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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
Commission file number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of |
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(I.R.S. Employer Identification No.) |
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incorporation or organization) |
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(Address of principal executive offices) |
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(Zip Code) |
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
☑
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
As of August 1, 2025, there were
CytoSorbents Corporation
FORM 10-Q
TABLE OF CONTENTS
This Report includes our trademarks and trade names, such as “CytoSorb,” “CytoSorb XL,” “ECOS-300CY,” “BetaSorb,” “ContrastSorb,” “DrugSorb,” “HemoDefend-RBC,” “HemoDefend-BGA, “K+ontrol” and “VetResQ,” which are protected under applicable intellectual property laws and are the property of CytoSorbents Corporation and its subsidiaries. This Report also contains the trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this Report may appear without the ™, ®, or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by these other parties.
2
PART I — FINANCIAL INFORMATION
Item 1. Financial Statements.
CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
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June 30, |
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December 31, |
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2025 |
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2024 |
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(unaudited) |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash, current |
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— |
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Grants and accounts receivable, net of allowances of $
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment - net |
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Restricted cash |
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Right-of-use asset |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses and other current liabilities |
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Lease liability – current portion |
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Total current liabilities |
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Lease liability, net of current portion |
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Long-term debt |
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Total liabilities |
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Commitments and Contingencies |
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Stockholders’ equity |
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Preferred Stock, par value $
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Common Stock, par value $
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Additional paid-in capital |
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Accumulated other comprehensive income (loss) |
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(
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Accumulated deficit |
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(
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(
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to condensed consolidated financial statements
3
CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Cost of goods sold |
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$ |
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Gross profit |
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Operating expenses |
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Research and development, net of grant income |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
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(
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(
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(
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(
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Other income (expense) |
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Interest expense, net |
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(
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(
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(
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(
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Gain (loss) on foreign currency transactions |
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(
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(
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Total other income (expense), net |
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(
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(
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Net income (loss) attributable to common stockholders |
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$ |
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$ |
(
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$ |
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$ |
(
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Basic net income (loss) per common share |
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$ |
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$ |
(
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$ |
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$ |
(
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Diluted net income (loss) per common share |
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$ |
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$ |
(
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$ |
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$ |
(
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Weighted Average Shares of Common Stock Outstanding |
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Basic |
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Diluted |
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Other comprehensive income (loss): |
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Foreign currency translation adjustment, net of tax |
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(
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(
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Comprehensive loss |
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$ |
(
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$ |
(
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$ |
(
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$ |
(
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See accompanying notes to condensed consolidated financial statements.
4
CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (UNAUDITED)
(in thousands, except share data)
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Accumulated |
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Additional |
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Other |
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Common Stock |
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Paid-In |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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Shares |
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Par value |
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Capital |
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Income (Loss) |
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Deficit |
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Equity |
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Balance as of March 31, 2025 (unaudited) |
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$ |
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$ |
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$ |
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$ |
(
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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Foreign translation adjustment |
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— |
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— |
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— |
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(
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— |
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(
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Net income |
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Balance at June 30, 2025 (unaudited) |
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$ |
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$ |
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$ |
(
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$ |
(
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$ |
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Balance at December 31, 2024 |
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$ |
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$ |
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$ |
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$ |
(
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$ |
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Stock-based compensation |
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— |
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— |
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Issuance of common stock and warrants from rights offerings, net of fees incurred |
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— |
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— |
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Issuance of common stock from exercise of warrants |
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— |
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— |
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Foreign translation adjustment |
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— |
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— |
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— |
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(
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— |
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(
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Net income |
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Balance as of June 30, 2025 (unaudited) |
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$ |
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$ |
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$ |
(
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$ |
(
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$ |
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Accumulated |
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Additional |
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Other |
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Common Stock |
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Paid-In |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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Shares |
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Par value |
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Capital |
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Income |
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Deficit |
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Equity |
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Balance as of March 31, 2024 (unaudited) |
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$ |
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$ |
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$ |
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$ |
(
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Warrants issued in connection with long-term debt |
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— |
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— |
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— |
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— |
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Foreign translation adjustment |
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— |
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— |
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— |
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— |
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Issuance of restricted stock options |
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— |
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(
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— |
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— |
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(
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Net loss |
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— |
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— |
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— |
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— |
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(
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(
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Balance at June 30, 2024 (unaudited) |
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$ |
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$ |
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$ |
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$ |
(
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$ |
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Balance at December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
(
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Warrants issued in connection with long-term debt |
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— |
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— |
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— |
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— |
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Foreign translation adjustment |
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— |
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— |
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— |
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— |
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Issuance of common stock offerings, net of fees |
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— |
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— |
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— |
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Issuance of restricted stock units |
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— |
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(
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— |
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— |
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(
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Net loss |
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— |
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— |
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— |
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— |
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(
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(
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Balance as of June 30, 2024 (unaudited) |
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$ |
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$ |
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$ |
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$ |
(
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$ |
|
See accompanying notes to condensed consolidated financial statements.
5
CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)
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Six |
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Six |
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Months Ended |
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Months Ended |
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June 30, |
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June 30, |
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2025 |
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2024 |
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Cash flows from operating activities |
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Net income (loss) attributable to common stockholders |
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$ |
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$ |
(
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Adjustments to reconcile net income (loss) attributable to common stockholders to net cash used in operating activities: |
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Accrued final fee |
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— |
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Amortization of debt discount |
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— |
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Depreciation and amortization |
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Amortization of right-of-use asset |
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Write-off of patent cost |
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— |
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Write-off of inventory |
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— |
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Bad debt expense |
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Stock-based compensation |
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Foreign currency transaction (gains) losses |
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(
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Changes in operating assets and liabilities |
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Grants and accounts receivable |
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(
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Inventories |
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(
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(
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Prepaid expenses and other current assets |
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Other assets |
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— |
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Accounts payable and accrued expenses |
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(
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(
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Net cash used in operating activities |
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(
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(
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Cash flows from investing activities |
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Purchases of property and equipment |
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(
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(
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Payments for patent costs |
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(
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(
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Net cash used in investing activities |
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(
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(
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Cash flows from financing activities |
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Proceeds from long-term debt |
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— |
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Repayment of long-term debt |
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— |
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(
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Payment of final fee |
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— |
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(
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Payment of loan costs |
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— |
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(
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Equity contributions - net of fees incurred |
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— |
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Proceeds from exercise of common stock warrants |
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— |
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Proceeds from rights offering, net of fees incurred |
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— |
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Net cash provided by financing activities |
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Effect of exchange rates on cash |
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(
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Net change in cash, cash equivalents, and restricted cash |
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(
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Cash, cash equivalents, and restricted cash at beginning of year |
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Cash, cash equivalents, and restricted cash – end of period |
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$ |
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$ |
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Supplemental disclosure of cash flow information |
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Cash paid for interest |
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$ |
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$ |
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Supplemental disclosure of non-cash financing activities |
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Warrants issued in connection with long-term debt |
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$ |
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$ |
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|
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|
See accompanying notes to condensed consolidated financial statements.
