Date and $5.0 million constitutes restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved: (i) the FDA has accepted Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company has received a minimum of $3.0 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”) consists of $5.0 million, which may be disbursed at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company receives FDA marketing approval of its DrugSorb-ATR application. The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and will additionally be used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment shall bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent (5.00%) or (B) thirteen and one-half percent (13.50%).

Table of Contents

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 provides for access to an additional aggregate $2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and for the extension of the interest only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027. The Company will have access to an additional aggregate $2.5 million (“Tranche 2b”) from Avenue Capital Group, subject to FDA approval of DrugSorb-ATR, between January 1, 2026 and December 31, 2026. Tranche 2a and Tranche 2b, in the aggregate, replace Tranche 2 of the 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 and also 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.

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

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.

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 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%, reduced and realigned operating and production expenses, and now expects that the Company will reach operating cash flow break-even in the first quarter of 2026. The Company expects to record a charge of up to $0.9 million that will include severance and other cash and non-cash charges related to the restructuring. The estimated costs that we expect to incur, and the timing thereof, are subject to a number of assumptions, and actual amounts may differ materially.

As of September 30, 2025, we had approximately $9.1 million in cash, including approximately $7.6 million in unrestricted cash and cash equivalents and $1.5 million of non-current restricted cash. These cash and restricted cash balances considered with our historical cash used in operations, notwithstanding our Strategic Workforce and Cost Reduction Plan and the impact of the Amended Loan and Security Agreement both of which were announced on November 13, 2025, raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying condensed consolidated financial statements are issued.

Table of Contents

On a proforma-basis, giving effect to the impact of receiving the additional $2.5 million from Tranche 2(a) of the Amended Loan and Security Agreement, as if it had occurred on September 30, 2025, our total cash balance would have been $11.6 million, including $10.1 million in unrestricted cash and cash equivalents and $1.5 million of non-current restricted cash.

As of September 30, 2025, the total amount of debt drawn under our Loan and Security Agreement was $15.0 million. On a proforma basis, giving effect to the impact of receiving the additional $2.5 million from Tranche 2 (a) of the Amended Loan and Security Agreement, as if it had occurred on September 30, 2025, our total debt drawn would have been $17.5 million.

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 decision is now expected in mid-2026, and the related opportunity to receive Tranche 2b of the Amended Avenue Capital Commitment by December 31, 2026. 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 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. As a result of these additional uncertainties, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates 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. A formal meeting with the FDA is anticipated in either late fourth quarter of 2025, or early 2026 to confirm the requirements for the new De Novo submission. A standard regulatory decision is expected in mid-2026 following a typical 150-day review process.

For further discussion regarding the Loan and Security Agreement, and Amended Load and Security Agreement please see Note 6, “Long Term Debt” and Note 10, “Subsequent Events” to our Condensed Consolidated Financial Statements, included elsewhere in this Quarterly Report on Form 10-Q.

Critical Accounting Policies and Estimates

Our condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. On an ongoing basis, we evaluate our estimates and assumptions based on historical experience and on various other assumptions that we believe are reasonable under the circumstances. Our actual results could differ from these estimates under different assumptions or conditions. Refer to “Critical Accounting Estimates” contained in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024 for a complete discussion of our critical accounting estimates. There have been no material changes to our critical accounting estimates since our Annual Report on Form 10-K for the year ended December 31, 2024.

Item 3. 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.

Table of Contents

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, as of the end of the period covered by this report, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Act of 1934. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be included in our SEC reports is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, relating to the Company, including our consolidated subsidiaries, and was made known to them by others within those entities, particularly during the period when this report was being prepared. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of September 30, 2025 because of the material weakness identified in our internal controls over financial reporting, which is being actively remediated (see below).

Management’s Report on Internal Control over Financial Reporting

The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is a process designed under the supervision of the Company’s principal executive officer and principal financial officer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the Company’s financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurances with respect to financial statement preparation and presentation. Additionally, projections of any evaluation 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.

Discussion of Material Weakness

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.

In connection with our preparation and the audit of our consolidated financial statements as of and for the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting related to the accounting for non-cash 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.

Table of Contents

Remediation Activities

We are actively engaged in remediating the identified material weakness. Management has begun implementing measures to strengthen our internal control over financial reporting, including redesigning internal control procedures and enhancing documentation processes related to 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.

We are committed to completing the remediation of this material weakness as expeditiously as possible and expect these enhancements to be fully implemented during the fiscal year ending December 31, 2025. However, the material weakness 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.

Notwithstanding the material weaknesses, management concluded that the consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q presented fairly, in all material respects, our financial position, results of operations and cash flows in conformity with GAAP.

Change in Internal Control over Financial Reporting

Except as discussed above, there have been no changes in the Company’s internal controls over financial reporting during the three months ended September 30, 2025, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Table of Contents

PART II. OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in litigation or other legal proceedings arising in the ordinary course of business. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact because of defense and settlement costs, diversion of management resources and other factors.

Item 1A. Risk Factors.

There have been no material changes to our critical accounting estimates since our Annual Report on Form 10-K for the year ended December 31, 2024. For a discussion of risks that affect the Company’s business, please refer to Part I, Item IA, “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In addition to the other information set forth in this Quarterly Report on Form 10-Q, please carefully consider the factors described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. The risks described are not the only risks facing us. Additional risks and uncertainties are not currently known to us, or that our management currently deems to be immaterial, also may adversely affect our business, financial condition, and/or operating results.

The following represent modification to risk factors that could materially harm our business, financial position, or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this report.

We may not be successful in obtaining the FDA’s or Health Canada’s authorization and successful commercialization for DrugSorb-ATR in the U.S. or Canada, respectively

On April 25, 2025, the FDA issued a denial letter regarding the Company’s De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company filed an appeal of the decision through the formal appeal process with the FDA. In July, the Company participated in an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR 10.75. The appeal hearing included FDA senior leadership, Company management and our external surgical experts.

On August 14, 2025, the Company received an FDA appeal decision following its July 2025 in-person supervisory administrative review (appeal) meeting with the FDA under 21 CFR 10.75. In the appeal decision, the FDA found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the Company’s desired label indication. Additionally, the FDA proactively proposed a potential expedited path forward for market authorization but noted the Company could also appeal to a final higher level within the FDA with the Director of the FDA’s Center for Devices and Radiologic Health (CDRH). On September 16, 2025, the Company announced that it decided to not file a final appeal with the CDRH because of positive FDA upper management feedback for a reasonable path forward that would allow for a suitable and potentially expedited De Novo grant for the Company’s original desired label indication. The Company expects to file a new De Novo application with additional information that includes analyses of new real-world data to support its desired label indication in early 2026. As part of the resubmission process, the Company filed a pre-submission meeting request with supporting documentation to the FDA on November 7, 2025. A formal meeting with the FDA is anticipated in either late fourth quarter of 2025, or early 2026 to confirm the requirements for the new De Novo submission. A regulatory decision is expected in mid-2026 following a typical 150-day review process.

On June 26, 2025, Health Canada issued a Notice of Refusal of the Company’s Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization. On September 16, 2025 the Company announced that it had timely filed a Level 1 “Request For Reconsideration” with Health Canada. However, following interactive discussions with the Medical Devices Directorate Bureau Director and the Company’s Canadian regulatory counsel, it was recommended that any subsequent review of DrugSorb-ATR in Canada be delayed until better clarity was received from the FDA. As such, the Company withdrew the Request for Reconsideration and will provide a new Medical Device License application to Health Canada with improved visibility from the FDA.

We may be unsuccessful in our appeal which may significantly impact our ability to generate any significant revenues or ever achieve and maintain a substantial level of sales of our product candidates in the U.S. and Canada.

Table of Contents

Acceptance of our medical devices in the marketplace is uncertain, and failure to achieve market acceptance will prevent or delay our ability to generate revenues.

Our future financial performance will depend, at least in part, upon the introduction, and customer and healthcare community acceptance of our products. Even with current or future regulatory or marketing approvals for our CytoSorb, ECOS-300CY, and PuriFi pump devices, other products like VetResQ, and product candidates such as DrugSorb-ATR, these products may not achieve market acceptance in the countries where they are sold. There is no guarantee that we will be able to achieve additional regulatory approvals, and even if we do, our products may not achieve market acceptance in the countries covered by such approvals. The degree of market acceptance will depend upon a number of factors, including:

●

the receipt of regulatory clearance of marketing claims for the uses that we are developing

●

the establishment, demonstration, and acceptance of the advantages, safety and efficacy of our polymer technology and products as evidenced by product adoption, sales, reimbursement, inclusion in treatment guidelines, etc.;

●

pricing and reimbursement policies of government and third-party payers such as insurance companies, health maintenance organizations and other health plan administrators;

●

the development by our competitors of products or product candidates that are similar or identical to ours;

●

our ability to attract corporate partners, including medical device companies, to assist in commercializing our products; and

●

our ability to effectively market our products

Physicians, patients, payers or the medical community in general may be unwilling to accept, utilize or recommend any of our products. For example, the approval of our CytoSorb device as a cytokine adsorber as well as the data we have gathered in our clinical studies to support device usage in this indication may not be sufficient for market acceptance in the medical community. We may also need to conduct additional clinical studies to gather additional data for marketing purposes. If we are unable to obtain regulatory approval or commercialize and market our products when planned, we may not achieve any market acceptance or generate revenue.

