CytoSorbents Reports Third Quarter 2026 Financial Results, Achieves Operating Cash Flow Breakeven, and Provides Business and Regulatory Update

Phillip Chan, Chief Executive Officer of CytoSorbents

“The third quarter marked an important financial milestone for CytoSorbents as we achieved our goal of operating cash flow breakeven, excluding restructuring-related payments. This achievement reflects a year of disciplined execution and meaningful improvements in our underlying business. Product gross margin expanded to 75%, operating expenses declined 11%, operating loss improved 59%, and notably, adjusted EBITDA loss narrowed 86% to approximately $0.3 million. These results demonstrate the impact of our more efficient cost structure and position us to benefit from improved operating leverage as revenue grows. Importantly, every dollar of operating cash burn we eliminate helps reduce our future financing needs and positions us to capture more of the potential value of future growth for our shareholders.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“We continue to advance four distinct value drivers, each with the potential to create meaningful shareholder value. These include achieving sustainable operating cash flow breakeven, restoring profitable growth in our core CytoSorb business, opening the U.S. market through DrugSorb-ATR, and unlocking the strategic value of HemoDefend-BGA. With our first milestone achieved, we are focused on sustaining this progress while advancing the remaining three opportunities.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“In the third quarter, we generated approximately $43,000 in positive operating cash flow, excluding $251,000 in restructuring-related payments, compared with operating cash burn of approximately $200,000 in Q2 2026 on the same basis and $2.7 million in Q3 2025.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“This improvement reflects a broad-based effort to optimize our operations. Manufacturing efficiencies and improved sourcing helped expand product gross margin to 75%, while a 24% reduction in headcount since September 2025 and disciplined expense management significantly lowered our cost structure. We also improved working capital management, reducing inventory from $5.3 million at year-end 2025 to $3.2 million at September 30, 2026.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Our focus now turns to sustaining operating cash flow at or near breakeven while selectively investing to accelerate sales growth, which has historically been constrained by limited resources. With a significantly leaner cost structure and healthy gross margins, we believe we are now better positioned to capitalize on growth opportunities and generate meaningful operating leverage as revenues increase. Although quarterly cash flow may fluctuate with the timing of revenue, collections, and working capital, our goal is to maintain financial discipline while translating incremental sales growth into improved profitability and long-term shareholder value.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Our second value driver is restoring consistent, profitable growth in our core CytoSorb franchise. Encouragingly, distributor and strategic partner sales grew 18% year-over-year and 10% sequentially in the third quarter, while direct sales outside Germany increased 4% year-over-year. Together, these markets accounted for 76% of quarterly sales, demonstrating continued momentum across the majority of our business.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Meanwhile, our 'Right Patient, at the Right Time, with the Right Dose' commercial strategy continues to gain traction, supported by our PuriFi® pump platform and HotSwap® technology, which simplify treatment delivery and enable earlier, more consistent CytoSorb use. We are also strengthening our clinical evidence base, including new data presented at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting highlighting applications in blood thinner removal, post-operative shock, VA-ECMO support, and heart transplantation, as well as findings from the international COSMOS critical care registry presented at the European Society of Intensive Care Medicine (ESICM) LIVES 2026 congress addressing sepsis, liver support, and VV-ECMO..”

