SeaStar Medical Holding Corporation (Nasdaq: ICU) announced its financial results for the three months ended September 30, 2026, and provided updates on its clinical trials and regulatory status. The company reported a significant increase in net revenue driven by the continued adoption of its QUELIMMUNE therapy.
For the third quarter of 2026, net revenue was approximately $0.6 million, representing a 247% increase compared to the $0.2 million reported in the same period of 2025. This growth was attributed to expanded sales of the QUELIMMUNE (SCD-PED) therapy for ultra-rare sepsis-associated acute kidney injury (AKI) in pediatric patients. The company noted that gross profit margins remained above 90%.
On the expense side, research and development costs rose to $3.6 million for the quarter, compared to $1.9 million in 2025. This increase was primarily driven by expanded clinical research activities for the NEUTRALIZE-AKI pivotal clinical trial and SCD development costs. General and administrative expenses decreased to approximately $1.6 million from $1.9 million, attributed to a reduction in personnel, legal, audit, and SEC-related costs.
SeaStar Medical reported a net loss of approximately $4.5 million for the quarter, or $1.03 per share, compared to a net loss of $3.5 million, or $1.30 per share, in the prior year. The company had approximately 4.4 million weighted-average shares outstanding during the quarter. As of September 30, 2026, the company reported cash of $4.0 million.
In business updates, the company announced that it has fulfilled FDA post-approval requirements for the SAVE Registry study for QUELIMMUNE. This decision is expected to enable hospitals to employ the therapy without the research infrastructure previously required. Additionally, SeaStar Medical reported that enrollment in the NEUTRALIZE-AKI pivotal clinical trial is nearly 75% complete, with 251 of 339 patients enrolled. The company has submitted the first module of a modular premarket approval application to the FDA and has been granted Breakthrough Device Designation for the SCD therapy for hyperinflammation in adult patients with sepsis.
