CytoSorbents(CTSO) - 2025 Q3 - Quarterly Results

Financial Performance - Third quarter 2025 revenue was $9.5 million, representing a 10% year-over-year increase from $8.6 million in Q3 2024[5] - Gross margin improved to 70% in Q3 2025, up from 61% in Q3 2024, due to resolved manufacturing issues and improved operational efficiencies[5] - Operating loss decreased to $2.9 million in Q3 2025, compared to $4.8 million in Q3 2024, driven by better gross margins and lower operating expenses[5] - Adjusted net loss improved to $2.6 million or $0.04 per share, compared to an adjusted net loss of $4.5 million or $0.08 per share in Q3 2024[5] - CytoSorbents reported revenue of $9.485 million for Q3 2025, a 10.1% increase from $8.613 million in Q3 2024[28] - Gross profit for Q3 2025 was $6.666 million, compared to $5.256 million in Q3 2024, reflecting a gross margin improvement[28] - The company incurred a net loss of $3.170 million in Q3 2025, compared to a net loss of $2.768 million in Q3 2024[28] - For the nine months ended September 30, 2025, the net loss was $2,701,000, a significant improvement compared to a net loss of $13,152,000 for the same period in 2024[30] - The company reported stock-based compensation of $1,879,000 for the nine months ended September 30, 2025, down from $2,840,000 in the same period of 2024[30] - The adjusted EBITDA for the nine months ended September 30, 2025, was $(7,348,000), an improvement from $(9,036,000) in the same period of 2024[31] - The basic net loss per common share for the three months ended September 30, 2025, was $(0.05), consistent with the same period in 2024[31] Cash Flow and Assets - The company expects to reach cash flow breakeven in Q1 2026 following a workforce reduction of approximately 10% and a cost reduction program[7] - Proforma cash, cash equivalents, and restricted cash was $11.6 million on September 30, 2025, assuming the additional term loan was drawn[6] - Cash and cash equivalents increased to $7.536 million as of September 30, 2025, up from $3.280 million at the end of 2024[27] - Cash, cash equivalents, and restricted cash at the end of the period were $9,058,000, compared to $12,168,000 at the end of September 30, 2024[30] - The net cash used in operating activities for the nine months ended September 30, 2025, was $7,552,000, compared to $12,087,000 for the same period in 2024[30] Liabilities and Equity - Total current assets decreased slightly to $21.313 million as of September 30, 2025, from $21.604 million as of December 31, 2024[27] - Total liabilities increased to $36.730 million as of September 30, 2025, compared to $36.265 million at the end of 2024[27] - The total stockholders' equity as of September 30, 2025, was $9,020,000, a decrease from $11,586,000 as of June 30, 2025[29] Regulatory and Product Development - The company submitted a De Novo pre-submission package for DrugSorb™-ATR to the FDA, with a regulatory decision anticipated by mid-2026[5][11] - CytoSorbents is actively pursuing regulatory approval for the DrugSorb™-ATR system with the U.S. FDA and Health Canada[20] - The company has multiple products under development, including ECOS-300CY®, CytoSorb-XL™, and DrugSorb™, protected by numerous patents[21] Clinical Programs and Research - Recent clinical data publications reinforce the effectiveness of CytoSorbents' therapies in managing sepsis and septic shock, highlighting significant reductions in mortality rates[14] - The company plans to expand clinical programs across all applications to improve patient outcomes and support healthcare workers globally[15] Financing and Credit - An amended credit agreement with Avenue Capital Group provides an additional $2.5 million in term loan capital and extends the interest-only period to December 31, 2026[8] - The company reported proceeds from the exercise of common stock warrants amounting to $1,439,000 for the nine months ended September 30, 2025[30] - The company incurred foreign currency transaction gains of $9,128,000 for the nine months ended September 30, 2025, compared to gains of $680,000 in the same period of 2024[30]