If we are not in compliance with the continued listing standards of the Nasdaq Stock Market LLC (“Nasdaq”), our common stock may be delisted, which could have a material adverse effect on the liquidity of our common stock.

Our common stock is listed on the Nasdaq Stock Market LLC (“Nasdaq”). On October 2, 2025, we were notified that we were not in compliance with the Nasdaq’s continued listing requirements relating to the minimum average closing price per share of our common stock, because the average closing price of our common stock over a consecutive 30 trading-day period was below $1.00 per share (the “Minimum Bid Price Requirement”).

We have timely notified the Nasdaq of our intent to regain compliance with the minimum price condition within a 180-day cure period provided by Nasdaq rules, or until March 31, 2026 (the “Compliance Date”). We can regain compliance at any time within the cure period if, the closing bid price of the Company’s common stock meets or exceeds $1.00 per common share for a minimum of 10 consecutive business days prior to the Compliance Date, unless the Nasdaq staff exercises its discretion to require the Company to meet the Minimum Bid Price Requirement for a longer period pursuant to applicable Nasdaq rules. If we fail to regain compliance with the Nasdaq’s minimum price condition by the end of the cure period, the Company would be eligible for an additional compliance period of 180 days provided it presents an acceptable plan to Nasdaq to regain compliance.

The Company intends to actively monitor the closing bid price of its common stock and will consider its options to regain compliance with the Minimum Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq listing standards. If the Company is unable to regain compliance with the Minimum Bid Price Requirement, our common stock will be subject to the Nasdaq’s suspension and delisting procedures.

Table of Contents

During this time, our common stock will continue to be listed on the Nasdaq, subject to our compliance with other Nasdaq continued listing requirements. However, there can be no assurance about our ability to regain compliance with the Nasdaq’s minimum price condition within the applicable cure periods.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Insider Trading Arrangements

No director or officer (as defined in Rule 16a-1(f) promulgated under the Exchange Act) of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408 during the quarter ended September 30, 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 provides for access to an additional aggregate $2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and for the extension of the interest only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027. The Company will have access to an additional aggregate $2.5 million (“Tranche 2b”) from Avenue Capital Group, subject to FDA approval of DrugSorb-ATR, between January 1, 2026 and December 31, 2026. Tranche 2a and Tranche 2b, in the aggregate, replace Tranche 2 of the original loan. The Amended Loan and Security Agreement requires that the Company maintain certain operating cash burn targets (as defined) prior to FDA approval of DrugSorb-ATR and provides for a further six-month extension of the interest only period to the July 1, 2027 maturity date upon FDA approval of DrugSorb-ATR.

Workforce and Cost Reduction Plan

On November 13, 2025, the Company announced it initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. This initiative follows a comprehensive review of the Company’s cost structure and operating model. As part of the strategic plan, the Company reduced its workforce by approximately 10%, reduced and realigned operating and production expenses, and now expects that the Company will reach operating cash flow break-even in the first quarter of 2026. The Company expects to record a charge of up to $0.9 million that will include severance and other cash and non-cash charges related to the restructuring. The estimated costs that the Company expects to incur, and the timing thereof, are subject to a number of assumptions, and actual amounts may differ materially.

Table of Contents

Item 6. Exhibits.

Number		Description
10.1*		First Amendment to Loan Documents, dated November 13, 2025, by an among CytoSorbents Corporation, the lenders, and the administrative and collateral agent party thereto
10.2*		Form of Warrant to Purchase Shares of Stock of CytoSorbents Corporation by and between the Company and Avenue Venture Opportunities Fund, LP, dated November 13, 2025.
10.3*		Form of Warrant to Purchase Shares of Stock of CytoSorbents Corporation y and between the Company and Avenue Venture Opportunities Fund II, LP, dated November 13, 2025.
31.1*		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of Sarbanes Oxley Act of 2002.
31.2*		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of Sarbanes Oxley Act of 2002.
32.1**		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of Sarbanes Oxley Act of 2002.*
32.2**		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of Sarbanes Oxley Act of 2002.*
101*		The following materials from CytoSorbents Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024, (ii) Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024, (iii) Consolidated Statement of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2025 and 2024, (iv) Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 and (v) Notes to Condensed Consolidated Financial Statements.
104*		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

* Filed herewith.

** Furnished herewith.

Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	CYTOSORBENTS CORPORATION

Dated: November 13, 2025	By:	/s/ Phillip P. Chan
		Name: Phillip P. Chan
		Title: Chief Executive Officer
		(Principal Executive Officer)

Dated: November 13, 2025	By:	/s/ Peter J. Mariani
		Name: Peter J. Mariani
		Title: Chief Financial Officer
		(Principal Financial and Accounting Officer)

EX-10.1 2 ctso-20250930xex10d1.htm EX-10.1

Exhibit 10.1

FIRST AMENDMENT TO LOAN DOCUMENTS

This First Amendment to Loan Documents (this “Amendment”) is entered into as of November 13, 2025 (the “First Amendment Effective Date”), by and among AVENUE CAPITAL MANAGEMENT II, L.P., a Delaware limited partnership (“Agent”), AVENUE VENTURE OPPORTUNITIES FUND, L.P., a Delaware limited partnership (“Avenue”), AVENUE VENTURE OPPORTUNITIES FUND II, L.P., a Delaware limited partnership (“Avenue 2”; together with Avenue, each “Lender” and, collectively, “Lenders”) and CYTOSORBENTS CORPORATION, a Delaware corporation (“Borrower”).

RECITALS

Agent, Lenders and Borrower are parties to those certain Loan Documents dated as of June 28, 2024, including that certain Loan and Security Agreement (as amended from time to time, the “Loan Agreement”) and Supplement to Loan and Security Agreement (as amended from time to time, the “Supplement”; and the together with the Agreement, the “Loan Documents”). The parties desire to amend the Loan Documents in accordance with the terms of this Amendment. Capitalized terms used but not defined herein have the meaning assigned to such terms in the Loan Agreement or Supplement, as the case may be.

NOW, THEREFORE, the parties agree as follows:

1.The following terms and their respective definitions are hereby either amended and restated, or if applicable added, in their entirety to Article 11 of the Loan Agreement as follows:

“Cash Burn” means, for any Testing Period, Borrower’s cash flow from operations and capital expenditures, in each case as determined in accordance with GAAP; provided, that for purposes of this definition, there shall be excluded any one-time, non-recurring cash outflows directly attributable to restructuring activities, in each case based upon written evidence thereof provided to, and in form and content reasonably acceptable to, and reviewed and approved by Agent with such approval not to be unreasonably withheld.

“FDA Marketing Approval” means the FDA (as defined in the Supplement) has issued to Borrower a final written marketing approval (including, without limitation, a marketing approval letter) permitting the commercial marketing and sale in the United States of the Borrower’s DrugSorb-ATR device for its intended indication, which approval (a) is not subject to any pending appeal, reconsideration, or material condition, limitation, or restriction (other than customary post-marketing requirements, including any potential post-market clinical studies) and (b) has not been withdrawn, suspended, or rescinded, all based upon written evidence thereof provided to, and in form and content reasonably acceptable to, and reviewed and approved by Agent with such approval not to be unreasonably withheld.

“FDA Marketing Approval Date” means the first date on which Borrower receives FDA Marketing Approval and delivers to Agent written evidence thereof, in form and content reasonably acceptable to, and reviewed and approved by Agent with such approval not to be unreasonably withheld.

2.The following terms and their respective definitions are hereby either amended and restated, or if applicable added, in their entirety to Part 1 of the Supplement as follows:

“Commitment” means, subject to the terms and conditions set forth in the Loan and Security Agreement and this Supplement, Lenders’ commitment to make Growth Capital Loans to Borrower up to an aggregate original principal amount of Twenty Million Dollars ($20,000,000), with Four Million Five Hundred Thousand Dollars ($4,500,000) funded by Avenue and Ten Million Five Hundred Thousand Dollars ($10,500,000) funded by Avenue 2 on the Closing Date (“Tranche 1”), Seven Hundred Fifty Thousand Dollars ($750,000) funded by Avenue and One Million Seven Hundred Fifty Thousand Dollars ($1,750,000) funded by Avenue 2 in November 2025 (“Tranche 2A”), and up to Two Million Five Hundred Thousand Dollars ($2,500,000) available from January 1, 2026 through and including December 31, 2026, and subject to Borrower’s achievement of FDA Marketing Approval and the conditions in Section 1 of Part 2 (“Tranche 2B”).