6
CYTOSORBENTS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025
|
1. |
NATURE OF BUSINESS AND BASIS OF PRESENTATION |
CytoSorbents Corporation (the “Company”) is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. The Company, through its subsidiary CytoSorbents Medical, Inc. based in New Jersey, is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly owned European subsidiary, CytoSorbents Europe GmbH, based in Berlin, Germany, conducts sales and marketing related operations for the CytoSorb device outside of the United States.
The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of June 30, 2025 and December 31, 2024, and for the three and six months ended June 30, 2025 and 2024. The Company’s condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and therefore, do not include all information and footnotes necessary for a fair presentation of consolidated financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2024, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments, for a fair presentation of the Company’s consolidated financial position and results of operations for the interim periods presented. Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The results for the three and 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 $
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 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. There is no assurance that the Company will be able to secure funding on terms acceptable, or at all. The increasing 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. As a result of these additional uncertainties, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates available financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors.
7
|
2. |
SIGNIFICANT ACCOUNTING POLICIES |
There have been no material changes to significant accounting policies disclosed in the Company’s consolidated financial statements from the Annual Report on Form 10-K for the year ended December 31, 2024.
Basis of Consolidation and Foreign Currency Translation
The condensed consolidated financial statements include the accounts of CytoSorbents Corporation and its wholly owned subsidiaries, CytoSorbents Medical, Inc. and CytoSorbents Europe GmbH. In addition, the consolidated financial statements include CytoSorbents Switzerland GmbH, CytoSorbents Poland Sp. z.o.o., CytoSorbents Medical UK Limited and CytoSorbents France SAS, wholly owned subsidiaries of CytoSorbents Europe GmbH, and CytoSorbents UK Limited 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 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 $
Income Taxes
The Company has
Deferred income taxes are accounted for using the balance sheet approach, which requires recognition of deferred tax assets and liabilities for the expected future consequences of temporary differences between the financial reporting basis and the tax basis of assets and liabilities. A valuation allowance is provided when it is more likely than not that a deferred tax asset will not be realized. A full valuation allowance has been established on the deferred tax asset as it is more likely than not that a future tax benefit will not be realized. In addition, future utilization of the available net operating loss carryforward may be limited under Internal Revenue Code Section 382 as a result of changes in ownership.
The Company follows accounting standards associated with uncertain tax positions. The Company had
The Company utilizes the Technology Business Tax Certificate Transfer Program to sell a portion of its New Jersey Net Operating Loss carryforwards to an industrial company.
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”). 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
8
A significant portion of the Company’s revenues is from product sales in Germany. Substantially all of the Company’s grant and other income is from government agencies in the United States.
As of June 30, 2025,
Shipping and Handling Costs
Total freight costs amounted to approximately $
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3. |
BALANCE SHEET COMPONENTS |
Inventories
The Company had the following major classes of inventories:
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June 30, 2025 |
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December 31, 2024 |
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(amounts, in thousands) |
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Raw materials |
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$ |
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$ |
|
|
Work in process |
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Finished goods |
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Inventories |
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$ |
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$ |
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Property and equipment, net
The Company’s property and equipment consist of the following:
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Depreciation/ |
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Amortization |
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June 30, 2025 |
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December 31, 2024 |
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Period |
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(amounts, in thousands) |
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||||
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Furniture and fixtures |
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$ |
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$ |
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Equipment and computers |
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Leasehold improvements |
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Less accumulated depreciation and amortization |
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Property and equipment, net |
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$ |
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$ |
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|
|
Depreciation expense for the six months ended June 30, 2025 and 2024 amounted to $
Other assets
Other assets consist of the following:
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June 30, 2025 |
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December 31, 2024 |
||
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(amounts, in thousands) |
||||
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Patent applications pending |
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$ |
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|
$ |
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|
Patents issued |
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Less accumulated amortization of patents issued |
|
|
(
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(
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|
Patents, net |
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Other |
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Other assets |
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$ |
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|
$ |
|
9
Patent amortization expenses amounted to $
Patent amortization expense for the next five years and thereafter is scheduled as follows:
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(amounts, in thousands) |
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Remainder of 2025 |
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$ |
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2026 |
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2027 |
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2028 |
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2029 |
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Thereafter |
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Scheduled amortization of patents issued |
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$ |
|
Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following:
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June 30, 2025 |
|
December 31, 2024 |
||
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(amounts, in thousands) |
||||
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Accrued salaries and commissions |
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$ |
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$ |
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|
Clinical studies |
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Deferred revenue |
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Professional fees |
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Royalties |
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Goods received not invoiced |
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Other |
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|
Accrued expenses and other current liabilities |
|
$ |
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|
$ |
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4. |
COMMON STOCK, STOCK-BASED COMPENSATION AND WARRANTS |
Common Stock
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 $
10
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Series A Right Warrant |
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Series B Right Warrant |
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Common Stock Price as of Issuance Date |
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$ |
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$ |
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Risk-Free Rate |
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% |
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% |
|
Dividend Rate |
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% |
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% |
|
Volatility |
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% |
|
|
% |
|
Minimum Exercise Price |
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$ |
|
|
$ |
|
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Maximum Exercise Price |
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$ |
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|
$ |
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Formula for Exercise Price |
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|||
Proceeds from the closing of the subscription period satisfy a debt covenant which allows for $
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,
Exercise of the Right Warrants require additional investment separate from the purchase of the Units.