Phillip Chan, Chief Executive Officer of CytoSorbents

“We believe a combination of renewed growth in Germany, sustained international momentum, an expanding clinical evidence base, and a leaner cost structure positions our core CytoSorb franchise to accelerate revenue growth, leverage our attractive gross margins, and translate increasing sales into meaningful improvements in profitability and cash flow.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Our third value driver is to obtain FDA marketing authorization for DrugSorb-ATR, potentially opening a second major engine for growth. DrugSorb-ATR is designed to remove commonly prescribed blood thinners during cardiopulmonary bypass in patients requiring urgent cardiac surgery, with the goal of reducing serious and life-threatening bleeding complications. Subject to regulatory authorization, we estimate an initial addressable market of approximately $300 million in the United States and Canada, that we estimate could expand to $1-2 billion with label expansion to other blood thinners and additional surgical indications.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“During the quarter, we made meaningful progress on our new intended De Novo submission to FDA on DrugSorb-ATR. At the European Society of Cardiology congress this past August, an independent patient-matched analysis evaluated 587 patients undergoing urgent coronary artery bypass grafting (CABG) surgery following recent exposure to Brilinta® (ticagrelor). The analysis demonstrated a statistically significant 37% relative reduction in severe BARC-4 bleeding with intraoperative CytoSorb use (21.8% versus 34.5% control; p=0.002), resulting in a clinically impactful NNT (Number Needed to Treat) of approximately eight patients to prevent one severe bleeding event. Significant reductions in chest tube drainage and red blood cell transfusions were also observed, with no serious device-related adverse events.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“This analysis of real-world data is particularly important because it was previously proposed by the FDA during the appeal of our original De Novo submission and is expected to be a key component of our planned new De Novo submission in early 2027. We expect this additional evidence to increase approximately fivefold the number of patients treated with our technology represented in the submission, to approximately 250 patients. Meanwhile, based on a constructive FDA pre-submission meeting in August, we are working to finalize an animal study protocol with the FDA to collect additional mechanistic data. Taken together with STAR-T data, and previously submitted safety data, we believe this real-world analysis and mechanistic data will provide a substantially expanded body of evidence supporting the clinical benefit of DrugSorb-ATR for FDA review.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“In parallel, in a separate FDA pre-submission meeting, we advanced discussions with the Agency regarding the data requirements of a separate De Novo submission expected next year for the removal of direct oral anticoagulants, including Eliquis® (apixaban) and Xarelto® (rivaroxaban), during urgent cardiac surgery, which could significantly expand the addressable U.S. market for our technology given the widespread use of these medications.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Importantly, the Brilinta® and direct oral anticoagulant programs offer two distinct potential pathways to U.S. commercialization, each supported by its own clinical evidence and regulatory strategy.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Our fourth value driver is realizing the strategic value of HemoDefend-BGA, a differentiated blood purification technology that we believe is not fully reflected in our current valuation.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Developed with approximately $16 million in prior non-dilutive U.S. government funding, HemoDefend-BGA is designed to remove anti-A and anti-B antibodies from plasma and platelet products, with the goal of enabling universal blood products that can be transfused regardless of recipient blood type - without electricity, capital equipment, or complex processing.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“The potential implications are substantial. Rather than maintaining separate plasma and platelet inventories for four blood types, hospitals could potentially simplify inventory management to just one universal plasma and one universal platelet product, reducing logistical complexity, waste, and costs. Longer term, the technology could enable first responders, ambulances, and military units to carry freeze-dried universal plasma that requires no refrigeration or blood typing, allowing faster treatment of life-threatening hemorrhage in emergency and battlefield settings.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“Following helpful FDA feedback in July regarding our anticipated clinical development pathway, we are evaluating opportunities to advance and realize the value of HemoDefend-BGA through additional non-dilutive government funding, commercial partnerships, licensing arrangements, and other strategic alternatives. We believe this asset offers opportunities to create shareholder value without necessarily requiring substantial investment from our core operations.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“With operating cash flow breakeven achieved and a more efficient cost structure in place, CytoSorbents is entering its next phase from a stronger operational position. Our priorities are clear: sustaining financial discipline, restoring profitable growth in our core CytoSorb franchise, advancing DrugSorb-ATR toward U.S. commercialization, and unlocking the strategic value of HemoDefend-BGA.”

Phillip Chan, Chief Executive Officer of CytoSorbents

“These four distinct value drivers provide multiple potential pathways to shareholder value creation, reducing our dependence on any single commercial, regulatory, or strategic outcome. With improving fundamentals, meaningful near-term catalysts, and substantial longer-term market opportunities, we believe CytoSorbents is positioned to become a stronger, more profitable, and more diversified medical technology company.”