What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2026-05-13 compared with 2025-11-13 · 245 added, 287 removed, 334 unchanged (61% of the section changed)

3 unchanged sentences

(in thousands, except share data)

September 30,

Current Assets:

Cash and cash equivalents

Restricted cash, current

Accounts receivable, net of allowances of $ 134 and $ 158 as of September 30, 2025 and December 31, 2024, respectively

Accounts receivable, net of allowances of $ 164 as of March 31, 2026 and December 31, 2025

Inventories - net

Prepaid expenses and other current assets

3 unchanged sentences

Right-of-use asset

Patents - net

LIABILITIES AND STOCKHOLDERS’ EQUITY

3 unchanged sentences

Lease liability – current portion

Current maturities of long-term debt, net of debt discount

Total current liabilities

Lease liability, net of current portion

Long-term debt

Long-term debt, net of current portion and debt discount

Total liabilities

2 unchanged sentences

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

no shares issued and outstanding as of March 31, 2026 and December 31, 2025

Common Stock, par value $ 0.001 , 100,000,000 shares authorized as of March 31, 2026 and December 31, 2025;

62,733,305 and 62,804,305 shares issued and outstanding as of March 31, 2026 and December 31, 2025 respectively

Additional paid-in capital

Accumulated other comprehensive income (loss)

Accumulated other comprehensive loss

Accumulated deficit

5 unchanged sentences

(in thousands, except share and per share data)

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Cost of goods sold

8 unchanged sentences

Total other income (expense), net

Loss before benefit from income taxes

Benefit from income taxes

Basic and diluted net loss per common share

11 unchanged sentences

Income (Loss)

Balance as of June 30, 2025 (unaudited)

Stock-based compensation

Foreign translation adjustment

Balance at September 30, 2025 (unaudited)

Balance at December 31, 2025

Stock-based compensation

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

Issuance of common stock from exercise of warrants

Foreign translation adjustment

Balance as of September 30, 2025 (unaudited)

Reversal of excess RSU shares issued

Foreign currency translation adjustment, net of tax

Balance at March 31, 2026

Comprehensive

Stockholders’

Balance as of June 30, 2024 (unaudited)

Stock-based compensation

Foreign translation adjustment

ATM activation fees

Issuance of restricted stock units

Balance at September 30, 2024 (unaudited)

Balance at December 31, 2024

Stock-based compensation

Foreign currency translation adjustment

Issuance of common stock offerings, net of fees

Warrants issued in connection with long-term debt

Issuance of restricted stock units

Balance as of September 30, 2024 (unaudited)

Issuance of common stock from exercise of warrants

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

Foreign currency translation adjustment, net of tax

Balance at March 31, 2025

See accompanying notes to condensed consolidated financial statements.

2 unchanged sentences

(in thousands)

September 30,

Cash flows from operating activities

Adjustments to reconcile net loss to net cash used in operating activities:

Accrued final fee

Amortization of debt discount

Amortization of loan costs

Depreciation and amortization

Amortization of patents

Amortization of right-of-use asset

Write-off of patent cost

Write-off of inventory

Bad debt expense

Loss on abandoned patents

Bad debt expense (recovery)

Stock-based compensation

Foreign currency transaction gains

Foreign currency transaction (gains) losses

Changes in operating assets and liabilities

5 unchanged sentences

Purchases of property and equipment

Disposals of property and equipment

Payments for patent costs

1 unchanged sentence

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

Cash for exercise of warrants, net

Proceeds from rights offering, net

Net cash provided by financing activities

6 unchanged sentences

Supplemental disclosure of non-cash financing activities

Warrants issued in connection with long-term debt

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

Offering fees included in accounts payable

See accompanying notes to condensed consolidated financial statements.

1 unchanged sentence

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2025

MARCH 31, 2026

NATURE OF BUSINESS AND BASIS OF PRESENTATION

2 unchanged sentences

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, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, based in Berlin, Germany, its wholly-owned Indian subsidiary, CytoSorbents India Private Limited, based in Kasavanahalli, India, and its wholly-owned Dubai entity, CytoSorbents MEA FZCO, based in CommerCity, Dubai, conducts sales and marketing related operations for the CytoSorb device outside of the United States.

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of March 31, 2026 and December 31, 2025, and for the three months ended March 31, 2026 and 2025.

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.

3 unchanged sentences

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.

