SeaStar Medical Holding Corporation Q1 FY2025 earnings call

Eric Schlorff's Remarks - Highlighted adding a prestigious nationally recognized Children's Hospital as a QUELIMMUNE customer, achieving 50% enrollment in the NEUTRALIZE-AKI trial, and being granted two new breakthrough device designations by the FDA. Mentioned the primary goal of growing the customer base this year and the potential market opportunity in the adult AKI market. - Discussed the NEUTRALIZE-AKI pivotal trial for adult patients with AKI and CRRT, which is well underway, and the plan to file a PMA for this indication in 2026.### Tim Varacek's Remarks - Reported solid revenue increase in the first quarter with repeat orders from existing sites. Announced shipping QUELIMMUNE Therapy to another new nationally recognized children's medical facility. Highlighted QUELIMMUNE as the only FDA-approved product for life-threatening acute kidney injury in critically ill pediatric patients and the potential $100 million total annual U.S. market opportunity based on a pediatric AKI population of approximately 4,000 patients. - Outlined the commercial strategy focused on site adoptions, particularly select children's medical facilities, and anticipation of bringing on new multiple sites by year-end.### Kevin Chung's Remarks - Stated the NEUTRALIZE-AKI trial has reached 100 patients enrolled, crossing the halfway point towards the goal of 200 patients. Explained the interim analysis by the Data Safety Monitoring Board (DSMB) will be conducted once the 100th patient reaches the 90-day primary endpoint and the DSMB's potential recommendations. - Talked about the strategic goal of widening the addressable market through additional clinical trials for other indications where the company has breakthrough device designations.### David Green's Remarks - Reported the highest quarterly revenue to-date with a fourfold increase in net revenue from QUELIMMUNE therapy. Mentioned operating expenses increased modestly due to commercial launch and trial enrollment, partially offset by reduced G&A expenses. Noted the company ended the quarter with approximately $5.3 million in cash and focused on new customer acquisition, NEUTRALIZE-AKI trial completion, and PMA filing preparation.

In the first quarter of 2025, SeaStar Medical achieved a fourfold increase in revenue compared to the fourth quarter of 2024. Net revenue from QUELIMMUNE therapy was $293,000 for the first quarter, whereas it was approximately $68,000 in the fourth quarter of 2024 and $0 in the year-ago first quarter. Cost of goods sold was $0 for the quarter as sales of QUELIMMUNE units were previously recognized as research and development expense. The revenue from QUELIMMUNE therapy was the key driver, with all existing customers purchasing the product during the quarter.

- The NEUTRALIZE-AKI pivotal trial for adult patients with AKI and CRRT is well underway, with a plan to file a PMA for this indication in 2026. - Anticipates continuing to grow the customer base for QUELIMMUNE. - Focuses on completing the NEUTRALIZE-AKI pivotal trial and preparing to file a PMA following the trial's completion.

- Forward-looking statements made during the call involve risks and uncertainties that could cause actual results to differ materially from any anticipated results. - Risks related to clinical trial outcomes, regulatory approvals, and market adoption of products as outlined in SeaStar Medical's filings with the Securities and Exchange Commission.

Q: Can you tell me how many sites are currently activated for the adult clinical trial?

A: Kevin Chung responded that there are 15 activated sites for the adult clinical trial and plans to activate another five over the next three months.

Q: What's the total number of pediatric hospitals that you have as customers currently?

A: Tim Varacek said there are six sites that are commercially active with multiple others moving through the IRB process.

Q: Talking about that IRB process and the pipeline, what sort of pipeline growth have you seen in the first quarter compared to the fourth quarter?

A: Tim Varacek explained it's a combination of word of mouth from existing sites sharing experiences and active engagement with hospitals, with no shortage of interest in QUELIMMUNE therapy.

Q: Can you talk about the new breakthrough designations and prioritization?

A: Kevin Chung discussed the clinical unmet need in cardiac surgeries and the need for additional trials, while Eric Schlorff added that the commercial and medical affairs teams are assessing market need penetration dynamics for the five additional indications with breakthrough device designations.