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]