SeaStar Medical Holding Corporation Common Stock Q3 2026 Earnings Recap

SeaStar Medical shares fell 44.7% after earnings, with the clearest disappointment being a delay in the NEUTRALIZE-AKI trial: enrollment is now expected to finish by mid-2027. QUELIMMUNE sales grew sharply, but that progress was overshadowed by the slower timeline for the pivotal adult AKI study.

Key Takeaways

• NEUTRALIZE-AKI has enrolled about 75% of its planned 339 patients; management now expects enrollment completion by mid-2027, citing strict eligibility criteria and a cautious outlook.
• QUELIMMUNE revenue was over $630,000 in Q3, up 247% year over year. Nine-month revenue reached $1.7 million, and management expects to exceed its $2 million full-year revenue guidance.
• Twenty of the 50 targeted pediatric medical centers are current customers; SeaStar has added 10 new customers so far in 2026.
• The FDA confirmed SeaStar met requirements for the mandatory SAVE post-approval registry, and CMS assigned ICD-10-PCS codes for procedures using QUELIMMUNE.
• SeaStar received FDA Breakthrough Device Designation for its SCD therapy for hyperinflammation in adults with sepsis and has submitted the first module of the adult AKI PMA.