SeaStar Medical Holding (ICU) Q2 2025 Earnings Call August 13, 2025 04:30 PM ET Speaker0Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical Second Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Due to the speakers' remarks, there will be a question and answer session.To ask a question, simply press star followed by the number one on your ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39927 SEASTAR MEDICAL HOLDING CORPORATION (Exact name of Registrant as specified in its Charter) Delaware 85-3681132 (State or ot ...

Business highlights include: Adult NEUTRALIZE-AKI trial enrolls 31 new patients, now over 60% enrolledThree new top-rated children’s hospitals adopt QUELIMMUNE therapy for ultra-rare pediatric Acute Kidney Injury (AKI)Positive survival results reported from QUELIMMUNE SAVE Surveillance RegistryWebcast call today at 4:30 p.m. Eastern Time DENVER, Aug. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for cr ...

Core Points - SeaStar Medical has successfully enrolled 125 out of 200 anticipated patients in the NEUTRALIZE-AKI pivotal clinical trial, achieving over 60% enrollment [1][4] - The company has activated a new clinical trial site at Methodist Hospital Metropolitan in San Antonio, Texas, bringing the total to 16 sites [1][3] - An interim analysis of the first 100 patients is expected in the third quarter of 2025, conducted by the independent Data Safety Monitoring Review Board (DSMB) [2][4] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [10] - The company's Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation from the FDA for six indications, including treatment for adult AKI requiring continuous renal replacement therapy (CRRT) [8][10] - SeaStar's first commercial product, QUELIMMUNE (SCD-PED), was approved by the FDA in 2024 for treating life-threatening acute kidney injury (AKI) in critically ill pediatric patients [10] Clinical Trial Details - The NEUTRALIZE-AKI trial aims to enroll up to 200 adult patients with AKI requiring CRRT, with a primary endpoint of 90-day mortality or dialysis dependency [4][5] - Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year [4] - The trial's interim analysis will assess the primary endpoint when approximately 50% of patients have completed the 90-day follow-up [5] Technology and Treatment - The SCD therapy is designed to neutralize over-active immune cells and mitigate hyperinflammation, which can lead to multi-organ dysfunction [9] - This therapy is integrated with existing CRRT systems to selectively target proinflammatory monocytes and promote a reparative state [9] - The SCD therapy has potential applications in multiple acute and chronic kidney and cardiovascular diseases, addressing a significant unmet medical need [9]

Core Points - SeaStar Medical Holding Corporation has entered into a definitive agreement for the issuance and sale of 4,960,544 shares of common stock at a price of $0.887 per share, along with unregistered warrants to purchase an equal number of shares at an exercise price of $0.762 [1][2] - The gross proceeds from this offering are expected to be approximately $4.4 million, which will be used for general corporate purposes, including working capital and capital expenditures [2] - The offering is being conducted under a shelf registration statement previously filed with the SEC, and the shares are being offered only by means of a prospectus [3] Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first commercial product, QUELIMMUNE, approved by the FDA in 2024 for life-threatening acute kidney injury in pediatric patients [6] - The company’s Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation from the FDA for six therapeutic indications, which may facilitate faster approval and better reimbursement dynamics [6] - SeaStar Medical is currently conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury, a condition affecting over 200,000 adults in the U.S. annually [6]

Core Insights - SeaStar Medical Holding Corporation announced positive preliminary results from the SAVE Surveillance Registry for its QUELIMMUNE therapy, showing a 75% survival rate among the first 20 pediatric patients treated for life-threatening Acute Kidney Injury (AKI) and sepsis [1][3] - The therapy is expected to validate or exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine [1][9] - QUELIMMUNE therapy has been adopted by leading children's medical centers in the U.S. and is designed to treat hyperinflammation that leads to organ failure [4][12] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure, with QUELIMMUNE being its first commercial product approved in 2024 [13] - The company has received FDA Breakthrough Device Designation for QUELIMMUNE and five other therapeutic indications, facilitating a faster approval process [13] - The QUELIMMUNE therapy is specifically for pediatric patients with AKI due to sepsis, requiring Renal Replacement Therapy (RRT) [8] Clinical Trials and Data - The SAVE Surveillance Registry is a Real-World Evidence program aimed at confirming the safety and efficacy of QUELIMMUNE, with plans to collect data from up to 300 patients [3] - Additional analyses of preliminary results will be submitted to a pediatric nephrology conference, including 60-day and 90-day survival results [2] - The NEUTRALIZE-AKI pivotal trial is currently evaluating the safety and efficacy of the Selective Cytopheretic Device (SCD) therapy in adults with AKI [11] Treatment Mechanism - The Selective Cytopheretic Device (SCD) therapy targets overactive immune cells to mitigate destructive hyperinflammation, potentially promoting long-term organ recovery [12] - The therapy integrates with existing CRRT systems to selectively transition pro-inflammatory monocytes to a reparative state [12] Market Impact - The initial results from the SAVE Surveillance Registry are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [3] - The therapy's success could lead to significant healthcare cost savings by reducing prolonged ICU stays and reliance on dialysis [5]