-1-

“Interest-only Milestone” means Borrower has achieved FDA Marketing Approval, based upon written evidence thereof provided to, and in form and content reasonably acceptable to, and reviewed and approved by Agent with such approval not to be unreasonably withheld.

“Interest-only Period” means the period commencing on the Closing Date and continuing until December 31, 2026; provided, however, that such period shall be extended for six (6) months if as of the last day of the Interest-only Period then in effect Borrower has achieved the Interest-only Milestone; provided, further, that the Interest-only Period shall not exceed thirty-six (36) months; provided, further, however, that no extension of the Interest-only Period shall be available if as of the last day of the Interest only Period then in effect an Event of Default shall have occurred and be continuing.

“Maturity Date” means July 1, 2027.

“Testing Period” means, for purposes of calculating Cash Burn, for (i) the reporting period ending March 31, 2026, the trailing three (3)-month period ending on such day, (ii) the reporting period ending April 30, 2026, the trailing four (4)-month period ending on such day, (iii) the reporting period ending May 31, 2026, the trailing five (5)-month period ending on such day and (iv) each monthly reporting period thereafter, the trailing six (6)-month period ending on the last day of each such calendar month.

3.New Section 5.13 hereby is added to the Loan Agreement to read as follows:

“5.13 Cash Burn. Borrower shall achieve Cash Burn for each Testing Period, as tested on a monthly basis beginning with the Testing Period ending March 31, 2026 and ending on the FDA Marketing Approval Date, of no more than Two Million Dollars ($2,000,000.00).”

4.The following defined term is hereby deleted from Part 1 of the Supplement and wherever it may appear in the Loan Documents: “Tranche 2 Availability Milestone”.

5.Section 1 of Part 2 of the Supplement hereby is amended and restated in its entirety to read as follows:

“1.Additional Condition(s) Precedent Regarding Growth Capital Loan Commitments.

In addition to the satisfaction of all of the other applicable conditions precedent specified in Sections 4.1 and 4.2 of the Loan and Security Agreement and this Supplement, each Lender’s obligation to fund Tranche 2A and Tranche 2B of its Commitment of Growth Capital Loans is subject to receipt by Lender of evidence that the following conditions precedent have been satisfied, as determined by Lender in its sole discretion:

(i)

with respect to Tranche 2B only, Borrower has achieved FDA

Marketing Approval; and

(ii)

no Event of Default shall have occurred and be continuing.

Subject to satisfaction of the conditions precedent specified in Sections 4.1 and Section 4.2 of the Loan and Security Agreement and this Supplement, each Lender agrees to make Growth Capital Loans to Borrower under Lender’s Commitment from time to time from and after the Closing Date up to and including the Termination Date in an aggregate, original principal amount up to, but not exceeding, then then-unfunded portion of such Lender’s Commitment.”

6.Exhibit C to the Supplement hereby is replaced in its entirety with Exhibit C attached hereto.

7.No course of dealing on the part of Agent or any Lender, nor any failure or delay in the exercise of any right by Agent or any Lender, shall operate as a waiver thereof, and any single or partial exercise of any such right shall not preclude any later exercise of any such right. Agent or any Lender’s failure at any time to require strict performance by Borrower of any provision shall not affect any right of Agent or any Lender thereafter to demand strict compliance and performance. Any suspension or waiver of a right must be in writing signed by an officer of Agent or Lender.

8.Unless otherwise defined, all initially capitalized terms in this Amendment shall be as defined in the Loan Documents (as defined in the Agreement). The Loan Documents, as amended hereby, shall be and remain in full force and effect in accordance with their respective terms and hereby are ratified and confirmed in all respects. Except as expressly set forth herein, the execution, delivery, and performance of this Amendment shall not operate as a waiver of, or as an amendment of, any right, power, or remedy of Agent or any Lender under the Loan Documents, as in effect prior to the date hereof.

9.As a condition to the effectiveness of this Amendment, Agent shall have received, in form and substance reasonably satisfactory to Agent, the following:

(a)this Amendment, duly executed by Borrower;

(b)a duly executed Warrant1 issued by CytoSorbents Corporation to each Lender;

(c)all reasonable Agent and Lender expenses incurred through the date of this Amendment; and

(d)such other documents, and completion of such other matters, as Agent may reasonably deem necessary or appropriate.

10.This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument.

[Balance of Page Intentionally Left Blank]

1 NTD: Form of Warrant was circulated on 11/9 with the initial draft of this Amendment.

IN WITNESS WHEREOF, the undersigned have executed this Amendment as of the first date above written.


BORROWER:

CYTOSORBENTS CORPORATION

By:
Name:	Phillip P. Chan, MD, Ph.D.
Title:	Chief Executive Officer

CYTOSORBENTS MEDICAL, INC.

By:
Name:	Phillip P. Chan, MD, Ph.D.
Title:	Chief Executive Officer

AGENT:

AVENUE CAPITAL MANAGEMENT II, L.P.

By: Avenue Capital Management II GenPar, LLC
Its: General Partner

By:
Name:	Sonia Gardner
Title:	Member

LENDERS:

AVENUE VENTURE OPPORTUNITIES FUND, L.P.

By: Avenue Venture Opportunities Partners, LLC
Its: General Partner

By:
Name:	Sonia Gardner
Title:	Authorized Signatory

AVENUE VENTURE OPPORTUNITIES FUND II,
L.P.

By: Avenue Venture Opportunities Partners II, LLC
Its: General Partner

By:
Name:	Sonia Gardner
Title:	Authorized Signatory

EXHIBIT C

FORM OF COMPLIANCE CERTIFICATE

Avenue Venture Opportunities Fund, L.P.

11 West 42nd Street, 9th Floor

New York, New York 10036

Avenue Venture Opportunities Fund II, L.P.

11 West 42nd Street, 9th Floor

New York, New York 10036

Re:CYTOSORBENTS CORPORATION; CYTOSORBENTS MEDICAL INC.

Ladies and Gentlemen:

Reference is made to the Loan and Security Agreement, dated as of June 28, 2024 (as the same has been and may be supplemented, amended and modified from time to time, the “Loan Agreement,” the capitalized terms used herein as defined therein), among Avenue Capital Management II, L.P. (“Agent”), as administrative agent and collateral agent (in such capacity, “Agent”), Avenue Venture Opportunities Fund, L.P., as a lender (“Avenue”), Avenue Venture Opportunities Fund II, L.P. (“Avenue 2” and together with Avenue, collectively, “Lenders”, and each a “Lender”), and CytoSorbents Corporation and CytoSorbents Medical Inc. (jointly and severally, individually and collectively, “Borrower”).

The undersigned authorized representative of Borrower hereby certifies in such capacity that in accordance with the terms and conditions of the Loan Agreement, (i) no Default or Event of Default has occurred and is continuing, except as noted below, and (ii) Borrower is in compliance for the financial reporting period ending with all required financial reporting under the Loan Agreement, except as noted below. Attached herewith are the required documents supporting the foregoing certification. The undersigned authorized representative of Borrower further certifies in such capacity that: (a) the accompanying financial statements have been prepared in accordance with GAAP throughout the periods indicated; and (b) the financial statements fairly present in all material respects the financial condition and operating results of Borrower and its Subsidiaries, if any, as of the dates, and for the periods, indicated therein, subject to the absence of footnotes and normal year-end audit adjustments (in the case of interim monthly financial statements), except as explained below.

Please provide the following requested information and

indicate compliance status by circling (or otherwise indicating) Yes/No under “Included/Complies”:

REPORTING REQUIREMENT	REQUIRED	INCLUDED/COMPLIES

Balance Sheet, Income Statement & Cash Flow Statement (as applicable)	Monthly, within 30 days	YES / NO / N/A

Operating Budgets, 409(A) Valuations	As modified	YES / NO / N/A

Annual Financial Statements	Annually, within 90 day of fiscal year-end	YES / NO / N/A

Board Packages	As modified	YES / NO / N/A

Date of most recent Board-approved budget/plan

Any change in budget/plan since version most recently
delivered to Agent		YES / NO / N/A
If Yes, please attach

Date of most recent capitalization table:

Any changes in capitalization table since version most recently delivered to Agent?:		YES / NO / N/A
If Yes, please attach a copy of latest capitalization table

EQUITY & CONVERTIBLE NOTE FINANCINGS

Please provide the following information (if applicable) regarding Borrower’s most-recent equity and/or convertible note financing each time this Certificate is delivered to Agent

Date of Last Round Raised:
Has there been any new financing since the last Compliance Certificate submitted?		YES / NO
If “YES” please attach a copy of the Capitalization Table

Date Closed: Series: Per Share Price: $
Amount Raised: Post Money Valuation:

Any stock splits since date of last report?		YES / NO
If yes, please provide any information on stock splits which would affect valuation:

Any dividends since date of last report?		YES / NO
If yes, please provide any information on dividends which would affect valuation:

Any unusual terms? (i.e., Anti-dilution, multiple preference, etc.)		YES / NO
If yes, please explain:

ACCOUNT CONTROL AGREEMENTS

Pursuant to Section 6.11 of the Loan Agreement, Borrower represents and warrants that: (i) as of the date hereof, it maintains only those deposit and investment accounts set forth below; and (ii) to the extent required by Section 6.11 of the Loan Agreement, a control agreement has been executed and delivered to Agent with respect to each such account [Note: If Borrower has established any new account(s) since the date of the last compliance certificate, please so indicate].

