In This Article:
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Net Revenue: $134,000 in 2024, reflecting initial product adoption timelines.
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Cash Position: Ended 2024 with $1.8 million in cash.
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Capital Raised: Approximately $25 million raised in 2024, with an additional $6 million in February 2025.
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Debt Reduction: Approximately $6 million of debt extinguished in 2024.
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Operating Expenses: Increased by approximately $3.6 million in 2024 due to commercial launch and clinical trial enrollment.
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Net Loss: $24.8 million in 2024, down from $26.2 million in 2023.
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Clinical Trial Enrollment: 94 out of 200 subjects enrolled in the Neutralized AKI Pivotal Trial.
Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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SeaStar Medical Holding Corp (NASDAQ:ICU) launched Coelimmune, witnessing significant positive patient outcomes, including life-saving interventions.
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The company received its first product approval for QELimmune and advanced its neutralized AKI clinical development program.
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SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric AKI treatment.
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The company secured key patents in the United States and Canada, strengthening its proprietary technology.
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SeaStar Medical raised approximately $25 million, improved its balance sheet, and reduced debt, positioning itself for future growth.
Negative Points
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The adoption process for Coelimmune is lengthy and unpredictable, involving Investigational Review Boards (IRBs) and patient registries.
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Sales of Coelimmune are expected to be 'lumpy' due to the time required for hospitals to adopt the therapy.
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The company is not providing specific revenue guidance due to uncertainties inherent in launching a new product.
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SeaStar Medical faced challenges with a national shortage of citrate, impacting the enrollment pace of its Neutralized AKI trial.
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Operating expenses increased by approximately $3.6 million in 2024, primarily due to commercial launch activities and clinical trial enrollments.
Q & A Highlights
Q: Can you provide an update on the Neutralize AKI trial enrollment and timeline for interim analysis? A: Eric Schlorff, CEO, explained that 94 out of the expected 200 patients have been enrolled. They anticipate reaching 100 patients by early April. The primary endpoint is a 90-day period for mortality or dialysis dependency, after which data will be reviewed by the DSMB. Interim analysis results are expected by the end of July or early August.