0000929638-25-002927.txt : 20250807 0000929638-25-002927.hdr.sgml : 20250807 20250807162245 ACCESSION NUMBER: 0000929638-25-002927 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20250807 ITEM INFORMATION: Completion of Acquisition or Disposition of Assets ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250807 DATE AS OF CHANGE: 20250807 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cytosorbents Corp CENTRAL INDEX KEY: 0001175151 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services EIN: 980373793 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36792 FILM NUMBER: 251194439 BUSINESS ADDRESS: STREET 1: 305 COLLEGE ROAD EAST CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: 973-329-8885 MAIL ADDRESS: STREET 1: 305 COLLEGE ROAD EAST CITY: PRINCETON STATE: NJ ZIP: 08540 FORMER COMPANY: FORMER CONFORMED NAME: MedaSorb Technologies CORP DATE OF NAME CHANGE: 20060807 FORMER COMPANY: FORMER CONFORMED NAME: GILDER ENTERPRISES INC DATE OF NAME CHANGE: 20020611 8-K 1 a8k.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

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

Date of Report (Date of earliest event reported): August 7, 2025

Cytosorbents Corp
(Exact name of registrant as specified in its charter)

Delaware
 
001-36792
 
98-0373793
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

305 COLLEGE ROAD EAST
PRINCETON, New Jersey
 
08540
(Address of principal executive offices)
 
(Zip code)

Registrant's telephone number, including area code (973) 329-8885

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value
 
NASDAQ

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter):

Emerging growth company

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


 
Item 2.02
Results of Operation and Financial Condition
 
On August 7, 2025, CytoSorbents Corporation issued a press release announcing its financial results for the quarter ended June 30, 2025. A copy of the press release is furnished herewith as Exhibit 99.1.*
 
Item 9.01
Exhibits
 
(d) Exhibits
 
Exhibit
No.
Description
104
Cover Page Interactive Data File (embedded with the Inline XBRL document)
 
* The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
 
 

 
 
 
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 hereunto duly authorized.
 
Dated: August 7, 2025
CYTOSORBENTS CORPORATION
 
 
 
 
By:
/s/ Dr. Phillip P. Chan
 
Name:
Dr. Phillip P. Chan
 
Title:
Chief Executive Officer
 
EX-99 2 exhbit99-1.htm




CytoSorbents Reports Second Quarter 2025 Financial Results and Provides Business Update

PRINCETON, N.J., August 7, 2025 — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today reported financial results for the second quarter ended June 30, 2025, and recent business highlights.

Second Quarter 2025 Financial Results


Revenue was $9.6 million, an increase of 9%, or 4% on a constant currency basis, compared to $8.8 million in Q2 2024, driven by 22% year-over-year and sequential sales growth in Germany.

Gross margin was 70.9% compared to 73.5% in Q2 2024.

Operating loss was $3.6 million, flat compared to Q2 2024.

Net income was $1.9 million or $0.03 per basic and diluted share, compared to a net loss of $4.3 million or $0.08 per basic and diluted share in Q2 2024.

Adjusted net loss was $3.7 million or $0.06 per basic and $0.05 per diluted share, compared to an adjusted net loss of $2.8 million, or $0.05 per basic and diluted share in Q2 2024.

Adjusted EBITDA loss was $2.6 million compared to a loss of $2.2 million in Q2 2024.

Total cash, cash equivalents, and restricted cash of $11.7 million at June 30, 2025, compared to $13.1 million as of March 31, 2025, which includes $1.7 million of proceeds received from the sale of its 2023 and amended 2022 Net Operating Loss and R&D tax credits from the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority (NJEDA).

“Our performance in the second quarter was led by strong 22% year-over-year and sequential sales growth in Germany and continued strength in our other direct sales territories.  Distributor sales were among our best ever, second only to a record quarter for distributor sales in the prior year,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “We initiated a proactive reorganization of our German commercial team and sales approach in the first quarter following two years of flat growth in this important market which caused a temporary sales disruption in the first quarter.  With the second quarter behind us, we are pleased with our initial progress of our Germany reorganization and remain confident it will lead to stronger execution, improved


performance, and more robust sales growth in our overall business this year and beyond.  Meanwhile, we are focused on driving growth in our key, high impact clinical applications, improving our gross margins, controlling costs and driving efficiencies to manage our core business to near breakeven as we exit 2025.”

