CTSO CytoSorbents Corporation

 

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): March 4, 2025

 

CYTOSORBENTS CORPORATION

(Exact name of registrant as specified in its charter) 

 

Delaware		001-36792		98-0373793
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. 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: (732) 329-8885

 

Not Applicable

(Former name or former address, if changed since last report.)

 

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))

 

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

 

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

 

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 March 4, 2025, CytoSorbents Corporation issued a press release reaffirming certain previously disclosed preliminary financial expectations for the quarter and year ended December 31, 2024, as well as announcing a delay of its previously announced earnings call, which is now expected to occur on March 25, 2025 due to the passing of the Company’s Vice President and Corporate Controller. A copy of the press release is furnished herewith as Exhibit 99.1.*

 

Item 7.01

Regulation FD Disclosure

 

The information set forth above in Item 2.02 of this Current Report on Form 8-K is incorporated herein by reference.*

 

Item 9.01

Exhibits

 

(d) Exhibits

 

Exhibit No.	Description
99.1	Press Release of the Company, dated March 4, 2025
104	Cover Page Interactive Data File (embedded with the Inline XBRL document)

 

* The information in Items 2.02 and 7.01 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: March 4, 2025	CYTOSORBENTS CORPORATION
	By:	/s/ Dr. Phillip P. Chan
	Name:	Dr. Phillip P. Chan
	Title:	Chief Executive Officer

 

 

 

 Exhibit 99.1 

 

 

CytoSorbents Postpones Earnings Release to Allow More Time to
Complete Annual Audit Following the Passing of Corporate Controller

 

 

The Company reaffirms previously provided preliminary financial results for the quarter and full year ended December 31, 2024, and continues to expect regulatory decisions on DrugSorb™-ATR marketing applications in 2025

 

PRINCETON, N.J., March 4, 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 announced that it is postponing its previously announced earnings call scheduled for March 6, 2025 to allow more time to complete the annual financial audit following the recent passing of the Company’s Vice President and Corporate Controller from natural causes.

 

The Company now expects to report fourth quarter and full year 2024 financial results after the market close on Tuesday, March 25, 2025. Management will host a live conference call, presentation webcast, and a question-and-answer session starting at 4:30PM ET the same day, and expects to file its Form 10-K in that timeframe.

 

The delay follows the unexpected passing of the Company’s Vice President and Corporate Controller, James E. Cason, Jr. Mr. Cason had a long and successful career and worked with the Company for the past 10 years.

 

“We are deeply saddened by the loss of our dear colleague, Jim,” said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Over the past decade, Jim was an exceptional leader, talented colleague, and trusted friend who contributed greatly to the growth and success of CytoSorbents, and was dedicated to our mission to help save lives around the world. We extend our deepest condolences to his family and many friends.”

 

Dr. Chan continued, “Though we will miss Jim, we are fortunate to have a strong financial team whose immediate focus has been to support one another and to ensure an effective transition of Jim’s important responsibilities during this difficult time. We believe this extension of time is a prudent decision to ensure the thorough completion of the year-end audit.”

 

 

The Company reiterates previously provided preliminary expectations, including:

 

·	Fourth quarter product revenue (excluding grant income) in the range of $9.0 million to $9.2 million, representing 22% to 25% growth versus $7.35 million in the fourth quarter of 2023

 

·	Full-year product revenue (excluding grant income) in the range of $35.4 million to $35.6 million, representing approximately 14% growth versus $31.1 million for the full-year 2023

 

·	Fourth quarter product gross margin of approximately 70%, compared to 61% in the prior quarter and 72% in the fourth quarter of 2023

 

DrugSorb-ATR Marketing Applications

 

The Company’s marketing applications for DrugSorb-ATR continue to be in substantive and interactive review with the U.S. FDA and Health Canada, and the Company continues to expect regulatory decisions from both agencies in 2025.

 

Estimated Pro-Forma December 31, 2024, Cash Balance and Q4 2024 Cash Burn

 

As previously disclosed, the Company has raised a total of $7.85 million of aggregate gross proceeds in the first quarter of 2025 inclusive of $6.25 million from the January 10, 2025, Rights Offering, and $1.6 million from the related February 24, 2025, exercise of Series A Right Warrants. Proceeds net of related fees is approximately $7.3 million. The pro forma balance of cash, cash equivalents, and restricted cash on December 31, 2024, after giving effect to the Rights Offering and the exercise of Series A Right Warrants as if they had occurred on December 31, 2024, would have been approximately $17.0 million, including unrestricted cash of approximately $15.5 million. These amounts reflect $7.3 million in net proceeds raised and net cash used in the fourth quarter of 2024 of approximately $2.5 million.

 

The estimated financial results, proforma cash balance and estimate of cash utilized in the fourth quarter remain preliminary and unaudited.

 

Conference Call and Webcast Details:

 

Date: Tuesday, March 25, 2025

Time: 4:30 PM ET

North American toll-free: 1-800-836-8184

International toll: 1-646-357-8785

Live webcast link: https://app.webinar.net/KGyNpgaYZgQ

 

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 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, ECMO, heart-lung machines). CytoSorbents’ technologies are used in a number of broad applications. Two important ones 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 in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis that can lead to massive inflammation, organ failure and patient death. 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 76 countries worldwide, with more than 250,000 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 medical device application 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. In November 2024, the Company received its Medical Device Single Audit Program (MDSAP) certification and submitted its Medical Device License (MDL) application to Health Canada. 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 www.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, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, 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.

 

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

 

 

v3.25.0.1

Cover	Mar. 04, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 04, 2025
Entity File Number	001-36792
Entity Registrant Name	CYTOSORBENTS CORPORATION
Entity Central Index Key	0001175151
Entity Tax Identification Number	98-0373793
Entity Incorporation, State or Country Code	DE
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	732
Local Phone Number	329-8885
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	CTSO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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