CytoSorbents(CTSO) - 2025 Q1 - Quarterly Report

Financial Performance - Total product revenue for Q1 2025 was $8.7 million, a decrease of $0.3 million, or 3%, compared to Q1 2024[90] - Gross profit for Q1 2025 was $6.2 million, a decrease of $0.7 million, or 10%, with gross margins of 71.1% compared to 76.5% in Q1 2024[93] - Loss from operations improved by 17% to approximately $3.9 million in Q1 2025, down from $4.7 million in Q1 2024, driven by a 12% reduction in total operating expenses[97] Expenses - Research and development expenses decreased by approximately $0.5 million, or 26%, to $1.7 million in Q1 2025, due to reduced clinical trial costs[94] - Selling, general and administrative expenses decreased by approximately $0.9 million, or 9%, to $8.4 million in Q1 2025, primarily due to lower royalty expenses[95] Currency and Financial Position - The gain on foreign currency transactions was approximately $3.0 million in Q1 2025, compared to a loss of approximately $1.4 million in Q1 2024[96] - Current assets as of March 31, 2025, were approximately $25.4 million, while current liabilities were approximately $9.7 million[98] - As of March 31, 2025, the Company has approximately $13.1 million in cash, including $11.6 million in unrestricted cash[101] Capital Raising and Commitments - The company completed a shareholder Rights Offering in January 2025, providing $5.4 million in net proceeds, and an additional $1.4 million from the exercise of Series A Right Warrant in February 2025[90] - The Company raised $6.25 million in gross proceeds from its Rights Offering, with $5.4 million net of fees, by selling 6.25 million Units[100] - The Company has an effective shelf registration statement allowing it to raise up to $150 million, with approximately $149.6 million available as of March 31, 2025[99] - The Avenue Capital Commitment includes a loan of up to $20 million, with $15 million available in the first tranche and a second tranche of $5 million contingent on FDA approval[103] - Proceeds from the Avenue Capital Commitment were used to pay off existing debt and for working capital purposes[106] Regulatory and Market Developments - The DrugSorb-ATR application is under advanced review in Canada, with an estimated total addressable market of $300 million today, potentially exceeding $1 billion over time[88] - The Company anticipates regulatory approval and introduction of DrugSorb-ATR in the U.S. and Canada in 2025[102] - The FDA issued a denial letter regarding the De Novo Request for DrugSorb-ATR, with a formal appeal expected if issues are not resolved by June 25, 2025[105] Operational Efficiency - The Company has lowered its spending significantly over the past year while maintaining tight control over expenditures[100] - The Company is exploring additional sources of liquidity, including equity securities issuance and debt financing[102] - The Company’s financial statements are prepared on a going concern basis, indicating uncertainties regarding future capital requirements[102]