Drive adoption of QUELIMMUNE for ultra-rare pediatric AKI, expanding revenue and doubling the customer base Advance SeaStar Medical’s first-in-class SCD therapy for the adult AKI indication – a potential $4.5 billion market – through completion of enrollment of the NEUTRALIZE-AKI pivotal trial and initiation of the PMA process Progress the clinical development of the SCD therapy in patients with severe heart failure Leverage rapid pathways to commercialization of the SCD therapy through additional FDA Human ...

Core Viewpoint - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure, with a significant emphasis on its QUELIMMUNE therapy for acute kidney injury [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to addressing organ failure in critically ill patients [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury due to sepsis in pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] Upcoming Events - Eric Schlorff, CEO of SeaStar Medical, will present at the Biotech Showcase 2026 Investor Conference on January 13, 2026 [1] - The live presentation will be accessible on the company's website, with a replay available for 30 days post-event [2] - SeaStar Medical's management will also engage with investors during the J.P. Morgan Healthcare Conference from January 12-14, 2026 [2] Clinical Trials - The company is conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury requiring continuous renal replacement therapy, a condition affecting over 200,000 adults in the U.S. annually [3]

U.S. stock futures were mostly lower this morning, with the Nasdaq 100 futures slipping around 0.1% on Wednesday.Shares of SeaStar Medical Holding Corp (NASDAQ:ICU) fell sharply in pre-market trading after the company announced a 1-for-10 reverse split.SeaStar Medical Holding shares dipped 9.5% to $0.21 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Coincheck Group NV (NASDAQ:CNCK) dipped 11% to $2.28 in pre-market trading.Ascent Solar Technologies, Inc. (NASDAQ:ASTI) di ...

U.S. stock futures were mostly lower this morning, with the Nasdaq 100 futures slipping around 0.1% on Wednesday.Shares of SeaStar Medical Holding Corp (NASDAQ:ICU) fell sharply in pre-market trading after the company announced a 1-for-10 reverse split.SeaStar Medical Holding shares dipped 9.5% to $0.21 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Coincheck Group NV (NASDAQ:CNCK) dipped 11% to $2.28 in pre-market trading.Ascent Solar Technologies, Inc. (NASDAQ:ASTI) di ...

DENVER, Dec. 23, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today the Company’s 1-for-10 reverse stock split (Reverse Split), which will become effective as of 12:01 a.m. Eastern Time on January 5, 2026. The Company’s common stock will begin trading on a post-split adjusted basis on The Nasdaq Capital Market (Nasdaq) ...

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients Compelling efficacy data to date along with completion of registry expected to expand QUELIMMUNE market opportunity DENVER, Dec. 02, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Ad ...

Core Insights - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][3] - The company will present at NobleCon21 on December 3, 2025, highlighting its advancements and products [1][2] Company Overview - SeaStar Medical is a commercial-stage healthcare company with a focus on critically ill patients [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury (AKI) in critically ill pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] - The company is conducting a pivotal trial for its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the U.S. annually [3]

Core Insights - SeaStar Medical Holding Corporation has appointed Michael Messinger as Chief Financial Officer, bringing over 25 years of healthcare industry experience to the company [1][2] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [4] - The company's first commercial product, QUELIMMUNE (SCD-PED) therapy, is FDA approved for life-threatening acute kidney injury (AKI) in critically ill pediatric patients [4] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [4] Leadership and Experience - Michael Messinger has extensive experience in financing and accounting for drug discovery and development organizations, previously serving as CFO of ContraFect Corporation [2] - He has successfully led companies through significant financial milestones, including a Nasdaq IPO and securing a $90 million contract with BARDA [2] Product and Market Potential - The QUELIMMUNE therapy has shown remarkable commercial results in pediatric AKI patients and aims to expand to address multiple indications [3] - SeaStar Medical is conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a condition affecting over 200,000 adults in the U.S. annually [4]

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]

Revenue Performance - SeaStar Medical reported a revenue of $0.9 million from the sale of QUELIMMUNE since receiving FDA approval in February 2024, with the first commercial units shipped in July 2024[149]. - For the three months ended September 30, 2025, revenue increased by 169% to $183,000 compared to $68,000 in the same period in 2024[159]. - Revenue for the nine months ended September 30, 2025, increased to $814,000, a 1097% increase compared to $68,000 for the same period in 2024[166]. - Gross profit for the nine months ended September 30, 2025, was $773,000, up 1037% from $68,000 in 2024[166]. Expenses and Losses - The company incurred a net loss of $3.472 million for the three months ended September 30, 2025, a decrease of 23% from a net loss of $4.478 million in the same period in 2024[159]. - Research and development expenses decreased by 21% to $1.85 million for the three months ended September 30, 2025, compared to $2.336 million in the same period in 2024[159]. - General and administrative expenses decreased by 13% to $1.898 million for the three months ended September 30, 2025, compared to $2.188 million in the same period in 2024[159]. - The total operating expenses for the three months ended September 30, 2025, were $3.748 million, a reduction of 17% from $4.524 million in the same period in 2024[159]. - Net loss for the nine months ended September 30, 2025, was approximately $9.2 million, a reduction of 55% compared to a net loss of $20.4 million in 2024[172]. - Total operating expenses for the nine months ended September 30, 2025, were $9.9 million, a decrease of 24% from $13.1 million in 2024[166]. Cash and Financial Position - As of September 30, 2025, the company had cash reserves of $13.8 million, a significant increase from $1.8 million as of December 31, 2024[145]. - The accumulated deficit as of September 30, 2025, was $148.8 million, up from $139.6 million as of December 31, 2024[144]. - The company recorded no provision for income taxes for the three months ended September 30, 2025, and September 30, 2024[164]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $9.5 million, a decrease of $1.8 million compared to $11.3 million for the same period in 2024[182]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $21.5 million, primarily from the issuance of new shares of common stock ($14.3 million) and proceeds from pre-funded warrants ($5.9 million)[183]. Clinical Development and Future Outlook - The company is conducting a pivotal clinical trial for its adult SCD therapy, which is crucial for future revenue generation[150]. - SeaStar Medical's SCD therapy has the potential to address a market of over one million patients annually facing life-threatening hyperinflammatory conditions[143]. - The company expects to incur significant expenses for the clinical development of its adult SCD and commercialization of QUELIMMUNE, necessitating additional funding[179]. - The company anticipates that its future funding requirements will depend on the progress of clinical trials and regulatory approvals[179]. Concerns and Commitments - The company has raised concerns about its ability to continue as a going concern due to insufficient cash to meet working capital and capital expenditure requirements for at least twelve months[175]. - As of September 30, 2025, the company has unused available capacity on the ATM Facility that allows for potential capital raising of approximately $2.2 million[176]. - The company does not plan to include potential cash proceeds from the exercise of warrants in its liquidity projections as of the date of the Quarterly Report[178]. - The company has no contractual obligations or commitments outstanding as of September 30, 2025[181]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay compliance with certain accounting standards[187].