SeaStar Medical (ICU) Q2 2026 earnings summary

Executive summary

• QUELIMMUNE therapy adoption in pediatric AKI accelerated, with 20 of the top 50 U.S. children's hospitals now using the therapy, up from 10 at the start of the year, and is the only FDA-approved device for pediatric AKI due to sepsis; first commercial sales began in July 2024.

• Net revenue for QUELIMMUNE reached $615,000 in Q2 2026, an 82% year-over-year increase, with six-month revenue at $1.1 million.

• The NEUTRALIZE-AKI pivotal trial for adult AKI enrolled 223 of 339 patients, with completion expected by year-end 2026 or early 2027, and additional sites being activated.

• SCD therapy, foundational to QUELIMMUNE, is positioned as a first-in-class immunomodulatory device with six FDA Breakthrough Device Designations, supporting multiple indications and expedited regulatory pathways.

• ICD-10-PCS codes for SCD therapy were assigned by CMS, effective October 1, 2026, facilitating standardized hospital billing and broader adoption.

Financial highlights

• Q2 2026 net revenue was $615,000, up 82% from $338,000 in Q2 2025; six-month revenue reached $1.1 million.

• Gross profit margin remained strong at 91% for Q2 2026, above 90% for five consecutive quarters.

• Operating expenses rose to $4.4 million in Q2 2026, up 111% year-over-year, driven by increased R&D and administrative costs.

• Net loss for Q2 2026 was $3.7 million ($0.91/share), compared to $2 million ($1.77/share) in Q2 2025.

• Cash balance at June 30, 2026, was $7.0 million, down from $12.0 million at year-end 2025.

Outlook and guidance

• Targeting 25 pediatric hospitals using QUELIMMUNE by year-end 2026, with expansion beyond the top 50 centers in 2027 and beyond.

• 2026 net revenue target for QUELIMMUNE is $2 million.

• NEUTRALIZE-AKI trial enrollment expected to complete by year-end 2026 or Q1 2027, with PMA submission planned for late 2027.

• Expects ICD-10-PCS codes to facilitate broader hospital adoption and reimbursement for SCD therapies starting October 2026.

• Substantial doubt exists about the ability to continue as a going concern for the next 12 months without additional capital.