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- **Revenue Milestone**: Q3 revenue of $183,000, on track for over $1 million in 2025, with Q4 sales surpassing Q3 levels.
- **Clinical Expansion**: NEUTRALIZE-AKI trial enrolling 146/339 patients across 17 sites, targeting 25 sites by year-end.
- **Financial Strength**: $13.8 million cash, raised $12.4 million, supporting clinical trial expansion.
- **Strategic Growth**: Quellimune adoption in 10 commercial sites, aiming for a $100 million market with 76% patient survival rates.

**Management Opening Remarks**
- Jackie Cossman provided an overview of the call, emphasizing forward-looking statements and risks associated with SeaStar Medical's operations.

**CEO Summary Section**
- **Revenue Growth**: Reported Q3 net revenue of $183,000, up from $68,000 in Q3 2024, with Q4 sales already exceeding Q3 levels. Full-year 2025 revenue expected to exceed $1 million.
- **Gross Margin**: Achieved a 92% gross profit margin in Q3, marking the first quarter of commercial sales.
- **Clinical Trials**: Expanded the NEUTRALIZE-AKI trial to 17 sites, enrolling 146 patients toward a target of 339. Launched a new CRS trial for cardiorenal syndrome, targeting 20 patients.
- **Strategic Focus**: Highlighted the potential of Quellimune therapy in treating hyperinflammation and its broader market application beyond AKI.

**Commercial Update**
- **Site Activation**: 10 active commercial sites, with four new additions in Q3. Q4 sales already surpassing Q3 levels.
- **Market Expansion**: Aiming to capture a $100 million U.S. market, focusing on simplifying adoption processes and cross-functional collaboration with hospitals.
- **Operational Efficiency**: Streamlined site activation processes, reducing adoption timelines from six months to a more accelerated pace.

**CMO Clinical Update**
- **NEUTRALIZE-AKI Trial**: 146 patients enrolled (target 339) across 17 sites, with safety data approved by the DSMB. Expanded to 25 sites to meet enrollment by end-2026.
- **Quellimune Registry**: 76% survival rate in 21 pediatric patients, supporting real-world evidence for FDA interactions.
- **CRS Trial**: Launched a single-arm study for cardiorenal syndrome, targeting 20 patients to demonstrate SCD therapy feasibility in chronic settings.

**CFO Financial Commentary**
- **Revenue**: Q3 net revenue $183,000 (92% gross margin), up 170% year-over-year.
- **Cost Management**: Operating expenses down 18% to $3.7 million, driven by reduced consulting and R&D costs.
- **Financial Health**: Cash balance of $13.8 million, raised $12.4 million in Q3, extending runway.
- **Net Loss**: $3.5 million for Q3, reflecting ongoing clinical trial investments.

**Q&A Highlights**
- **Trial Enrollment**: Projected to meet 339-patient target by end-2026 with 25 activated sites. Adjustments will be made if enrollment slows.
- **CRS Trial Progress**: Expected to enroll 20 patients within a year, leveraging existing NEUTRALIZE-AKI sites.
- **Revenue Visibility**: Q4 sales already exceed Q3, with a focus on reducing revenue variability through site expansion.

SeaStar Medical Holding Corp (ICU) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: Q2 revenue up 15% ($338K), YTD $631K, with 370% YTD growth in Quellimmune adoption.
- **Trial Progress**: Neutralized AKI trial enrolling 125/200 patients; interim analysis completed, DSMB recommendation expected Q3.
- **Market Potential**: Adult AKI market of 200K patients annually, $4B potential, with FDA breakthrough designation for 5 indications.
- **Financial Health**: Gross margin 92%, operating expenses down 55%, net loss reduced to $2M, $6.3M cash post-Q2 raise.
- **Strategic Focus**: Completing pivotal trial, filing PMA for adult AKI, and expanding Quellimmune adoption.

