What changed in this filing

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Item 1. Financial Statements

2025-08-07 compared with 2025-05-14 · 234 added, 182 removed, 343 unchanged (55% of the section changed)

2 unchanged sentences

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

Current Assets:

1 unchanged sentence

Restricted cash, current

Grants and accounts receivable, net of allowances of $ 173,356 and $ 157,701 as of March 31, 2025 and December 31, 2024, respectively

Grants and accounts receivable, net of allowances of $ 140 and $ 158 as of June 30, 2025 and December 31, 2024, respectively

Prepaid expenses and other current assets

15 unchanged sentences

Preferred Stock, par value $ 0.001 , 5,000,000 shares authorized;

no shares issued and outstanding as of March 31, 2025 and December 31, 2024

Common Stock, par value $ 0.001 , 100,000,000 shares authorized as of March 31, 2025 and December 31, 2024;

and 62,529,466 and 54,830,146 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

no shares issued and outstanding as of June 30, 2025 and December 31, 2024

Common Stock, par value $ 0.001 , 100,000,000 shares authorized as of June 30, 2025 and December 31, 2024;

62,610,376 and 54,830,146 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

Accumulated other comprehensive income

Accumulated other comprehensive income (loss)

Accumulated deficit

( 305,486,976 )

( 304,008,618 )

Total stockholders’ equity

3 unchanged sentences

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)

Three Months Ended March 31,

Product revenue

(in thousands, except share and per share data)

Three Months Ended June 30,

Six Months Ended June 30,

Cost of goods sold

4 unchanged sentences

Loss from operations

( 3,887,208 )

( 4,656,368 )

Other income (expense)

1 unchanged sentence

Gain (loss) on foreign currency transactions

( 1,425,690 )

Total other income (expense), net

( 1,432,343 )

Loss before benefit from income taxes

( 1,478,358 )

( 6,088,711 )

Benefit from income taxes

Net loss attributable to common stockholders

( 1,478,358 )

( 6,088,711 )

Basic and diluted net loss per common share

Weighted average number of shares of common stock outstanding

Comprehensive loss:

Net loss attributable to common stockholders

( 1,478,358 )

( 6,088,711 )

Net income (loss) attributable to common stockholders

Basic net income (loss) per common share

Diluted net income (loss) per common share

Weighted Average Shares of Common Stock Outstanding

Other comprehensive income (loss):

Foreign currency translation adjustment, net of tax

( 2,736,354 )

Comprehensive loss

( 4,214,712 )

( 4,865,536 )

See accompanying notes to condensed consolidated financial statements.

1 unchanged sentence

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

(in thousands, except share data)

Comprehensive

1 unchanged sentence

Income (Loss)

Balance as of December 31, 2024

( 304,008,618 )

Balance as of March 31, 2025 (unaudited)

Stock-based compensation

Foreign translation adjustment

Balance at June 30, 2025 (unaudited)

Balance at December 31, 2024

Stock-based compensation

Issuance of common stock and warrants from rights offerings, net of fees incurred

Issuance of common stock from exercise of warrants

Issuance of common stock and warrants from rights offering, net of fees incurred

Other comprehensive loss, foreign currency translation adjustment, net of tax

( 2,736,354 )

( 1,478,358 )

Balance as of March 31, 2025

( 305,486,976 )

Foreign translation adjustment

Balance as of June 30, 2025 (unaudited)

Comprehensive

Stockholders’

Balance as of December 31, 2023

( 283,289,661 )

Balance as of March 31, 2024 (unaudited)

Stock-based compensation

Issuance of common stock offerings, net of fees incurred

Other comprehensive income, foreign currency translation adjustment, net of tax

( 6,088,711 )

Balance as of March 31, 2024

( 289,378,372 )

Warrants issued in connection with long-term debt

Foreign translation adjustment

Issuance of restricted stock options

Balance at June 30, 2024 (unaudited)

Balance at December 31, 2023

Stock-based compensation

Warrants issued in connection with long-term debt

Foreign translation adjustment

Issuance of common stock offerings, net of fees

Issuance of restricted stock units

Balance as of June 30, 2024 (unaudited)

See accompanying notes to condensed consolidated financial statements.

