CytoSorbents (NASDAQ:CTSO) shareholders approved a reverse stock split authorization and re-elected the company’s five directors at its 2026 annual meeting, as management outlined a plan to reach operating cash flow breakeven in the second half of the year, restore growth in its core business and advance U.S. regulatory pathways for DrugSorb-ATR.
Christopher J. Woods, vice president of American Election Services LLC and the meeting’s inspector of elections, reported that 42.5 million shares were represented virtually or by proxy, exceeding the quorum requirement. The company had 62.8 million shares outstanding and eligible to vote.
Reverse Split Authorization Approved
Investors approved an amendment authorizing the board to implement a reverse split of the company’s common shares at a ratio between 1-for-5 and 1-for-20. The board may select the exact ratio at any point before the first anniversary of the annual meeting.
Chan said the vote gives the company “another option to regain our Nasdaq compliance.” The company said it will report final voting results in a Form 8-K within four business days of the meeting’s conclusion.
Management Targets Cash Flow Breakeven
Bator, CytoSorbents’ chairman, acknowledged shareholders’ concerns about the company’s performance, saying its share price reflects skepticism about its ability to execute and grow. He said the company has reduced costs, improved manufacturing efficiency, strengthened its commercial operations and cut cash burn.
“We recognize that our share price continues to reflect skepticism regarding our ability to execute and grow,” Bator said. “In fact, we believe the company today is stronger and better positioned than it was just one year ago.”
Chan said 2025 revenue rose 4% to $37.1 million. Direct sales outside Germany increased 13% during the year, while distributor sales grew 11%, he said. The company reported 71% gross margin for 2025 and said its product gross margin reached 73% in the second quarter of 2026.
Chief Financial Officer Peter Mariani said the company’s operating loss declined 27% through the second quarter, while adjusted EBITDA loss improved 38%. Operating cash burn was reduced to $200,000, excluding restructuring payments, he said.
Mariani said CytoSorbents remained on track to achieve operating cash flow breakeven during the second half of 2026. President and Chief Operating Officer Vince Capponi said production restructuring, inventory management and engineering efforts reduced global device inventory by 43%, to approximately $1.5 million at the end of June from $2.7 million at year-end 2025.
Capponi said manufacturing initiatives involving production efficiency, packaging, suppliers and workforce cross-training were expected to generate about $1.2 million in annualized savings. Chan said the company has reduced its workforce by 23% since September 2025.
Core Business Growth Varies by Region
The company said CytoSorb has been used in more than 300,000 treatments in over 70 countries. Mariani said the company generates about 32% of revenue from direct sales in Germany, 24% from direct sales in nine other countries, with the remainder derived from distributors and partners.
Christian Steiner, executive vice president of sales and marketing, said the company is seeking to expand adoption outside the U.S. by standardizing treatment practices and promoting use of its HotSwap accessory, which is designed to facilitate exchange of adsorbers during therapy.
International distributor business grew 16% year over year in the second quarter, while direct business outside Germany rose 9%, according to Steiner. However, Germany sales declined 24% in the quarter, which he attributed primarily to a difficult critical-care environment around septic shock and reduced field coverage.
Steiner said the company is rebuilding territory coverage in Germany, focusing accounts with greater adoption potential and seeking deeper penetration in cardiac surgery while continuing selected critical-care programs.
DrugSorb-ATR and HemoDefend Plans
Chief Medical Officer Makis Deliargyris said the FDA previously denied the company’s September 2024 De Novo submission for DrugSorb-ATR, despite what he described as no major device safety concerns. He said the STAR-T study missed its primary endpoint after inclusion of a small number of surgeries that were imbalanced between treatment groups.
Deliargyris said the company plans a second De Novo submission in early 2027, incorporating additional mechanistic data and real-world evidence. He said a real-world analysis is scheduled for presentation at the European Society of Cardiology meeting in Munich later in the month.
The company also has scheduled a separate FDA meeting concerning DrugSorb-ATR’s potential use to remove direct oral anticoagulants, including Eliquis and Xarelto, from patients undergoing cardiac surgery. Deliargyris said the meeting is intended to determine what additional information may be required for a parallel De Novo submission.
Chris Cramer, senior vice president of business development, said HemoDefend is designed to remove anti-A and anti-B antibodies from blood products, with the goal of creating more broadly compatible platelet and plasma products. He said the program has received approximately $16 million in non-dilutive funding for development, manufacturing, testing and regulatory planning.
Cramer said recent written FDA feedback supported elements of the company’s plasma development strategy, including antibody endpoints and portions of its bench-testing and clinical approach. The company is also discussing potential additional U.S. government funding that could support clinical trials, he said.
In response to shareholder questions, Bator said management and the board are responsible for delivering on commitments related to financing, sales, regulatory progress and manufacturing. He said the company began reducing costs about three years ago after completion of the STAR-T trial, but accelerated cost-cutting after anticipated U.S. approval did not materialize.
About Cytosorbents (NASDAQ:CTSO)
Cytosorbents Corporation, founded in 2011 and headquartered in Princeton, New Jersey, is a medical device company focused on critical care and extracorporeal blood purification. The company’s flagship product, CytoSorb, is a hemoadsorption cartridge designed to remove excessive inflammatory mediators such as cytokines, bilirubin and myoglobin from a patient’s blood. By targeting the molecular drivers of hyperinflammation, CytoSorb is intended to stabilize patients undergoing septic shock, cardiac surgery, trauma and organ failure.
CytoSorb has secured regulatory clearance in Europe (CE mark) and is available in more than 65 countries, with a growing presence in Asia, the Middle East and Latin America.