DrugSorb™-ATR Updates


In July, the Company conducted an in-person appeal hearing with the U.S. FDA for supervisory review (administrative appeal) under 21 CFR 10.75 for its De Novo Request for DrugSorb™-ATR.  The appeal hearing included FDA senior leadership and review team, Company management, our FDA regulatory counsel, and our external cardiac surgery 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.

The Company continues to work with Health Canada after receipt of their Notice of Refusal in June.  As part of Health Canada’s prescribed reconsideration process, and after discussions with Health Canada, 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 the completion of the Company’s review with the U.S. FDA.

In May 2025, Prof. Matthias Thielmann, STAR Registry investigator, received the “Best Oral Presentation Award” at the 73rd International Congress of the European Society for Cardiovascular and Endovascular Surgery for his presentation entitled, “Early CABG with Intraoperative Hemoadsorption in Patients on Ticagrelor: Real World Data from the International Safe and Timely Antithrombotic Removal (STAR) Registry” - underscoring the importance of our technology and these findings in the international community.

In May 2025, a new comparative real-world data analysis was presented at EuroPCR, highlighting the intraoperative use of our technology to significantly and safely 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, reinforcing the clinical value of our therapy.

“Following our recent meeting with the FDA, we remain committed to working collaboratively with the agency to secure marketing authorization for DrugSorb-ATR, an FDA Breakthrough Designated Device,” said Dr. Chan.  “Meanwhile adoption of our blood thinner removal application continues to grow with an increasing number of heart centers around the world incorporating our technology as part of their standard care to reduce bleeding complications in patients on blood thinners undergoing cardiac surgery.  We remain confident in the strength of


our DrugSorb-ATR market authorization requests with both FDA and Health Canada and believe that the remaining issues can be expeditiously and successfully addressed.”

Turning the Tide in Sepsis and Septic Shock with CytoSorb

Dr. Chan stated, “On September 10, 2025, we invite you to participate in our World Sepsis Day Global Webinar that is intended to spotlight the vital and evolving role of CytoSorb® in the treatment of sepsis and septic shock – among the deadliest challenges in critical care medicine today – and a major global growth opportunity for us.  This special presentation, which will feature physician-user guests discussing CytoSorb therapy best practices and its impact in the fight against sepsis, along with our recent press release on the topic, commemorates Sepsis Awareness Month and World Sepsis Day in September.”

Turning the Tide in Sepsis and Septic Shock:  Real World Insights with CytoSorb
Date:  Wednesday, September 10, 2025
Time:  11:00 AM EDT
Webinar registration required:   https://cyto.news/webinar-sepsis/sep10

“CytoSorbents has worked closely with clinicians and scientists for more than a decade to advance the treatment of sepsis and septic shock by complementing traditional antibiotics with the broad-spectrum, blood purification capability of CytoSorb®.  While antibiotics fight the infection, CytoSorb broadly targets the other key drivers of septic shock, including severe inflammation driven by cytokine storm and bacterial toxins, circulatory collapse, capillary leak, fluid overload, and organ failure.  We believe this dual approach, when combined with standard of care therapy, represents a paradigm shift in how to treat septic shock - emphasizing early, intensive, and sufficiently long CytoSorb treatment, much like the principles guiding effective antibiotic therapy.”

“This philosophy of treating the “Right Patient at the Right Time with the Right Dose” was highlighted in recent published, peer-reviewed septic shock studies, including:


The first CytoSorb septic shock meta-analysis from Steindl et al., from the well-respected Charité Berlin Hospital in Germany, showing a statistically significant reduction of mortality with CytoSorb, in the Journal of Clinical Medicine (2025)

A large retrospective 175 patient septic shock study from Berlot and team emphasizing high survival with early and intensive CytoSorb treatment, in the Journal of Intensive Care Medicine (2025), and



The positive clinical outcomes from the first 150 patients (58% had septic shock) enrolled in the international, prospective COSMOS (CytOSorb treatMent Of critically ill patientS) critical care registry, reported by Ferrer et al. in the Journal of Intensive Medicine (2025)

Backed by these and other robust peer-reviewed clinical and scientific data, CytoSorb is being used by physicians around the world to help turn the tide for patients with sepsis and septic shock by sequentially achieving the following key treatment goals:


1)
Break the vicious cycle of uncontrolled inflammation

2)
Reverse shock and restore oxygenated blood flow

3)
Promote the repair of leaky blood vessels

4)
Actively remove excessive fluid and reduce fluid overload in organs

5)
Prevent or treat multiple organ failure

Our World Sepsis Day Global Webinar on September 10, 2025 is intended to highlight the leadership role that CytoSorbents and its many collaborators have been playing to advance a new era in sepsis management.  We also invite you to follow our new septic shock blog series where we delve into greater detail on these points, found here.  Meanwhile, watch videos from healthcare providers from around the world who detail their first-hand experiences with CytoSorb in the treatment of septic shock and other critical illnesses in our “Voices Around the World” segment, found here.”


