CytoSorbents Q1 Revenue Up 2% to $8.9M; Cash at $6.4M, FDA Filing Planned
CytoSorbents posted Q1 revenue of $8.9M, up 2%, with a 69% gross margin, and operating loss narrowed to $3.0M, while net loss widened to $5.1M ($0.08/share). The company ended with $6.4M cash and plans to file a new DrugSorb-ATR De Novo application in late 2026 after FDA feedback.
1. First Quarter Financial Performance
CytoSorbents generated $8.9 million in Q1 revenue, a 2% increase over the prior year, achieving a 69% gross margin. Operating loss improved to $3.0 million from $3.9 million in Q1 2025, but net loss widened to $5.1 million ($0.08 per share) primarily due to foreign currency headwinds.
2. Cash Position and Outlook
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. Management expects to reach operating cash flow breakeven in the second half of 2026, driven by ongoing cost controls and margin improvements.
3. Cost Reduction and Operational Improvements
In late 2025, the company reduced headcount by approximately 10% and implemented production volume cuts to lower inventory and working capital. These measures contributed to reduced operating expenses and a narrower adjusted EBITDA loss of $2.2 million in Q1, compared to $2.7 million a year earlier.
4. DrugSorb-ATR Regulatory Update
Following FDA appeal feedback, CytoSorbents plans to submit a new De Novo application for DrugSorb-ATR in late 2026. The FDA has requested additional mechanistic data alongside real-world evidence, and the company is evaluating expedited options to meet these requirements under the 150-day review timeline.