• Net Revenue: $134,000 in 2024, reflecting initial product adoption timelines.
• Cash Position: Ended 2024 with $1.8 million in cash.
• Capital Raised: Approximately $25 million raised in 2024, with an additional $6 million in February 2025.
• Debt Reduction: Approximately $6 million of debt extinguished in 2024.
• Operating Expenses: Increased by approximately $3.6 million in 2024 due to commercial launch and clinical trial enrollment.
• Net Loss: $24.8 million in 2024, down from $26.2 million in 2023.
• Clinical Trial Enrollment: 94 out of 200 subjects enrolled in the Neutralized AKI Pivotal Trial.

• Warning! GuruFocus has detected 5 Warning Signs with ICU.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• SeaStar Medical Holding Corp (NASDAQ:ICU) launched Coelimmune, witnessing significant positive patient outcomes, including life-saving interventions.
• The company received its first product approval for QELimmune and advanced its neutralized AKI clinical development program.
• SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric AKI treatment.
• The company secured key patents in the United States and Canada, strengthening its proprietary technology.
• SeaStar Medical raised approximately $25 million, improved its balance sheet, and reduced debt, positioning itself for future growth.

Negative Points

• The adoption process for Coelimmune is lengthy and unpredictable, involving Investigational Review Boards (IRBs) and patient registries.
• Sales of Coelimmune are expected to be 'lumpy' due to the time required for hospitals to adopt the therapy.
• The company is not providing specific revenue guidance due to uncertainties inherent in launching a new product.
• SeaStar Medical faced challenges with a national shortage of citrate, impacting the enrollment pace of its Neutralized AKI trial.
• 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.

Q: What are the plans for expanding Salesforce capabilities in 2025 for the Coelimmune product? A: Tim Varacek, SVP of Commercial & Business Operations, stated that the current team is right-sized for the small market. They have field-facing staff and operational support, including skilled nurses for training. The focus is on working through the IRB process and customer setup with a healthy pipeline of interested accounts.

Q: What have you learned from the first hospital activations, and what does a typical conversion look like? A: Tim Varacek noted that the IRB process involves both the device and a patient registry, with the latter being more complex. They have learned to create more efficient processes tailored to each hospital's unique setup. The decoupling of the IRB process has been a significant learning, allowing for quicker patient treatment and product sales.

Q: How does the decoupling of the IRB process impact the adoption of Coelimmune? A: Eric Schlorff highlighted that decoupling the IRB process allows for treating patients even if the registry isn't fully operational, which facilitates quicker product sales and potentially saves lives. This approach is encouraged by the FDA to prioritize patient care.

Q: What strategies have been effective in expediting the hospital activation process? A: Eric Schlorff mentioned that involving ICU doctors and nephrologists early in the process has been a significant time saver, helping to streamline the adoption and activation of Coelimmune in hospitals.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.