The results for the three months ended March 2026 and 2025, are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period.

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.

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.

Going Concern

As of March 31, 2026, the Company’s total cash and cash equivalents and restricted cash was approximately $ 6.3 million, with $ 1.5 million classified as restricted, and $ 4.8 million as unrestricted and available to fund operations.

These cash and restricted cash balances considered with the Company’s historical and expected future cash used in operations, notwithstanding the Company’s Strategic Workforce and Cost Reduction Plan (see Note 11, “Restructuring”) and the impact of the Amended Loan and Security Agreement (see Note 6, “Long - Term Debt”) raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying 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 United States which would allow for the opportunity to receive Tranche 2 (b) of the Amended Avenue Capital Commitment by December 31, 2026 and receive an additional 6-month extension of the interest-only period on the credit facility.

Additional sources of liquidity available to the Company include the 2024 Shelf, other public or private equity offerings, debt financing or from other sources.

2 unchanged sentences

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.

6 unchanged sentences

and CytoSorbents Europe GmbH.

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

In addition, the condensed 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.

3 unchanged sentences

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.

Loss on Abandoned Patents

During the three months ended March 31, 2026 and 2025, the Company recorded non-cash charges of approximately $ 0.3 million and $ 0.0 million respectively, related to the loss on abandonment of certain 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 recorded an income tax benefit of $ 0.4 million for the three and nine months ended September 30, 2025.

This benefit was realized by utilizing the New Jersey Technology Business Tax Certificate Program (the “Program”) whereby the State of New Jersey allows the Company to sell a portion of its state net operating losses and research and development (“R&D”) credits to a third party.

The Company received $ 1.7 million from the Program in April of 2025 resulting from the sale of 2023 and amended 2022 net operating losses and R&D credits.

The Company anticipates receiving the current benefit of $ 0.4 million in the second quarter of 2026.

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

The Company has no t recorded income tax expense or income tax benefit for the three months ended March 31, 2026 and 2025 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 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.

The Company files tax returns in the United States federal and state, and international jurisdictions.

The Company utilizes 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 $ 0.4 million from the Program in March of 2026 resulting from the sale of 2024 net operating losses and R&D credits.

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.

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.

The Company maintains cash balances with financial institutions, at times, in excess of amounts insured by the Federal Deposit Insurance Corporation (“FDIC”) up to a $250,000 limit.

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.

3 unchanged sentences

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.

See Note 5, Revenue, for additional information relating to the Company’s revenue.

The Company does not have any significant concentration of risk with respect to any one particular supplier.

As of March 31, 2026, distributor A and distributor B accounted for approximately 17 % and 11 %, respectively, of the Company’s outstanding accounts receivable.

As of December 31, 2025, distributor A accounted for approximately 17 % of outstanding accounts receivable.

For the three months ended March 31, 2026, distributor A accounted for approximately 14 % of the Company’s revenue.

For the three months ended March 31, 2025, 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.

Total freight costs amounted to approximately $ 0.1 million for each of the three months ended March 31, 2026 and 2025.

BALANCE SHEET COMPONENTS

Cash, cash equivalents, and restricted cash

The following table provides a reconciliation of cash, cash equivalents, and restricted cash shown in the condensed consolidated balance sheets and the condensed consolidated statements of cash flows:

March 31, 2026

December 31, 2025

(amounts, in thousands)

Cash and cash equivalents

Restricted cash

Total cash, cash equivalents, and restricted cash

Inventories - net

The Company had the following major classes of inventories:

September 30, 2025

March 31, 2026

December 31, 2025

3 unchanged sentences

Finished goods

Inventories - Net

Property and equipment - net

1 unchanged sentence

Depreciation/

September 30, 2025

March 31, 2026

December 31, 2025

6 unchanged sentences

Property and equipment, net

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.

Other assets consist of the following:

September 30, 2025

Depreciation expense for each of the three months ended March 31, 2026 and 2025 amounted to approximately $ 0.3 million.

Patents - net

Patents consist of the following:

March 31, 2026

December 31, 2025

3 unchanged sentences

Less accumulated amortization of patents issued

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 expenses amounted to $ 0.1 million for each of the three months ended March 31, 2026 and 2025.

