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8-K: SeaStar Medical Reports Second Quarter 2024 Financial Results and Provides a Business Update

8-K: SeaStar Medical Reports Second Quarter 2024 Financial Results and Provides a Business Update

8-K：SeaStar Medical公布2024年第二季度财务业绩并提供业务最新情况
美股SEC公告 ·  2024/08/13 16:47

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SeaStar Medical announced its Q2 2024 financial results, highlighting the first commercial sales of QUELIMMUNE device for treating pediatric acute kidney injury and sepsis. The company reported a net loss of $3.2 million ($1.03 per share) compared to $2.4 million ($4.10 per share) in Q2 2023. R&D expenses increased to $2.3 million from $2.0 million YoY.The company achieved significant milestones including initial QUELIMMUNE sales, with two critically ill children already treated. The NEUTRALIZE-AKI pivotal trial for adults has enrolled 42 subjects at nine sites, with Medicare/Medicaid Category B coverage approval expected to reduce trial costs. Additionally, the company strengthened its financial position through a $10 million registered direct offering in July 2024.As of July 31, 2024, SeaStar Medical's cash balance was approximately $6.9 million, following the July financing and debt reduction of $2.7 million. The company continues to advance its commercialization strategy for QUELIMMUNE while progressing its adult AKI program, targeting FDA approval in first half of 2026.
SeaStar Medical announced its Q2 2024 financial results, highlighting the first commercial sales of QUELIMMUNE device for treating pediatric acute kidney injury and sepsis. The company reported a net loss of $3.2 million ($1.03 per share) compared to $2.4 million ($4.10 per share) in Q2 2023. R&D expenses increased to $2.3 million from $2.0 million YoY.The company achieved significant milestones including initial QUELIMMUNE sales, with two critically ill children already treated. The NEUTRALIZE-AKI pivotal trial for adults has enrolled 42 subjects at nine sites, with Medicare/Medicaid Category B coverage approval expected to reduce trial costs. Additionally, the company strengthened its financial position through a $10 million registered direct offering in July 2024.As of July 31, 2024, SeaStar Medical's cash balance was approximately $6.9 million, following the July financing and debt reduction of $2.7 million. The company continues to advance its commercialization strategy for QUELIMMUNE while progressing its adult AKI program, targeting FDA approval in first half of 2026.
SeaStar Medical公布了其2024年第二季度财务结果，强调了QUELIMMUNE设备首次商业销售，用于治疗儿童急性肾损伤和败血症。公司报告净亏损为320万美元（每股1.03美元），相比之下，2023年第二季度的净亏损为240万美元（每股4.10美元）。研发费用从200万美元同比增长至230万美元。公司在初步QUELIMMUNE销售中取得了重大里程碑，已成功治疗两名重症儿童。针对成人的NEUTRALIZE-AKI关键试验已在九个地点招募了42名参与者，预计Medicare/Medicaid B类覆盖批准将降低试验成本。此外，公司的财务状况也得到了加强，通过2024年7月的1000万美...展开全部
SeaStar Medical公布了其2024年第二季度财务结果，强调了QUELIMMUNE设备首次商业销售，用于治疗儿童急性肾损伤和败血症。公司报告净亏损为320万美元（每股1.03美元），相比之下，2023年第二季度的净亏损为240万美元（每股4.10美元）。研发费用从200万美元同比增长至230万美元。公司在初步QUELIMMUNE销售中取得了重大里程碑，已成功治疗两名重症儿童。针对成人的NEUTRALIZE-AKI关键试验已在九个地点招募了42名参与者，预计Medicare/Medicaid B类覆盖批准将降低试验成本。此外，公司的财务状况也得到了加强，通过2024年7月的1000万美元注册直接发行。截至2024年7月31日，SeaStar Medical的现金余额约为690万美元，此前进行的融资和270万美元的债务减少使得这一余额得以实现。公司继续推进QUELIMMUNE的商业化策略，同时推动其成人急性肾损伤项目，目标是在2026年上半年获得FDA批准。

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