SeaStar Medical (ICU) Q3 2025 Earnings Transcript

Core Insights - The company reported a gross profit margin of 92% for Quellimmune, indicating strong financial performance and potential for future cash generation [1][28] - Quellimmune orders in the first half of the fourth quarter have already surpassed total orders from the entire third quarter, suggesting increasing market traction [2][9] - The company anticipates full-year revenue for 2025 to exceed one million dollars, laying a solid foundation for growth into 2026 [2][42] Financial Performance - Net revenue from Quellimmune sales for the third quarter was approximately $183,000, a significant increase from $68,000 in the same period last year, reflecting a 169% year-over-year growth [3][27] - Operating expenses decreased to $3.7 million in Q3 2025 from $4.5 million in Q3 2024, primarily due to reduced consulting and personnel costs [28] - 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 previous year [29] Clinical Developments - The company has onboarded three additional clinical sites for the neutralized AKI pivotal trial, bringing total enrollment to 146 patients, with a target of 339 patients [16][21] - An interim analysis confirmed the safety of the SCD therapy, with no device-related adverse events observed, which is crucial for regulatory acceptance [17][20] - The SAVE surveillance registry reported a 76% survival rate through 60 days and 71% through 90 days for pediatric patients treated with Quellimmune, highlighting its life-saving potential [22][23] Market Strategy - The company aims to add 20 new pediatric hospitals to drive product revenue, with 10 active commercial pediatric hospitals already in place [8][14] - Efforts are being made to streamline the adoption process for Quellimmune therapy across hospital systems, which includes identifying key staff and facilitating communication [11][12] - The total U.S. market for Quellimmune is estimated at about $100 million, with the company targeting to capture a significant portion of this market [14] Future Outlook - The company is focused on expanding the use of Quellimmune therapy to more pediatric hospital systems and is actively working to reduce revenue variability by increasing the number of sites [14][30] - A new trial for neutralized CRS therapy is set to enroll 20 patients, aiming to demonstrate improvements in renal and cardiac function, which could open new market opportunities [24][25] - The company is optimistic about the potential for Quellimmune to transform outcomes in patients affected by hyperinflammation across various indications [26]