SeaStar Medical — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net revenue for the three months ended September 30, 2026, was $635,000, a 247% increase compared to $183,000 in the same period of 2025.
• Gross profit margins remained above 90% for the quarter.
• Cost of goods sold was $48,000 for the quarter, compared to $14,000 in the prior year period.
• Research and development expenses were $3.6 million for the quarter, up from $1.9 million in the prior year period, driven by increased clinical research activities for the NEUTRALIZE-AKI trial and personnel costs.
• General and administrative expenses were $1.6 million for the quarter, down from $1.9 million in the prior year period, due to declines in personnel, legal, audit, and SEC-related costs.
• Net loss for the quarter was $4.5 million ($1.03 per share) compared to a net loss of $3.5 million ($1.30 per share) in the prior year period.
• Cash balances were $4.0 million at September 30, 2026, down from $12.0 million at December 31, 2025.
• Total liabilities were $4.8 million at September 30, 2026, compared to $3.7 million at December 31, 2025.
• Stockholders' equity was $469,000 at September 30, 2026, down from $10.4 million at December 31, 2025.

Guidance and Future Outlook:

• The NEUTRALIZE-AKI pivotal clinical trial is expected to complete enrollment by mid-year 2027.
• Management anticipates that fulfilling FDA post-approval requirements for the SAVE Registry may increase the availability of QUELIMMUNE therapy for critically ill pediatric patients.
• The company expects the Breakthrough Device Designation for the SCD therapy to enable a priority review once the final module of the premarket approval application is submitted, provided the trial yields a positive outcome.

Business Segments and Product Lines:

• QUELIMMUNE (SCD-PED) therapy adoption expanded to treat ultra-rare sepsis-associated AKI in pediatric patients receiving renal replacement therapy (RRT).
• The NEUTRALIZE-AKI pivotal clinical trial evaluating SCD therapy for adult patients with AKI receiving continuous renal replacement therapy (CRRT) has enrolled 251 of 339 intended patients (nearly 75%).
• The company submitted the first module of a modular premarket approval (PMA) application to the FDA for SCD therapy in adult patients with AKI receiving CRRT.
• The company received dedicated ICD-10-PCS codes from CMS effective October 1, 2026, enabling billing for SCD therapy in inpatient hospital settings for AKI patients requiring RRT.
• The FDA granted Breakthrough Device Designation for SCD therapy for the treatment of hyperinflammation in adult patients with sepsis, marking the seventh such designation for the therapy across various indications.

Market and Competitive Landscape:

• Real-world data presented at ASN Kidney Week 2026 showed statistically significant higher survival for QUELIMMUNE-treated pediatric patients versus comparator cohorts at Day 60, Day 90, and hospital discharge.
• The SAVE Registry study, involving 50 critically ill pediatric patients, reported no device-related adverse events for QUELIMMUNE-treated patients.
• The company notes that the adult AKI market impacted by the NEUTRALIZE-AKI trial involves over 200,000 adults in the U.S. annually with no effective treatment options.

Risks and Challenges:

• Forward-looking statements highlight risks including the potential inability to obtain regulatory approval for SCD product candidates.
• Risks include the potential inability to raise sufficient capital to fund operations and clinical trials.
• There is a risk that the company may never achieve or sustain profitability.
• Potential risks include failure to secure additional financing on acceptable terms, supply chain disruptions, product liability lawsuits, and intellectual property protection issues.

Management Commentary and Tone:

• CEO Eric Schlorff expressed confidence that the strength of QUELIMMUNE adoption in the ultra-rare pediatric AKI market provides great promise for pipeline indications.
• Management highlighted momentum in educating the critical care pediatric healthcare community regarding the statistically significant survival benefits presented at ASN Kidney Week 2026.
• The CEO noted that the modular submission approach to the FDA is intended to speed the potential approval process for the adult AKI indication.

Other Key Points:

• The company fulfilled FDA post-approval requirements for the SAVE Registry study, allowing hospitals to employ QUELIMMUNE therapy without the previous research infrastructure demands.
• Warrant exercises totaling $3.3 million in gross proceeds occurred in October 2026, which are not reflected in the September 30, 2026, cash balance.
• The company has 4,461,965 shares issued and outstanding as of September 30, 2026.
• The SCD therapy is designed to neutralize over-active immune cells and stop cytokine storms, with potential applications beyond kidney disease in acute and chronic cardiovascular conditions.