**【CEO Opening Remarks】**
- Enrolled 125 patients in the neutralized AKI trial, with 3 new Quellimmune customers from top US children's hospitals.
- Q2 net revenue increased 15%, YTD growth of 370%, driven by pediatric adoption.
- Positive survival results from 20 pediatric patients in the SAVE registry (75% 28-day survival).
- Raised $12.4M post-Q2 to strengthen balance sheet.
- Anticipate lumpy sales but expect sequential growth in Quellimmune adoption.

**【Commercial Achievements】**
- Q2 revenue up 15%, YTD $631K, with 3 new customers (e.g., Texas Children's Hospital).
- Planning to present expanded SAVE registry data at a pediatric nephrology meeting.
- Adult SCD therapy market: 200K annual patients, $4B potential, with FDA breakthrough designation for 5 additional indications.
- Pre-commercialization efforts leveraging pediatric experience for faster adult adoption.

**【CMO Update】**
- Neutralized AKI trial: 125/200 patients enrolled (31 new in Q2), interim analysis of 100 patients completed.
- DSMB recommendation expected in Q3; 80% of eligible patients consented.
- Enrichment criteria: CRP >3.5 mg/dL to target inflammatory patients.
- Aiming to add 3-4 sites by Q3 end; 75% survival in 20 pediatric registry patients.

**【CFO Financial Commentary】**
- Q2 revenue $338K, 15% QoQ growth, gross margin 92%.
- Operating expenses down 55% to $2.1M, net loss $2M (down 37%).
- Cash $6.3M; raised $12.4M post-Q2 for trial completion and PMA filing.
- Focus on adult AKI market, with potential PMA filing in 2026 if trial successful.

**【CEO Closing Remarks】**
- Excited about adult AKI market potential ($4B) and FDA breakthrough designation.
- Plan to file PMA in 2026 if trial meets primary endpoint.
- Emphasizes value creation for investors through life-saving therapies and market expansion.

SeaStar Medical Holding Corp (ICU) Q2 2025 Earnings Call Transcript

- **Revenue Surge**: Q1 2025 revenue jumped 4x to $293K, fueled by new pediatric hospital activations and repeat orders.
- **Adult AKI Trial Milestone**: NEUTRALIZE-AKI trial reached 50% enrollment (100 patients), with interim DSMB analysis due in Q3.
- **$4.5B Market Opportunity**: Adult AKI requiring CRRT affects 200K+ U.S. patients annually, with no FDA-approved treatments.
- **Pipeline Expansion**: Two new FDA breakthrough designations target cardiac surgery patients, aligning with hospital resource needs.
- **Cost Efficiency**: Operating expenses down 5% YOY to $4.1M, supporting lean execution of clinical and commercial goals.

**【CEO Summary Section】**
- Q1 2025 revenue increased fourfold to $293,000, driven by repeat orders from existing pediatric AKI customers and new hospital activations.
- Achieved 50% enrollment (100 patients) in the NEUTRALIZE-AKI trial for adult AKI, with an interim DSMB analysis expected in Q3 2025.
- Expanded pipeline with two new FDA breakthrough device designations for adult and pediatric cardiac surgery, targeting over 200,000 annual adult AKI patients ($4.5B market opportunity).

**【CFO Financial Commentary】**
- Q1 2025 net loss narrowed to $3.7M (vs. $12.7M in Q1 2024), with operating expenses down 5% year-over-year to $4.1M due to cost control.
- Cash balance of $5.3M as of Q1 2025, supporting ongoing clinical trials and commercial expansion.
- 2025 priorities: pediatric site activations, NEUTRALIZE-AKI enrollment completion, and PMA filing preparation.

**【Q&A Key Highlights】**
- 15 active sites in the adult AKI trial, with 5 more planned by Q3 2025.
- 6 commercial pediatric sites, with multiple others in IRB approval process.
- Breakthrough designations for cardiorenal and hepatorenal syndromes could enable rapid post-AKI market expansion.
- Word-of-mouth adoption among pediatric hospitals is accelerating site activations despite lengthy IRB processes.

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