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

4 unchanged sentences

Accrued expenses and other current liabilities consist of the following:

September 30, 2025

March 31, 2026

December 31, 2025

5 unchanged sentences

Goods received not invoiced

Accrued operating expenses

Accrued expenses and other current liabilities

COMMON STOCK, STOCK-BASED COMPENSATION AND WARRANTS

Rights Offering

January 10, 2025 Rights Offering

On January 10, 2025, the Company closed the subscription period of its previously announced rights offering (the “Rights Offering”), raising aggregate gross proceeds of $ 6.25 million ($ 5.4 million net of fees) from the sale of all 6.25 million Units reserved for the Rights Offering.

Participants in the Rights Offering received Units, each Unit comprising of one share of common stock of the Company, one Series A Right Warrant to purchase one share of common stock, and one Series B Right Warrant to purchase one share of common stock (collectively, the “Rights Warrants”).

Up to an additional 6.25 million shares of common stock may be issued upon exercise of the Right Warrants.

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

Management and the Board of Directors of the Company are estimated to have

subscribed for approximately 450,000 of the total Units prior to any pro rata adjustment.

Up to an additional 6.25 million shares of common stock were available for issuance upon exercise of the Right Warrants.

Once the 6.25 million shares of common stock reserved for the Right Warrants were issued, the remaining outstanding and unexercised Right Warrants would have expired worthless.

Management and the Board of Directors of the Company subscribed for approximately 450,000 of the total Units prior to any pro rata adjustment.

Subscribers of basic subscription rights in the Rights Offering were allocated Units based upon their pro-rata share of 6.25 million Units.

21 unchanged sentences

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.

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

(amounts, in thousands)

Cost of goods sold

Research and development, net of grant income

Selling, general and administrative

Total stock-based compensation expense

Nine Months Ended September 30,

Three Months Ended March 31,

Stock-based compensation expense by category

4 unchanged sentences

Total stock-based compensation expense

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.

For the three months ended March 31, 2026 and 2025, approximately $ 0.4 million and $ 0.7 million of stock-based compensation expense relates to stock options, respectively.

For each of the three months ended March 31, 2026 and 2025, approximately $ 0.1 million relates to RSUs.

Stock-options

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

The summary of the stock option activity for the three months ended March 31, 2026, is as follows:

Exercise Price

Outstanding, December 31, 2025

Outstanding, September 30, 2025

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:

Outstanding, March 31, 2026

The Company estimated the fair value of stock options granted during the three months ended March 31, 2026 using a Black-Scholes pricing model, which used the following inputs:

Exercise price (per share)

7 unchanged sentences

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 September 30, 2025 of $ 0.93 and the exercise price of the shares.

The intrinsic value is calculated as the difference between the market value of the shares as of March 31, 2026 of $ 0.57 and the exercise price of the shares.

Options Outstanding

Outstanding at

September 30,

(in thousands)

2 unchanged sentences

Exercisable at

September 30,

(in thousands)

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

The summary of the status of the Company’s non-vested options for the three months ended March 31, 2026, is as follows:

Non-vested, December 31, 2025

( 2,926,891 )

Non-vested, September 30, 2025

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 .

Non-vested, March 31, 2026

As of March 31, 2026, the Company had approximately $ 1.4 million of total unrecognized compensation cost related to stock options which will, on average, be amortized over approximately 19 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 Board of Directors has granted RSUs to members of the Board of Directors, to the Company’s executive officers, and to employees of the Company.

These RSUs 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:

Weighted Average Grant Date Fair Value

(amounts in thousands, except share data)

Outstanding, December 31, 2025

Outstanding, September 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.

Outstanding, March 31, 2026

Due to the uncertainty over whether these restricted stock units will vest, which will only happen upon a Change in Control, or upon certain life events, the Company will only record expense upon an actual vesting event.

For the three months ended March 31, 2026, the Company did not record any charges for these restricted stock units.

Other RSU Awards

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

The Board of Directors has granted RSUs to members of the Board of Directors, to the Company’s executive officers, and to employees of the Company.

These RSUs will vest over specified service periods and are settled in shares of common stock upon vesting.

The grant-date fair value of RSUs is recognized as stock-based compensation expense over the requisite service period.

The following table outlines the restricted stock unit activity for the three months ended March 31, 2026:

Non-vested, January 1, 2025

Unvested shares forfeited

Non-vested, September 30, 2025

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.

Non-vested, March 31, 2026

Although the RSUs vested during the three months ended March 31, 2026, the related shares will not be issued until a later date.

