SeaStar Medical(US:ICU)2025-11-13 21:53Revenue Performance - SeaStar Medical reported a revenue of $0.9 million from the sale of QUELIMMUNE since receiving FDA approval in February 2024, with the first commercial units shipped in July 2024[149]. - For the three months ended September 30, 2025, revenue increased by 169% to $183,000 compared to $68,000 in the same period in 2024[159]. - Revenue for the nine months ended September 30, 2025, increased to $814,000, a 1097% increase compared to $68,000 for the same period in 2024[166]. - Gross profit for the nine months ended September 30, 2025, was $773,000, up 1037% from $68,000 in 2024[166]. Expenses and Losses - The company incurred a net loss of $3.472 million for the three months ended September 30, 2025, a decrease of 23% from a net loss of $4.478 million in the same period in 2024[159]. - Research and development expenses decreased by 21% to $1.85 million for the three months ended September 30, 2025, compared to $2.336 million in the same period in 2024[159]. - General and administrative expenses decreased by 13% to $1.898 million for the three months ended September 30, 2025, compared to $2.188 million in the same period in 2024[159]. - The total operating expenses for the three months ended September 30, 2025, were $3.748 million, a reduction of 17% from $4.524 million in the same period in 2024[159]. - Net loss for the nine months ended September 30, 2025, was approximately $9.2 million, a reduction of 55% compared to a net loss of $20.4 million in 2024[172]. - Total operating expenses for the nine months ended September 30, 2025, were $9.9 million, a decrease of 24% from $13.1 million in 2024[166]. Cash and Financial Position - As of September 30, 2025, the company had cash reserves of $13.8 million, a significant increase from $1.8 million as of December 31, 2024[145]. - The accumulated deficit as of September 30, 2025, was $148.8 million, up from $139.6 million as of December 31, 2024[144]. - The company recorded no provision for income taxes for the three months ended September 30, 2025, and September 30, 2024[164]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $9.5 million, a decrease of $1.8 million compared to $11.3 million for the same period in 2024[182]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $21.5 million, primarily from the issuance of new shares of common stock ($14.3 million) and proceeds from pre-funded warrants ($5.9 million)[183]. Clinical Development and Future Outlook - The company is conducting a pivotal clinical trial for its adult SCD therapy, which is crucial for future revenue generation[150]. - SeaStar Medical's SCD therapy has the potential to address a market of over one million patients annually facing life-threatening hyperinflammatory conditions[143]. - The company expects to incur significant expenses for the clinical development of its adult SCD and commercialization of QUELIMMUNE, necessitating additional funding[179]. - The company anticipates that its future funding requirements will depend on the progress of clinical trials and regulatory approvals[179]. Concerns and Commitments - 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 twelve months[175]. - As of September 30, 2025, the company has unused available capacity on the ATM Facility that allows for potential capital raising of approximately $2.2 million[176]. - The company does not plan to include potential cash proceeds from the exercise of warrants in its liquidity projections as of the date of the Quarterly Report[178]. - The company has no contractual obligations or commitments outstanding as of September 30, 2025[181]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay compliance with certain accounting standards[187].