SeaStar Medical Holding Corporation Q4 FY2025 earnings call

In 2025 and into Q1 2026, Seastar Medical expanded the use of Quell Immune therapy for ultra-rare pediatric AJI, adding 13 new customers from top-rated children's hospitals, bringing the total customer base to 16. Reported net revenue of over 1 million from Quell Immune sales in 2025 with gross profit margins above 90%. Advanced development of SCD therapy for adult AKI in ICU, achieving over 50% enrollment in the trial with 181 of 339 patients enrolled. Initiated modular PMA submission for SCD therapy for adult AKI indication, granted breakthrough device designation by FDA. Maintained good cost controls and improved balance sheet with approximately $24 million capital added in 2025 and over $3 million reduction in operating liabilities. In 2026, goal to advance SCD therapy for adult AKI, plan to complete enrollment in neutralized AKI pivotal trial around end of 2026. Aim to expand Quellabium customer base, add 15 new top-ranked children's medical centers, goal of $2 million net product revenue from Quell Immune sales in 2026. Evaluate broader applicability of SCD therapy in new indication with FDA breakthrough device designation, initiated clinical trial of SCD therapy in patients with acute congestive heart failure with cardiorenal syndrome awaiting LVAD implantation. Work with FDA for expedited approval of pipeline indications.

In 2025, Quell Immune sales generated net revenue of over 1 million. In the fourth quarter of 2025, net revenue from Quell Immune Sales was approximately $315,000, compared to $67,000 in the fourth quarter of 2024, and the first quarter of 2026 has already exceeded the fourth quarter sales. In the fourth quarter of 2025, $105,000 of net revenue was recognized from the sale of the SCD to the Arriva Research Institute, with a second order up to an additional $100,000 anticipated. For the full year 2025, Quell Immune net revenue was $1.1 million compared to $135,000 in 2024. Quell Immune had pharmaceutical-like gross profit margins above 90%.

In 2026, plan to complete enrollment in the neutralized AKI pivotal trial around year end. Aim to achieve $2 million in net product revenue from Quell Immune sales in 2026. Evaluate broader applicability of SCD therapy in new indication. Work with FDA for expedited approval of pipeline indications, leveraging breakthrough device designations for earlier access to patients.

Comments made during the call include forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from any anticipated results. For a list and description of these risks and uncertainties, please review Seastar Medical's filings with the Securities and Exchange Commission.

Q: David Botts asked about Quell Immune adoption and additional centers, asking what gives confidence to hit 15 additional pediatric centers goal this year.

A: Tim responded that they've already added six sites in Q1, have an organized list of top 50 hospitals, working through adoption process, and SAVE registry progress may allow quicker site adoption.

Q: David Botts asked about manufacturing capacity for SCD.

A: Eric responded that contract manufacturer Fresenius Medical has deep skill and capacity to produce enough SCDs for pediatrics and adults.

Q: David Botts asked about CRS study timelines and next steps if positive.

A: Kevin responded that no guidance on study completion timeline, but successful study would make indication eligible for humanitarian device exemption.

Q: Anthony Vandetti asked about number of treated patients in neutralized AKI trial and lessons learned.

A: Kevin responded that clinically can't share lessons from 181 patients yet, but had investigators meeting sharing best practices.

Q: Anthony Vandetti asked about pediatric AKI side, Quell Immune learnings and sales reps for adding 15 centers.

A: Kevin talked about positive outcomes in pediatric SAVE registry, Tim responded that they're not adding additional salespeople, but increasing clinical representation within hospitals and using educational opportunities and advisory board to enhance momentum.