SeaStar Medical Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

Core Insights - SeaStar Medical Holding Corporation has made significant progress in 2024, including the approval and commercial launch of its QUELIMMUNE therapy, and is positioned for a transformational year in 2025 [2][3] Business Highlights - The FDA granted approval for QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) due to sepsis, impacting approximately 4,000 pediatric patients annually [3] - QUELIMMUNE therapy has been adopted by five customers, with a growing pipeline of prospective customers [3] - The NEUTRALIZE AKI pivotal trial has enrolled 94 out of the anticipated 200 patients, with participation from prestigious medical centers [3][12] - SeaStar Medical received its fourth Breakthrough Device Designation for the Selective Cytopheretic Device (SCD) therapy, aimed at treating chronic systemic inflammation in end-stage renal disease patients [3] - The National Institutes of Health awarded a $3.6 million grant for a clinical trial evaluating SCD therapy as a bridging strategy for patients with chronic heart failure [3] - The company was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric patients with AKI [3] Financial Performance - For the year ended December 31, 2024, net revenue was $0.1 million, a significant increase from no revenue in 2023, attributed to the initiation of QUELIMMUNE sales [5] - Research and development expenses rose to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs [6] - General and administrative expenses increased to $8.9 million in 2024 from $8.2 million in 2023, primarily due to higher headcount and legal expenses [7] - The net loss for the year was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with a net loss per share of $6.63 compared to $30.26 in the previous year [9][23] Balance Sheet Improvements - The company improved its balance sheet by adding approximately $31 million in capital and reducing debt and liabilities [4] - Cash and cash equivalents at December 31, 2024, were $1.8 million, reflecting a significant increase from $176,000 at the end of 2023 [20]