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]

Core Insights - SeaStar Medical Holding Corporation has expanded its QUELIMMUNE™ pediatric Acute Kidney Injury (AKI) customer base and completed key clinical trial milestones, indicating strong momentum in its business operations [1][2][3] Business Updates - The company has added 13 new customers from top-ranked children's hospitals, increasing its total customer base to 16 [3] - Enrollment in the FDA-mandated QUELIMMUNE SAVE Post-Marketing Registry has been completed with 50 patients enrolled [3] - The pivotal NEUTRALIZE-AKI trial for adult patients with AKI has surpassed the 50% enrollment milestone, with 181 out of 339 patients enrolled [3] - A cardio-renal clinical trial has been initiated to further advance the company's pipeline [1][2] Financial Performance - For the three months ended December 31, 2025, net revenue was approximately $420 thousand, a significant increase from $67 thousand in the same period in 2024, driven by product sales to an expanding customer base [5] - The cost of goods sold for the same period was $12 thousand, resulting in a gross margin greater than 90% [6] - Research and development expenses decreased to $2.2 million from $2.7 million year-over-year, primarily due to reduced consulting and personnel costs [7] - General and administrative expenses also decreased to approximately $1.2 million from $2.1 million, reflecting lower personnel and consulting costs [9] - The net loss for the three months ended December 31, 2025, was approximately $2.9 million, or $0.80 per share, compared to a net loss of approximately $4.4 million, or $8.98 per share, in the same period in 2024 [11] Future Outlook - The company anticipates achieving approximately $2 million in net product revenue in 2026 [8] - Plans to submit a modular Premarket Application (PMA) to expedite the FDA review process for the SCD therapy are underway [8] - The NEUTRALIZE-AKI pivotal trial is expected to complete enrollment by the end of 2026 [8] - The company aims to explore additional regulatory pathways for the SCD therapy to facilitate rapid commercialization [8]

SeaStar Medical Conference Summary Company Overview - **Company Name**: SeaStar Medical - **Ticker Symbol**: ICU (NasdaqCM) - **Focus**: Treating hyperinflammation in critically ill patients, particularly those facing organ failure or life-threatening conditions such as Acute Kidney Injury and cardiovascular diseases [4][5] Core Products and Pipeline - **FDA-Approved Product**: QUELIMMUNE for Children - **Pipeline**: Includes the Selective Cytopheretic Device (SCD), which has received Breakthrough Device designation from the FDA for various applications [4][5] - **Market Opportunity**: Approximately 1 million patients annually could benefit from SCD, with significant revenue potential from capturing even a modest market share [5] Clinical Data and Efficacy - **SCD Mechanism**: A therapeutic medical device that neutralizes overactive immune cells, reducing mortality and dialysis dependency [6][10] - **Pediatric Study Results**: - Registration study with 22 patients showed a 50% improvement in survival rates (from 50% to 77%) and no long-term dialysis patients at Day 60 [14][15] - SAVE Registry confirmed similar results in real-world settings, with a reduction in mortality and dialysis dependency [15][16] - **Regulatory Updates**: FDA approved a reduction in the number of patients required for the SAVE Registry from 300 to 50, with 50 patients now enrolled [17][18] Commercial Strategy - **Customer Base Growth**: - End of 2024: 2 active customers - End of 2025: 10 customers - Goal for 2026: Double the customer base [22] - **Target Market**: Focus on the top 50 children's hospitals in the U.S., which represent half of the eligible patient population [22][23] Ongoing Trials - **NEUTRALIZE-AKI Trial**: - A randomized controlled study with 339 patients, currently 40% enrolled [25] - Primary endpoints include mortality rates and dialysis dependency [26] - Expected to complete enrollment by the end of 2026, with top-line data available in the first half of 2027 [29] Competitive Advantage - **Comparison with Standard Care**: Current standard of care (Continuous Renal Replacement Therapy) has a 50% mortality rate and is not disease-modifying. SCD aims to improve outcomes significantly [34] - **Economic Benefits**: QUELIMMUNE can reduce ICU length of stay and overall healthcare costs, potentially saving hospitals $40,000 to $50,000 per patient [35] Future Opportunities - **Cardiorenal Syndrome**: SCD may help patients bridge to LVAD or transplant by reducing inflammation [37] - **Regulatory Pathways**: Plans to submit modular pieces for PMA to expedite the approval process [30][31] Financial Overview - **Revenue Projections**: Expected to generate over $1 million in revenue for QUELIMMUNE in 2025, with a goal to double that in 2026 [40] - **Cash Position**: As of November, approximately $13.5 million in cash, with a monthly burn rate of $1 million to $1.3 million [41] Key Milestones for Investors - Completion of NEUTRALIZE-AKI enrollment - Doubling the customer base for QUELIMMUNE - Progress in NEUTRALIZE-CRS study and potential regulatory applications [50][51]

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]