Second Quarter 2025 Earnings Conference Call

CytoSorbents’ management will host a live conference call, presentation webcast, and a question-and-answer session with the following information:

Date: Thursday August 7, 2025
Time: 4:30 PM EDT
North American toll-free: 1-800-836-8184
International toll: 1-646-357-8785
Live webcast link:  https://app.webinar.net/r8q0jNyG9lB
It is recommended that participants dial in approximately 10 minutes prior to the start of the call.

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at https://ir.cytosorbents.com/



About Non-GAAP Financial Measures

To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Common Share, respectively. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by investors and the analyst community to help them analyze the performance of our business, the Company’s cash available for operations, and the Company’s ability to meet future capital expenditure and working capital requirements.  For a reconciliation of non-GAAP financial measures to the most comparable GAAP measure, see the reconciliation included in the financial tables.  All non-GAAP adjustments are presented pre-tax.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is 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 includes, 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, and 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 over 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 Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure.  CytoSorb is not yet approved or cleared in the United States.

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 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.  In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval 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 2025, the Company attended an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR10.75.  The appeal hearing included FDA senior leadership and review team, Company management, our FDA regulatory counsel, and our external cardiac 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.

In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada.  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 after discussions with Health Canada, 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 the completion of the Company’s review with the U.S. FDA.

DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company’s website at https://ir.cytosorbents.com/  or follow us on Facebook and X. 

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA denial letter and the Health Canada Notice of Refusal and/or successfully appeal the FDA’s and Health Canada’s decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us


from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.



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U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
pmariani@cytosorbents.com

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
ir@cytosorbents.com


CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)

             
   
June 30, 
 
December 31, 
   
2025
 
2024
 
    
(unaudited)
    
 
ASSETS
   
  
 
 
  
Current Assets:
   
  
 
 
  
Cash and cash equivalents
 
$
 10,204
 
$
 3,280
Restricted cash, current
   
 —
   
 5,000
Grants and accounts receivable, net of allowances of $140 and $158 as of June 30, 2025 and December 31, 2024, respectively
 
 
 7,743
 
 
 7,320
Inventories
 
 
 3,710
 
 
 2,733
Prepaid expenses and other current assets
 
 
 1,330
 
 
 3,271
Total current assets
 
 
 22,987
 
 
 21,604
   
 
   
 
 
Property and equipment - net
 
 
 8,466
 
 
 9,002
Restricted cash
   
 1,522
   
 1,484
Right-of-use asset
   
 11,223
   
 11,511
Other assets
 
 
 3,792
 
 
 3,771
Total assets
 
$
 47,990
 
$
 47,372
   
 
   
 
  
LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
  
 
 
  
Current Liabilities:
 
 
  
 
 
  
Accounts payable
 
$
 3,394
 
$
 3,340
Accrued expenses and other current liabilities
   
 5,953
   
 6,032
Lease liability – current portion
   
 495
   
 453
Total current liabilities
 
 
 9,842
 
 
 9,825
Lease liability, net of current portion
   
 12,185
   
 12,444
Long-term debt
   
 14,377
   
 13,996
Total liabilities
 
 
 36,404
 
 
 36,265
   
 
  
 
 
  
Commitments and Contingencies
 
 
   
 
 
             
Stockholders’ equity
 
 
  
 
 
  
Preferred Stock, par value $0.001, 5,000,000 shares authorized; no shares issued and outstanding as of June 30, 2025 and December 31, 2024
   
   
Common Stock, par value $0.001, 100,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 62,610,376 and 54,830,146 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively
 
 
 63
 
 
 55
Additional paid-in capital
 
 
 319,023
 
 
 310,809
Accumulated other comprehensive income (loss)
 
 
 (3,960)
 
 
 4,252
Accumulated deficit
 
 
 (303,540)
 
 
 (304,009)
Total stockholders’ equity
 
 
 11,586
 
 
 11,107
Total liabilities and stockholders’ equity
 
$
 47,990
 
$
 47,372

See accompanying notes to condensed consolidated financial statements


CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per share data)

                         
   
