SeaStar Medical(US:ICU)2025-05-14 21:00Financial Performance - SeaStar Medical reported a revenue of $0.293 million for the three months ended March 31, 2025, compared to no revenue in the same period in 2024, marking a significant increase as commercial sales of QUELIMMUNE began in July 2024 [152]. - The net loss for the three months ended March 31, 2025, was $3.772 million, a 70% reduction from the net loss of $12.697 million in the same period in 2024 [152]. - The net loss for the three months ended March 31, 2025, was approximately $3.8 million, a decrease of $8.9 million compared to a net loss of $12.7 million for the same period in 2024 [160]. - Net cash used in operating activities was $2.7 million for the three months ended March 31, 2025, compared to $3.5 million for the same period in 2024, reflecting a decrease of $0.8 million [171]. Expenses - Research and development expenses rose by 43% to $2.431 million for the three months ended March 31, 2025, compared to $1.697 million in the same period in 2024 [152]. - General and administrative expenses decreased by 25% to $1.684 million for the three months ended March 31, 2025, down from $2.253 million in the same period in 2024 [152]. - Clinical trial costs rose by $0.7 million due to the expansion of the NEUTRALIZE-AKI pivotal trial from 5 to 16 clinical trial sites, contributing significantly to the increase in R&D expenses [155]. - General and administrative expenses decreased to approximately $1.7 million for the three months ended March 31, 2025, down from $2.3 million in 2024, a reduction of about 26% [157]. Cash and Funding - The company had cash reserves of $5.3 million as of March 31, 2025, an increase from $1.8 million as of December 31, 2024 [136]. - Cash and cash equivalents as of March 31, 2025, were $5.3 million, an increase from $1.8 million as of December 31, 2024 [163]. - Net cash provided by financing activities was $6.1 million for the three months ended March 31, 2025, primarily from the issuance of new shares and pre-funded warrants [172]. - The company anticipates significant future funding requirements to support ongoing clinical development and commercialization efforts [168]. - The company has raised concerns about its ability to continue as a going concern due to insufficient cash to meet working capital and capital expenditure requirements for at least the next twelve months [164]. Accumulated Deficit - SeaStar Medical has an accumulated deficit of $143.3 million as of March 31, 2025, compared to $139.6 million as of December 31, 2024 [135]. - The accumulated deficit increased to approximately $143.3 million as of March 31, 2025, compared to $139.6 million as of December 31, 2024 [162]. Regulatory Approvals and Market Potential - SeaStar Medical received FDA approval for its pediatric SCD therapy under a Humanitarian Device Exemption on February 21, 2024, and shipped its first commercial units in July 2024 [125]. - The SCD therapy has been awarded Breakthrough Device Designation for six therapeutic indications, facilitating a potentially expedited approval process [126]. - The company aims to capture a sizable market for its SCD therapy, targeting over one million patients annually facing life-threatening hyperinflammatory conditions [134]. - SeaStar Medical has generated approximately $0.5 million in revenue from the sale of commercialized pediatric SCD products to date [140]. Company Classification - The company will remain an Emerging Growth Company (EGC) under the JOBS Act until the earliest of the last day of its first fiscal year following the fifth anniversary of the Business Combination, total annual gross revenue of at least $1.235 billion, or being deemed a "large-accelerated filer" with at least $700.0 million of outstanding securities held by non-affiliates [178]. - The company has issued more than $1.0 billion in non-convertible debt securities during the previous three years, which may affect its EGC status [178]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [179].