Financial Data and Key Metrics Changes - SeaStar Medical reported net revenue of over $1 million from QUELIMMUNE sales in 2025, a significant increase from $135,000 in 2024, reflecting the first full year of product sales [22][24] - The gross profit margin for QUELIMMUNE sales was above 90% for both the fourth quarter and the full year [22][24] - Operating expenses decreased to $3.4 million in Q4 2025 from $4.8 million in Q4 2024, and for the full year, they were reduced to $13.4 million from $18 million [23][24] - The net loss for Q4 2025 was approximately $2.9 million, compared to a net loss of $4.4 million in Q4 2024 [24] Business Line Data and Key Metrics Changes - QUELIMMUNE net revenue in Q4 2025 was $315,000, compared to $67,000 in Q4 2024, with first quarter 2026 revenue already exceeding this figure [20][22] - The company added 13 new customers from top-rated children's hospitals, bringing the total customer base to 16 [3][4] - The SCD therapy is currently in the NEUTRALIZE-AKI pivotal trial, with 181 of the 339 patients enrolled [4][14] Market Data and Key Metrics Changes - The pediatric AKI market is estimated to be around $100 million, with SeaStar targeting the top 50 children's hospitals in the U.S. [12] - The company plans to add 15 new top-ranked children's medical centers in 2026, aiming for $2 million in product revenue from QUELIMMUNE sales [7][12] Company Strategy and Development Direction - SeaStar Medical aims to advance the SCD therapy for adult AKI, with a market opportunity 50 times that of the pediatric AKI market [5][8] - The company is focused on expanding QUELIMMUNE adoption and evaluating broader applicability of SCD therapy in new indications [7][8] - The company has received Breakthrough Device Designation from the FDA for SCD therapy, which may expedite the approval process [4][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting strong momentum in the pediatric market and plans for further expansion [6][25] - The company is committed to maintaining good cost controls and improving its balance sheet, having added approximately $24 million in capital during 2025 [4][24] - Management emphasized the importance of QUELIMMUNE in saving lives and its potential to improve outcomes in critically ill pediatric patients [17][46] Other Important Information - The company has no long-term debt and approximately $12 million in cash as of December 31, 2025, compared to $1.8 million at the end of 2024 [24] - The SAVE registry, which tracks the commercial use of QUELIMMUNE therapy, has completed enrollment of 50 patients, with positive early results reported [16][17] Q&A Session Summary Question: Confidence in QUELIMMUNE adoption in additional centers - Management expressed confidence in adding 15 new pediatric centers, having already added six in Q1 2026, and highlighted the importance of the SAVE registry in facilitating quicker site activation [28][29] Question: Manufacturing capacity for SCD - Management assured that the supply chain for SCD is robust, with contract manufacturer Fresenius Medical capable of meeting demand for both pediatric and adult indications [30] Question: Timeline for CRS study and next steps - Management did not provide specific timelines for the CRS study but indicated that a successful study could lead to a humanitarian device exemption for commercialization [32] Question: Spending outlook for 2026 - Management expects spending to align more with 2025 levels, supported by a capable team to execute the commercial and clinical plans [34][35] Question: Insights from NEUTRALIZE-AKI trial - Management indicated that while specific clinical insights from the 181 enrolled patients cannot be shared yet, there is enthusiasm about the trial's progress and the addition of new clinical sites [40][42] Question: Pediatric AKI outcomes and sales strategy - Management highlighted the positive outcomes from the SAVE trial and confirmed that no additional sales representatives will be added, focusing instead on enhancing clinical representation within existing hospitals [48][49]

