CTSO · Cytosorbents Corporation

CytoSorbents reported first quarter 2026 revenue of $8.9 million, a 2% increase from $8.7 million in the prior year period. Growth was driven by a 13% increase in direct sales territories outside Germany, while distributor sales were flat due to delayed orders of approximately $500,000 from the Middle East and neighboring regions attributed to geopolitical instability related to the U.S.-Iran war. Germany sales were slightly below last year but with a smaller, more focused team. Gross margin declined to 69% from 71%, primarily due to intentionally reduced production volumes aimed at lowering inventory and improving working capital. Operating loss improved to $3.0 million from $3.9 million, reflecting the initial benefits of a workforce and cost reduction initiative implemented in Q4 2025 that reduced headcount by approximately 10%. Net loss widened to $5.1 million ($0.08 per share) from $1.5 million ($0.02 per share), driven primarily by non-cash changes in foreign currency transactions. Adjusted net loss improved to $3.4 million ($0.05 per share) from $3.7 million ($0.06 per share), and adjusted EBITDA loss improved to $2.2 million from $2.7 million. Total cash, cash equivalents, and restricted cash stood at $6.4 million as of March 31, 2026, down from $7.8 million at year-end 2025. Cash burn in the quarter, excluding $0.3 million in restructuring payments, was approximately $1.1 million. Management reiterated its goal of achieving operating cash flow breakeven in the second half of 2026. On the regulatory front, the FDA has requested additional mechanistic data for the DrugSorb-ATR De Novo submission for ticagrelor removal, and the company now expects to submit a new application in late 2026 or early 2027. Separately, CytoSorbents plans to submit a pre-submission request to the FDA within 30 days to discuss a potential parallel De Novo submission for DOAC removal (apixaban and rivaroxaban), which could expand the U.S. market opportunity.