1 unchanged sentence

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(in thousands)

Cash flows from operating activities

Net loss attributable to common stockholders

( 1,478,358 )

( 6,088,711 )

Adjustments to reconcile net loss attributable to common shareholders to net cash used in operating activities:

Net income (loss) attributable to common stockholders

Adjustments to reconcile net income (loss) attributable to common stockholders to net cash used in operating activities:

Accrued final fee

Amortization of debt discount

1 unchanged sentence

Amortization of right-of-use asset

Write-off of patent cost

Write-off of inventory

Bad debt expense

Impairment of patents

Foreign currency transaction (gains) losses

( 3,013,984 )

Stock-based compensation

Foreign currency transaction (gains) losses

Changes in operating assets and liabilities

2 unchanged sentences

Accounts payable and accrued expenses

( 1,281,724 )

Net cash used in operating activities

( 3,464,955 )

( 4,829,759 )

Cash flows from investing activities

Purchases of property and equipment

Payments for patent costs

Net cash used in investing activities

Cash flows from financing activities

Proceeds from long-term debt

Repayment of long-term debt

Payment of final fee

Payment of loan costs

Equity contributions - net of fees incurred

Proceeds from exercise of common stock warrants

Proceeds from rights offering, net of fees incurred

Net cash provided by (used in) financing activities

Net cash provided by financing activities

Effect of exchange rates on cash

Net change in cash, cash equivalents, and restricted cash

( 5,522,757 )

Cash, cash equivalents, and restricted cash at beginning of year

3 unchanged sentences

Supplemental disclosure of non-cash financing activities

Fair value of common stock warrants issued in connection with the rights offering

Offering fees included in accounts payable

Reconciliation of cash, cash equivalents, and restricted cash to the condensed consolidated balance sheets

Cash and cash equivalents

Restricted cash

Total cash, cash equivalents, and restricted cash

Warrants issued in connection with long-term debt

See accompanying notes to condensed consolidated financial statements.

1 unchanged sentence

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2025

JUNE 30, 2025

NATURE OF BUSINESS AND BASIS OF PRESENTATION

1 unchanged sentence

The Company, through its subsidiary CytoSorbents Medical, Inc.

and 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.

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 March 31, 2025 and December 31, 2024, and for the three months ended March 31, 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 (“U.S.

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of June 30, 2025 and December 31, 2024, and for the three and six months ended June 30, 2025 and 2024.

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.

2 unchanged sentences

GAAP have been condensed or omitted.

The results for the three months ended March 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.

As of March 31, 2025, the Company’s total cash and cash equivalents and restricted cash was approximately $ 13.1 million, with $ 1.5 million classified as restricted, and $ 11.6 million as unrestricted and available to fund operations.

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 regulatory approval and introduction of DrugSorb-ATR in the U.S.

and Canada which is expected in 2025, and the related opportunity to receive Tranche 2 of Avenue Capital Commitment (see note 6.

The results for the three and six months ended June 2025 and 2024, are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period.

Beginning in the current quarter, the Company presents amounts in thousands unless otherwise stated.

Prior periods have been adjusted accordingly for consistent presentation.

Certain prior year amounts in the footnotes have been reclassified to conform to the current year presentation.

As of June 30, 2025, the Company’s total cash and cash equivalents and restricted cash was approximately $ 11.7 million, with $ 1.5 million classified as restricted, and $ 10.2 million as unrestricted and available to fund operations, which raises substantial doubt about the Company’s ability to continue as a going concern.

The Company’s expected future capital requirements may depend on many factors including expanding the Company’s customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb-ATR in the U.S.

and Canada, which regulatory decisions are expected in 2025, and the related opportunity to receive Tranche 2 of Avenue Capital Commitment (see Note 6.