Financial Data and Key Metrics Changes - SeaStar Medical reported net revenue of over $1 million from QUELIMMUNE sales in 2025, a significant increase from $135,000 in 2024, reflecting the first full year of product sales [22][20] - The gross profit margin for QUELIMMUNE sales was above 90% for both the fourth quarter and the full year [22][24] - Operating expenses decreased to $3.4 million in Q4 2025 from $4.8 million in Q4 2024, and for the full year, they were reduced to $13.4 million from $18 million [23][24] - The net loss for Q4 2025 was approximately $2.9 million, compared to a net loss of $4.4 million in Q4 2024 [24] Business Line Data and Key Metrics Changes - QUELIMMUNE net revenue in Q4 2025 was $315,000, compared to $67,000 in Q4 2024, with first quarter 2026 revenue already exceeding this figure [20][9] - The SCD therapy generated $105,000 in revenue from the AREVA Research Institute in Q4 2025, marking the first of two orders [21] Market Data and Key Metrics Changes - The pediatric AKI market is estimated to be around $100 million, with SeaStar targeting the top 50 children's hospitals in the U.S. [12] - The company aims to add 15 new top-ranked children's medical centers in 2026, building on the momentum from existing customer orders [7][9] Company Strategy and Development Direction - SeaStar Medical plans to advance the SCD therapy for adult AKI, with a market opportunity 50 times larger than the pediatric AKI market [5] - The company is focused on expanding QUELIMMUNE adoption and evaluating broader applicability for SCD therapy in new indications [7][8] - The strategy includes working with the FDA for expedited approval of pipeline indications, leveraging Breakthrough Device Designation [8][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting strong momentum in the pediatric market and the potential for significant revenue growth [5][9] - The company is committed to completing enrollment in the NEUTRALIZE-AKI pivotal trial by the end of 2026, with top-line results expected in mid-2027 [14][15] Other Important Information - SeaStar Medical improved its balance sheet by adding approximately $24 million in capital during 2025 and reducing operating liabilities by over $3 million [4][24] - The company has no long-term debt and reported approximately $12 million in cash as of December 31, 2025, compared to $1.8 million at the end of 2024 [24] Q&A Session Summary Question: Confidence in QUELIMMUNE adoption in additional centers - Management highlighted the addition of six sites in Q1 2026 and a structured approach to onboarding new hospitals, with expectations for continued momentum [28][29] Question: Manufacturing capacity for SCD - Management expressed confidence in the supply chain and production capacity through their contract manufacturer, Fresenius Medical [30] Question: Timeline for CRS study and next steps - Management did not provide specific timelines but indicated ongoing activation of clinical sites and potential for humanitarian device exemption for successful studies [31][32] Question: Spending outlook for 2026 - Management anticipates spending to align more with 2025 levels, supported by a capable team to execute the commercial and clinical plans [34][35] Question: Insights from treated patients in NEUTRALIZE-AKI trial - Management refrained from sharing specific clinical insights but noted the importance of best practices shared among investigators to enhance enrollment [40][41] Question: Pediatric AKI outcomes and sales strategy - Management emphasized the positive outcomes from QUELIMMUNE and indicated no plans to add sales personnel, focusing instead on enhancing clinical representation within existing hospitals [43][48]

Financial Data and Key Metrics Changes - SeaStar Medical reported net revenue of over $1 million from QUELIMMUNE sales in 2025, a significant increase from $135,000 in 2024 [21][24] - The fourth quarter of 2025 saw net revenue from QUELIMMUNE sales of approximately $315,000, compared to $67,000 in the fourth quarter of 2024 [19][24] - Gross profit margins for QUELIMMUNE sales were above 90% [4][22] - Operating expenses decreased to $3.4 million in Q4 2025 from $4.8 million in Q4 2024, and for the full year, operating expenses were reduced to $13.4 million from $18 million [23][24] - The net loss for Q4 2025 was approximately $2.9 million, or $0.80 per share, compared to a net loss of $4.4 million, or $8.98 per share in Q4 2024 [23][24] - The company improved its balance sheet by adding approximately $24 million in capital during 2025 and reducing operating liabilities by over $3 million [4][24] Business Line Data and Key Metrics Changes - The QUELIMMUNE therapy expanded its customer base to 16, adding 13 new customers from top-rated children's hospitals [3][4] - The SCD therapy is currently in the NEUTRALIZE-AKI pivotal trial, with 181 of the 339 patients enrolled, achieving over 50% enrollment [4][13] - The company plans to achieve $2 million in product revenue from QUELIMMUNE sales in 2026, a significant increase over 2025 [6] Market Data