Deposit Accounts4


	Name of Institution	Account Number	Control Agt. In place?	Complies	New Account

1.)	[ ]	[ ]	YES / NO	YES / NO	YES / NO

2.)			YES / NO	YES / NO	YES / NO

4 Company: Please complete with existing accounts.

Investment Accounts


	Name of Institution	Account Number	Control Agt. In place?	Complies	New Account

1.)	None		YES / NO	YES / NO	YES / NO

2.)			YES / NO	YES / NO	YES / NO

3.)			YES / NO	YES / NO	YES / NO

4.)			YES / NO	YES / NO	YES / NO

AGREEMENTS WITH PERSONS IN POSSESSION OF TANGIBLE COLLATERAL

Pursuant to Section 5.9(e) of the Loan Agreement, Borrower represents and warrants that: (i) as of the date hereof, tangible Collateral is located at the addresses set forth below; and (ii) to the extent required by Section 5.9(e) of the Loan Agreement, a Waiver has been executed and delivered to Agent, or such Waiver has been waived by Agent, [Note: If Borrower has located Collateral at any new location since the date of the last compliance certificate, please so indicate].

	Location of Collateral	Value of Collateral at such Locations	Waiver In place?	Complies?	New Location?

1.)		$	YES / NO	YES / NO	YES / NO

2.)		$	YES / NO	YES / NO	YES / NO

3.)		$	YES / NO	YES / NO	YES / NO

4.)		$	YES / NO	YES / NO	YES / NO

SUBSIDIARIES AND OTHER PERSONS

Pursuant to Section 6.14(a) of the Loan Agreement, Borrower represents and warrants that: (i) as of the date hereof, it has directly or indirectly acquired or created, or it intends to directly or indirectly acquire or create, each Subsidiary or other Person described below; and (ii) such Subsidiary or Person has been made a co-borrower under the Loan Agreement or a guarantor of the Obligations [Note: If Borrower has acquired or created any Subsidiary since the date of the last compliance certificate, please so indicate].

	Name:	Jurisdiction of formation or organization:5	Co-borrower or guarantor?	Complies?	New Subsidiary or Person?

1.)			YES / NO	YES / NO	YES / NO

2.)			YES / NO	YES / NO	YES / NO

3.)			YES / NO	YES / NO	YES / NO

4.)			YES / NO	YES / NO	YES / NO

5 Under the “Explanations” heading (see below) please include a description of such Subsidiary’s or Person’s fully diluted capitalization and Borrower’s purpose for its acquisition or creation of such Subsidiary if such information has not been previously furnished to Agent.

FINANCIAL COVENANT – LTM PRODUCT REVENUE

Required:

Each Month Ending on or During the Following Periods:	LTM Product Revenue
June 30, 2024 – December 31, 2024	$31,000,000
January 31, 2025 – December 31, 2025	$31,000,000
January 31, 2026 and thereafter	$33,000,000

Actual: $

FINANCIAL COVENANT – CASH BURN*

Required: Borrower shall achieve Cash Burn for each Testing Period, as tested on a monthly basis beginning with the Testing Period ending March 31, 2026, of no more than Two Million Dollars ($2,000,000.00).

Actual: $

*Cash Burn tested only until FDA Marketing Approval Date.

EXPLANATIONS

[Remainder of this page intentionally left blank; signature page follows]

[Signature page to Compliance Certificate]


	Very truly yours,

	CYTOSORBENTS CORPORATION

	By:
	Name:	Phillip P. Chan, MD, Ph.D.
	Title:	Chief Executive Officer

EX-10.2 3 ctso-20250930xex10d2.htm EX-10.2

Exhibit 10.2

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPINION OF COUNSEL IN A FORM REASONABLY ACCEPTABLE TO COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED DUE TO AN EXEMPTION THEREFROM UNDER SAID ACT AND ANY APPLICABLE STATE SECURITIES LAWS OR (C) CYTOSORBENTS CORPORATION OTHERWISE SATISFIES ITSELF THAT SUCH TRANSACTION IS COMPLIANT WITH SUCH LAWS.

Date of Issuance: November 13, 2025

WARRANT TO PURCHASE

SHARES OF STOCK OF

CYTOSORBENTS CORPORATION

(Void after November 13, 2030)

This certifies that AVENUE VENTURE OPPORTUNITIES FUND, LP, a Delaware limited partnership, or permitted assigns (“Holder”), for value received, is entitled to purchase from CYTOSORBENTS CORPORATION, a Delaware corporation (“Company”), the Applicable Number (hereinafter defined) of fully paid and nonassessable shares of the Company’s Common Stock (“Common Stock”), for cash, at a purchase price per share equal to the Exercise Price (hereinafter defined). Holder may also exercise this Warrant on a cashless or “net issuance” basis as described in Section 1(b) below, and this Warrant shall be deemed to have been exercised in full on such basis on the Expiration Date (hereinafter defined), to the extent not fully exercised prior to such date. This Warrant is issued in connection with that certain Loan and Security Agreement and Supplement thereto, both of even date herewith (as amended, restated and supplemented from time to time, the “Loan Agreement” and the “Supplement”, respectively), among Company, as borrower, AVENUE CAPITAL MANAGEMENT II, L.P., a Delaware limited partnership, as Agent, and Holder, as lender (“Lender”). Capitalized terms used herein and not otherwise defined in this Warrant shall have the meaning(s) ascribed to them in the Loan Agreement and the Supplement, unless the context would otherwise require.

“Applicable Number” means 428,571

“Exercise Price” means $0.70

“Trading Day” means a day when the New York Stock Exchange is open for trading in shares of the Common Stock.

Subject to Section 4.3, this Warrant may be exercised at any time or from time to time up to and including 5:00 p.m. (Pacific time) on November 13, 2030 (the “Expiration Date”), upon surrender to Company at its principal office at 305 College Road East, Princeton, NJ 08540 (or at such other location as Company may advise Holder in writing) of this Warrant properly endorsed with the Form of Subscription attached hereto duly completed and signed and upon payment in cash or by check of the aggregate Exercise Price for the number of shares for which this Warrant is being exercised determined in accordance with the provisions hereof. The Exercise Price and the number of shares purchasable hereunder are subject to further adjustment as provided in Section 4 of this Warrant.

This Warrant is subject to the following terms and conditions:

1.Exercise; Issuance of Certificates; Payment for Shares.

(a)

Unless an election is made pursuant to clause (b) of this Section 1, this Warrant shall be

exercisable at the option of Holder, at any time or from time to time, on or before the Expiration Date for all or any portion of the shares of Common Stock (but not for a fraction of a share) which may be purchased hereunder for the Exercise Price multiplied by the number of shares to be purchased. Company agrees that the shares of Common Stock purchased under this Warrant shall be and are deemed to be issued to Holder as the record owner of such shares as of the close of business on the date on which the form of subscription shall have been delivered and payment made for such shares. Subject to the provisions of Section 2, certificates for the shares of Common Stock so purchased, together with any other securities or property to which Holder is entitled upon such exercise, shall be delivered to Holder by Company at Company’s expense within a reasonable time after the rights represented by this Warrant have been so exercised. Except as provided in clause (b) of this Section 1, in case of a purchase of less than all the shares which may be purchased under this Warrant, Company shall cancel this Warrant and execute and deliver a new Warrant or Warrants of like tenor for the balance of the shares purchasable under this Warrant surrendered upon such purchase to Holder within a reasonable time. Each stock certificate so delivered shall be in such denominations of Common Stock as may be requested by Holder and shall be registered in the name of such Holder or such other name as shall be designated by such Holder, subject to the limitations contained in Section 2.

(b)Holder, in lieu of exercising this Warrant by the cash payment of the Exercise Price pursuant to clause (a) of this Section 1, may elect, at any time on or before the Expiration Date, to surrender this Warrant and receive that number of shares of Common Stock computed using the following formula:

X =	Y(A − B)
X =		A

Where: X = the number of shares of Common Stock to be issued to Holder.

Y = the number of shares of Common Stock that Holder would otherwise have been entitled to purchase hereunder pursuant to Section 1(a) (or such lesser number of shares as Holder may designate in the case of a partial exercise of this Warrant).

A = the price per share of the Common Stock as of the last Trading Day immediately prior to the date of exercise under this Section 1(b).

B = the Exercise Price then in effect.

Election to exercise under this Section 1(b) may be made by delivering a signed form of subscription to Company via facsimile, to be followed by delivery of this Warrant. Notwithstanding anything to the contrary contained in this Warrant, if as of the close of business on the last business day preceding the Expiration Date this Warrant remains unexercised as to all or a portion of the shares of Common Stock purchasable hereunder, then effective as 9:00 a.m. (Pacific time) on the Expiration Date, Holder shall be deemed, automatically and without need for notice to Company, to have elected to exercise this Warrant in full pursuant to the provisions of this Section 1(b), and upon surrender of this Warrant shall be entitled to receive that number of shares of Common Stock computed using the above formula, provided that the application of such formula as of the Expiration Date yields a positive number for “X”.

2.Limitation on Transfer.

(a)This Warrant and the Common Stock issuable hereunder shall not be transferable except upon the conditions specified in this Section 2, which conditions are intended to ensure compliance with the provisions of the Securities Act of 1933, as amended (the “Securities Act”). Each holder of this Warrant or the Common Stock issuable hereunder will cause any proposed transferee of the Warrant or Common Stock to agree to take and hold such securities subject to the provisions and upon the conditions specified in this Section 2. Notwithstanding the foregoing and any other provision of this Section 2 but subject to the last sentence of Section 2(c), Holder may freely transfer all or part of this Warrant or the shares issuable upon exercise of this Warrant (or the securities issuable, directly or indirectly, upon conversion of the shares, if any) at any time to any affiliate of Lender under the Loan Agreement, by giving Company notice of the portion of the Warrant being transferred setting forth the name, address and taxpayer identification number of the transferee and surrendering this Warrant to Company for reissuance to the transferees(s) (and Holder, if applicable).

(b)Each certificate representing (i) this Warrant and (ii) the Common Stock issued upon exercise hereof or upon any stock split, stock dividend, recapitalization, merger, consolidation or similar event, shall (unless otherwise permitted by the provisions of this Section 2 or unless such securities have been registered under the Securities Act or sold under Rule 144) be stamped or otherwise imprinted with a legend substantially in the following form (in addition to any legend required under applicable state securities laws):

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPINION OF COUNSEL IN A FORM REASONABLY ACCEPTABLE TO COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED DUE TO AN EXEMPTION THEREFROM UNDER SAID ACT AND ANY APPLICABLE STATE SECURITIES LAWS OR (C) CYTOSORBENTS CORPORATION OTHERWISE SATISFIES ITSELF THAT SUCH TRANSACTION IS COMPLIANT WITH SUCH LAWS.

(c)Holder of this Warrant and each person to whom this Warrant is subsequently transferred represents and warrants to Company and agrees (by acceptance of such transfer) that it will not transfer this Warrant (or securities issuable upon exercise hereof unless a registration statement under the Securities Act was in effect with respect to such securities at the time of issuance thereof) unless (i) there is an effective registration statement under the Securities Act and applicable state securities laws covering any such transaction, (ii) pursuant to Rule 144 under the Securities Act (or any other rule under the Securities Act relating to the disposition of securities), (iii) Company receives an opinion of counsel, reasonably satisfactory to Company, that an exemption from such registration is available or (iv) the Company otherwise satisfies itself that such transaction is exempt from registration. Notwithstanding the foregoing or any other provision of this Section 2, Holder shall not transfer this Warrant (or securities issuable upon exercise hereof, or securities issuable, directly or indirectly, upon conversion of such securities, if any) to any competitor of Company, as determined in good faith by the Board, without the prior written consent of Company.

(d)As a condition to the exercise of this Warrant and the issuance of Common Stock, if requested by the Company by reasonable notice to Holder, Holder shall agree in writing to be fully bound by any investors rights, shareholder or similar agreements applicable to holders of Common Stock (“Investor Agreements”), provided that Holder shall not be required to agree to any terms of such agreements that are inconsistent with the terms of this Warrant.

3.Shares to be Fully Paid; Reservation of Shares. Company covenants and agrees that all shares of Common Stock which may be issued upon the exercise of the rights represented by this Warrant will, upon issuance, be duly authorized, validly issued, fully paid and nonassessable and free from all preemptive rights of any stockholder and free of all taxes, liens and charges with respect to the issue thereof. Company further covenants and agrees that during the period within which the rights represented by this Warrant may be exercised, Company will at all times have authorized and reserved, for the purpose of issue or transfer upon exercise of the subscription rights evidenced by this Warrant, a sufficient number of shares of authorized but unissued Common Stock, or other securities and property, when and as required to provide for the exercise of the rights represented by this Warrant. Company will take all such action as may be necessary to assure that such shares of Common Stock may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of any domestic securities exchange upon which the Common Stock may be listed. Company will not take any action which would result in any adjustment of the Exercise Price (as described in Section 4 hereof) (i) if the total number of shares of Common Stock issuable after such action upon exercise of all outstanding warrants, together with all shares of Common Stock then outstanding and all shares of Common Stock then issuable upon exercise of all options and upon the conversion of all convertible securities then outstanding, would exceed the total number of shares of Common Stock then authorized by Company’s Certificate of Incorporation (as amended from time to time, the “Charter”), (ii) if the total number of shares of Common Stock issuable after such action upon the conversion of all such shares of Common Stock together with all shares of Common Stock then outstanding and then issuable upon exercise of all options and upon the conversion of all convertible securities then outstanding would exceed the total number of shares of Common Stock then authorized by Company’s Charter or (iii) if the par value per share of the Common Stock would exceed the Exercise Price.

4.Adjustment of Exercise Price and Number of Shares. The Exercise Price and the number of shares purchasable upon the exercise of this Warrant shall be subject to adjustment from time to time upon the occurrence of certain events described in this Section 4.

4.1Subdivision or Combination of Stock. In case Company shall at any time subdivide its outstanding shares of Common Stock into a greater number of shares, the Exercise Price in effect immediately prior to such subdivision shall be proportionately reduced, and conversely, in case the outstanding shares of Common Stock of Company shall be combined into a smaller number of shares, the Exercise Price in effect immediately prior to such combination shall be proportionately increased. In each case, the number of shares of Common Stock for which this Warrant is exercisable shall be subject to appropriate adjustment.

4.2Dividends. If at any time or from time to time the holders of Common Stock (or any shares of stock or other securities at the time receivable upon the exercise of this Warrant) shall have received or become entitled to receive,

(a)Common Stock, or any shares of stock or other securities whether or not such securities are at any time directly or indirectly convertible into or exchangeable for Common Stock, or any rights or options to subscribe for, purchase or otherwise acquire any of the foregoing by way of dividend or other distribution,

(b)any cash paid or payable including as a cash dividend, or

(c)Common Stock or other or additional stock or other securities or property (including cash) by way of spin off, split-up, reclassification, combination of shares or similar corporate rearrangement, (other than shares of Common Stock issued as a stock split, adjustments in respect of which shall be covered by the terms of Section 4.1 above),

then and in each such case, Holder hereof shall, upon the exercise of this Warrant, be entitled to receive, in addition to the number of shares of Common Stock receivable thereupon, and without payment of any additional consideration therefor, the amount of stock and other securities and property (including cash in the cases referred to in clauses (b) and (c) above) which such Holder would hold on the date of such exercise had it been the holder of record of such Common Stock as of the date on which holders of Common Stock received or became entitled to receive such shares and/or all other additional stock and other securities and property.

4.3Change of Control. In the event of a Change of Control (as hereinafter defined), this Warrant shall be automatically exchanged for a number of shares of Company’s securities, such number of shares being equal to the maximum number of shares issuable pursuant to the terms hereof (after taking into account all adjustments described herein) had Holder elected to exercise this Warrant immediately prior to the closing of such Change of Control and purchased all such shares pursuant to the cash exercise provision set forth in Section 1(a) hereof (as opposed to the cashless exercise provision set forth in Section 1(b)). Company acknowledges and agrees that Holder shall not be required to make any payment (cash or otherwise) for such shares as further consideration for their issuance pursuant to the terms of the preceding sentence. “Change of Control” shall mean any sale, license, or other disposition of all or substantially all of the assets of Company, any reorganization, consolidation, merger or other transaction involving Company where the holders of Company’s securities before the transaction beneficially own less than 50% of the outstanding voting securities of the surviving entity after the transaction; provided that an issuance of equity securities for the primary purpose of raising capital shall not be considered a Change of Control under this Warrant. This Warrant shall terminate upon Holder’s receipt of the number of shares of Company’s equity securities described in this Section 4.3.

4.4Sale or Issuance Below Purchase Price; “Pay-to-Play” Exemption.

(a)The other antidilution rights applicable to the shares of Common Stock purchasable hereunder, if any, are set forth in Company’s Charter. Such antidilution rights shall not be restated, amended, modified or waived in any manner without Holder’s prior written consent if the effect of such restatement, amendment, modification or waiver on Holder would be more adverse to Holder with respect to the shares of Common Stock issuable upon the exercise of this Warrant than, and substantially dissimilar to, its effect on the other holders of the same class or series of Company’s Common Stock. Company shall promptly provide Holder with any restatement, amendment, modification or waiver of the Charter with respect to any such antidilution rights promptly after the same has been made.

(b)In the event that Company’s Charter provides, or is amended to so provide, for the amendment or modification of the rights, preferences or privileges of the shares of Common Stock issuable upon the exercise of this Warrant, or the reclassification, conversion or exchange of the outstanding shares of such Common Stock, in the event that a holder of shares thereof fails to participate in an equity financing or debt financing transaction (as applicable, a “Pay-to-Play Provision”), and in the event that such Pay-to-Play Provision becomes operative in a transaction occurring after the date hereof, this Warrant shall automatically and without any action required become exercisable for that type of shares of equity securities as would have been issued or exchanged, or would have remained outstanding, in respect of the shares of Common Stock issuable hereunder had this Warrant been exercised in full prior to such event (and for that number of shares of equity securities as would have been issued or exchanged, or would have remained outstanding, in respect of the shares of Common Stock issuable hereunder had this Warrant been exercised in full prior to such event, if applicable), and had Holder participated in the equity or debt financing to the maximum extent permitted.

attached hereto, shall be signed by Company’s chief financial officer and shall state the Exercise Price resulting from such adjustment and the increase or decrease, if any, in the number of shares purchasable at such price upon the exercise of this Warrant, setting forth in reasonable detail the method of calculation and the facts upon which such calculation is based.

4.6Other Notices. If at any time:

(a)

Company shall declare any cash dividend upon its Common Stock;

(b)Company shall declare any dividend upon its Common Stock payable in stock or make any special dividend or other distribution to the holders of its Common Stock;

(c)Company shall offer for subscription pro rata to the holders of its Common Stock any additional shares of stock of any class or other rights;

(d)there shall be any capital reorganization or reclassification of the capital stock of Company, or consolidation or merger of Company with, or sale of all or substantially all of its assets to, another entity;

(e)there shall be a voluntary or involuntary dissolution, liquidation or winding-up of Company; or

(f)Company shall take or propose to take any other action, notice of which is actually provided to holders of the Common Stock;

then, in any one or more of said cases, Company shall give Holder, pursuant to Section 12, (i) at least 20 days’ prior written notice of the date on which the books of Company shall close or a record shall be taken for such dividend, distribution or subscription rights or for determining rights to vote in respect of any such reorganization, reclassification, consolidation, merger, sale, dissolution, liquidation or winding-up, or other action and (ii) in the case of any such reorganization, reclassification, consolidation, merger, sale, dissolution, liquidation or winding-up, or other action, at least 20 days’ written notice of the date when the same shall take place. Any notice given in accordance with the foregoing clause (i) shall also specify, in the case of any such dividend, distribution or subscription rights, the date on which the holders of Common Stock shall be entitled thereto. Any notice given in accordance with the foregoing clause (ii) shall also specify the date on which the holders of Common Stock shall be entitled to exchange their Common Stock for securities or other property deliverable upon such reorganization, reclassification, consolidation, merger, sale, dissolution, liquidation or winding-up, or other action as the case may be.

4.7Certain Events. If any change in the outstanding Common Stock of Company or any other event occurs as to which the other provisions of this Section 4 are not strictly applicable or if strictly applicable would not fairly effect the adjustments to this Warrant in accordance with the essential intent and principles of such provisions, then the Board shall make in good faith an adjustment in the number and class of shares issuable under this Warrant, the Exercise Price and/or the application of such provisions, in accordance with such essential intent and principles, so as to protect such purchase rights as aforesaid. The adjustment shall be such as will give Holder of this Warrant upon exercise for the same aggregate Exercise Price the total number, class and kind of shares as Holder would have owned had this Warrant been exercised prior to the event and had Holder continued to hold such shares until after the event requiring adjustment.

5.Issue Tax. The issuance of certificates for shares of Common Stock upon the exercise of this Warrant shall be made without charge to Holder of this Warrant for any issue tax in respect thereof; provided, however, that Company shall not be required to pay any tax which may be payable in respect of any transfer involved in the issuance and delivery of any certificate in a name other than that of the then Holder of this Warrant being exercised.

6.Closing of Books. Company will at no time close its transfer books against the transfer of this Warrant or of any shares of Warrant Stock issued or issuable upon the exercise of this Warrant in any manner which interferes with the timely exercise of this Warrant.

7.No Voting Rights; Limitation of Liability. Nothing contained in this Warrant shall be construed as conferring upon Holder hereof the right to vote or to consent as a stockholder in respect of meetings of stockholders for the election of directors of Company or any other matters or any rights whatsoever as a stockholder of Company. No dividends or interest shall be payable in respect of this Warrant or the interest represented hereby or the shares purchasable hereunder until, and only to the extent that, this Warrant shall have been exercised; provided, however, that if any dividends are due or paid at any time on the underlying securities for which this Warrant is exercisable, then upon exercise, the securities issued to Holder shall be deemed to have accrued dividends and be paid identical dividends from the same time as the outstanding shares for which this Warrant is exercisable were first issued (or, if later, the date of this Warrant). No provisions hereof, in the absence of affirmative action by Holder to purchase shares of Common Stock, and no mere enumeration herein of the rights or privileges of Holder hereof, shall give rise to any liability of such Holder for the Exercise Price or as a stockholder of Company, whether such liability is asserted by Company or by its creditors.

8.Amendment of Charter. Unless Holder consents thereto in writing, Company shall not amend its Charter prior to the exercise of this Warrant if the Common Stock would be adversely affected by such amendment in a manner that would be more adverse to Holder with respect to the shares of Common Stock issuable upon the exercise of this Warrant than, and substantially dissimilar to, such amendment’s effect on the other holders of the same class or series of Common Stock.

9.Reserved.

10.Rights and Obligations Survive Exercise of Warrant. The rights and obligations of Company, of Holder of this Warrant and of the holder of shares of Common Stock issued upon exercise of this Warrant, contained in Sections 6 and 8 shall survive the exercise of this Warrant.

11.Modification and Waiver. This Warrant and any provision hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the party against which enforcement of the same is sought.

12.Notices. Any notice, request or other document required or permitted to be given or delivered to Holder or Company shall be deemed to have been given (i) upon receipt if delivered personally or by courier (ii) upon confirmation of receipt if by telecopy or (iii) three business days after deposit in the US mail, with postage prepaid and certified or registered, to each such Holder at its address as shown on the books of Company or to Company at the address indicated therefor in the opening paragraphs of this Warrant (or at such other location as Company may advise Holder in writing).

13.Survival of Certain Obligations. All of the obligations of Company relating to the Common Stock issuable upon the exercise of this Warrant shall survive the exercise and termination of this Warrant. All of the covenants and agreements of Company shall inure to the benefit of and be binding upon the successors and permitted assigns of Holder. Company will, at the time of the exercise of this Warrant, in whole or in part, upon request of Holder but at Company’s expense, acknowledge in writing its continuing obligation to Holder in respect of any rights (including, without limitation, any right to registration of the shares of Common Stock) to which Holder shall continue to be entitled after such exercise in accordance with this Warrant; provided, that the failure of Holder to make any such request shall not affect the continuing obligation of Company to Holder in respect of such rights.

14.Descriptive Headings and Governing Law. The descriptive headings of the several sections and paragraphs of this Warrant are inserted for convenience only and do not constitute a part of this Warrant. This Warrant shall be construed and enforced in accordance with, and the rights of the parties shall be governed by, the laws of the State of Delaware.

15.Lost Warrants or Stock Certificates. Company agrees that upon receipt of evidence reasonably satisfactory to Company of the loss, theft, destruction, or mutilation of any Warrant or stock certificate and, in the case of any such loss, theft or destruction, upon receipt of an indemnity reasonably satisfactory to Company, or in the case of any such mutilation upon surrender and cancellation of such Warrant or stock certificate, Company at its expense will make and deliver a new Warrant or stock certificate, of like tenor, in lieu of the lost, stolen, destroyed or mutilated Warrant or stock certificate.

16.Fractional Shares. No fractional shares shall be issued upon exercise of this Warrant. Company shall, in lieu of issuing any fractional share, pay the holder entitled to such fraction a sum in cash equal to such fraction multiplied by the then effective Exercise Price.

17.Representations of Holder. With respect to this Warrant, Holder represents and warrants to Company as follows:

17.1Experience. It is experienced in evaluating and investing in companies engaged in businesses similar to that of Company; it understands that investment in this Warrant involves substantial risks; it has made detailed inquiries concerning Company, its business and services, its officers and its personnel; the officers of Company have made available to Holder any and all written information it has requested; the officers of Company have answered to Holder’s satisfaction all inquiries made by it; in making this investment it has relied upon information made available to it by Company; and it has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of investment in Company and it is able to bear the economic risk of that investment.

17.2Investment. It is acquiring this Warrant for investment for its own account and not with a view to, or for resale in connection with, any distribution thereof. It understands that this Warrant, the shares of Common Stock issuable upon exercise thereof and the shares of Common Stock issuable upon conversion of the Common Stock, have not been registered under the Securities Act, nor qualified under applicable state securities laws.

17.3Rule 144. It acknowledges that this Warrant and the Common Stock issuable upon exercise of this Warrant must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available. It has been advised or is aware of the provisions of Rule 144 promulgated under the Securities Act.

17.4Access to Data. It has had an opportunity to discuss Company’s business, management and financial affairs with Company’s management and has had the opportunity to inspect Company’s facilities.

17.5Accredited Investor. It is an “accredited investor” within the meaning of Regulation D promulgated under the Securities Act.

18.Additional Representations and Covenants of Company. Company hereby represents, warrants and agrees as follows:

18.1Corporate Power. Company has all requisite corporate power and corporate authority to issue this Warrant and to carry out and perform its obligations hereunder.

18.2Authorization. All corporate action on the part of Company, its directors and stockholders necessary for the authorization, execution, delivery and performance by Company of this Warrant has been taken. This Warrant is a valid and binding obligation of Company, enforceable in accordance with its terms.

18.3Offering. Subject in part to the truth and accuracy of Holder’s representations set forth in Section 17 hereof, the offer, issuance and sale of this Warrant is, and the issuance of Common Stock upon exercise of this Warrant, will be exempt from the registration requirements of the Securities Act, and are exempt from the qualification requirements of any applicable state securities laws; and neither Company nor anyone acting on its behalf will take any action hereafter that would cause the loss of such exemptions.

18.4Listing; Stock Issuance. Company shall secure and maintain the listing of the Common Stock issuable upon exercise of this Warrant upon each securities exchange or over-the-counter market upon which securities of the same class or series issued by Company are listed, if any. Upon exercise of this Warrant, Company will use commercially reasonable efforts to cause stock certificates representing the shares of Common Stock purchased pursuant to the exercise to be issued in the names of Holder, its nominees or assignees, as appropriate at the time of such exercise.

18.5Charter Documents. Company has provided Holder with true and complete copies of Company’s Charter, By-Laws, and each Certificate of Designation or other charter document setting, forth any rights, preferences and privileges of Company’s capital stock, each as amended and in effect on the date of issuance of this Warrant.

18.6Reserved.

18.7Financial and Other Reports. Until the earlier of (a) the Expiration Date, (b) the termination of this Warrant pursuant to Section 4.3, and (c) the exercise of this Warrant pursuant to Section 1, Company shall furnish to Holder (i) promptly following delivery to the Board after the close of each fiscal year of Company, a balance sheet, together with an income statement, a cash flow statement and a statement of changes in equity, for such fiscal year, in substantially the same form as such annual financial statements are furnished to the Board; (ii) within 60 days after the close of each fiscal quarter of Company, an unaudited balance sheet, income statement and cash flow statement, each at and as of the end of such quarter. In addition, until the earlier of (a) the Expiration Date, (b) the termination of this Warrant pursuant to Section 4.3, and (c) the exercise of this Warrant pursuant to Section 1, Company agrees to provide Holder at any time and from time to time with such information as Holder may reasonably request for purposes of Holder’s compliance (as determined by Holder in its reasonable discretion) with regulatory, accounting and reporting requirements applicable to Holder (e.g., Fair Value Accounting Standard 157), including any 409A valuation reports (or equivalent reports) and budgets, as well as information with respect to whether the securities issuable upon the exercise hereof constitute “qualified small business stock” for purposes of Section 1202(c) of the Internal Revenue Code and Section 18152.5 of the California Revenue and Taxation Code. Notwithstanding the foregoing, Company shall not be required to furnish to Holder the financial information described in this Section 18.7 in the event such financial information has been previously delivered to Lender pursuant to the Loan Agreement. For avoidance of doubt, any information provided hereunder (including, without limitation, under this Section 18.7) that constitutes confidential information under the Loan Agreement shall be subject to the confidentiality provisions thereof.

19.Compliance with Insider Trading and Public Disclosure Law. Holder acknowledges that it may become aware of material, non-public information concerning the Company hereunder or under the Loan Document. Accordingly, Holder covenants and agrees not to, at any time while in possession of material non-public information concerning the Company: (i) effect or seek, offer or propose (whether publicly or otherwise) to effect, or cause or participate in, or in any way assist any other person to effect or seek, offer or propose (whether publicly or otherwise) to effect, or cause or participate in, any trading of any securities (or beneficial ownership thereof) of the Company, (ii) disclose or “tip” material, non-public information concerning the Company to any person or entity, or (iii) give trading

advice of any kind to any person or entity concerning the Company. This Section 19 shall survive termination of this Warrant.

20.Counterparts; Facsimile. Holder’s execution and delivery of Holder’s counterpart signature page to this Warrant via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) shall constitute Holder’s effective execution and delivery of this Warrant and agreement to and acceptance of the terms hereof for all purposes.

[Remainder of this page intentionally left blank; signature page follows]

[Signature Page to Warrant]

IN WITNESS WHEREOF, Company has caused this Warrant to be duly executed by its officer, thereunto duly authorized as of the date of issuance set forth on the first page hereof.

CYTOSORBENTS CORPORATION

By:
Name:	Phillip P. Chan, MD, Ph.D.
Title:	Chief Executive Officer

AGREED AND ACCEPTED:

HOLDER:

AVENUE VENTURE OPPORTUNITIES FUND, LP

By:	Avenue Venture Opportunities Partners, LLC
Its:	General Partner

By:
Name:	Sonia Gardner
Title:	Authorized Signatory

FORM OF SUBSCRIPTION

(To be signed only upon exercise of Warrant)

To:

☐

The undersigned, the holder of the within Warrant, hereby irrevocably elects to exercise the purchase right represented by such Warrant for, and to purchase thereunder, (1) ( ) shares1 (the “Shares”) of Stock of and herewith makes payment of Dollars ($ ) therefor, and requests that the certificates for such shares be issued in the name of, and delivered to, , whose address is .

☐	The undersigned hereby elects to convert percent ( %) of the value of the Warrant pursuant to the provisions of Section 1(b) of the Warrant.

The undersigned acknowledges that it has reviewed the representations and warranties contained in Section 17 of this Warrant and by its signature below hereby makes such representations and warranties to Company.

	Dated

	Holder:

	By:

	Its:

	(Address)

1 Insert here the number of shares called for on the face of the Warrant (or, in the case of a partial exercise, the portion thereof as to which the Warrant is being exercised), in either case without making any adjustment for additional Common Stock or any other stock or other securities or property or cash which, pursuant to the adjustment provisions of the Warrant, may be issuable upon exercise.

ASSIGNMENT

FOR VALUE RECEIVED, the undersigned, the holder of the within Warrant, hereby sells, assigns and transfers all of the rights of the undersigned under the within Warrant, with respect to the number of shares of Common Stock covered thereby set forth herein below, unto:

Name of Assignee

Address

No. of Shares

	Dated

	Holder:

	By:

	Its:

EXHIBIT “A”

[On letterhead of Company]

Reference is hereby made to that certain Warrant dated November 13, 2025 issued by CYTOSORBENTS CORPORATION, a Delaware corporation (the “Company”), to AVENUE VENTURE OPPORTUNITIES FUND, LP, a Delaware limited partnership (the “Holder”).

[IF APPLICABLE] The Warrant provides that the actual number and type of shares of Company’s capital stock issuable upon exercise of the Warrant and the initial exercise price per share are to be determined by reference to one or more events or conditions subsequent to the issuance of the Warrant. Such events or conditions have now occurred or lapsed, and Company wishes to confirm the actual number of shares issuable and the initial exercise price. The provisions of this Supplement to Warrant are incorporated into the Warrant by this reference, and shall control the interpretation and exercise of the Warrant.

[IF APPLICABLE] Notice is hereby given pursuant to Section 4.5 of the Warrant that the following adjustment(s) have been made to the Warrant: [describe adjustments, setting forth details regarding method of calculation and facts upon which calculation is based].

This certifies that Holder is entitled to purchase from Company , at the Holder’s option, either (i) ( ) fully paid and nonassessable shares of Company’s Stock at a price of Dollars ($ ) per share or (ii) ( ) fully paid and nonassessable shares of Company’s Stock at a price of Dollars ($ ) per share. The applicable Exercise Price and the number of shares purchasable under the Warrant remain subject to adjustment as provided in Section 4 of the Warrant.

Executed this day of , 20 .

	CYTOSORBENTS CORPORATION

	By:

	Name:

	Title:

EX-10.3 4 ctso-20250930xex10d3.htm EX-10.3

Exhibit 10.3

Date of Issuance: November 13, 2025

WARRANT TO PURCHASE

SHARES OF STOCK OF

CYTOSORBENTS CORPORATION

(Void after November 13, 2030)

This certifies that AVENUE VENTURE OPPORTUNITIES FUND II, LP, a Delaware limited partnership, or permitted assigns (“Holder”), for value received, is entitled to purchase from CYTOSORBENTS CORPORATION, a Delaware corporation (“Company”), the Applicable Number (hereinafter defined) of fully paid and nonassessable shares of the Company’s Common Stock (“Common Stock”), for cash, at a purchase price per share equal to the Exercise Price (hereinafter defined). Holder may also exercise this Warrant on a cashless or “net issuance” basis as described in Section 1(b) below, and this Warrant shall be deemed to have been exercised in full on such basis on the Expiration Date (hereinafter defined), to the extent not fully exercised prior to such date. This Warrant is issued in connection with that certain Loan and Security Agreement and Supplement thereto, both of even date herewith (as amended, restated and supplemented from time to time, the “Loan Agreement” and the “Supplement”, respectively), among Company, as borrower, AVENUE CAPITAL MANAGEMENT II, L.P., a Delaware limited partnership, as Agent, and Holder, as lender (“Lender”). Capitalized terms used herein and not otherwise defined in this Warrant shall have the meaning(s) ascribed to them in the Loan Agreement and the Supplement, unless the context would otherwise require.

“Applicable Number” means 1,000,000

“Exercise Price” means $0.70

“Trading Day” means a day when the New York Stock Exchange is open for trading in shares of the Common Stock.

This Warrant is subject to the following terms and conditions:

1.Exercise; Issuance of Certificates; Payment for Shares.

(a)Unless an election is made pursuant to clause (b) of this Section 1, this Warrant shall be exercisable at the option of Holder, at any time or from time to time, on or before the Expiration Date for all or any portion of the shares of Common Stock (but not for a fraction of a share) which may be purchased hereunder for the Exercise Price multiplied by the number of shares to be purchased. Company agrees that the shares of Common Stock purchased under this Warrant shall be and are deemed to be issued to Holder as the record owner of such shares as of the close of business on the date on which the form of subscription shall have been delivered and payment made for such shares. Subject to the provisions of Section 2, certificates for the shares of Common Stock so purchased, together with any other securities or property to which Holder is entitled upon such exercise, shall be delivered to Holder by Company at Company’s expense within a reasonable time after the rights represented by this Warrant have been so exercised. Except as provided in clause (b) of this Section 1, in case of a purchase of less than all the shares which may be purchased under this Warrant, Company shall cancel this Warrant and execute and deliver a new Warrant or Warrants of like tenor for the balance of the shares purchasable under this Warrant surrendered upon such purchase to Holder within a reasonable time. Each stock certificate so delivered shall be in such denominations of Common Stock as may be requested by Holder and shall be registered in the name of such Holder or such other name as shall be designated by such Holder, subject to the limitations contained in Section 2.

X =	Y(A − B)
X =		A

Where: X = the number of shares of Common Stock to be issued to Holder.

A = the price per share of the Common Stock as of the last Trading Day immediately prior to the date of exercise under this Section 1(b).

B = the Exercise Price then in effect.

2.Limitation on Transfer.

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE AND DISTRIBUTION THEREOF, AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF (A) SUCH REGISTRATION, (B) AN OPINION OF COUNSEL IN A FORM REASONABLY ACCEPTABLE TO COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED DUE TO AN EXEMPTION THEREFROM UNDER SAID ACT AND ANY APPLICABLE STATE SECURITIES LAWS OR (C) CYTOSORBENTS CORPORATION OTHERWISE SATISFIES ITSELF THAT SUCH TRANSACTION IS COMPLIANT WITH SUCH LAWS.

(b)any cash paid or payable including as a cash dividend, or

4.4Sale or Issuance Below Purchase Price; “Pay-to-Play” Exemption.

4.5Notice of Adjustment. Upon any adjustment of the Exercise Price, and/or any increase or decrease in the number of shares purchasable upon the exercise of this Warrant, Company shall give written notice thereof to Holder pursuant to Section 12. The notice, which may be substantially in the form of Exhibit “A” attached hereto, shall be signed by Company’s chief financial officer and shall state the Exercise Price resulting from such adjustment and the increase or decrease, if any, in the number of shares purchasable at such price upon the exercise of this Warrant, setting forth in reasonable detail the method of calculation and the facts upon which such calculation is based.

4.6Other Notices. If at any time:

(a)Company shall declare any cash dividend upon its Common Stock;

(b)Company shall declare any dividend upon its Common Stock payable in stock or make any special dividend or other distribution to the holders of its Common Stock;

(c)Company shall offer for subscription pro rata to the holders of its Common Stock any additional shares of stock of any class or other rights;

(e)there shall be a voluntary or involuntary dissolution, liquidation or winding-up of Company; or

(f)Company shall take or propose to take any other action, notice of which is actually provided to holders of the Common Stock;

9.Reserved.

17.Representations of Holder. With respect to this Warrant, Holder represents and warrants to Company as follows:

17.5Accredited Investor. It is an “accredited investor” within the meaning of Regulation D promulgated under the Securities Act.

18.Additional Representations and Covenants of Company. Company hereby represents, warrants and agrees as follows:

18.1Corporate Power. Company has all requisite corporate power and corporate authority to issue this Warrant and to carry out and perform its obligations hereunder.

18.6Reserved.

advice of any kind to any person or entity concerning the Company. This Section 19 shall survive termination of this Warrant.

[Remainder of this page intentionally left blank; signature page follows]

[Signature Page to Warrant]

IN WITNESS WHEREOF, Company has caused this Warrant to be duly executed by its officer, thereunto duly authorized as of the date of issuance set forth on the first page hereof.


CYTOSORBENTS CORPORATION

By:
Name:	Phillip P. Chan, MD, Ph.D.
Title:	Chief Executive Officer


AGREED AND ACCEPTED:

HOLDER:

AVENUE VENTURE OPPORTUNITIES FUND II, LP

By:	Avenue Venture Opportunities Partners II, LLC
Its:	General Partner


By:
Name:	Sonia Gardner
Title:	Authorized Signatory

FORM OF SUBSCRIPTION

(To be signed only upon exercise of Warrant)

To:

☐

☐	The undersigned hereby elects to convert percent ( %) of the value of the Warrant pursuant to the provisions of Section 1(b) of the Warrant.

	Dated

	Holder:

	By:

	Its:


	(Address)

ASSIGNMENT

Name of Assignee

Address

No. of Shares

	Dated

	Holder:

	By:

	Its:

EXHIBIT “A”

[On letterhead of Company]

Reference is hereby made to that certain Warrant dated November 13, 2025 issued by CYTOSORBENTS CORPORATION, a Delaware corporation (the “Company”), to AVENUE VENTURE OPPORTUNITIES FUND II, LP, a Delaware limited partnership (the “Holder”).

[IF APPLICABLE] The Warrant provides that the actual number and type of shares of Company's capital stock issuable upon exercise of the Warrant and the initial exercise price per share are to be determined by reference to one or more events or conditions subsequent to the issuance of the Warrant. Such events or conditions have now occurred or lapsed, and Company wishes to confirm the actual number of shares issuable and the initial exercise price. The provisions of this Supplement to Warrant are incorporated into the Warrant by this reference, and shall control the interpretation and exercise of the Warrant.

Executed this day of , 20 .

	CYTOSORBENTS CORPORATION

	By:

	Name:

	Title:

EX-31.1 5 ctso-20250930xex31d1.htm EX-31.1

Exhibit 31.1

Certification of Chief Executive Officer

Pursuant to pursuant to Rule 13a-14(a) or Rule 15d-14(a)

of the Securities Exchange Act of 1934, as amended

I, Phillip P. Chan, Chief Executive Officer, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of CytoSorbents Corporation;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Signature	Title	Date

/s/ Dr. Phillip P. Chan	Chief Executive Officer	November 13, 2025
Dr. Phillip P. Chan	(Principal Executive Officer) and Director

EX-31.2 6 ctso-20250930xex31d2.htm EX-31.2

Exhibit 31.2

Certification of Chief Financial Officer

Pursuant to pursuant to Rule 13a-14(a) or Rule 15d-14(a)

of the Securities Exchange Act of 1934, as amended

I, Peter J. Mariani, Chief Financial Officer, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of CytoSorbents Corporation;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Signature	Title	Date

/s/ Peter J. Mariani	Chief Financial Officer	November 13, 2025
Peter J. Mariani	(Principal Financial Officer)

EX-32.1 7 ctso-20250930xex32d1.htm EX-32.1

Exhibit 32.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. Section 1350, AS

ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of CytoSorbents Corporation (the “Company”) for the quarterly period ended September 30, 2025, as filed with the Securities and Exchange Commission (the “Report”), I, Phillip P. Chan, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge and belief: (1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Signature	Title	Date

/s/ Dr. Phillip P. Chan	Chief Executive Officer	November 13, 2025
Dr. Phillip P. Chan	(Principal Executive Officer) and Director

EX-32.2 8 ctso-20250930xex32d2.htm EX-32.2

Exhibit 32.2

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. Section 1350, AS

ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of CytoSorbents Corporation (the “Company”) for the quarterly period ended September 30, 2025, as filed with the Securities and Exchange Commission (the “Report”), I, Peter J. Mariani, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge and belief: (1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Signature	Title	Date

/s/ Peter J. Mariani	Chief Financial Officer	November 13, 2025
Peter J. Mariani	(Principal Financial Officer)