Long-Term Debt) by December 31, 2025 and extend the principal re-payment terms of the facility beginning in the third quarter of 2026.

Additional sources of liquidity available to the Company include issuance of additional equity securities through the Series B Right Warrant, which expires June 10, 2025, or other public or private equity offerings, debt financings or from other sources.

Additional sources of liquidity available to the Company include the 2024 Shelf (as defined in Note 4, Common Stock, Stock-Based Compensation and Warrants), other public or private equity offerings, debt financings or from other sources.

The sale of additional equity may result in dilution to shareholders.

6 unchanged sentences

SIGNIFICANT ACCOUNTING POLICIES

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

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

Basis of Consolidation and Foreign Currency Translation

The condensed consolidated financial statements include the accounts of CytoSorbents Corporation and its wholly owned subsidiaries, CytoSorbents Medical, Inc.

and CytoSorbents Europe GmbH.

In addition, the consolidated financial statements include CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp.

z.o.o., CytoSorbents Medical UK Limited and CytoSorbents France SAS, wholly owned subsidiaries of CytoSorbents Europe GmbH, and CytoSorbents UK Limited and CytoSorbents India Private Limited, wholly-owned subsidiaries of CytoSorbents Medical, Inc.

All significant intercompany transactions and balances have been eliminated in consolidation.

Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year.

Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recorded in cumulative translation adjustment, a component of accumulated other comprehensive income.

Foreign currency transactions gains and losses are included in other income (loss), net in the consolidated statements of operations and other comprehensive loss.

Impairment or Disposal of Long-Lived Assets

During the three months ended March 31, 2025 and 2024, the Company recorded impairment charges of zero and approximately $ 64,000 , 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 legal, financial and other consulting in the condensed consolidated statements of operations and comprehensive loss.

The Company has no t recorded income tax expense or income tax benefit for the three months ended March 31, 2025 and 2024 due to the generation of net operating losses, the benefits of which have been fully reserved.

During the six months ended June 30, 2025, the Company did not record any impairment charges.

During the six months ended June 30, 2024, the Company recorded impairment charges of approximately $ 0.3 million, related to the impairment of certain issued patents and pending patent applications in certain specific jurisdictions and the abandonment of certain pending patent application costs in the ordinary course of business.

This charge is included in selling, general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.

The Company has no t recorded income tax expense or income tax benefit for the six months ended June 30, 2025 and 2024 due to the generation of net operating losses, the benefits of which have been fully reserved.

Deferred income taxes are accounted for using the balance sheet approach, which requires recognition of deferred tax assets and liabilities for the expected future consequences of temporary differences between the financial reporting basis and the tax basis of assets and liabilities.

3 unchanged sentences

The Company follows accounting standards associated with uncertain tax positions.

The Company had no unrecognized tax benefits as of March 31, 2025 and December 31, 2024.

The Company had no unrecognized tax benefits as of June 30, 2025 and December 31, 2024.

The Company is accounting for an uncertain tax position of approximately $ 2.2 million as of December 31, 2024.

4 unchanged sentences

The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation (“FDIC”).

Through the IntraFi Network the Company maintains an Insured Cash Sweep account whereby all cash held in the Company’s money market accounts is swept daily in increments of less than $250,000 and deposited in a number of IntraFi’s network of 3,000 financial institutions.

Through the IntraFi Network, the Company maintains an Insured Cash Sweep account whereby all cash held in the Company’s money market accounts is swept daily in increments of less than the FDIC insurance limit and deposited in a number of IntraFi’s network of 3,000 financial institutions.

This arrangement provides FDIC insurance coverage for all of the cash balances held in the money market accounts, which represents all of the cash and cash equivalents held at Bridge Bank.

3 unchanged sentences

Substantially all of the Company’s grant and other income is from government agencies in the United States.

As of March 31, 2025, one distributor accounted for approximately 14.7 % of outstanding grants and accounts receivable.