and Key Metrics Changes - The pediatric AKI market is estimated to be around $100 million, with SeaStar targeting the top 50 children's hospitals in the U.S. [12] - The market opportunity for the adult AKI indication is projected to be 50 times larger than that of the pediatric AKI market [5] Company Strategy and Development Direction - SeaStar Medical aims to advance the SCD therapy for adult AKI and complete enrollment in the NEUTRALIZE-AKI trial by the end of 2026 [5][6] - The company is also exploring broader applicability for the SCD therapy in new indications, including acute congestive heart failure [6][18] - The strategy includes working with the FDA for expedited approval of pipeline indications, leveraging Breakthrough Device Designation [8][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future potential revenue from the SCD therapy and the ongoing momentum in the pediatric market [5][6] - The management highlighted the importance of QUELIMMUNE in saving lives and its validation in the pediatric AKI field [9][10] - The company is focused on expanding its customer base and enhancing the adoption of QUELIMMUNE therapy [12][51] Other Important Information - SeaStar Medical has no long-term debt and approximately $12 million in cash as of December 31, 2025, compared to $1.8 million at the end of 2024 [24][25] - The company is actively enrolling patients in the NEUTRALIZE-CRS clinical trial for chronic heart failure and cardiorenal syndrome [18] Q&A Session Summary Question: What gives confidence in adding 15 additional pediatric centers for QUELIMMUNE? - Management noted that six sites have already been added in Q1 2026 and emphasized a structured approach to the adoption process [28][30] Question: Is there a need for investment in manufacturing capacity for SCD? - Management expressed confidence in the supply chain and production capacity through their contract manufacturer, Fresenius Medical [31] Question: What are the timelines for the CRS study and next steps if positive? - Management did not provide specific timelines but indicated that a successful study could lead to a humanitarian device exemption for the CRS indication [32][33] Question: How should spending be viewed for this year? - Management indicated that spending would be more in line with 2025 levels, supported by the existing team to execute the plan [34][35]

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 a total annual U.S. market opportunity of approximately $100,000,000 based on a pediatric AKI population of about 4,000 patients [14] Market Data and Key Metrics Changes - The adult AKI market represents a significant opportunity with over 200,000 adults affected, translating to a total annual market opportunity of about $4,500,000,000 in the U.S. [9][18] - The company is focusing on the top 50 pediatric sites in the U.S. for Quellimmune therapy adoption, with a strong interest from these institutions [15][16] Company Strategy and Development Direction - The primary goal for 2025 is to grow the customer base for Quellimmune therapy and complete the neutralized AKI pivotal trial [5][11] - The company aims to file a PMA for the adult AKI indication in 2026, contingent on positive trial results [27][37] - The strategic goal includes expanding the addressable market to target other critical unmet medical needs for treating destructive hyperinflammation [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future opportunities for SeaStar Medical, highlighting the potential to capture a significant portion of the adult AKI market [37] - The company is focused on maintaining careful attention to spending while pushing forward with its commercial launch and clinical trials [30][34] Other Important Information - The neutralized AKI trial has reached the 50% enrollment milestone, triggering an interim analysis by the independent Data Safety Monitoring Board [10][21] - The company has received breakthrough device designations for five other indications, indicating a robust pipeline for future growth [28] 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's 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 [41] 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 actively engaging in adopting Quellimmune therapy [42][44] Question: How important are the two additional breakthrough designations? - The company views cardiac surgery as a significant opportunity and plans to pursue additional clinical trials funded by grants and investigator-initiated studies [48][51]

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]