What factors drove the changes in SeaStar Medical's revenue and profit?

What were the key takeaways from SeaStar Medical’s earnings call?

What guidance did SeaStar Medical's management provide for the next earnings period?

What were the key takeaways from SeaStar Medical's earnings call?

Did SeaStar Medical beat or miss consensus estimates last quarter?

What is the revenue and EPS growth rate for SeaStar Medical year over year?

What is SeaStar Medical's gross profit margin?

What is the market's earnings forecast for SeaStar Medical next quarter?

- **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.

ICU

ICU fundamentals

You can ask Aime