SeaStar Medical Reports Third Quarter 2025 Financial Results and Provides Business Updates

Core Insights - SeaStar Medical Holding Corporation reported strong progress in the third quarter of 2025, highlighting growth in customer base and impressive survival results for its QUELIMMUNE therapy [2][3][4] Business Highlights - Three top-ranked children's medical centers adopted QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) [3][4] - QUELIMMUNE therapy demonstrated a survival rate of 76% at 60 days and 71% at 90 days for 21 pediatric patients, indicating a potential 50% reduction in loss of life compared to historical data [4][14] - The company raised $12.4 million to strengthen its balance sheet and support future operations [5][11] Clinical Trials and Research - The NEUTRALIZE-AKI pivotal clinical trial is ongoing, with an interim analysis showing positive safety signals and no device-related safety issues [4][16] - Total enrollment for the NEUTRALIZE-AKI trial has been adjusted to approximately 339 patients, with 146 patients enrolled to date [4][16] - A new clinical trial for NEUTRALIZE-CRS therapy has been initiated, targeting patients with acute chronic systolic heart failure [4] Financial Performance - Net revenue for the third quarter of 2025 was approximately $0.2 million, compared to $0.1 million in the same period of 2024 [6] - Research and development expenses decreased to $1.9 million from $2.3 million year-over-year, while general and administrative expenses also saw a decline [8][9] - The net loss for the third quarter was approximately $3.5 million, or $0.13 per share, an improvement from a net loss of $4.5 million, or $1.10 per share, in the prior year [11][27] Market Position and Future Outlook - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening pediatric AKI due to sepsis, with significant market potential in both pediatric and adult applications [19] - The company is focused on expanding its market share and generating sales in the adult AKI market, which is significantly larger than the pediatric segment [5][19]