SeaStar Medical (NasdaqCM:ICU) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Company ParticipantsAnthony Vendetti - Executive Managing Director of ResearchEric Schlorff - CEOJackie Cossmon - ConsultantKevin Chung - Chief Medical OfficerMike Messinger - CFOTim Varacek - SVP of Commercial and Business OperationsConference Call ParticipantsDavid Bautz - Senior AnalystOperatorI would now like to hand the conference over to your speaker today, Jackie Cossmon.Jackie CossmonThank you, Josh. Good afternoon, and ...

SeaStar Medical (NasdaqCM:ICU) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Company ParticipantsAnthony Vendetti - Executive Managing Director of ResearchEric Schlorff - CEOJackie Cossmon - ConsultantKevin Chung - Chief Medical OfficerMike Messinger - CFOTim Varacek - SVP of Commercial and Business OperationsConference Call ParticipantsDavid Bautz - Senior AnalystOperatorI would now like to hand the conference over to your speaker today, Jackie Cossmon.Jackie CossmonThank you, Josh. Good afternoon, and ...

SeaStar Medical (NasdaqCM:ICU) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Speaker6I would now like to hand the conference over to your speaker today, Jackie Cossmon.Speaker3Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical fourth quarter and year-end 2025 financial results conference call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer, Dr. Kevin Chung, Chief Medical Officer, Tim Var ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 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 ...

Adds top-rated children's hospitals to QUELIMMUNE™ pediatric AKI customer base Completes enrollment in FDA-mandated QUELIMMUNE SAVE Post-Marketing Registry Exceeds 50% enrollment milestone in pivotal trial of SCD therapy in adult patients with AKI Advances pipeline indications with initiation of cardio-renal clinical trial Exhibit 99.1 SeaStar Medical Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates Webcast today at 4:30 pm Eastern Time DENVER, CO., March 25, 2026 – ...

Added top-rated children’s hospitals to QUELIMMUNE™ pediatric Acute Kidney Injury (AKI) customer base Completed enrollment in FDA-mandated QUELIMMUNE SAVE Post-Marketing Registry Exceeded 50% enrollment milestone in pivotal trial of SCD therapy in adult patients with AKI Advanced pipeline indications with initiation of cardio-renal clinical trial Webcast today at 4:30 pm Eastern Time DENVER, March 25, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare ...

DENVER, March 18, 2026 (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 that it will report its fourth quarter and year-end 2025 financial results after market close on Wednesday, March 25, 2026, and host a webcast and conference call to discuss its financial results and business progress. Date/Time:Wednesday, March 25, 20 ...

SeaStar Medical Conference Summary Company Overview - **Company Name**: SeaStar Medical - **Ticker Symbol**: ICU (NasdaqCM) - **Focus**: Treating hyperinflammation in critically ill patients, particularly those facing organ failure or life-threatening conditions such as Acute Kidney Injury and cardiovascular diseases [4][5] Core Products and Pipeline - **FDA-Approved Product**: QUELIMMUNE for Children - **Pipeline**: Includes the Selective Cytopheretic Device (SCD), which has received Breakthrough Device designation from the FDA for various applications [4][5] - **Market Opportunity**: Approximately 1 million patients annually could benefit from SCD, with significant revenue potential from capturing even a modest market share [5] Clinical Data and Efficacy - **SCD Mechanism**: A therapeutic medical device that neutralizes overactive immune cells, reducing mortality and dialysis dependency [6][10] - **Pediatric Study Results**: - Registration study with 22 patients showed a 50% improvement in survival rates (from 50% to 77%) and no long-term dialysis patients at Day 60 [14][15] - SAVE Registry confirmed similar results in real-world settings, with a reduction in mortality and dialysis dependency [15][16] - **Regulatory Updates**: FDA approved a reduction in the number of patients required for the SAVE Registry from 300 to 50, with 50 patients now enrolled [17][18] Commercial Strategy - **Customer Base Growth**: - End of 2024: 2 active customers - End of 2025: 10 customers - Goal for 2026: Double the customer base [22] - **Target Market**: Focus on the top 50 children's hospitals in the U.S., which represent half of the eligible patient population [22][23] Ongoing Trials - **NEUTRALIZE-AKI Trial**: - A randomized controlled study with 339 patients, currently 40% enrolled [25] - Primary endpoints include mortality rates and dialysis dependency [26] - Expected to complete enrollment by the end of 2026, with top-line data available in the first half of 2027 [29] Competitive Advantage - **Comparison with Standard Care**: Current standard of care (Continuous Renal Replacement Therapy) has a 50% mortality rate and is not disease-modifying. SCD aims to improve outcomes significantly [34] - **Economic Benefits**: QUELIMMUNE can reduce ICU length of stay and overall healthcare costs, potentially saving hospitals $40,000 to $50,000 per patient [35] Future Opportunities - **Cardiorenal Syndrome**: SCD may help patients bridge to LVAD or transplant by reducing inflammation [37] - **Regulatory Pathways**: Plans to submit modular pieces for PMA to expedite the approval process [30][31] Financial Overview - **Revenue Projections**: Expected to generate over $1 million in revenue for QUELIMMUNE in 2025, with a goal to double that in 2026 [40] - **Cash Position**: As of November, approximately $13.5 million in cash, with a monthly burn rate of $1 million to $1.3 million [41] Key Milestones for Investors - Completion of NEUTRALIZE-AKI enrollment - Doubling the customer base for QUELIMMUNE - Progress in NEUTRALIZE-CRS study and potential regulatory applications [50][51]