On February 24, 2025, approximately
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 $
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:
|
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Three Months Ended June 30, |
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Stock-based compensation expense by category |
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2025 |
|
2024 |
||
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(amounts, in thousands) |
||||
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Cost of goods sold |
|
$ |
|
|
$ |
— |
|
Research and development, net of grant income |
|
|
|
|
|
— |
|
Selling, general and administrative |
|
|
|
|
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|
11
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Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
|
|
Six Months Ended June 30, |
||||
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Stock-based compensation expense by category |
|
2025 |
|
2024 |
||
|
|
|
(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 $
Stock-options
The summary of the stock option activity for the six months ended June 30, 2025, is as follows:
|
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Weighted |
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Weighted |
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Average |
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|
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Average |
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Remaining |
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Exercise Price |
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Contractual |
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Shares |
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per Share |
|
Life (Years) |
|
|
Outstanding, December 31, 2024 |
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$ |
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|
Granted |
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|
|
|
|
|
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Forfeited |
|
(
|
|
|
|
|
|
|
Expired |
|
(
|
|
|
|
|
|
|
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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$ |
|
|
|
Expected volatility |
|
|
|
% |
|
Expected term* |
|
|
|
|
|
Risk-free rate |
|
|
|
% |
|
Dividends |
|
|
|
% |
*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 June 30, 2025 of $
|
Options Outstanding |
||||||||||
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|
|
Number |
|
Weighted |
|
Weighted |
|
Aggregate |
||
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Range of |
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Outstanding at |
|
Average |
|
Average |
|
Intrinsic |
||
|
Exercise |
|
June 30, |
|
Exercise |
|
Remaining |
|
Value |
||
|
Price |
|
2025 |
|
Price |
|
Life (Years) |
|
(in thousands) |
||
|
$
|
|
|
|
$ |
|
|
|
|
$ |
|
12
|
Options Exercisable |
||||||
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Number |
|
Weighted |
|
Aggregate |
||
|
Exercisable at |
|
Average |
|
Intrinsic |
||
|
June 30, |
|
Exercise |
|
Value |
||
|
2025 |
|
Price |
|
(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:
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant Date |
|
|
|
|
Shares |
|
Fair Value |
|
|
|
|
|
|
|
|
|
Non-vested, December 31, 2024 |
|
|
|
$ |
|
|
Granted |
|
|
|
$ |
|
|
Forfeited |
|
(
|
|
$ |
|
|
Vested |
|
(
|
|
$ |
|
|
Non-vested, June 30, 2025 |
|
|
|
$ |
|
As of June 30, 2025, the Company had approximately $
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 only vest upon a Change in Control of the Company, as defined in the Amended and Restated CytoSorbents Corporation 2014 Long-Term Incentive Plan.
The following table is a summary of these restricted stock units:
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|
|
Total |
|
Intrinsic Value |
|
|
|
|
(amounts in thousands, except share data) |
|||
|
Outstanding, December 31, 2024 |
|
|
|
$ |
|
|
Granted |
|
|
|
|
|
|
Vested |
|
(
|
|
|
|
|
Forfeited |
|
(
|
|
|
|
|
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.
13
Other RSU Awards
The following table outlines the restricted stock unit activity for the six months ended June 30, 2025:
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant Date |
|
|
|
|
Shares |
|
Fair Value |
|
|
Non-vested, January 1, 2025 |
|
|
|
$ |
|
|
Granted |
|
|
|
|
|
|
Vested |
|
(
|
|
|
|
|
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
Warrants related to the December 2023 equity offering and June 2024 Loan and Security Agreement
As of June 30, 2025, the Company had
|
5. |
REVENUE AND SEGMENT INFORMATION |
The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended June 30, 2025:
|
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|
Distributors/ |
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|
|
|
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|
|
Direct |
|
Strategic Partners |
|
Total |
|||
|
|
|
(amounts, in thousands) |
|||||||
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
|
|
$ |
— |
|
$ |
|
|
Germany |
|
|
|
|
|
— |
|
|
|
|
All other countries |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended June 30, 2024:
|
|
|
|
|
|
Distributors/ |
|
|
|
|
|
|
|
Direct |
|
Strategic Partners |
|
Total |
|||
|
|
|
(amounts, in thousands) |
|||||||
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
|
|
$ |
|
|
$ |
|
|
Germany |
|
|
|
|
|
— |
|
|
|
|
All other countries |
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
14
The following table disaggregates the Company’s revenue by customer type and geographic area for the six months ended June 30, 2025:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributors/ |
|
|
|
|
|
|
|
Direct |
|
Strategic Partners |
|
Total |
|||
|
|
|
(amounts, in thousands) |
|||||||
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
|
|
$ |
— |
|
$ |
|
|
Germany |
|
|
|
|
|
— |
|
|
|
|
All other countries |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
The following table disaggregates the Company’s revenue by customer type and geographic area for the six months ended June 30, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributors/ |
|
|
|
|
|
|
|
Direct |
|
Strategic Partners |
|
Total |
|||
|
|
|
(amounts, in thousands) |
|||||||
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
|
|
$ |
|
|
$ |
|
|
Germany |
|
|
|
|
|
— |
|
|
|
|
All other countries |
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
15
CytoSorb Sales
The Company sells its CytoSorb device using both its own sales force (direct sales) and through the use of distributors and/or strategic partners. The majority of sales of the device are outside the United States, as CytoSorb is not yet approved for commercial sale in the United States. However, in April 2020, the Company was granted Emergency Use Authorization (“EUA”) of CytoSorb for use in critically-ill patients infected with COVID-19 with imminent or confirmed respiratory failure by the United States Food and Drug Administration (the “FDA”). Direct sales outside the United States relate to sales to hospitals located in Germany, Switzerland, Austria, Poland, the Netherlands and the United Kingdom. Direct sales are fulfilled from the Company’s warehouse facility in Berlin, Germany. There are no formal sales contracts with any direct customers relating to product price or minimum purchase requirements. However, there are agreements in place with certain direct customers that provide for either free of charge product or rebate credits based upon achieving minimum purchase levels. The Company records the value of these items earned as a reduction of revenue. These customers submit purchase orders and the order is fulfilled and shipped directly to the customer. Prices to all direct customers are based on a standard price list based on the packaged quantity (6 packs versus 12 packs).
Distributor and strategic partner sales make up the remaining product sales. These distributors are located in various countries throughout the world. In general, the Company has formal written contracts with each of its distributors and strategic partners. These contracts have terms ranging from
Most distributor’s/strategic partner’s contracts have minimum annual purchase requirements in order to maintain exclusivity in their respective territories.
There is no additional consideration or monetary penalty that would be required to be paid to CytoSorbents if a distributor does not meet the minimum purchase commitments included in the contract; however, at the discretion of the Company, the distributor may lose its exclusive rights in the territory if such commitments are not met.
In summary, the contracts the Company has with customers are the distributor/strategic partner contracts related to CytoSorb product sales, agreements with direct customers related to free-of-charge product and credit rebates based upon achieving minimum purchase levels. The Company does not currently incur any outside third-party incremental costs to obtain any of these contracts.