The issuance of shares is expected to occur in the three months ended June 30, 2026.

As of March 31, 2026, the remaining weighted average vesting period for restricted stock awards subject to vesting was 22 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 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.

As of March 31, 2026, the Company had 5,780,701 warrants outstanding.

Of this amount, 2,706,561 warrants outstanding are related to the Company’s December 13, 2023 offering.

These warrants are immediately cash exercisable at an exercise price of $ 2.00 per share and expire on December 13, 2028.

Another 1,645,569 warrants were issued on June 28, 2024 in connection with the 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.

Long-Term Debt) and 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/

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 three months ended September 30, 2024:

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 nine months ended September 30, 2025:

These warrants are exercisable into the Company’s common stock.

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

The number of warrants and exercise price are fixed.

The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2026:

Distributors/

3 unchanged sentences

All other countries

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

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

Distributors/

5 unchanged sentences

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.

CytoSorb is not yet approved for commercial sale in the United States.

The Company’s United States sales relate to its VetResQ related products for emergency and critical care in animals.

Direct sales outside the United States include sales to hospitals located primarily in Germany, Austria, Poland, Switzerland, the Netherlands, and the United Kingdom.

Direct sales are fulfilled from the Company’s warehouse facility in Berlin, Germany.

3 unchanged sentences

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).

Prices to all direct customers are based on a standard price list based on the packaged quantity.

Distributor and strategic partner sales make up the remaining product sales.

These distributors are located in various countries throughout the world.

In general, the Company has formal written contracts with each of its distributors and strategic partners.

These distributors are located in various countries throughout the world , including Italy, India, and other countries across Europe, Central and South America, the Middle East, and South East Asia.

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

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:

September 30, 2025

March 31, 2026

December 31, 2025

2 unchanged sentences

Contract liabilities

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.

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.

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,

(amounts, in thousands)

Total operating expenses

Loss from operations

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

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

Stock-based compensation

Loss (gain) on foreign currency transactions

Adjusted EBITDA, a non-GAAP measure

Adjusted net loss, a non-GAAP measure:

Stock-based compensation

Loss (gain) on foreign currency transactions

Adjusted net loss, a non-GAAP measure

Total cash used in operating and investing activities

September 30, 2025

December 31, 2024

(amounts, in thousands)

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

Three Months Ended

Nine Months Ended

September 30,

(amounts, in thousands)

Research and development:

Clinical expenses

Other research and development expenses

Total research and development

Selling, general and administrative

Royalty expense

Stock-based compensation

Legal, financial and consulting

Other general and administrative

Total selling, general and administrative

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.

Contract receivables represent unconditional rights to consideration for goods delivered or services performed under contracts with customers, including purchase orders.

These amounts, which are included in accounts receivable on the condensed consolidated balance sheets, were approximately $ 6.9 million, $ 7.1 million at March 31, 2026, and December 31, 2025, respectively.

LONG-TERM DEBT

Avenue Capital Group

Loan and Security Agreement

June 28, 2024 Loan

On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with 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 first tranche of $ 15 million (“Tranche 1”), consisted of $ 10 million which was available to the Company on the Closing Date and $ 5 million constituted restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved:

(i) the United States Food and Drug Administration (the “FDA”) has accepted the Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company received a minimum of $ 3 million in net

proceeds from the sale of its equity securities after the Closing Date.

The restriction was released on a dollar-for-dollar basis for equity raised between $ 3 million and $ 5 million.

The second tranche (“Tranche 2”) 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 %).

The second tranche (“Tranche 2”) consisted of $ 5 million, which would have been disbursed at the Company’s request between July 1, 2025 and December 31, 2025, subject to the Company receiving FDA marketing approval of its DrugSorb-ATR application, which the Company did not receive.

The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and were additionally used for working capital purposes and to fund general business requirements.

Amounts borrowed under the Avenue Capital Commitment bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent ( 5.00 %) or (B) thirteen and one-half percent ( 13.50 %).

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

The number of warrants is fixed;

These warrants meet the criteria for equity classification under ASC 815.

The loan required interest-only payments for the first 24 months , through July 1, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity, on July 1, 2027;

provided, however, that if the Company had drawn the full amount of Tranche 2 by December 31, 2025, and achieves for the trailing six-month period ended June 30, 2026, at least $ 25 million of revenue, (the Interest only Milestone as defined in the Loan), the Interest only Period would have been extended by six months to January 1, 2027, followed by equal monthly installments of principal plus accrued and unpaid interest through January 1, 2028.

