SeaStar Medical(ICU) - 2025 Q3 - Quarterly Results

Financial Performance - SeaStar Medical reported net revenue of approximately $0.2 million for Q3 2025, up from $0.1 million in Q3 2024, reflecting sales of the QUELIMMUNE pediatric SCD therapy[6]. - Net revenue for the three months ended September 30, 2025, was $183,000, a significant increase from $68,000 in the same period of 2024, representing a growth of 169%[28]. - Gross profit for the nine months ended September 30, 2025, reached $773,000, compared to $68,000 for the same period in 2024, indicating a substantial increase[28]. - The net loss for the nine months ended September 30, 2025, was $9,246,000, an improvement compared to a net loss of $20,411,000 for the same period in 2024, showing a reduction of 54%[30]. - Total operating expenses for the three months ended September 30, 2025, were $3,748,000, down from $4,524,000 in the same period of 2024, reflecting a decrease of 17%[28]. - Research and development expenses for the nine months ended September 30, 2025, were $5,318,000, down from $6,367,000 in the same period of 2024, indicating a reduction of 17%[28]. Cash and Financing - The company raised $12.4 million in Q3 2025 through equity offerings and warrant exercises, strengthening its balance sheet[5]. - Cash at September 30, 2025, was $13.8 million, a significant increase from $1.8 million at December 31, 2024[11]. - Cash at the end of the period on September 30, 2025, was $13,763,000, a significant increase from $2,082,000 at the end of the same period in 2024[30]. - The net cash provided by financing activities for the nine months ended September 30, 2025, was $21,449,000, compared to $13,220,000 for the same period in 2024, showing an increase of 62%[30]. Clinical Trials and Research - The NEUTRALIZE-AKI pivotal clinical trial has adjusted total enrollment from 200 to approximately 339 patients, with 146 patients enrolled to date[4][5]. - SeaStar Medical initiated its first clinical site for the NEUTRALIZE-CRS trial, targeting 20 patients with acute chronic systolic heart failure[5]. - The company anticipates completing enrollment for the NEUTRALIZE-AKI trial by the end of 2026 based on current enrollment rates[4]. - QUELIMMUNE therapy demonstrated a 76% survival rate at 60 days and 71% at 90 days for 21 pediatric patients, indicating a potential 50% reduction in loss of life compared to historical data[4]. Operational Metrics - General and administrative expenses decreased to approximately $1.9 million in Q3 2025 from $2.2 million in Q3 2024, attributed to lower franchise tax and legal fees[9]. - The company added three top-ranked children's hospitals to its customer base for QUELIMMUNE therapy, with fourth quarter orders already exceeding those of Q3 2025[3][4]. - Total assets as of September 30, 2025, amounted to $15,530,000, compared to $4,658,000 as of December 31, 2024, indicating a growth of 233%[26]. - Total liabilities remained stable at $4,066,000 as of September 30, 2025, compared to $6,841,000 as of December 31, 2024, reflecting a decrease of 40%[26]. - Research and development expenses decreased to $1.9 million in Q3 2025 from $2.3 million in Q3 2024, primarily due to lower consulting and personnel costs[8]. - The company reported a weighted-average of 26,393,400 shares outstanding for the three months ended September 30, 2025, compared to 4,086,871 shares for the same period in 2024[28].