SeaStar Medical Holding Corporation Q3 FY2025 earnings call

• Added three top-ranked children's medical centers to the customer base. - Reported impressive survival results for Quell immune therapy in pediatric patients. - Quellimmune net revenue in Q3 was $183,000, with revenue up 45% over six months. - Gross profit margin for Q3 was 92%. - Completed interim analysis for neutralized AKI pivotal trial, adding clinical sites. - Opened first site for neutralized CRS clinical trial. - Raised over $12 million to strengthen balance sheet. - Continued efforts to reduce costs while achieving strong operational results. - 10 active commercial pediatric hospitals with 4 new customers added since Q3 start, working on more site additions. - Refining Quellimmune adoption process, approached FDA to relieve mandatory registry for Quellimmune.

In the third quarter, SeaStar Medical reported net revenue of $183,000 from Quellimmune sales. For the six months ended September 30 compared to the six months ended March 30, revenue was up 45%. The gross profit margin for the third quarter was 92%. Quellimmune revenue contribution isn't explicitly given as a percentage of total revenue, but it's a key product segment.

• Anticipates full-year 2025 revenue will be over a million dollars. - Neutralized AKI pivotal trial aims to enroll 339 patients, with 146 enrolled as of now and working on activating additional sites to meet the target by Dec 2026. - Neutralized CRS clinical trial aims to enroll 20 patients within a year in a single-arm feasibility study.

• Volatility in Quellimmune sales from quarter to quarter. - Uncertainties in clinical trial enrollment and patient recruitment for neutralized AKI and CRS trials. - Regulatory risks related to the mandatory registry for Quellimmune, though the company has approached the FDA to relieve it.

Q: Update on neutralized AKI trial enrollment and site activation.

A: Currently, 146 patients are enrolled, 17 sites are activated, and working on activating at least 8 additional sites.

Q: Update on neutralized CRS trial.

A: Launched, it's a single-arm feasibility study to enroll 20 patients, aiming to enroll within a year.

Q: Full-year 2025 revenue guidance.

A: On target to be over a million dollars.