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): July 26, 2024

 

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 7.01

Regulation FD Disclosure.

 

On August 1, 2024, CytoSorbents Corporation (the “Company”) issued a press release announcing that it has regained compliance with the minimum bid price requirement set forth in The Nasdaq Stock Market LLC (“Nasdaq”) Listing Rule 5550(a)(2). A copy of the press release is furnished as Exhibits 99.1 to this Current Report on Form 8-K.

 

The information set forth in this Item 7.01 and Exhibit 99.1 shall not be deemed to be “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, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

 

Item 8.01

Other Events.

 

On July 26, 2024, the Company received a letter from the Listing Qualifications Department of Nasdaq informing the Company that it has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) because the Company’s common stock had a minimum closing price of at least $1.00 per share for a minimum ten consecutive business days.

 

As previously reported in a Current Report on Form 8-K filed on May 22, 2024, the Company received written notice from Nasdaq indicating that the Company was not in compliance with Nasdaq Listing Rule 5450(a)(1) because the closing bid price for the Company’s common stock had closed below $1.00 per share for the 30 consecutive business days preceding the date of the notification (the “Minimum Bid Price Requirement”). The notification letter stated that the Company would be provided 180 calendar days to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the closing bid price of the Company’s common stock had to be at least $1.00 for a minimum of 10 consecutive business days at any time before November 16, 2024. Subsequently, the Staff determined that, from July 12 to July 25, 2024, the closing bid price of the Company’s common stock had been at least $1.00 per share. Accordingly, the Company had regained compliance with Nasdaq Listing Rule 5550(a)(2) and Nasdaq now considers this matter closed.

 

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release of the Company, dated August 1, 2024
104		Cover Page Interactive Data File (embedded within Inline XBRL document)

 

 

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 1, 2024	CYTOSORBENTS CORPORATION
	By:	/s/ Dr. Phillip P. Chan
	Name:	Dr. Phillip P. Chan
	Title:	Chief Executive Officer

 

 

Exhibit 99.1

 

 

 

CytoSorbents Announces Compliance with Nasdaq Minimum Bid Price Requirement

 

PRINCETON, N.J., August 1, 2024 -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of deadly conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces that it has regained compliance with the Nasdaq Stock Market’s minimum bid price requirement of $1.00 per share.

 

On July 26, 2024, CytoSorbents received notification from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) that it has regained compliance with the minimum bid price requirement in Nasdaq Listing Rule 5550(a)(2) as a result of the closing bid price of CytoSorbents’ common stock being $1.00 per share or greater for 10 consecutive trading sessions ending July 25, 2024. Accordingly, Nasdaq has determined that this matter is now closed.

 

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "We are pleased to confirm that CytoSorbents is now back in full compliance with Nasdaq's listing requirements, strengthening our market position as we approach our expected regulatory submissions for DrugSorb®-ATR marketing approval to U.S. FDA and Health Canada in the next several months. With recent operational progress on the clinical, regulatory, commercial, manufacturing, and financing fronts, coupled with continued aggressive cost cutting, we have been systematically putting into place the foundation of what we believe will be an exciting new phase of our business.”

 

About CytoSorbents Corporation (NASDAQ: CTSO)

 

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses 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. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively. 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 in the United States.

 

 

The DrugSorb™-ATR antithrombotic removal system, an investigational device based on the same polymer technology as CytoSorb, 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. The Company has completed the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.

 

CytoSorbents’ 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. Its technologies have received non-dilutive grant, contract, and other funding of approximately $50 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. 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 websites at www.cytosorbents.com and www.cytosorb.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 timing of our expected 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.

 

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U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
kbloch@cytosorbents.com

 

Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55^th St, #3401
New York, NY 10019
+1 (646) 751-4363
ir@cytosorbents.com

 

 

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Cover	Jul. 26, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 26, 2024
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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