Company Overview - SeaStar Medical Holding Corporation is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [5] - The company's first commercial product, QUELIMMUNE (SCD-PED), was approved by the U.S. FDA in 2024 and is the only FDA-approved product for life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [5] - SeaStar's Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for four therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [5] Recent Developments - SeaStar Medical announced the publication of positive safety and patient outcomes data from the SAVE Surveillance Registry in pediatric patients treated with QUELIMMUNE in the journal Pediatric Nephrology [9] - The company is currently enrolling patients in the pivotal NEUTRALIZE-AKI clinical trial, evaluating the safety and efficacy of SCD therapy in adults with AKI in the ICU [9] - SeaStar has initiated the NEUTRALIZE-CRS clinical trial to treat patients with acute chronic systolic heart failure with cardiorenal syndrome (CRS) [9] Upcoming Events - Eric Schlorff, CEO of SeaStar Medical, will participate in a fireside chat at the Life Sciences Investor Forum on March 11, 2026 [1] - The event will be an interactive online forum allowing real-time questions from investors and industry professionals [2]

Core Insights - SeaStar Medical Holding Corporation has completed enrollment in the SAVE Registry, a Post-Approval Study required by the FDA to confirm the safety of QUELIMMUNE therapy for children with acute kidney injury (AKI) due to sepsis [1][5] - The SAVE Registry has enrolled 50 patients, and the company plans to report 28-day safety results to the FDA after data analysis [1][2] - Early results from the SAVE Registry indicate valuable clinical outcomes data on the safety and probable benefit of QUELIMMUNE therapy [2][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [10] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [10] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications by the FDA, facilitating a faster approval process [10] Product and Technology - QUELIMMUNE therapy is designed for children aged 22 years or younger with AKI due to sepsis, requiring renal replacement therapy [5] - The SCD therapy aims to neutralize over-active immune cells and stop cytokine storms, which can lead to destructive hyperinflammation [9] - Clinical studies have shown a 77% survival rate with QUELIMMUNE therapy, representing a 50% reduction in loss of life compared to historical data [6][7] Clinical Studies and Trials - The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of SCD therapy in 339 adults with AKI in the ICU [8] - The primary endpoint of the NEUTRALIZE-AKI trial is a composite of 90-day mortality or dialysis dependency [8] - Recent data from the SAVE Registry aligns with previous clinical trial results, reinforcing the therapy's effectiveness [7] Market and Adoption - QUELIMMUNE therapy has been adopted by several nationally recognized children's medical centers in the U.S., indicating strong interest and potential for market expansion [2] - The complexities of setting up and running patient registries have previously hindered faster adoption, but the company is optimistic about future growth [2]