The following table provides information about receivables and contract liabilities from contracts with customers:
|
|
|
June 30, 2025 |
|
December 31, 2024 |
||
|
|
|
(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 $
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 $
16
Segment Information
The Company operates and manages its business as
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 as
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 |
|
Six Months Ended |
|
||||||||
|
|
|
June 30, |
|
June 30, |
|
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
||||
|
|
|
(amounts, in thousands) |
|
||||||||||
|
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
Gross profit |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
Gross margin |
|
|
|
% |
|
|
% |
|
|
% |
|
|
% |
|
Total operating expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
Loss from operations |
|
$ |
(
|
|
$ |
(
|
|
$ |
(
|
|
$ |
(
|
|
|
EBITDA and Adjusted EBITDA (both non-GAAP measures): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders |
|
$ |
|
|
$ |
(
|
|
$ |
|
|
$ |
(
|
|
|
Interest expense, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (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: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common stockholders |
|
$ |
|
|
$ |
(
|
|
$ |
|
|
$ |
(
|
|
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (gain) on foreign currency transactions |
|
|
(
|
|
|
|
|
|
(
|
|
|
|
|
|
Adjusted net loss, a non-GAAP measure |
|
$ |
(
|
|
$ |
(
|
|
$ |
(
|
|
$ |
(
|
|
|
Total cash used in operating and investing activities |
|
$ |
(
|
|
$ |
(
|
|
$ |
(
|
|
$ |
(
|
|
|
|
|
June 30, 2025 |
|
December 31, 2024 |
||
|
|
|
(amounts, in thousands) |
||||
|
Total assets |
|
$ |
|
|
$ |
|
17
Significant expense categories regularly provided to the CODM consist of the following:
|
|
|
Three Months Ended |
|
Six Months Ended |
||||||||
|
|
|
June 30, |
|
June 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(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 $
|
6. |
LONG-TERM DEBT |
Avenue Capital Group
On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group (“Loan”). Avenue Capital Group agreed to loan the Company up to an aggregate of $
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 $
The loan requires interest-only payments for the first
18
As of the Closing Date, the Company recorded the following discounts:
|
|
|
(amounts, in thousands) |
|
|
Fair value of warrants issued to Avenue Capital Group |
|
$ |
|
|
Debt issuance cost |
|
|
|
|
Commitment fee paid on the Closing Date (
|
|
|
|
|
Total discounts recorded at inception against Avenue Capital Group Long-Term Debt |
|
$ |
|
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 $
Upon a prepayment, the Company would incur a fee ranging from
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 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 $
The Lenders were also granted the right while the Commitment is outstanding to convert up to an aggregate amount of $
The Company’s obligations under the Loan and Security Agreement are joint and several. The obligations under the Loan and Security Agreement are secured by a first priority security interest in favor of the Lenders with respect to the Company’s Shares (as defined in the Loan and Security Agreement) and the Company’s Collateral (as defined in the Loan and Security Agreement), which includes the Company’s intellectual property, pursuant to that certain Intellectual Property Security Agreement, dated as of June 28, 2024, by and between the Company and the Administrative and Collateral Agent.
As of June 30, 2025, long-term debt consists of the following:
|
|
|
(amounts, in thousands) |
|
|
Principal amount |
|
$ |
|
|
Plus: final payment upon maturity |
|
|
|
|
Less unamortized debt discount |
|
|
(
|
|
Subtotal |
|
|
|
|
Less current maturities |
|
|
— |
|
Long-term debt |
|
$ |
|
As of June 30, 2025, principal payments of long-term debt are due as follows:
|
|
|
(amounts, in thousands) |
|
|
2026 |
|
$ |
|
|
2027 |
|
|
|
|
Total |
|
$ |
|
19
Bridge Bank
On June 28, 2024, concurrent with the closing of the Avenue Capital Group financing discussed above, the Company paid off its previously outstanding debt with Bridge Bank.
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
Pursuant to the 2022 Success Fee Letter, the Borrower will pay to the Bank a success fee equal to (i)
|
7. |
COMMITMENTS AND CONTINGENCIES |
Litigation
The Company is, from time to time, subject to claims and litigation arising in the ordinary course of business. The Company intends to defend vigorously against any future claims and litigation.
Royalty Agreements
The Company is party to various royalty and license agreements that require the payment of royalty fees. Royalty expense amounted to approximately $
401(k) Plan
Employees are eligible to participate in the Company’s 401(k) plan on the first day of the calendar quarter following
full months of employment. Participants may defer up to
20
|
8. |
LEASES |
The Company has operating leases that primarily relate to operating facilities in both the United States and Germany. The Company leases its operating facilities under operating lease arrangements with varying expiration dates through March 2037. As of June 30, 2025, the remaining lease term of the Company’s operating leases ranges from
to
Supplemental statement of operations and cash flows related to the operating lease liability is as follows (excluding variable payments and expenses):
|
|
|
June 30, |
||||
|
|
|
2025 |
|
2024 |
||
|
|
|
(amounts, in thousands) |
||||
|
Cash paid in connection with the operating leases |
|
$ |
|
|
$ |
|
Supplemental balance sheet information related to operating leases is as follows:
|
|
|
June 30, |
|
December 31, |
|
||
|
|
|
2025 |
|
2024 |
|
||
|
|
|
(amounts, in thousands) |
|
||||
|
Right-of-use asset |
|
$ |
|
|
$ |
|
|
|
Lease liability - current portion |
|
$ |
|
|
$ |
|
|
|
Lease liability - net of current portion |
|
|
|
|
|
|
|
|
Total lease liability |
|
$ |
|
|
$ |
|
|
|
Weighted average discount rate |
|
|
|
% |
|
|
% |
|
Weighted average remaining lease term |
|
|
|
|
|
|
|
Lease Expense
The components of lease expense were as follows:
|
|
|
Three Months Ended June 30, |
||||
|
|
|
2025 |
|
2024 |
||
|
|
|
(amounts, in thousands) |
||||
|
Operating lease cost |
|
$ |
|
|
$ |
|
|
Variable lease cost |
|
$ |
|
|
$ |
|
|
Total lease cost |
|
$ |
|
|
$ |
|
|
|
|
Six Months Ended June 30, |
||||
|
|
|
2025 |
|
2024 |
||
|
|
|
(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 |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Thereafter |
|
|
|
|
Future operating lease payments |
|
|
|
|
Imputed interest |
|
|
(
|
|
Total operating lease liability |
|
$ |
|
21
|
9. |
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 |
||||||||
|
|
|
June 30, |
|
June 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(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. |
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.
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.
22
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary Notes Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q, or this Report, contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. Forward-looking statements discuss matters that are not historical facts. Because they discuss future events or conditions, forward-looking statements may include words such as “anticipate,” “believe,” “estimate,” “intend,” “could,” “should,” “would,” “may,” “seek,” “plan,” “might,” “will,” “expect,” “predict,” “project,” “forecast,” “potential,” “continue,” negatives thereof or similar expressions. These forward-looking statements are found at various places throughout this Report and include information concerning possible or assumed future results of our operations; business strategies; future cash flows; financing plans; plans and objectives of management; any other statements regarding future operations, future cash needs, business plans and future financial results, and any other statements that are not historical facts. Unless otherwise indicated, the terms “CytoSorbents,” “Company,” “we,” “us” and “our” refer to CytoSorbents Corporation.
