SeaStar Medical (ICU) Q4 2024 earnings summary

Executive summary

• Achieved first FDA approval and commercial launch of QUELIMMUNE for pediatric AKI, with five hospitals adopting therapy and a growing pipeline; strong early clinical outcomes and expanding hospital adoption.

• Advanced NEUTRALIZE-AKI pivotal trial for adult AKI, enrolling 94 of 200 patients, with 14 new clinical sites added and interim analysis expected in mid-2025.

• Secured multiple Breakthrough Device designations, expanded indications pipeline including chronic dialysis and cardiorenal syndrome, and received $3.6M NIH grant for SCD therapy trial in heart failure.

• Expanded IP protection with new US and Canadian patents; recognized with the 2025 Corporate Innovator Award by the National Kidney Foundation.

• Improved balance sheet by raising $31M in capital and reducing debt and liabilities.

Financial highlights

• Raised $25 million in 2024, used $16 million for operations, extinguished $6 million in debt, and ended the year with $1.8 million in cash; additional $6 million raised in February 2025.

• Booked first product revenue of $134,000 in 2024 following QUELIMMUNE launch; net revenue for 2024 was $0.1M, up from zero in 2023.

• Net loss for 2024 was $24.8 million, down from $26.2 million in 2023, with $6.9 million of 2024 loss from non-cash items; net loss per share was $6.63 versus $30.26.

• Operating expenses increased by $3.6 million year-over-year, mainly due to commercial launch and clinical trial costs; R&D expenses rose to $9.1M and G&A to $8.9M in 2024.

• Weighted-average shares outstanding increased to 3.7M in 2024 from 0.9M in 2023, reflecting capital raises.

Outlook and guidance

• Not providing formal revenue guidance due to launch unpredictability, but internal targets for 2025 are on track; anticipates continued commercial adoption of QUELIMMUNE and further enrollment in NEUTRALIZE-AKI trial.

• Focused on expanding QUELIMMUNE adoption, completing NEUTRALIZE-AKI trial, and preparing for PMA filing; FDA approved feasibility study for SCD therapy in cardiorenal syndrome.

• Anticipates adult AKI market launch in second half of 2026, pending positive trial results and FDA approval.