SeaStar Medical Reports $24.8 Million Net Loss, First Revenue from QUELIMMUNE Sales

SeaStar Medical Holding Corporation reported its financial results for the fiscal year ending December 31, 2024, revealing a net loss of $24.8 million, a slight improvement from the $26.2 million loss recorded in 2023. The company generated $135,000 in revenue, marking its first sales following the FDA's approval of its pediatric Selective Cytopheretic Device (SCD), branded as QUELIMMUNE, in February 2024. This revenue was recognized after the company began shipping its first commercial units in July 2024. The increase in revenue is attributed to the commencement of sales after receiving regulatory approval, contrasting with the previous year when no revenue was reported.

Research and development expenses rose significantly to $9.1 million from $6.0 million in 2023, driven by increased clinical trial costs associated with the ongoing NEUTRALIZE-AKI trial for adult patients with acute kidney injury (AKI). General and administrative expenses also increased to $8.9 million, up from $8.2 million, primarily due to higher payroll costs and expenses related to the restatement of financial statements. The total operating expenses for the year were $18.0 million, compared to $14.2 million in the prior year.

The company’s accumulated deficit reached approximately $139.6 million as of December 31, 2024, up from $114.7 million the previous year. As of the same date, SeaStar Medical had cash and cash equivalents of $1.8 million, a significant increase from $0.2 million in 2023. However, the company indicated that its existing cash reserves are insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern without additional capital.

In terms of strategic developments, SeaStar Medical has focused on expanding its commercial operations following the termination of its distribution agreement with Nuwellis, which was settled for $900,000. The company is now directly marketing QUELIMMUNE and has initiated efforts to commercialize its adult SCD product. The company has also received Breakthrough Device Designation from the FDA for multiple indications, which is expected to expedite the regulatory approval process for its adult SCD.

Looking ahead, SeaStar Medical plans to continue its clinical development and commercialization efforts, but it acknowledges the need for additional funding to support these activities. The company is exploring various financing options, including equity and debt offerings, to secure the necessary capital for its operations and growth initiatives. The management remains optimistic about the potential of its SCD technology to address significant medical needs in the treatment of hyperinflammation and organ failure.