From time to time, forward-looking statements also are included in our other periodic reports on Forms 10-K and 8-K, in our press releases, in our presentations, on our website and in other materials released to the public. Any or all of the forward-looking statements included in this Report and in any other reports or public statements made by us are not guarantees of future performance and may turn out to be inaccurate. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors. Many of those factors are outside of our control and could cause actual results to differ materially from the results expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of the applicable Report or public statement. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report or public statement and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report.
Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise. For discussion of factors that we believe could cause our actual results to differ materially from expected and historical results see “Item 1A - Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Overview
We are a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents’ proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents’ technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses include, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.
CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide, with nearly 300,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA EUA in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved in the United States.
23
In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company submitted a De Novo Request to the FDA in September 2024, requesting marketing authorization of DrugSorb-ATR to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company’s De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process. In July, the Company participated in an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR 10.75. The appeal hearing included FDA senior leadership, Company management and our external surgical experts. The Company continues to believe that remaining deficiencies in its DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025.
On November 1, 2024 we received Medical Device Single Audit Program (MDSAP) certification, a key regulatory milestone that certifies compliance of our quality management system with the standard regulatory requirements of Canada, the United States, Brazil, Japan and Australia; and then promptly submitted our Medical Device License (MDL) marketing application to Health Canada on November 1, 2024, with MDSAP certification - a requirement for the submission. On June 26, 2025, Health Canada issued a Notice of Refusal of the Company’s Medical Device License application, identifying remaining deficiencies that must be addressed before the application can be granted and the device is authorized for commercialization. As part of Health Canada’s prescribed reconsideration process, and following discussions with Health Cananda, the Company has filed a Level 1 “Request for Reconsideration” and with agreement from the Medical Devices Directorate Bureau Director will pursue the review following conclusion of the Company’s review with the FDA. If marketing authorization is not received as part of the reconsideration process, the Company can then file a formal Appeal with the Director General of the Medical Devices Directorate. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.
Upon approval, the Company expects to rapidly commercialize DrugSorb-ATR in the U.S. and Canada to address this large unmet medical need, with an initial estimated total addressable market of $300 million today to over $1 billion over time as we pursue additional indications for DrugSorb-ATR to remove additional classes of blood thinners and expansion of the antithrombotic removal application beyond cardiac surgery and across other surgical specialties. We believe that DrugSorb-ATR has the potential to become an “all-in-one” countermeasure for these agents.
Our executive offices are located at 305 College Road East, Princeton, New Jersey 08540, and our telephone number is (732) 329-8885. Our website address is http://www.cytosorbents.com. We have included our website address as an inactive textual reference only. We make available free of charge through our website our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material, or furnish it to the SEC. We also similarly make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10% stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons. We are not including the information contained at http://www.cytosorbents.com, or at any other website address, as part of, or incorporating it by reference into, this Quarterly Report on Form 10-Q.
Summary of Operational and Recent Business Highlights
| ● | Total revenue was $18.3 million for the six months ended June 30, 2025, an increase of $0.5 million, or 2.9%, compared to the prior year. |
| ● | Gross profit was $13.0 million for the six months ended June 30, 2025, a decrease of $0.4 million, or 2.7%, compared to the prior year. Gross margin was 71% for the six months ended June 30, 2025, compared to 75% in the prior year. |
| ● | Our loss from operations improved by 8.8% to approximately $7.5 million, from $8.2 million for the six months ended June 30, 2025, and 2024, respectively. This improvement was driven by a 5.0% reduction in total operating expense year over year. |
24
| ● | We strengthened our balance sheet with the completion of a shareholder Rights Offering in January 2025 that provided $5.4 million net proceeds, and then added another $1.4 million, net proceeds with the exercise of the Series A Right Warrant in February 2025. |
| ● | In April 2025, we further supplemented our cash balance with the receipt of $1.7 million from the sale of our 2023 and amended 2022 Net Operating Loss (NOL) and R&D tax credits from the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority (NJEDA). |
| ● | Appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy and execution of DrugSorb-ATR in the U.S. and Canada; and appointed Melanie Grossman, CPA as Vice President and Corporate Controller. |
| ● | On May 22, 2025, a new contemporary real-world data analysis was presented at EuroPCR, highlighting the intraoperative use of the Company’s technology to significantly reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not completed the recommended drug washout period. (R.F. Storey, et al. Early CABG with intraoperative hemadsorption in patients on ticagrelor; Cardiovascular Revascularization Medicine.) The information in this data analysis are referenced for general information only and are not incorporated by reference into this Report. |
| ● | On July 31, 2025 the Company highlighted data demonstrating the vital and evolving role of CytoSorb therapy in the treatment of sepsis and septic shock–among the deadliest challenges in critical care medicine. Recent data demonstrate early and intensive use of CytoSorb therapy improves clinical outcomes for patients suffering from these conditions. The Company will present a World Sepsis Day Global Webinar on September 10, 2025 in commermoration of Sepsis Awareness Month and World Sepsis Day. See our Current Report on Form 8-K, filed with the SEC on August 1, 2025, for additional information. |
Results of Operations:
Comparison for the three months ended June 30, 2025 and 2024:
|
|
|
Three Months Ended June 30, |
|
||||||||
|
|
|
2025 |
|
2024 |
|
||||||
|
|
|
|
|
% of |
|
|
|
% of |
|
||
|
|
|
Amount |
|
Revenue |
|
Amount |
|
Revenue |
|
||
|
|
|
(in thousands) |
|
|
|
(in thousands) |
|
|
|
||
|
Revenue |
|
$ |
9,617 |
|
100 |
% |
$ |
8,842 |
|
100 |
% |
|
Cost of goods sold |
|
|
2,803 |
|
29.1 |
|
|
2,339 |
|
26.5 |
|
|
Gross profit |
|
|
6,814 |
|
70.9 |
|
|
6,503 |
|
73.5 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,262 |
|
13.1 |
|
|
1,519 |
|
17.2 |
|
|
Selling, general and administrative |
|
|
9,167 |
|
95.3 |
|
|
8,554 |
|
96.7 |
|
|
Total operating expenses |
|
|
10,429 |
|
108.4 |
|
|
10,073 |
|
113.9 |
|
|
Loss from operations |
|
|
(3,615) |
|
(37.6) |
|
|
(3,570) |
|
(40.4) |
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(616) |
|
(6.4) |
|
|
(180) |
|
(2.0) |
|
|
Gain (loss) on foreign currency transactions |
|
|
6,178 |
|
64.2 |
|
|
(544) |
|
(6.2) |
|
|
Total other income (expense), net |
|
|
5,562 |
|
57.8 |
|
|
(724) |
|
(8.2) |
|
|
Income (Loss) before benefit from income taxes |
|
$ |
1,947 |
|
20.2 |
% |
$ |
(4,294) |
|
(48.6) |
% |
25
Revenues
For the three months ended June 30, 2025, we generated total revenue of approximately $9.6 million, an increase of approximately $0.8 million, or 8.8%, as compared to revenues of approximately $8.8 million for the three months ended June 30, 2024. Revenue growth was led by strength in our direct German and International territories compared to lower performance in the second quarter of 2024 and the first quarter of 2025. The Company began a proactive reorganization and strategic realignment of our German commercial team and sales approach in the first quarter of 2025. We are making steady progress with this important initiative and are pleased with this initial improvement in our second quarter of 2025, and remain confident it will lead to stronger execution and improved performance in Germany and our financial results overall this year.
