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]

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]