Core Insights - SeaStar Medical Holding Corporation has expanded its QUELIMMUNE therapy user base by adding a recognized Texas-based children's hospital, which is significant for treating pediatric patients with ultra-rare Acute Kidney Injury (AKI) [1][5] - The QUELIMMUNE therapy was approved by the FDA in 2024 under a Humanitarian Device Exemption to address life-threatening AKI due to sepsis or septic conditions [1][5] - The SAVE Surveillance Registry has been established to monitor safety and outcomes for pediatric patients treated with QUELIMMUNE compared to standard care, with early data analysis expected to be presented at an upcoming medical conference [2][3] Company Developments - SeaStar Medical is making progress in introducing QUELIMMUNE to top children's hospitals in the U.S. and is collecting significant data on its performance through the SAVE Surveillance Registry [3] - The company is conducting the NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of the Selective Cytopheretic Device (SCD) therapy in adults with AKI, with 119 out of 200 planned subjects enrolled [3][9] - SeaStar Medical has received FDA Breakthrough Device Designation for QUELIMMUNE and five other indications, which may facilitate faster approval and better reimbursement dynamics [11] Clinical Outcomes - Data from clinical studies indicate a 77% survival rate for patients treated with QUELIMMUNE, representing a 50% reduction in loss of life compared to historical data, with 87.5% of survivors achieving normal kidney function by Day 60 post-ICU discharge [7] - The NEUTRALIZE-AKI trial's primary endpoint includes a composite of 90-day mortality or dialysis dependency, with secondary endpoints assessing various health outcomes [9] Industry Context - AKI is characterized by a sudden loss of kidney function and can lead to severe complications, including multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4] - The QUELIMMUNE therapy is specifically designed for pediatric patients weighing 10 kilograms or more who are on antibiotics and receiving Renal Replacement Therapy in the ICU [5][10] - SeaStar Medical's SCD therapy aims to modulate the immune response to prevent destructive hyperinflammation, which is critical for improving outcomes in patients with AKI and other related conditions [10]

Core Viewpoint - SeaStar Medical Holding Corporation has announced a definitive agreement for the issuance and sale of 5,242,464 shares of common stock at a price of $0.763 per share, along with unregistered warrants to purchase an equal number of shares at an exercise price of $0.638, aiming to raise approximately $4 million for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes a registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement for unregistered warrants [1][2]. - The gross proceeds from the offering are expected to be around $4 million, with net proceeds intended for general corporate purposes, including working capital and capital expenditures [2]. Group 2: Regulatory and Compliance Information - The shares are being offered under a shelf registration statement previously filed with the SEC, which became effective on December 22, 2023 [3]. - The unregistered warrants are not registered under the Securities Act and cannot be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved by the FDA in 2024 for life-threatening acute kidney injury in pediatric patients [6]. - The company’s Selective Cytopheretic Device therapy has received Breakthrough Device Designation for six therapeutic indications, indicating a potential for expedited approval processes [6]. - SeaStar is conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury, a condition affecting over 200,000 adults in the U.S. annually [6].

Core Insights - SeaStar Medical Holding Corporation has introduced QUELIMMUNE therapy at Texas Children's Hospital, which is a potential life-saving treatment for pediatric patients with acute kidney injury (AKI) due to sepsis [1][2] - The QUELIMMUNE therapy has shown a 77% survival rate compared to standard care, indicating a 50% reduction in loss of life in this patient population [1][4] - The therapy is designed to neutralize over-active immune cells and mitigate hyperinflammation, which is critical in treating AKI [2][8] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [9] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI in critically ill pediatric patients [9] - The company has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process [9] Clinical Data and Trials - Clinical data published in Kidney Medicine supports the efficacy of QUELIMMUNE, showing no dialysis required for survivors at Day 60 post-ICU discharge [1][6] - SeaStar Medical is conducting the NEUTRALIZE-AKI pivotal trial to evaluate the safety and efficacy of SCD therapy in adults with AKI [3][7] - The primary endpoint of the NEUTRALIZE-AKI trial includes a composite of 90-day mortality or dialysis dependency [7] Market Impact - The introduction of QUELIMMUNE addresses a significant unmet need for organ-sparing therapies in pediatric patients [2] - The therapy aims to reduce healthcare costs associated with prolonged ICU stays and reliance on dialysis [3] - SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric AKI treatment [6]

Company Overview - Medical Holding Corporation (Nasdaq: ICU) has confirmed compliance with the minimum $2.5 million stockholders' equity requirement for continued listing on The Nasdaq Capital Market, closing the previously disclosed listing matter [1] - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first commercial product QUELIMMUNE approved in 2024 for pediatric patients with AKI due to sepsis [9] Product and Therapy Details - QUELIMMUNE therapy is designed for children with AKI and sepsis, showing a 77% survival rate compared to standard care, which represents a 50% reduction in loss of life [4] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize over-active immune cells and mitigate hyperinflammation, with applications in various acute and chronic kidney and cardiovascular diseases [7][8] Clinical Trials and Research - The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of SCD therapy in 200 adults with AKI, focusing on 90-day mortality and dialysis dependency as primary endpoints [6] - The trial will also assess secondary endpoints including mortality at 28 days and major adverse kidney events at Day 90 [6] Awards and Recognition - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to improving the lives of pediatric patients with AKI [5]