On 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.

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

Proceeds from the Rights Offering on January 10, 2025 satisfied the second condition of the debt covenant which allowed for the $ 5 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use.

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

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

November 13, 2025 Amended Loan and Security Agreement

On November 13, 2025, the Company and Avenue Capital Group entered into the First Amendment to Loan Documents (the “Amended Loan and Security Agreement”), amending the Company’s Loan and Security Agreement, dated June 28, 2024, as supplemented.

The Amended Loan and Security Agreement funded an additional aggregate $ 2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and extended the interest-only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027.

The Company would have access to an additional aggregate $ 2.5 million (“Tranche 2b”) from Avenue Capital Group and receive a further six-month extension of the interest only period to the July 1, 2027 maturity date, subject to FDA approval of DrugSorb-ATR, between January 1, 2026 and December 31, 2026, which approval is now expected beyond this time frame.

Tranche 2a and Tranche 2b, in the aggregate, replace Tranche 2 of the Loan.

The Amended Loan and Security Agreement requires that the Company maintain revenue and certain operating cash burn targets prior to FDA approval of DrugSorb-ATR.

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

The Loan and Security Agreement includes customary loan conditions, company representations and warranties, company affirmative covenants and company negative covenants for secured transactions of this type.

As of March 31, 2026, the Company was in compliance with these covenants.

The Company evaluated the amendment in accordance with applicable accounting guidance and determined that the amendment should be accounted for as a debt modification.

As a result of the debt amendment, there were no write-offs of existing unamortized deferred

financing costs.

The Company recorded additional deferred financing costs of approximately $ 0.6 million related to the fair value of warrants issued in connection with the debt amendment.

The Company incurred approximately $ 0.1 million of third-party costs which were recorded as other expenses related to financing.

The Company’s obligations under the Amended Loan and Security Agreement are joint and several (see June 28, 2024 Loan for obligation under original loan agreement).

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

The number of warrants and exercise price are fixed.

Debt Discounts Related to Avenue Capital Group Agreements

In connection with the long-term debt transactions, the Company recorded the following discounts:

(amounts, in thousands)

Fair value of warrants issued to Avenue Capital Group - 2024

Fair value of warrants issued to Avenue Capital Group - 2025

Debt issuance cost

4 unchanged sentences

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.

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

The number of warrants is fixed;

These warrants meet the criteria for equity classification under Accounting Standards Codification 815.

The Company’s obligations under the Loan and Security Agreement are joint and several.

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:

Long-term debt as of March 31, 2026 and December 31, 2025 consists of the following:

March 31, 2026

December 31, 2025

(amounts, in thousands)

1 unchanged sentence

final payment upon maturity

Less unamortized debt discount

Long-term debt

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)

Total principal

unamortized debt discount

current maturities, net of debt discount

Long-term debt net of current maturities and debt discount

As of March 31, 2026, 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 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:

As of March 31, 2026, 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

3 unchanged sentences

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 right of the Bank to receive the Success Fees and the obligation of the Borrower to pay the Success Fees hereunder shall terminate on the date that is fifth anniversary of the funding date of the last Term C Loans made but shall survive the termination of the Loan Agreement and any prepayment of the Term C Loans.

Prior to repayment of the loan on June 28, 2024, the Company had drawn the first tranche of the loan and would be subject to total success fees of less than $ 0.1 million if the stock price exceeds $ 8.00 for five consecutive trading days prior to December 27, 2027.

The Company did no t draw down the second or third tranche prior to repayment of the loan.

The termination date of the 2022 Success Fee Letter is December 27, 2027.

1 unchanged sentence

The Company is, from time to time, subject to claims and litigation arising in the ordinary course of business.

We are not currently a party to any litigation or legal proceedings that, in the opinion of management, are likely to have a material adverse effect on the Company’s business.

The Company intends to defend vigorously against any future claims and litigation.

1 unchanged sentence

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.

Currently the Company records royalty expense of 3 % on sales of Covered Products, under the ROKK, LLC Royalty Contract.

Royalty expense amounted to approximately $ 0.3 million for each of the three months ended March 31, 2026, and 2025.

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.

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.

Matching contributions amounted to approximately $ 0.1 million for each of the three months ended March 31, 2026 and 2025.