Three Months Ended June 30, 
 
Six Months Ended June 30, 
 
   
2025
   
2024
 
2025
 
2024
Revenue
 
$
 9,617
 
$
 8,842
 
$
 18,344
 
$
 17,831
Cost of goods sold
   
 2,803
 
$
 2,339
   
 5,323
   
 4,455
Gross profit
 
 
 6,814
 
 
 6,503
   
 13,021
   
 13,376
                         
Operating expenses
 
 
   
 
   
 
   
 
 
Research and development, net of grant income
 
 
 1,262
 
 
 1,519
   
 2,924
   
 3,766
Selling, general and administrative
 
 
 9,167
 
 
 8,554
   
 17,599
   
 17,837
Total operating expenses
 
 
 10,429
 
 
 10,073
   
 20,523
   
 21,603
Loss from operations
 
 
 (3,615)
 
 
 (3,570)
   
 (7,502)
   
 (8,227)
                         
Other income (expense)
 
 
   
 
   
 
   
 
 
Interest expense, net
 
 
 (616)
 
 
 (180)
   
 (1,221)
   
 (187)
Gain (loss) on foreign currency transactions
   
 6,178
   
 (544)
   
 9,192
   
 (1,970)
Total other income (expense), net
 
 
 5,562
 
 
 (724)
   
 7,971
   
 (2,157)
   
 
   
 
   
 
   
 
 
Net income (loss) attributable to common stockholders
 
$
 1,947
 
$
 (4,294)
 
$
 469
 
$
(10,384)
   
 
                   
Basic net income (loss) per common share
 
$
 0.03
 
$
 (0.08)
 
$
 0.01
 
$
 (0.19)
                         
Diluted net income (loss) per common share
 
$
 0.03
 
$
 (0.08)
 
$
 0.01
 
$
 (0.19)
                         
Weighted Average Shares of Common Stock Outstanding
                       
Basic
 
 
 62,608,598
   
 54,306,041
   
 61,675,447
   
 54,284,416
Diluted
   
 67,166,377
   
 54,306,041
   
 66,255,298
   
 54,284,416
                         
Other comprehensive income (loss):
 
 
                   
Foreign currency translation adjustment, net of tax
 
 
 (5,476)
   
 421
   
 (8,212)
   
 1,644
Comprehensive loss
 
$
 (3,529)
 
$
 (3,873)
 
$
 (7,743)
 
$
 (8,740)

See accompanying notes to condensed consolidated financial statements.


CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (UNAUDITED)
(in thousands, except share data)

                                   
                   
Accumulated
           
             
Additional
 
Other
           
   
Common Stock
 
Paid-In
 
Comprehensive
 
Accumulated
 
Stockholders’
 
    
Shares
    
Par value
    
Capital
    
Income (Loss)
    
Deficit
    
Equity
Balance as of March 31, 2025 (unaudited)
 
 62,529,466
 
$
 63
 
$
 318,452
 
$
 1,516
 
$
 (305,487)
 
$
 14,544
Stock-based compensation
 
 80,910
   
 —
   
 571
   
 —
   
 —
   
 571
Foreign translation adjustment
 
 —
   
 —
   
 —
   
 (5,476)
   
 —
   
 (5,476)
Net income
 
 —
   
 —
   
 —
   
 —
   
 1,947
   
 1,947
Balance at June 30, 2025 (unaudited)
 
 62,610,376
 
$
 63
 
$
 319,023
 
$
 (3,960)
 
$
 (303,540)
 
$
 11,586
                                   
Balance at December 31, 2024
 
 54,830,146
 
$
 55
 
$
 310,809
 
$
 4,252
 
$
 (304,009)
 
$
 11,107
Stock-based compensation
 
 113,231
   
 1
   
 1,390
   
 —
   
 —
   
 1,391
Issuance of common stock and warrants from rights offerings, net of fees incurred
 
 6,249,791
   
 6
   
 5,386
   
 —
   
 —
   
 5,392
Issuance of common stock from exercise of warrants
 
 1,417,208
   
 1
   
 1,438
   
 —
   
 —
   
 1,439
Foreign translation adjustment
 
 —
   
 —
   
 —
   
 (8,212)
   
 —
   
 (8,212)
Net income
 
 —
   
 —
   
 —
   
 —
   
 469
   
 469
Balance as of June 30, 2025 (unaudited)
 
 62,610,376
 
$
 63
 
$
 319,023
 
$
 (3,960)
 
$
 (303,540)
 
$
 11,586

                                   
                   
