Seastar Medical Holding Corporation
08/14/2025 | Press release | Distributed by Public on 08/14/2025 07:07
Amendment to Current Report (Form 8-K/A)
SeaStar Medical Reports Second Quarter 2025 Financial Results and
Provides Business Updates
Business highlights include:
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Adult NEUTRALIZE-AKI trial enrolls 31 new patients, now over 60% enrolled
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Three new top-rated children's hospitals adopt QUELIMMUNE therapy for ultra-rare pediatric Acute Kidney Injury (AKI)
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Positive survival results reported from QUELIMMUNE SAVE Surveillance Registry
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Webcast call today at 4:30 p.m. Eastern Time
DENVER, CO (August 13, 2025) - 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 financial results for the three months ended June 30, 2025, and provided business updates on key initiatives.
"Since the beginning of the second quarter, we have made great progress on several fronts," said Eric Schlorff, CEO of SeaStar Medical. "We enrolled 31 additional patients in the NEUTRALIZE-AKI trial, reported three new QUELIMMUNE customers from top-rated U.S.-based children's hospitals, announced positive survival results for the first 20 pediatric patients treated in a commercial setting with QUELIMMUNE from the SAVE Surveillance Registry, and raised additional capital to shore up our balance sheet."
Mr. Schlorff continued, "We are now focused on several important upcoming, value-creating milestones. These include the interim results for the first 100 patients in the NEUTRALIZE-AKI trial, presentation of additional data from the SAVE Surveillance Registry, and the onboarding of other notable children's hospitals to our customer list. Also, assuming a successful outcome from our NEUTRALIZE-AKI trial, in 2026 we plan to file our Pre-Marketing Approval (PMA) application for our Selective Cytopheretic Device (SCD) therapy as an organ-sparing and life-saving treatment for adult patients with Acute Kidney Injury (AKI) requiring continuous renal replacement therapy (CRRT)."
Key Business Highlights
Since the beginning of the second quarter, SeaStar Medical's key business updates include the following:
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Achieved the 50% patient enrollment milestone (100 patients) in the NEUTRALIZE-AKI pivotal clinical trial, triggering the interim analysis, and subsequently increased total enrollment to 125
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of 200 total anticipated patients. Recommendations from the per protocol prespecified interim analysis by the trial's independent Data Safety Monitoring Review Board (DSMB) are expected to be provided to the Company in the third quarter of 2025.
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Broadened the QUELIMMUNE customer base, securing three new customers from top-rated children's hospitals.
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Reported positive survival data from the SAVE Surveillance Registry, evaluating the QUELIMMUNE therapy in the first 20 critically ill pediatric patients with life-threatening AKI and sepsis or a septic condition in the commercial setting. The preliminary results showed no device related safety events with the QUELIMMUNE therapy and 75% of patients survived through 28 days. These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported previously in Kidney Medicine.
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Received agreement from the U.S. Centers for Medicare & Medicaid Services (CMS) to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the NEUTRALIZE-CRS investigational clinical trial - a rare award with less than 100 clinical trials covered annually.
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Announced that a $2 million United States Department of Defense (DoD) grant was awarded to The Autonomous Reanimation and Evacuation (AREVA) Research Institute to support a three-year research study that will explore the application of SeaStar Medical's SCD therapy to reduce hyperinflammation in warfighters after severe burns, inhalation injury, and infection. The grant is one of four selected out of 160 total submissions by the 2024 Military Burn Research Program and represents cutting-edge research for extracorporeal immunomodulation to reduce inflammation after severe burns, inhalation injury, and septicemia.
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Implemented additional cost-saving measures to increase the company's financial runway and focus its cash resources on the development of its SCD therapy for adult patients with AKI requiring CRRT, an annual U.S. market opportunity that is 50 times larger than the U.S. pediatric AKI market.
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Raised $12.4 million in gross proceeds, before deducting offering-related expenses, through a public offering in June 2025 and two registered direct offerings in July and August 2025. These offerings were priced at-the-market and proceeds will support the company's ongoing operations into 2026.
Financial Results for the Second Quarter 2025
Net revenue for the three months ended June 30, 2025, was approximately $0.3 million, reflecting sales of the QUELIMMUNE pediatric SCD therapy that was approved under a Humanitarian Device Exemption in February 2024 and launched as a commercial product by SeaStar Medical in July 2024.
Research and development expenses for the three months ended June 30, 2025, and 2024, were $1.0 million and $2.3 million, respectively. The decrease in research and development expenses was primarily driven by a decline in preclinical and clinical trial expenses, consulting expenses, and personnel costs.
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General and administrative expenses for the three months ended June 30, 2025, and 2024, were approximately $1.0 million and $2.3 million, respectively. The decrease in general and administrative expenses was the result of a decline in audit and accounting related fees, Directors' compensation, certain Securities and Exchange Commission (SEC) fees, personnel costs, and consultant expenditures.
Other expenses (net) increased approximately $1.7 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The increase was primarily related the decline in favorable gains from the change in fair value of liability classified warrants, a one-time financing fee, offset by the retirement of outstanding debt obligations since March 31, 2024.
Net loss for the three months ended June 30, 2025, was approximately $2.0 million, or $0.18 per share on approximately 11.3 million weighted-average shares outstanding. This compares with a net loss of approximately $3.2 million, or $1.03 per share, on approximately 3.2 million weighted-average shares outstanding for the three months ended June 30, 2024.
Cash at June 30, 2025 was $6.3 million, compared to $1.8 million at December 31, 2024. In July and August 2025 the Company raised an additional $8.4 million in two registered direct offerings.
SeaStar Medical Second Quarter Financial Results Conference Call
Date/Time: Wednesday, August 13, 2025, at 4:30 p.m. ET / 2:30 p.m. MT
Webcast: The live webcast and replay can be found here.
Conference ID: 2078693
Dial-in numbers: 1 (800) 715-9871 within the U.S.
1 (646) 307-1963 from outside the U.S.
A replay of the call will be available after 7:30 p.m. ET and can be accessed as follows:
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The webcast replay is available here.
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The call replay number is 1 (609) 800-9909 and will be available through August 20, 2025.
About QUELIMMUNE
The QUELIMMUNE (SCD-PED) therapy is SeaStar Medical's first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. The QUELIMMUNE™ therapy is being commercialized for children (age 22 or younger) with AKI and sepsis or a septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application that requires medical institutions to also participate in the SAVE Surveillance Registry and complete Institutional Review Board approvals prior to adoption and use of the QUELIMMUNE therapy. This prolongs the adoption timeline by medical institutions, but provides important data on the use of QUELIMMUNE in the "real-world" setting.
Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an
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approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge.
In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.
About NEUTRALIZE-AKI Pivotal Trial
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device - a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. 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. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
About Acute Kidney Injury (AKI) and Hyperinflammation
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy
The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient's body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future CRRT, including dialysis, and prevent loss of life.
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About SeaStar Medical
SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. The QUELIMMUNE (SCD-PED) therapy is SeaStar Medical's first commercial product based on its patented Selective Cytopheretic Device (SCD) technology. The QUELIMMUNE (SCD-PED) therapy was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar's Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.
For more information visit www.seastarmedical.com or visit us on LinkedIn or X.
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