As of June 30, 2025, no distributor or direct customers accounted for more than 10 % of the Company’s outstanding grants and accounts receivable.

As of December 31, 2024, one distributor accounted for approximately 19 % of outstanding grants and accounts receivable.

For the three months ended March 31, 2025 and 2024, no distributor or direct customers accounted for more than 10 % of the Company’s total revenue.

For the three and six months ended June 30, 2025 and 2024, no distributor or direct customers accounted for more than 10 % of the Company’s total revenue.

Shipping and Handling Costs

Total freight costs amounted to approximately $ 90,000 and $ 114,000 for the three months ended March 31, 2025 and 2024, respectively.

Total freight costs amounted to approximately $ 0.2 million and $ 0.1 million for the three months ended June 30, 2025 and 2024, respectively, and $ 0.3 million and $ 0.2 million for the six months ended June 30, 2025 and 2024, respectively.

BALANCE SHEET COMPONENTS

The Company had the following major classes of inventories:

March 31, 2025

June 30, 2025

December 31, 2024

(amounts, in thousands)

Raw materials

1 unchanged sentence

Finished goods

Property and equipment

Property and equipment, net

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

Depreciation/

March 31, 2025

June 30, 2025

December 31, 2024

(amounts, in thousands)

Furniture and fixtures

4 unchanged sentences

Property and equipment, net

Depreciation expense for the three months ended March 31, 2025 and 2024, amounted to $ 305,700 and $ 342,200 , respectively.

Depreciation expense for the six months ended June 30, 2025 and 2024 amounted to $ 0.6 million and $ 0.8 million, respectively.

Other assets consist of the following:

March 31, 2025

June 30, 2025

December 31, 2024

(amounts, in thousands)

Patent applications pending

1 unchanged sentence

Less accumulated amortization of patents issued

( 1,312,727 )

( 1,254,850 )

Patent amortization expenses amounted to $ 62,800 and $ 55,100 for the three months ended March 31, 2025 and 2024, respectively.

Patent amortization expenses amounted to $ 0.1 million for the six months ended June 30, 2025 and 2024.

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

(amounts, in thousands)

Remainder of 2025

Scheduled amortization of patents issued

1 unchanged sentence

Accrued expenses and other current liabilities consist of the following:

March 31, 2025

June 30, 2025

December 31, 2024

(amounts, in thousands)

Accrued salaries and commissions

10 unchanged sentences

Once the 6.25 million shares of common stock reserved for the Right Warrants are issued, the remaining outstanding and unexercised Right Warrants will expire worthless.

The Series A Right Warrants and the Series B Right Warrants expire on February 24, 2025 and April 10, 2025, respectively.

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 $ 288,442 and $ 54,563 has been allocated to the Series A Right Warrant and the Series B Right Warrant, respectively, and recorded within additional paid-in capital.

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:

8 unchanged sentences

90 % of the 5-day volume weighted average stock price as of the exercise date rounded down to the nearest cent, not to fall outside the range of the maximum and minimum exercise prices.

Proceeds from the closing of the subscription period satisfy a debt covenant which allows for $ 5,000,000 of restricted cash on the Company’s condensed consolidated balance sheets to become unrestricted, and available for use.

The Right Warrants are exercisable commencing on their date of issuance and the exercise price is equal to (i) in the case of the Series A Right Warrants, 90 % of the 5-day volume weighted average price of Common Stock over the last 5-trading days prior to the expiration date of the Series A Right Warrants on February 24, 2025, rounded down to the nearest whole cent but (x) not lower than $ 1.00 and (y) not higher than $ 2.00 , and (ii) in the case of the Series B Right Warrants, 90 % of the 5-day volume weighted average price of Common Stock over the last 5-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 .

