SeaStar Medical Holding Corporation Q3 FY2025 earnings call

• Product Growth: Added three top-ranked children's medical centers, Quellimmune net revenue was $183,000 in Q3 2025, and revenue was up 45% in the six months ended September 30 vs. March 30. Q4 orders for Quellimmune already exceed the entire third quarter, and the company anticipates full-year 2025 revenue will be over a million dollars.
• Clinical Trials: Completed interim analysis for the neutralized AKI pivotal trial, added clinical sites for the neutralized AKI trial, and opened the first site for the neutralized CRS clinical trial. The neutralized AKI trial had 146 patients enrolled out of a new target of 339, and the DSMB recommended increasing enrollment to 339 for adequate power.
• Commercial Efforts: There are 10 active commercial pediatric hospitals that have completed all IRB approvals and ordered products, with four new customers added since the start of the third quarter. The company is working to add more sites, leveraging best practices for brand awareness, clinical performance, and patient identification, and has approached the FDA to request relief from the mandatory registry.
• Registry Data: The SAVE surveillance registry presented data showing 76% survival at 60 days and 71% at 90 days for 21 pediatric patients treated with Quell immune therapy in a commercial setting.
• Cost Management: The company had disciplined efforts to reduce costs, and raised over $12 million to strengthen the balance sheet.

In the third quarter, SeaStar Medical reported net revenue of $183,000 from Quellimmune sales. For the six months ended September 30 versus the six months ended March 30, revenue was up 45%. The gross profit margin for the third quarter was 92%, representing the first full quarter of matching cost of goods sold against Quellimmune unit sales. Quellimmune revenue contribution to the company's overall financials isn't explicitly stated as a percentage, but the focus is on the growth in Quellimmune sales and margin.

• The company anticipates full-year 2025 revenue will be over a million dollars.
• Quellimmune orders in the first half of the fourth quarter are already exceeding the entire third quarter.
• Goal to add new pediatric hospital sites to drive a predictable stream of revenue in 2026 and beyond.
• Plan to remove hurdles to the adoption process for new target accounts for Quellimmune.

• Uncertainties in clinical trial enrollment and achieving the new enrollment target of 339 patients for the neutralized AKI trial.
• Revenue variability due to sales being lumpy from quarter to quarter.
• Dependence on FDA approval for relief from the mandatory registry and the outcome of clinical trials for regulatory and commercial success.

Q: Update on the number of enrolled patients in the neutralized AKI trial and site activation?

A: Currently, 146 patients are enrolled, 17 sites are activated, and the company is working to activate at least eight additional sites, aiming to meet the new enrollment target of 339 by December 2026.

Q: Color on the neutralized CRS clinical trial?

A: The neutralized CRS trial will enroll 20 patients in a single-arm feasibility study, with the goal of demonstrating improvement in renal and cardiac function. The company expects to enroll at least five sites and projects enrolling the 20 patients within a year.

Q: Full-year 2025 revenue guidance?

A: The company is on target to do over a million dollars in revenue for the full year 2025.