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8-K: BioCardia Reports Third Quarter 2024 Business Highlights and Financial Results

8-K: BioCardia Reports Third Quarter 2024 Business Highlights and Financial Results

8-K:BioCardia公布2024年第三季度业务亮点和财务业绩
美股SEC公告 ·  2024/11/13 15:14

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BioCardia reported Q3 2024 financial results and provided updates on its cell therapy programs. The CardiAMP Heart Failure Trial completed its last follow-up visit, with top-line data expected in Q1 2025. Japan's PMDA consultation is scheduled for late November regarding potential approval based on U.S. data.The company's net loss narrowed to $1.7 million in Q3 2024 from $2.6 million in Q3 2023. Research and development expenses decreased to $931,000 from $1.9 million, while selling, general and administrative expenses reduced to $825,000 from $1.1 million. BioCardia closed a $7.2 million upsized public offering in September 2024.BioCardia also received FDA approval for its Morph DNA Steerable Introducer product family and is preparing for commercial release. The company anticipates several milestones in Q4 2024 and Q1 2025, including data lock for the CardiAMP Heart Failure I Trial, enrollment in the CardiAMP Heart Failure II Trial, and completion of enrollment in the low-dose cohort of the CardiALLO allogeneic cell therapy study.
BioCardia reported Q3 2024 financial results and provided updates on its cell therapy programs. The CardiAMP Heart Failure Trial completed its last follow-up visit, with top-line data expected in Q1 2025. Japan's PMDA consultation is scheduled for late November regarding potential approval based on U.S. data.The company's net loss narrowed to $1.7 million in Q3 2024 from $2.6 million in Q3 2023. Research and development expenses decreased to $931,000 from $1.9 million, while selling, general and administrative expenses reduced to $825,000 from $1.1 million. BioCardia closed a $7.2 million upsized public offering in September 2024.BioCardia also received FDA approval for its Morph DNA Steerable Introducer product family and is preparing for commercial release. The company anticipates several milestones in Q4 2024 and Q1 2025, including data lock for the CardiAMP Heart Failure I Trial, enrollment in the CardiAMP Heart Failure II Trial, and completion of enrollment in the low-dose cohort of the CardiALLO allogeneic cell therapy study.
BioCardia报告了2024年第三季度的财务结果,并提供了关于其电芯治疗项目的更新。CardiAMP心力衰竭试验完成了最后的跟踪访视,预计顶线数据将在2025年第一季度公布。日本的PMDA咨询定于11月底进行,以便根据美国的数据讨论潜在批准。公司的净亏损在2024年第三季度缩小至170万美元,相较于2023年第三季度的260万美元。研究和开发费用从190万美元减少至931,000美元,而销售、一般和行政费用从110万美元减少至825,000美元。BioCardia在2024年9月完成了一项720万美元的增额公开募股。BioCardia还获得了FDA对其Morph DNA可操作引导产品系列的批准,并正准备进行商业发布。公司预计在2024年第四季度和2025年第一季度将有几个里程碑,包括CardiAMP心力衰竭I试验的数据锁定、CardiAMP心力衰竭II试验的招募,以及CardiALLO异体电芯治疗研究低剂量组的招募完成。
BioCardia报告了2024年第三季度的财务结果,并提供了关于其电芯治疗项目的更新。CardiAMP心力衰竭试验完成了最后的跟踪访视,预计顶线数据将在2025年第一季度公布。日本的PMDA咨询定于11月底进行,以便根据美国的数据讨论潜在批准。公司的净亏损在2024年第三季度缩小至170万美元,相较于2023年第三季度的260万美元。研究和开发费用从190万美元减少至931,000美元,而销售、一般和行政费用从110万美元减少至825,000美元。BioCardia在2024年9月完成了一项720万美元的增额公开募股。BioCardia还获得了FDA对其Morph DNA可操作引导产品系列的批准,并正准备进行商业发布。公司预计在2024年第四季度和2025年第一季度将有几个里程碑,包括CardiAMP心力衰竭I试验的数据锁定、CardiAMP心力衰竭II试验的招募,以及CardiALLO异体电芯治疗研究低剂量组的招募完成。
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