SeaStar Medical (ICU) Q1 2026 earnings summary

Executive summary

• Q1 2026 revenue grew 69% year-over-year to $0.5 million, driven by expanded QUELIMMUNE adoption, including seven new hospital customers and strong pediatric AKI therapy sales.

• Net loss narrowed to $3.5 million ($0.90/share) from $3.8 million ($4.38/share) in Q1 2025, reflecting higher sales and cost controls.

• Cash balance as of March 31, 2026, was $9.3 million, up from $5.2 million a year earlier, but substantial doubt exists about ability to continue as a going concern without new capital.

• Advanced NEUTRALIZE-AKI pivotal trial for adult AKI, enrolling 198 of 339 planned patients, with top-line results expected mid-2027.

• Completed required 50-patient SAVE Registry for QUELIMMUNE in pediatric AKI; 28-day safety data to be submitted to FDA.

Financial highlights

• Q1 2026 net revenue was $0.5 million, up from $0.3 million in Q1 2025, with gross profit margin above 90%.

• Operating expenses remained flat at $4.1 million, with R&D expenses at $2.3 million and G&A at $1.7 million.

• Net loss per share improved to $0.90 from $4.38 year-over-year, reflecting increased share count.

• Cash used in operating activities was $2.8 million for Q1 2026.

• Working capital was $6.8 million as of March 31, 2026.

Outlook and guidance

• On track to achieve $2 million in net revenue for 2026, targeting expansion to 15 new QUELIMMUNE customers and continued order momentum.

• Research and development expenses expected to rise modestly (~5% per quarter) as clinical trial enrollment expands.

• General and administrative expenses projected to remain stable through 2026.

• Completion of NEUTRALIZE-AKI enrollment targeted for year-end 2026, with top-line data anticipated mid-2027 and PMA submission for adult AKI in 2027.

• Substantial doubt remains about ability to continue as a going concern without new funding; additional capital required for operations and trials.