Gross Profit
Gross profit was approximately $6.8 million for the three months ended June 30, 2025, an increase of approximately $0.3 million, or 4.8%, as compared to gross profit of $6.5 million for the three months ended June 30, 2024. Gross margins were 70.9% and 73.5% for the three months ended June 30, 2025 and 2024, respectively. The decrease in gross margin was primarily due to the write - off of inventory of $0.1 million which had a negative impact on gross margin of 1.5%.
Research and Development Expenses
Our research and development costs were approximately $1.3 million and $1.5 million for the three months ended June 30, 2025 and 2024, respectively, a decrease of approximately $0.3 million, or 16.9%. This decrease was driven by a decrease in our clinical trial costs due to the completion of the STAR-T clinical trial, and other payroll and project-related cost reductions.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses were approximately $9.2 million and $8.6 million for the three months ended June 30, 2025 and 2024, respectively, an increase of approximately $0.6 million, or 7.2%. This increase was mainly due to higher legal, financial and consulting costs of $0.5 million and net other compensation expenses of $0.1 million, partially offset by lower royalty expenses of and $0.2 million. The decrease in royalty expense was the result of the expiration of a 4% royalty in August of 2024.
Gain (Loss) on Foreign Currency Transactions
For the three months ended June 30, 2025, the gain on foreign currency transactions was approximately $6.2 million, as compared to a loss on foreign currency transactions of approximately $0.5 million for the three months ended June 30, 2024. The gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2025 to $1.17 per Euro from $1.08 at March 31, 2025. The prior year loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2024, to $1.07 per Euro from $1.08 per Euro at March 31, 2024.
Loss From Operations
Our loss from operations was flat at approximately $3.6 million for each of the three months ended June 30, 2025 and 2024.
26
Comparison for the six months ended June 30, 2025 and 2024:
|
|
|
Six Months Ended June 30, |
|
||||||||
|
|
|
2025 |
|
|
2024 |
|
|||||
|
|
|
|
|
|
% of |
|
|
|
|
% of |
|
|
|
|
Amount |
|
Revenue |
|
Amount |
|
Revenue |
|
||
|
|
|
(in thousands) |
|
|
|
(in thousands) |
|
|
|
||
|
Revenue |
|
$ |
18,344 |
|
100 |
% |
$ |
17,831 |
|
100 |
% |
|
Cost of goods sold |
|
|
5,323 |
|
29.0 |
|
|
4,455 |
|
25.0 |
|
|
Gross profit |
|
|
13,021 |
|
71.0 |
|
|
13,376 |
|
75.0 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,924 |
|
15.9 |
|
|
3,766 |
|
21.1 |
|
|
Selling, general and administrative |
|
|
17,599 |
|
95.9 |
|
|
17,837 |
|
100.0 |
|
|
Total operating expenses |
|
|
20.523 |
|
111.9 |
|
|
21,603 |
|
121.2 |
|
|
Loss from operations |
|
|
(7,502) |
|
(40.9) |
|
|
(8,227) |
|
(46.1) |
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(1.221) |
|
(6.7) |
|
|
(187) |
|
(1.0) |
|
|
Gain (loss) on foreign currency transactions |
|
|
9,192 |
|
50.1 |
|
|
(1,970) |
|
(11.0) |
|
|
Total other income (expense), net |
|
|
7,971 |
|
43.5 |
|
|
(2,157) |
|
(12.1) |
|
|
Income (loss) before benefit from income taxes |
|
$ |
469 |
|
2.6 |
% |
$ |
(10,384) |
|
(58.2) |
% |
Revenues
For the six months ended June 30, 2025, we generated total revenue of approximately $18.3 million, an increase of approximately $0.5 million, or 2.9%, and 1.8% on a constant currency basis, as compared to revenues of approximately $17.8 million for the six months ended June 30, 2024. Revenue growth was led by strength in our direct German and International territories compared to lower performance in the second quarter of 2024 and the first quarter of 2025. The Company began a proactive reorganization and strategic realignment of our German commercial team and sales approach in the first quarter of 2025. We are making steady progress with this important initiative, and are pleased with this initial improvement in our second quarter of 2025, and remain confident it will lead to stronger execution and improved performance in Germany and our financial results overall this year.
Gross Profit
Gross profit was approximately $13.0 million for the six months ended June 30, 2025, a decrease of approximately $0.4 million, or 2.7%, as compared to gross profit of $13.4 million for the six months ended June 30, 2024. Gross margins were 71.0% and 75.0% for the six months ended June 30, 2025 and 2024, respectively. The decrease in gross margin was primarily due to a 8.9% reduction in the number of units produced, and the write-off of inventory of $0.3 million which had a negative impact on gross margin of 1.4%.
Research and Development Expenses
Our research and development costs were approximately $2.9 million and $3.8 million for the six months ended June 30, 2025 and 2024, respectively, a decrease of approximately $0.8 million, or 22.4%. This decrease was driven by a decrease in our clinical trial costs due to the completion of the STAR-T clinical trial, and other payroll and project-related cost reductions.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses were approximately $17.6 million and $17.8 million for the six months ended June 30, 2025 and 2024, respectively, a decrease of approximately $0.2 million, or 1.3%. This decrease was mainly due to decreases in stock-based compensation and royalty expenses of $0.9 million and $0.7 million, respectively, which was partially offset by increases in legal, financial and consulting costs of $0.5 million, and net other compensation expenses of approximately $0.6 million. The decrease in royalty expense was the result of the expiration of a 4% royalty in August of 2024.