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

The Right Warrants were exercisable commencing on their date of issuance and the exercise price is equal to (i) in the case of the Series A Right Warrants, 90 % of the 5 -day volume weighted average price of Common Stock over the last five -trading days prior to the expiration date of the Series A Right Warrants on February 24, 2025, rounded down to the nearest whole cent but (x) not lower than $ 1.00 and (y) not higher than $ 2.00 , and (ii) in the case of the Series B Right Warrants, 90 % of the 5 -day volume weighted average price of Common Stock over the last five -trading days prior to the extended expiration date of the Series B Right Warrants on June 10, 2025, rounded down to the nearest whole cent but (x) not lower than $ 2.00 and (y) not higher than $ 4.00 .

Exercise of the Right Warrants require additional investment separate from the purchase of the Units.

6.25 million shares of common stock have been reserved for exercise of the Right Warrants, after which any remaining unexercised Right Warrants will immediately expire worthless.

The Right Warrants are transferable until they have expired.

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.

As of March 31, 2025, the number of Series B Right Warrants unexercised warrants amounted to 6.25 million, of which only 4.85 million can be exercised pursuant to the maximum number of shares reserved for the Rights Warrants.

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

5 unchanged sentences

Stock-Based Compensation

The following table summarizes the Company’s stock-based compensation expense:

Three Months Ended March 31,

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

Three Months Ended June 30,

Stock-based compensation expense by category

Stock-options

Restricted stock-units (“RSUs”)

(amounts, in thousands)

Cost of goods sold

Research and development, net of grant income

Selling, general and administrative

Total stock-based compensation expense

Stock-based compensation expense was recorded as follows:

$ 59,000 , $ 132,000 and $ 627,000 in cost of goods sold, research and development, and selling, general and administrative expenses for the three months ended March 31, 2025, respectively, and $ 959,000 was recorded in the selling, general and administrative expenses for the three months ended March 31, 2024 within the condensed consolidated statements of operations and comprehensive loss.

Six Months Ended June 30,

Stock-based compensation expense by category

(amounts, in thousands)

Cost of goods sold

Research and development, net of grant income

Selling, general and administrative

Total stock-based compensation expense

For the six months ended June 30, 2025 and 2024, approximately $ 1.1 and $ 1.5 million of stock-based compensation expense relates to stock options, and approximately $ 0.3 and $ 0.4 million relates to RSUs, respectively.

For the three months ended June 30, 2025 and 2024, approximately $ 0.4 and $ 0.8 million of stock-based compensation expense relates to stock options, and approximately $ 0.1 and $ 0.2 million relates to RSUs, respectively.

Stock-options

The summary of the stock option activity for the three months ended March 31, 2025, is as follows:

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

Exercise Price

Outstanding, December 31, 2024

Outstanding, March 31, 2025

The Company estimated the fair value of stock options granted during the three months ended March 31, 2025 using a Black-Scholes pricing model, which used the following inputs:

Outstanding, June 30, 2025

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

Exercise price (per share)

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*The expected term of the options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term.

The simplified method is used as the Company’s employee exercise history may not be indicative for estimating future exercises.

In addition, the Company recognizes forfeitures as they occur.

The intrinsic value is calculated as the difference between the market value of the shares as of March 31, 2025, of $ 1.00 and the exercise price of the shares.

The intrinsic value is calculated as the difference between the market value of the shares as of June 30, 2025 of $ 1.28 and the exercise price of the shares.

Options Outstanding

Outstanding at

(in thousands)

$ 0.82 - $ 13.20

1 unchanged sentence

Exercisable at

The summary of the status of the Company’s non-vested options for the three months ended March 31, 2025 is as follows:

(in thousands)

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

Non-vested, December 31, 2024

Non-vested, March 31, 2025

As of March 31, 2025, the Company had approximately $ 2,267,000 of total unrecognized compensation cost related to stock options which will, on average, be amortized over approximately 35 months .

( 2,329,220 )

Non-vested, June 30, 2025

As of June 30, 2025, the Company had approximately $ 2.2 million of total unrecognized compensation cost related to stock options which will, on average, be amortized over approximately 17 months .

