Financial Data and Key Metrics Changes - SeaStar Medical reported net revenue of approximately $183,000 for Q3 2025, an increase from $68,000 in Q3 2024, reflecting a significant growth trajectory [25] - The gross profit margin for Q3 2025 was approximately 92%, marking the first full quarter of cost of goods sold matched against Quellimune unit sales [26] - 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 [26] - The net loss for Q3 2025 was approximately $3.5 million, or $0.13 per share, compared to a net loss of approximately $4.5 million, or $1.10 per share, in Q3 2024 [26][27] - Cash at September 30, 2025, was $13.8 million, a significant increase from $1.8 million at December 31, 2024 [27] Business Line Data and Key Metrics Changes - Quellimune revenue for the first half of Q4 2025 has already exceeded the total revenue for Q3 2025, indicating strong sales momentum [5][10] - The company added three top-ranked children's medical centers to its customer base, enhancing its market presence [4] Market Data and Key Metrics Changes - The total U.S. market for Quellimune therapy is estimated at about $100 million, with the company aiming to capture a significant portion of this market [15] Company Strategy and Development Direction - The company is focused on expanding the use of Quellimune therapy to more pediatric hospitals, with a goal of activating up to 20 new pediatric hospitals to drive product revenue [10] - SeaStar Medical is also pursuing the NEUTRALIZE-AKI trial, with plans to increase enrollment to 339 patients to enhance the statistical power of the study [18][19] - The launch of the NEUTRALIZE-CRS trial aims to evaluate SCD therapy in patients with chronic systolic heart failure, potentially broadening the application of their technology [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future growth opportunities for SeaStar Medical, emphasizing the life-saving potential of Quellimune therapy for critically ill patients [28] - The company is actively working to streamline the adoption process for new target accounts, aiming to reduce barriers to entry for Quellimune therapy [12] Other Important Information - SeaStar Medical raised over $12 million to strengthen its balance sheet and extend its financial runway [8] - The company is committed to reducing costs while achieving strong operational results [8] Q&A Session Summary Question: Update on patient enrollment and site activation for NEUTRALIZE-AKI trial - As of the call, 146 patients were enrolled with 17 sites activated, and the company is working to activate at least eight additional sites to meet the new target of 339 patients by December 2026 [35][36] Question: Details on the new cardiorenal trials - The company expects to enroll at least five sites for the new trial, aiming to complete enrollment of 20 patients within a year, subject to site activation pace [41][42] Question: Clarification on revenue targets for 2025 - Management confirmed that they are on target to achieve over $1 million in revenue for the full year 2025 [43][44]

Financial Data and Key Metrics Changes - The company recorded its highest quarterly revenue to date, achieving a 15% increase in sequential quarter revenue through sales of Quellimmune therapy, with revenue for Q2 2025 at $338,000 compared to approximately $293,000 in Q1 2025 and $0 in Q2 2024 [27] - Year-to-date revenue reached $631,000, attributed to existing customers expanding their usage of Quellimmune and the addition of new hospital customers [27] - The net loss for Q2 2025 declined to $2,000,000 compared to a loss of $3,200,000 in Q2 2024 [28] Business Line Data and Key Metrics Changes - Quellimmune net revenue for Q2 increased 15% sequentially, with a nearly 370% increase in revenue in the first six months of launch compared to the previous year [6][11] - The company added three new customers for Quellimmune since the beginning of Q2, indicating strong enthusiasm for the therapy [10] Market Data and Key Metrics Changes - The total U.S. market opportunity for the adult SCD therapy is estimated to be over $4 billion annually, with a potential patient population of approximately 200,000 facing organ failure [12] - The company has received FDA breakthrough device designation for five additional indications, indicating a significant market potential for adult indications [13] Company Strategy and Development Direction - The company aims to complete the neutralized AKI pivotal trial for adults and prepare to file a PMA following the trial's completion [30] - The broader strategy includes expanding the use of FCD therapy across a range of hyper-inflammatory conditions beyond AKI, targeting both pediatric and adult populations [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future prospects for SeaStar Medical, particularly regarding the adult AKI market and the potential for significant revenue generation [31] - The company is focused on enrolling the right type of patients in clinical trials to demonstrate therapeutic effects effectively [19] Other Important Information - The company raised $12.4 million in new equity capital through public offerings and registered direct offerings [26] - The gross profit margin for Q2 was approximately 92%, reflecting the transition to recognizing COGS as the company moves into commercial operations [28] Q&A Session Summary Question: What are the expectations for the adult AKI pivotal trial? - Management expects to reach full enrollment by the end of the year and plans to file a PMA in 2026 if the data supports it [22][32] Question: How is the company addressing the enrollment pace in clinical trials? - The company is actively adding new sites and expanding screening into additional ICUs to optimize enrollment rates [21][22]

Financial Data and Key Metrics Changes - The company reported a net revenue of $134,000 for 2024, marking the first product revenue from the launch of Quellimmune in Q3 2024 [37] - The net loss for 2024 decreased to $24.8 million from $26.2 million in 2023, with approximately $6.9 million of the loss attributed to non-cash items [40] - The company raised approximately $25 million in 2024 and an additional $6 million in February 2025, improving its balance sheet by reducing debt and liabilities [34][35] Business Line Data and Key Metrics Changes - Quellimmune therapy has shown a 60% higher survival rate in pediatric acute kidney injury patients compared to standard care, with nearly 80% of patients surviving with Quellimmune [16] - The number of pediatric hospitals adopting Quellimmune doubled from Q3 to Q4 2024, with further increases noted in early 2025 [17] - The company anticipates a total addressable market of approximately $100 million for Quellimmune, with expectations of significant market penetration over time [20] Market Data and Key Metrics Changes - The adult AKI market is estimated to be 50 times larger than the pediatric market, with around 200,000 patients annually facing organ failure without FDA-approved treatment options [21] - The projected market opportunity for adult AKI is approximately $4.5 billion, with significant revenue upside expected even with modest market penetration [22] Company Strategy and Development Direction - The company aims to expand its product offerings beyond pediatric AKI to address larger markets, including chronic dialysis and cardiorenal syndrome [21][30] - The strategic shift to a direct sales model is intended to enhance control over the sales process and improve relationships with healthcare providers [36] - The company is focused on completing the adult AKI pivotal trial and preparing for a PMA filing following the trial's completion [41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing significant market opportunities and the potential for growth driven by the successful launch of Quellimmune and ongoing clinical trials [42] - The company is committed to improving clinical outcomes and addressing unmet medical needs in nephrology, as evidenced by recent awards and recognitions [11] Other Important Information - The company received its fourth breakthrough device designation for chronic dialysis and has been recognized with the 2025 Corporate Innovator Award by the National Kidney Foundation [9][11] - The neutralized AKI pivotal trial is progressing with 94 of the anticipated 200 subjects enrolled, with an interim analysis expected after reaching 100 patients [23][24] Q&A Session Summary Question: Update on NEUTRALIZE AKI trial enrollment and interim analysis timeline - Management confirmed that 94 patients have been enrolled and anticipates reaching 100 patients in April, with the interim analysis expected around July or early August [45][49] Question: Plans to expand sales force capabilities in 2025 - The company is currently right-sized for the small market and has a healthy pipeline of new accounts, focusing on operational support and training for hospital staff [50][51] Question: Learnings from initial hospital activations and typical conversion timelines - The company has learned to streamline the IRB process and emphasized the importance of early collaboration between ICU doctors and nephrologists to save time [57][58]