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]

Financial Data and Key Metrics Changes - The company reported a fourfold increase in net revenue for the first quarter of 2025, achieving $293,000 compared to approximately $68,000 in the fourth quarter of 2024 and $0 in the first quarter of the previous year [31][34] - The net loss for the first quarter of 2025 declined to $3,700,000 compared to a loss of $12,700,000 in the first quarter of 2024 [34] Business Line Data and Key Metrics Changes - The Quellimmune therapy saw increased adoption, driving revenue growth, with all existing customers purchasing the therapy during the quarter [31][32] - The company anticipates that sales will be lumpy initially but expects an overall trend of revenue increases as more hospitals adopt Quellimmune therapy [31] Market Data and Key Metrics Changes - The pediatric AKI market is estimated to have about 4,000 patients annually in the U.S., representing a total annual market opportunity of approximately $100,000,000 [12][13] - The adult AKI market is significantly larger, with over 200,000 adults affected, translating to a total annual market opportunity of about $4,500,000,000 in the U.S. [7][18] Company Strategy and Development Direction - The primary goal for the year is to grow the customer base for Quellimmune therapy, focusing on top pediatric medical facilities [13][15] - The company is also focused on penetrating the adult AKI market and expanding its pipeline with additional breakthrough device designations for various indications [10][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future opportunities for SeaStar Medical, particularly in capturing a significant portion of the adult AKI market [37] - The company is committed to providing life-saving therapy to critically ill patients and plans to file a PMA in 2026 if clinical trial results are supportive [37] Other Important Information - The Neutralize AKI trial has reached the 50% enrollment milestone, which will trigger an interim analysis by the independent Data Safety Monitoring Board [9][21] - The company has strengthened its balance sheet with new capital and maintained careful attention to spending [30] Q&A Session Summary Question: How many sites are currently activated for the adult clinical trial? - The company currently has 15 activated sites and plans to activate another five over the next three months [39] Question: What is the total number of pediatric hospitals that you have as customers currently? - The company has six commercially active sites and multiple others moving through the IRB process [40] Question: What sort of pipeline growth have you seen in the first quarter compared to the fourth quarter? - The growth is attributed to the experience of existing sites and word-of-mouth, with hospitals showing interest in adopting Quellimmune therapy [42][44] Question: How important are the two additional breakthrough designations and how are you prioritizing the regulatory processes? - The company views cardiac surgery as a significant opportunity and plans to pursue additional clinical trials, potentially funded by grants [46][48]