Change in Control-Based RSUs

3 unchanged sentences

Intrinsic Value

(amounts in thousands, except share data)

Outstanding, December 31, 2024

Outstanding, March 31, 2025

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

Outstanding, June 30, 2025

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.

Other RSU Awards

The following table outlines the restricted stock unit activity for the three months ended March 31, 2025:

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

Non-vested, January 1, 2025

Non-vested, March 31, 2025

As of March 31, 2025, the remaining weighted average vesting period for restricted stock awards subject to vesting was 28 months and the remaining unrecognized restricted stock unit compensation expense was $ 407,000 .

Unvested shares forfeited

Non-vested, June 30, 2025

As of June 30, 2025, the remaining weighted average vesting period for restricted stock awards subject to vesting was 28 months and the remaining unrecognized restricted stock unit compensation expense was $ 0.4 million.

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

As of March 31, 2025, the Company had 4,352,130 warrants outstanding.

As of June 30, 2025, the Company had 4,352,130 warrants outstanding.

2,706,561 warrants outstanding are related to the Company’s December 13, 2023 offering, and these warrants are immediately cash exercisable at an exercise price of $ 2.00 per share and expire on December 13, 2028.

6 unchanged sentences

REVENUE AND SEGMENT INFORMATION

The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2025:

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

Distributors/

Strategic Partners

Product revenue:

(amounts, in thousands)

United States

All other countries

Product revenue

The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2024:

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

Distributors/

Strategic Partners

Product revenue:

(amounts, in thousands)

United States

All other countries

Product revenue

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

Distributors/

Strategic Partners

(amounts, in thousands)

United States

All other countries

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

Distributors/

Strategic Partners

(amounts, in thousands)

United States

All other countries

CytoSorb Sales

11 unchanged sentences

These distributors are located in various countries throughout the world.

The Company has a formal written contract with each distributor/strategic partner.

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.

5 unchanged sentences

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

March 31, 2025

June 30, 2025

December 31, 2024

Contract receivables, which are included in grants and accounts receivable

Contract liabilities, which are included in accrued expenses and other current liabilities

Contract receivables represent balances due from product sales to distributors amounting to $ 5,583,481 and $ 4,233,888 as of March 31, 2025 and December 31, 2024, respectively, and billed and unbilled amounts due on government contracts amounting to $ 278,197 and $ 193,002 as of March 31, 2025 and December 31, 2024, respectively.

Contract liabilities 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 $ 183,714 and $ 176,714 as of March 31, 2025 and December 31, 2024, respectively, and deferred grant liability related to the billing on fixed price government contracts in excess of costs incurred, which amounted to $ 546,028 and $ 419,328 as of March 31, 2025 and December 31, 2024, respectively.

(amounts in thousands)

Contract receivables

Contract liabilities

Contract receivables, which are included in grants and accounts receivable on the condensed consolidated balance sheets, represent balances due from product sales to direct and distributor customers amounting to $ 6.4 million and $ 4.2 million as of June 30, 2025 and December 31, 2024, respectively, and billed and unbilled amounts due on government contracts amounting to $ 0.2 million each as of June 30, 2025 and December 31, 2024.

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

Segment Information

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Three Months Ended

Product revenue

Six Months Ended

(amounts, in thousands)

Total operating expenses

Loss from operations

EBITDA and Adjusted EBITDA (both non-GAAP measures):

Net loss attributable to common stockholders

( 1,478,358 )

( 6,088,711 )

Net income (loss) attributable to common stockholders

Interest expense, net

Benefit from income taxes

Depreciation and amortization expense

Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure

( 5,684,772 )

Income (loss) before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure

Stock-based compensation

Loss (gain) on foreign currency transactions

( 3,013,984 )

Adjusted EBITDA, a non-GAAP measure

( 2,700,279 )

( 3,299,617 )

Adjusted net loss, a non-GAAP measure:

Net loss attributable to common stockholders

( 1,478,358 )

( 6,088,711 )

Net income (loss) attributable to common stockholders

Stock-based compensation

Loss (gain) on foreign currency transactions

( 3,013,984 )

Adjusted net loss, a non-GAAP measure

( 3,673,916 )

( 3,703,556 )

Total cash used in operating and investing activities

( 3,512,197 )

( 4,956,777 )

March 31, 2025

June 30, 2025

December 31, 2024

(amounts, in thousands)

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

Three Months Ended

Six Months Ended

(amounts, in thousands)

Research and development:

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Total selling, general and administrative

Capital expenditures of the segment totaled $ 47,242 and $ 127,018 for the three months ended March 31, 2025 and 2024, respectively.