Accumulated
           
             
Additional
 
Other
           
   
Common Stock
 
Paid-In
 
Comprehensive
 
Accumulated
 
Stockholders’
 
    
Shares
    
Par value
    
Capital
    
Income
    
Deficit
    
Equity
Balance as of March 31, 2024 (unaudited)
 
 54,293,555
 
$
 54
 
$
 307,200
 
$
 1,752
 
$
 (289,380)
 
$
 19,626
Stock-based compensation
 
 —
   
 —
   
 989
   
 —
   
 —
   
 989
Warrants issued in connection with long-term debt
 
 —
   
 —
   
 691
   
 —
   
 —
   
 691
Foreign translation adjustment
 
 —
   
 —
   
 —
   
 421
   
 —
   
 421
Issuance of restricted stock options
 
 12,860
   
 —
   
 (6)
   
 —
   
 —
   
 (6)
Net loss
 
 —
   
 —
   
 —
   
 —
   
 (4,294)
   
 (4,294)
Balance at June 30, 2024 (unaudited)
 
 54,306,415
 
$
 54
 
$
 308,874
 
$
 2,173
 
$
 (293,674)
 
$
 17,427
                                   
Balance at December 31, 2023
 
 54,240,265
 
$
 54
 
$
 306,187
 
$
 529
 
$
 (283,290)
 
$
 23,480
Stock-based compensation
 
 —
   
 —
   
 1,949
   
 —
   
 —
   
 1,949
Warrants issued in connection with long-term debt
 
 —
   
 —
   
 691
   
 —
   
 —
   
 691
Foreign translation adjustment
 
 —
   
 —
   
 —
   
 1,644
   
 —
   
 1,644
Issuance of common stock offerings, net of fees
 
 53,290
   
 —
   
 53
   
 —
   
 —
   
 53
Issuance of restricted stock units
 
 12,860
   
 —
   
 (6)
   
 —
   
 —
   
 (6)
Net loss
 
 —
   
 —
   
 —
   
 —
   
 (10,384)
   
 (10,384)
Balance as of June 30, 2024 (unaudited)
 
 54,306,415
 
$
 54
 
$
 308,874
 
$
 2,173
 
$
 (293,674)
 
$
 17,427

See accompanying notes to condensed consolidated financial statements






CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)

             
   
Six
 
Six
   
Months Ended
 
Months Ended
   
June 30, 
 
June 30, 
   
2025
 
2024
Cash flows from operating activities
     
 
 
  
Net income (loss) attributable to common stockholders
 
$
 469
 
$
 (10,384)
Adjustments to reconcile net income (loss) attributable to common stockholders to net cash used in operating activities:
       
 
 
Accrued final fee
   
 —
   
 111
Amortization of debt discount
   
 381
   
 —
Depreciation and amortization
   
 773
 
 
 798
Amortization of right-of-use asset
   
 72
   
 92
Write-off of patent cost
   
 —
 
 
 250
Write-off of inventory
   
 253
   
 —
Bad debt expense
   
 9
   
 29
Stock-based compensation
   
 1,391
   
 1,949
Foreign currency transaction (gains) losses
   
 (9,192)
 
 
 1,970
Changes in operating assets and liabilities
       
 
 
Grants and accounts receivable
   
 257
 
 
 (1,952)
Inventories
   
 (925)
 
 
 (1,030)
Prepaid expenses and other current assets
   
 1,897
 
 
 574
Other assets
   
 —
 
 
 1
Accounts payable and accrued expenses
   
 (360)
 
 
 (2,032)
Net cash used in operating activities
   
 (4,975)
 
 
 (9,624)
             
Cash flows from investing activities
       
 
  
Purchases of property and equipment
   
 (39)
 
 
 (63)
Payments for patent costs
   
 (140)
 
 
 (183)
Net cash used in investing activities
   
 (179)
 
 
 (246)
Cash flows from financing activities
       
 
  
Proceeds from long-term debt
   
 —
   
 15,000
Repayment of long-term debt
   
 —
 
 
 (5,000)
Payment of final fee
   
 —
   
 (150)
Payment of loan costs
   
 —
 
 
 (640)
Equity contributions - net of fees incurred
   
 —
   
 53
Proceeds from exercise of common stock warrants
   
 1,439
   
 —
Proceeds from rights offering, net of fees incurred
   
 5,392
   
 —
Net cash provided by financing activities
   
 6,831
   
 9,263
Effect of exchange rates on cash
   
 285
 
 
 (64)
Net change in cash, cash equivalents, and restricted cash
   
 1,962
 
 
 (671)
             
Cash, cash equivalents, and restricted cash at beginning of year
   
 9,764
 
 
 15,615
Cash, cash equivalents, and restricted cash – end of period
 
$
 11,726
 
$
 14,944
             
Supplemental disclosure of cash flow information
       
 
 
Cash paid for interest
 
$
 1,018
 
$
 538
             
Supplemental disclosure of non-cash financing activities
       
 
 
Warrants issued in connection with long-term debt
 
$
 556
 
$
 691
             

See accompanying notes to condensed consolidated financial statements.


Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures


 
    
Three Months Ended
    
Six Months Ended
   
June 30, 
 
June 30, 
 
    
2025
    
2024
    
2025
    
2024
 
    
(amounts, in thousands)
Net income (loss) attributable to common stockholders
 
$
               1,947
 
$
             (4,294)
 
$
                  469
 
$
           (10,384)
Depreciation and amortization expense
 
$
                  404
 
$
                  401
 
$
                  773
 
$
                  798
Income tax expense (benefit)
 
 -
 
 -
 
 -
 
 -
Interest expense (income)
 
$
                  616
 
$
                  180
 
$
               1,221
 
$
                  187
EBITDA – non-GAAP measure
 
$
               2,967
 
$
             (3,713)
 
$
               2,463
 
$
             (9,399)
                         
Non-cash stock-based compensation expense
 
$
                  571
 
$
                  989
 
$
               1,391
 
$
               1,949
(Gain)/Loss on foreign currency transactions
 
 
             (6,178)
 
 
                  544
 
 
             (9,192)
 
 
               1,970
Adjusted EBITDA – non-GAAP measure
 
$
             (2,640)
 
 
             (2,180)
 
$
             (5,338)
 
$
             (5,480)
                         
Net income (loss) attributable to common stockholders
 
$
               1,947
 
$
             (4,294)
 
$
                  469
 
$
           (10,384)
Non-cash stock-based compensation expense
   
                  571
   
                  989
   
               1,391
   
               1,949
(Gain)/Loss on foreign currency transactions
 
$
             (6,178)
 
$
                  544
 
$
             (9,192)
 
$
               1,970
Adjusted net income (loss) – non-GAAP measure
 
             (3,660)
 
$
             (2,761)
 
$
             (7,332)
 
$
             (6,465)
Weighted average common shares outstanding
 
 
 
 
 
 
 
 
 
 
 
 
Basic
   
      62,608,598
   
      54,306,041
   
      61,675,447
   
      54,284,416
Diluted
 
 
      67,166,377
 
 
      54,306,041
 
 
      66,255,298
 
 
      54,284,416
Basic net income (loss) per common share
 
$
                 0.03
 
$
               (0.08)
 
$
                 0.01
 
$
               (0.19)
Diluted net income (loss) per common share
 
$
                 0.03
 
$
               (0.08)
 
$
                 0.01
 
$
               (0.19)
                         
Non-cash stock-based compensation expense - basic
 
$
                 0.01
 
$
                 0.02
 
$
                 0.02
 
$
                 0.04
Non-cash stock-based compensation expense - diluted
 
$
                 0.01
 
$
                 0.02
 
$
                 0.02
 
$
                 0.04
(Gain)/Loss on foreign currency transactions - basic
 
$
               (0.10)
 
$
                 0.01
 
$
               (0.15)
 
$
                 0.04
(Gain)/Loss on foreign currency transactions - diluted
 
$
               (0.09)
 
$
                 0.01
 
$
               (0.14)
 
$
                 0.04
Adjusted net income (loss) per common share – basic – non-GAAP measure
 
$
               (0.06)
 
$
               (0.05)
 
$
               (0.12)
 
$
               (0.12)
Adjusted net income (loss) per common share – diluted – non-GAAP measure
 
$
               (0.05)
 
$
               (0.05)
 
$
               (0.11)
 
$
               (0.12)






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Document and Entity Information
Aug. 07, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 07, 2025
Entity File Number 001-36792
Entity Registrant Name Cytosorbents Corp
Entity Central Index Key 0001175151
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 98-0373793
Entity Address, Address Line One 305 COLLEGE ROAD EAST
Entity Address, City or Town PRINCETON
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 08540
City Area Code 973
Local Phone Number 329-8885
Entity Emerging Growth Company false
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(g) Security Common Stock, $0.001 par value
No Trading Symbol Flag true
Security Exchange Name NASDAQ

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