27
Gain (Loss) on Foreign Currency Transactions
For the six months ended June 30, 2025, the gain on foreign currency transactions was approximately $9.2 million, as compared to a loss on foreign currency transactions of approximately $2.0 million for the six months ended June 30, 2024. The gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2025 to $1.17 per Euro from $1.03 per Euro at December 31, 2024. The prior year loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2024, to $1.07 per Euro from $1.11 per Euro at December 31, 2023.
Loss From Operations
Our loss from operations decreased by 9.4% to approximately $7.5 million, from $8.2 million for the six months ended June 30, 2025, and 2024, respectively. This improvement was primarily the result of a 5.0% reduction in operating expenses year over year, partially offset by the decrease in gross profit.
Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of June 30, 2025, we had current assets of approximately $23.0 million and current liabilities of approximately $9.8 million.
We have an effective shelf registration statement dated September 30, 2024 with the SEC which enables us to raise up to $150 million in one or more offerings, through the issuance and sale of any combination of equity securities, debt securities, warrants and units. Approximately $149.7 million of this amount was available as of June 30, 2025. We have also allocated $20 million of our total shelf amount to our ATM facility. At June 30, 2025, approximately $19.4 million was available for use under the ATM facility.
On January 10, 2025, the Company closed the subscription period of its previously announced rights offering (the “Rights Offering”), raising aggregate gross proceeds of $6.25 million ($5.4 million net of fees) from the sale of all 6.25 million Units reserved for the Rights Offering. Participants in the Rights Offering received Units, each Unit comprising of one share of common stock of the Company, one Series A Right Warrant to purchase one share of common stock with an expiration date of February 24, 2025, and one Series B Right Warrant to purchase one share of common stock with an expiration date of April 10, 2025. Up to an additional 6.25 million shares of common stock may be issued upon exercise of the Right Warrants. Proceeds from the closing of the subscription period satisfy a debt covenant which allowed for $5 million of restricted cash on the Company’s consolidated balance sheets to now become unrestricted, and available for use. On February 24, 2025, approximately 1.4 million Series A Right Warrants were exercised by holders, including members of management and the Board of Directors, at an exercise price of $1.13 per warrant, providing an additional $1.6 million in aggregate gross proceeds ($1.4 million net of fees). On April 4, 2025, the Board of Directors extended the expiration date of the Series B Right Warrants from April 10, 2025 to June 10, 2025. On June 11, 2025, the 5-day volume weighted average price of Common Stock over the last five-trading days prior to June 10, 2025 was lower than the minimum required price of $2.00 and, as a result, the Series B Right Warrants issued in connection with the previously announced Rights Offering expired worthless pursuant to their terms.
28
We are also proactively managing our resources with a focus on driving commercial success, investing in key areas such as our regulatory submissions of DrugSorb-ATR to the FDA and Health Canada and the development of clinical data. We have also instituted and continue to maintain tight control over expenditures and have lowered our spending over the past year.
As of June 30, 2025, we had approximately $11.7 million in cash, including approximately $10.2 million in unrestricted cash and cash equivalents and $1.5 million of non-current restricted cash, which raises substantial doubt about the Company’s ability to continue as a going concern.
Our expected future capital requirements may depend on many factors, including expanding our customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb-ATR in the U.S. and Canada which decisions are expected in 2025, our ability to successfully appeal the denial letter received from the FDA, relating to our De Novo Request for DrugSorb-ATR, and the related opportunity to receive Tranche 2 of Avenue Capital Commitment by December 31, 2025 and achieve the Interest-Only Milestone of the Avenue Capital Commitment and extend the interest-only period by six months to January 1, 2027. Additional sources of liquidity available to us include the 2024 Shelf, other public or private equity offerings, debt financing or from other sources. The sale of additional equity may result in dilution to our shareholders. There is no assurance that we will be able to secure funding on terms acceptable to us, or at all. The increasing need for capital could also make it more difficult to obtain funding through either equity or debt. Should additional capital not become available to us as needed, we may be required to take certain actions, such as slowing sales and marketing expansion, delaying further regulatory approvals, or reducing headcount. As a result of these additional uncertainties, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates other financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors.
Loan and Security Agreement
On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group. Avenue Capital Group agreed to loan the Company up to an aggregate of $20 million, to be disbursed in two tranches: (1) one tranche of $15 million (“Tranche 1”), of which $10 million is available to the Company on the Closing Date and $5 million which remained classified as restricted cash through January 10, 2025, when it was released from its restriction as the following conditions were met: (i) the FDA has accepted Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company has received a minimum of $3 million in net proceeds from the sale of its equity securities after the Closing Date. A second tranche of up to $5 million, may be disbursed at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company receives FDA marketing approval of its DrugSorb-ATR application (“Tranche 2” and together with Tranche 1, the “Avenue Capital Commitment”). All unpaid principal and accrued and unpaid interest shall be due and payable in full by the maturity date. If the 2nd tranche is fully funded by December 2025, and the Company achieves the Interest-Only Milestone of the Avenue Capital Commitment, the maturity date is January 1, 2028; otherwise, the maturity date is July 1, 2027. Commencing on August 1, 2024, the Company makes monthly interest only payments during the initial 25-month period following the Closing Date, followed by equal monthly installments through the maturity date consisting of principal plus accrued and unpaid interest, unless otherwise extended by six months upon achievement of the Interest-Only Milestone.
On October 22, 2024, the Company announced that the FDA had accepted its application of DrugSorb-ATR, which was one of the two conditions required by the restricted cash debt covenant. Proceeds from the Rights Offering on January 10, 2025 satisfied the second condition of the debt covenant which now allows for the $5.0 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use.
On April 25, 2025, the FDA issued a denial letter regarding the Company’s De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process. In July, the Company participated in an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR 10.75. The appeal hearing included FDA senior leadership, Company management and our external surgical experts. The Company continues to believe that remaining deficiencies in its DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025.
29
The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and will additionally be used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment shall bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent (5.00%) or (B) thirteen and one-half percent (13.50)%.
For further discussion regarding the Loan Agreement please see Long Term Debt note to our Condensed Consolidated Financial Statements, included elsewhere in this Quarterly Report on Form 10-Q.
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. On an ongoing basis, we evaluate our estimates and assumptions based on historical experience and on various other assumptions that we believe are reasonable under the circumstances. Our actual results could differ from these estimates under different assumptions or conditions. Refer to “Critical Accounting Estimates” contained in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024 for a complete discussion of our critical accounting estimates. There have been no material changes to our critical accounting estimates since our Annual Report on Form 10-K for the year ended December 31, 2024.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, as of the end of the period covered by this report, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Act of 1934. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be included in our SEC reports is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, relating to the Company, including our consolidated subsidiaries, and was made known to them by others within those entities, particularly during the period when this report was being prepared. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of June 30, 2025 because of the material weakness identified in our internal controls over financial reporting, which is being actively remediated (see below).
