SeaStar Medical (ICU) investor relations material

Executive summary

• Q3 revenue rose 247% YoY to $635K on increased QUELIMMUNE adoption; gross margin exceeded 90%.

• NEUTRALIZE-AKI enrolled 251 of 339 patients; the first modular PMA module was submitted to FDA, with enrollment completion anticipated by mid-2027.

• Cash was $3.989M at September 30, 2026; recurring losses and funding needs raised substantial doubt about the ability to continue as a going concern for 12 months.

Financial highlights

• Q3 revenue was $635K vs. $183K YoY; gross profit was $587K vs. $169K, and gross margin exceeded 90%.

• Q3 operating expenses were $5.168M vs. $3.7M; R&D rose with clinical activity and development costs, while G&A declined.

• Q3 operating loss was $4.581M vs. $3.579M; net loss was $4.529M vs. $3.472M, and loss per share was $1.03 vs. $1.30.

• 9M revenue increased 114% YoY to $1.745M; net loss was $11.780M vs. $9.246M.

• 9M 2026 other income benefited from higher interest income compared with 2025, which included a one-time $0.3M SEPA financing charge.

Outlook and guidance

• NEUTRALIZE-AKI enrollment completion is anticipated by mid-2027; topline results are expected in 2027, and a PMA application is expected subject to positive trial results.

• The final PMA module is anticipated about nine months after enrollment completion; FDA review is described as 180 days, with modular submissions potentially shortening the process.

• Management expects 2026 QUELIMMUNE revenue to exceed $2M guidance; no revised numerical target was set, and 2027 guidance is expected earlier in 2027.

• R&D spending is expected to increase for the foreseeable future, subject to funding, as adult and next-generation SCD development continues.