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 .

As of March 31, 2026, the remaining lease term of the Company’s operating leases ranges from six to twelve years .

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

September 30,

(amounts, in thousands)

1 unchanged sentence

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

September 30,

(amounts, in thousands)

7 unchanged sentences

The components of lease expense were as follows:

Three Months Ended September 30,

(amounts, in thousands)

Operating lease cost

Variable lease cost

Total lease cost

Nine Months Ended September 30,

Three Months Ended March 31,

(amounts, in thousands)

2 unchanged sentences

Total lease cost

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

As of March 31, 2026, the maturities of the operating lease liability are as follows:

Remainder of 2026

3 unchanged sentences

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 loss per share and diluted loss per share for the three months ended March 31, 2026 and 2025 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 or loss per common share is calculated as basic net income per share and diluted net income per share, in the case of recognizing net income.

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

6 unchanged sentences

and (vi) if convertible debt was converted to common stock.

The computation of diluted net loss per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings.

The following table summarizes earnings per share calculations:

Three Months Ended

Nine Months Ended

September 30,

Basic and Diluted

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

Basic and diluted earnings per common share:

Basic and diluted weighted average common shares outstanding

Basic and 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 11,264,903 and 11,387,763 for the three and nine months ended September 30, 2025, respectively.

The following table presents the potentially dilutive shares that were excluded from the computation of diluted net loss per share of common stock attributable to common stockholders, because their effect was anti-dilutive:

March 31, 2026

March 31, 2025

Stock options outstanding

Warrants for common stock

Convertible securities

* Total number of RSUs include 2,635,500 and 2,787,500 units with a Change in Control-Based performance condition as of March 31, 2026 and March 31, 2025, respectively.

SEGMENT INFORMATION

The Company operates and manages its business as one reportable segment and one operating segment, which is the business of developing, testing and selling blood purification medical devices.

The Company’s chief operating decision maker, or CODM, is the Company’s Chief Executive Officer.

The CODM assesses performance of the segment and decides how to allocate resources based on revenue growth, gross margin, operating expenses, adjusted net loss, adjusted EBITDA (EBITDA as defined below, adjusted for stock-based compensation, (gain) loss on foreign currency transactions, and restructuring) and cash burn (cash used in operating and investing activities) derived from the Company’s consolidated results of operations and cash flows and total assets of the segment.

The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.

All material long-lived assets are located in New Jersey, and Berlin, Germany.

Long-lived assets consist of property and equipment, net and operating lease right-of-use assets.

The components presented in the condensed consolidated statements of operations and comprehensive loss also present the components of the Company’s single operating segment.

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

(amounts, in thousands)

Total operating expenses

Loss from operations

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

Interest expense, net

Depreciation and amortization expense

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

Stock-based compensation

(Gain) loss on foreign currency transactions

Adjusted EBITDA, a non-GAAP measure

Adjusted net loss, a non-GAAP measure:

Stock-based compensation

(Gain) loss on foreign currency transactions

Adjusted net loss, a non-GAAP measure

Total cash used in operating and investing activities

March 31, 2026

December 31, 2025

(amounts, in thousands)

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

Three Months Ended

(amounts, in thousands)

Research and development:

Clinical expenses

Other research and development expenses

Total research and development

Selling, general and administrative

Royalty expense

Stock-based compensation

Legal, financial and consulting

Other general and administrative

Total selling, general and administrative

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 the each of the three months ended March 31, 2026 and 2025.

RESTRUCTURING

Restructuring Plan

During the fourth quarter of 2025 and into the first quarter of fiscal 2026, the Company initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability.

This initiative follows a comprehensive review of the Company’s cost structure and operating model.

As part of the Strategic Workforce and Cost Reduction Plan, the Company reduced its workforce by approximately 10 %, and reduced and realigned operating and production expenses.

Restructuring Charges

The table below sets forth the estimated amount of unpaid restructuring charges as of March 31, 2026 and December 31, 2025 included in accrued expenses that are expected to be paid in less than one year.

Total additions to unpaid restructuring charges are limited to workforce reductions as the other components of restructuring costs do not require cash payments.

March 31, 2026

December 31, 2025

(amounts, in thousands)

Restructuring charges, beginning of the year

Restructuring charges unpaid and outstanding, end of period

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

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.

The number of warrants and exercise price are fixed.

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.

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