Amounts presented within research and development expenses in the table above are inclusive of stock-based compensation expense.

Refer to Note 4, Common Stock, Stock-Based Compensation and Warrants, for additional information.

Capital expenditures of the segment totaled $ 0.1 million for each of the six months ended June 30, 2025 and 2024.

LONG-TERM DEBT

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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 (see note 10.

Subsequent Events) 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.

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 product revenue, 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

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.

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

(amounts, in thousands)

Fair value of warrants issued to Avenue Capital Group

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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 $ 900,000 .

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 of the time of payment in relation to 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 March 31, 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 $ 690,709 to purchase an aggregate of 1,645,569 shares of the Company’s common stock for cash at the exercise price of $ 0.79 , which expire on June 28, 2029.

As of June 30, 2025, the Company was in compliance with these covenants.

As additional consideration for the Commitment, on June 28, 2024, the Company also issued Avenue Capital Group with warrants with a fair value of $ 0.7 million to purchase an aggregate of 1,645,569 shares of the Company’s common stock for cash at the exercise price of $ 0.79 , which expire on June 30, 2029.

The number of warrants is fixed;

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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 March 31, 2025, long-term debt consists of the following:

As of June 30, 2025, long-term debt consists of the following:

(amounts, in thousands)

Principal amount

final payment upon maturity

Less unamortized debt discount

Less current maturities

Long-term debt

As of March 31, 2025, principal payments of long-term debt are due as follows:

On June 28, 2024, concurrent with the closing of the Avenue Capital Group financing discussed above, the Company paid off its existing outstanding debt with Bridge Bank.

As of March 31, 2025, the following commitments survive after the termination of the Bridge Bank Amended and Restated Loan and Security Agreement and related amendments:

As of June 30, 2025, principal payments of long-term debt are due as follows:

(amounts, in thousands)

On June 28, 2024, concurrent with the closing of the Avenue Capital Group financing discussed above, the Company paid off its previously outstanding debt with Bridge Bank.

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

2022 Success Fee Letter

1 unchanged sentence

(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 $ 5,000,000 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”).

and (iii) 2 % of $ 5.0 million if the Company draws down the third tranche of the Term C Loan and is payable only if the Company’s stock price equals or exceeds $ 12 for five consecutive trading days (together, the “Success Fee”).

Borrower may pay the Success Fee in cash or in shares of common stock, at Borrower’s sole discretion.

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The Company is party to various royalty and license agreements that require the payment of royalty fees.

Royalty expense amounted to approximately $ 258,000 and $ 712,000 for the three months ended March 31, 2025, and 2024, respectively.

Royalty expense amounted to approximately $ 0.5 million and $ 1.2 million for the six months ended June 30, 2025, and 2024, respectively.

Royalty expense amounted to approximately $ 0.3 million and $ 0.5 million for the three months ended June 30, 2025, and 2024, respectively.

Royalty expense is included in selling, general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.

1 unchanged sentence

Participants may defer up to 100 % of their eligible compensation subject to certain Internal Revenue Code limitations.

The Company matches one hundred percent of the participants contribution up to three percent of compensation plus fifty percent of the participants contribution over three percent of compensation up to a maximum of five percent of compensation.

Matching contributions amounted to $ 87,000 and $ 95,000 for the three months ended March 31, 2025 and 2024, respectively.

Matching contributions amounted to $ 0.2 million for each of the six months ended June 30, 2025 and 2024.

