SeaStar Medical (ICU) Q4 2025 earnings summary

Executive summary

• Expanded QUELIMMUNE pediatric AKI therapy to 16 top children's hospitals in 2025, with strong adoption and increased customer orders.

• Achieved over $1 million in net revenue from QUELIMMUNE sales in 2025, with gross profit margins above 90%.

• Advanced SCD therapy for adult AKI, enrolling over 50% of patients in the NEUTRALIZE-AKI pivotal trial and initiating a cardio-renal clinical trial.

• Improved balance sheet with $23.9 million in new capital and $3.1 million reduction in operating liabilities in 2025.

• Initiated modular PMA submission for SCD therapy, leveraging FDA Breakthrough Device Designation.

Financial highlights

• Q4 2025 net revenue was $420,000, up from $67,000 in Q4 2024; full-year 2025 net revenue reached $1.2 million, compared to $135,000 in 2024.

• Gross profit margin exceeded 90% for both Q4 and full year 2025.

• Operating expenses declined to $3.4 million in Q4 2025 from $4.8 million in Q4 2024; full year expenses dropped to $13.4 million from $18 million.

• Net loss for Q4 2025 was $2.9 million ($0.80/share), improved from $4.4 million ($8.98/share) in Q4 2024; full year net loss was $12.2 million ($5.86/share), down from $24.8 million ($66.33/share).

• Ended 2025 with $12 million in cash, up from $1.8 million at end of 2024.

Outlook and guidance

• Targeting completion of NEUTRALIZE-AKI trial enrollment by end of 2026, with top-line results expected mid-2027.

• Plans to add 15 new pediatric hospital customers for QUELIMMUNE in 2026, targeting $2 million in product revenue.

• Spending in 2026 expected to be in line with 2025 levels.

• Exploring rapid regulatory pathways and additional Breakthrough Device and Humanitarian Use designations for SCD therapy.