Management’s Report on Internal Control over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control over financial reporting is a process designed under the supervision of the Company’s principal executive officer and principal financial officer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the Company’s financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurances with respect to financial statement preparation and presentation. Additionally, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Discussion of Material Weakness
A material weakness (as defined in Rule 12b-2 under the Exchange Act) is a deficiency, or combination of deficiencies, in our internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements would not be prevented or detected on a timely basis.
30
In connection with our preparation and the audit of our consolidated financial statements as of and for the year ended December 31, 2024, we identified a material weakness in our internal control over financial reporting related to the accounting for non-cash stock-based compensation corresponding to grants of Restricted Stock Units. Specifically, our controls were not effectively designed or operating to ensure that restricted stock unit grants or vesting activities were recorded within the proper accounts and at the proper amounts.
Remediation Activities
We are actively engaged in remediating the identified material weakness. Management has begun implementing measures to strengthen our internal control over financial reporting, including redesigning internal control procedures and enhancing documentation processes related to the accounting for restricted stock unit grant and vesting events. These efforts are intended to ensure accurate and timely reporting in accordance with U.S. GAAP for both interim and annual periods. Key steps in our remediation plan include:
| - | Developing and implementing more robust control procedures to validate that the inputs and assumptions used in stock-based compensation expense calculation models are accurate and reflect proper application of generally accepted accounting principles. |
| - | Increasing oversight and review by executive management to ensure the completeness and accuracy of restricted stock unit expense calculations and their corresponding journal entries. |
We are committed to completing the remediation of this material weakness as expeditiously as possible and expect these enhancements to be fully implemented during the fiscal year ending December 31, 2025. However, the material weakness will not be considered fully remediated until the new controls have been operational for a sufficient period of time and tested to demonstrate their effectiveness.
Notwithstanding the material weaknesses, management concluded that the consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q presented fairly, in all material respects, our financial position, results of operations and cash flows in conformity with GAAP.
Change in Internal Control over Financial Reporting
Except as discussed above, there have been no changes in the Company’s internal controls over financial reporting during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
31
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation or other legal proceedings arising in the ordinary course of business. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
There have been no material changes to our critical accounting estimates since our Annual Report on Form 10-K for the year ended December 31, 2024. For a discussion of risks that affect the Company’s business, please refer to Part I, Item IA, “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In addition to the other information set forth in this Quarterly Report on Form 10-Q, please carefully consider the factors described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. The risks described are not the only risks facing us. Additional risks and uncertainties are not currently known to us, or that our management currently deems to be immaterial, also may adversely affect our business, financial condition, and/or operating results.
The following represent modification to risk factors that could materially harm our business, financial position, or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this report.
We may not be successful in obtaining the FDA’s or Health Canada’s authorization and successful commercialization for DrugSorb-ATR in the U.S. or Canada, respectively
On April 25, 2025, the FDA issued a denial letter regarding the Company’s De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process. In July, the Company participated in an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR 10.75. The appeal hearing included FDA senior leadership, Company management and our external surgical experts. The Company continues to believe that remaining deficiencies in its DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025.
On June 26, 2025, Health Canada issued a Notice of Refusal of the Company’s Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization. As part of Health Canada’s prescribed reconsideration process, and following discussions with Health Cananda, the Company has filed a Level 1 “Request for Reconsideration” and with agreement from the Medical Devices Directorate Bureau Director will pursue the review following conclusion of the Company’s review with the FDA. If marketing authorization is not received as part of the reconsideration process, the Company can then file a formal Appeal with the Director General of the Medical Devices Directorate.
We may be unsuccessful in our appeal which may significantly impact our ability to generate any significant revenues or ever achieve and maintain a substantial level of sales of our product candidates in the U.S. and Canada.
Acceptance of our medical devices in the marketplace is uncertain, and failure to achieve market acceptance will prevent or delay our ability to generate revenues.
Our future financial performance will depend, at least in part, upon the introduction, and customer and healthcare community acceptance of our products. Even with current or future regulatory or marketing approvals for our CytoSorb, ECOS-300CY, and PuriFi pump devices, other products like VetResQ, and product candidates such as DrugSorb-ATR, these products may not achieve market acceptance in the countries where they are sold. There is no guarantee that we will be able to achieve additional regulatory approvals, and even if we do, our products may not achieve market acceptance in the countries covered by such approvals. The degree of market acceptance will depend upon a number of factors, including:
| ● | the receipt of regulatory clearance of marketing claims for the uses that we are developing |
32
| ● | the establishment, demonstration, and acceptance of the advantages, safety and efficacy of our polymer technology and products as evidenced by product adoption, sales, reimbursement, inclusion in treatment guidelines, etc; |
| ● | pricing and reimbursement policies of government and third-party payers such as insurance companies, health maintenance organizations and other health plan administrators; |
| ● | the development by our competitors of products or product candidates that are similar or identical to ours; |
| ● | our ability to attract corporate partners, including medical device companies, to assist in commercializing our products; and |
| ● | our ability to effectively market our products |
Physicians, patients, payers or the medical community in general may be unwilling to accept, utilize or recommend any of our products. For example, the approval of our CytoSorb device as a cytokine adsorber as well as the data we have gathered in our clinical studies to support device usage in this indication may not be sufficient for market acceptance in the medical community. We may also need to conduct additional clinical studies to gather additional data for marketing purposes. If we are unable to obtain regulatory approval or commercialize and market our products when planned, we may not achieve any market acceptance or generate revenue.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Insider Trading Arrangements
On
Other than the individual disclosed above, none of our directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408.
33
Item 6. Exhibits.
|
Number |
|
Description |
|
31.1 |
||
|
31.2 |
||
|
32.1 |
||
|
32.2 |
||
|
101 |
The following materials from CytoSorbents Corporation’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024, (ii) Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024, (iii) Consolidated Statement of Changes in Stockholders’ Equity for the three and six months ended June 30, 2025 and 2024, (iv) Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024 and (v) Notes to Condensed Consolidated Financial Statements. |
|
|
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* In accordance with SEC Release 33-8238, Exhibits 32.1 and 32.2 are being furnished and not filed.
34
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
CYTOSORBENTS CORPORATION |
|
|
|
|
|
|
Dated: August 7, 2025 |
By: |
/s/ Phillip P. Chan |
|
|
|
Name: Phillip P. Chan |
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Title: Chief Executive Officer |
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(Principal Executive Officer) |
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Dated: August 7, 2025 |
By: |
/s/ Peter J. Mariani |
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Name: Peter J. Mariani |
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Title: Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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