Matching contributions amounted to approximately $ 0.1 million for each of the three months ended June 30, 2025 and 2024.

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 March 31, 2025, the remaining lease term of the Company’s operating leases ranges from six to twelve years .

As of June 30, 2025, the remaining lease term of the Company’s operating leases ranges from six to twelve years .

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

(amounts, in thousands)

Cash paid in connection with the operating leases

Operating lease expense

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

(amounts, in thousands)

Right-of-use asset

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Weighted average remaining lease term

As of March 31, 2025, the maturities of the operating lease liability are as follows:

2025 (since April 1, 2025)

Lease Expense

The components of lease expense were as follows:

Three Months Ended June 30,

(amounts, in thousands)

Operating lease cost

Variable lease cost

Total lease cost

Six Months Ended June 30,

(amounts, in thousands)

Operating lease cost

Variable lease cost

Total lease cost

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

Remainder of 2025

Future operating lease payments

Imputed interest

( 9,229,203 )

Total operating lease liability

NET LOSS PER SHARE

Basic loss per share and diluted loss per share for the three months ended March 31, 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.

All outstanding warrants, options and restricted stock awards representing approximately 20,092,880 and 16,061,000 incremental shares for the three months ended March 31, 2025 and 2024, respectively, have been excluded from the computation of diluted loss per share as they are anti-dilutive.

NET INCOME (LOSS) PER SHARE

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

Net income per common share is calculated as basic net income per share and diluted net income per share.

Basic net income per share excludes dilution and is computed by dividing net income by the weighted average number of common shares outstanding for the period.

Diluted net income per share is computed in the same manner as basic net income after assuming issuance of common stock for all potentially dilutive equivalent shares, which includes the potential dilution that could occur:

(i) if the RSUs with service conditions were fully vested (using the treasury stock method);

(ii) if all of the Company’s outstanding stock options that are in-the-money were exercised (using the treasury stock method);

(iii) if the RSUs with service and market conditions were considered contingently issuable;

and (iv) if the RSUs with service and performance conditions were considered contingently issuable.

The following table summarizes earnings per share calculations:

Three Months Ended

Six Months Ended

(amounts, in thousands, except share and per share data)

Basic earnings per common share:

Net income (loss) attributable to common stockholders

Basic weighted average common shares outstanding

Basic earnings per common share

Diluted earnings per common share

Net income (loss) attributable to common stockholders

Basic weighted average common shares outstanding

Effect of dilutive securities

Diluted weighted average common shares outstanding

Diluted earnings per common share

Certain stock options and restricted stock units are not included in the diluted earnings per share calculation when the effect would be anti-dilutive.

The number of anti-dilutive shares were 10,819,609 and 10,820,859 for the three and six months ended June 30, 2025, respectively.

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, other than those described below:

Receipt of $ 1.7 million from New Jersey Business Tax Certificate Program

On April 21, 2025, the Company announced that it received $ 1.7 million in cash proceeds from the sale of 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).

The program allows technology and biotechnology businesses with net operating losses to turn their tax losses and credits into cash to buy equipment or facilities, or for other allowable expenditures.

The Company amended its tax return for 2022 following the passage of New Jersey tax reform legislation, A.B.

5323, on July 3, 2023, containing provisions that retroactively allowed taxpayers in New Jersey to immediately deduct from research and experimental (R&E) expenditures for which state R&D credit is claimed.

The legislation was retroactive to January 1, 2022.

The Company intends to utilize the funding to help drive ongoing growth, including preparations for the anticipated launch of DrugSorb-ATR in the U.S.

and Canada, scaling up manufacturing in the Princeton facility, and supporting other key strategic initiatives.

On July 4, 2025, the One Big Beautiful Bill Act was signed into law in the U.S.

The Company is currently evaluating the provisions of the bill and any potential impacts on its financial position and operations, but does not anticipate any material impacts to its financial statements for the year ending December 31, 2025.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements