MULHOUSE, France, and SUNNYVALE, Calif., July 08, 2024 (GLOBE NEWSWIRE) -- CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announce success from a collaborative Phase II trial of ProtheraCytes for the treatment of acute myocardial infarction (AMI) led by CellProthera, as well as plans to continue the re ...

SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled "Radial and Transendocardial Delivery Catheter," with a patent term that will expire in 2036. The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial ...

SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled "Radial and Transendocardial Delivery Catheter," with a patent term that will expire in 2036. The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial ...

SUNNYVALE, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that, following approval by the Company's stockholders and its Board of Directors, the Company intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 15 pre-split shares. The reverse stock split will become effective at 12:01 a.m. Eastern Daylight Tim ...

文章核心观点 - 公司拟进行1:15的反向股票拆分 [1][2][4] - 反向拆股旨在提高公司股票在纳斯达克资本市场的最低交易价格要求 [1] - 反向拆股不会改变股东在公司股权中的百分比权益 [4] - 公司将调整普通股的法定股数,从100,000,000股减至50,000,000股 [7] 根据相关目录分别进行总结 反向拆股的具体安排 - 反向拆股生效时间为2024年5月30日东部夏令时12:01 [1][2] - 拆股比例为1:15,即15股拆为1股 [1][2] - 拆股后公司普通股将继续在纳斯达克资本市场交易,股票代码不变 [1] - 持有实物股票的股东需要通过公司转让代理人进行股票兑换 [3] - 不会产生碎股,碎股部分将以现金方式支付给股东 [4][5] - 公司的股票期权和认股权证将按比例进行调整 [6] - 公司普通股的CUSIP编号将发生变化 [6] 公司基本情况 - 公司总部位于加州Sunnyvale,主要从事心血管和肺部疾病的细胞治疗产品研发 [9] - 公司的主要治疗平台包括CardiAMP自体细胞疗法和CardiALLO异体细胞疗法 [9] - 公司还为合作伙伴提供生物治疗递送系统及临床前和临床开发服务 [9]

财务数据和关键指标变化 - 公司Q1 2024年收入为55,000美元,与上年同期的65,000美元基本持平 [39] - 研发费用从上年同期的2.4百万美元下降到1.2百万美元,主要是由于CardiAMP心力衰竭试验在2023年第四季度完成入组,相关的临床和支持职能费用有所减少 [40] - 销售、一般及管理费用从上年同期的1.2百万美元略有下降至1.1百万美元 [41] - 公司净亏损从上年同期的3.5百万美元下降到2.3百万美元,主要由于前述费用的减少 [42] - 公司Q1 2024年经营活动使用现金1.5百万美元,上年同期为2.6百万美元,公司能够高效运营并实现目标 [43] 各条业务线数据和关键指标变化 - CardiAMP自体细胞治疗在ischemic心力衰竭患者中显示出显著的疗效,包括86%的心脏死亡风险降低和24%的非致死性主要不良心血管事件降低 [13][14][15] - CardiAMP心力衰竭II期试验已获FDA批准,并获得Medicare报销,预计有90%的成功概率 [21][22][23] - CardiAMP慢性心肌缺血(CMI)项目的前期试验结果显示,患者运动耐受时间平均增加107秒,心绞痛发作次数减少82% [27][28] - CardiALLO异体细胞治疗心力衰竭项目的1/2期试验中,首例低剂量患者未出现不良事件 [30][31] 各个市场数据和关键指标变化 - 公司计划在日本获得CardiAMP的首个批准,预计可能在2025年获批 [37] - 日本已批准一种细胞治疗心力衰竭的疗法,但需要手术介入,而CardiAMP则没有这一要求,有望获得批准并进行头对头临床试验 [56][57] - 日本心力衰竭患者约100万人,CardiAMP有望获得较高的价格和利润空间 [82][83] 公司战略和发展方向及行业竞争 - 公司正在积极推进三大心血管生物治疗临床项目,并通过生物治疗递送合作伙伴关系创造价值 [34][35][36] - 公司拥有广泛的心血管生物治疗递送技术专利,是该领域的领先者 [71][72] - 公司正在与多家潜在合作伙伴进行洽谈,希望找到合适的合作伙伴共同推进产品开发和商业化 [68][69][72][73] 管理层对经营环境和未来前景的评论 - 公司的治疗候选药物和技术有望惠及数百万心脏病患者,每个项目都有带来可观投资回报的潜力 [89] - 公司正在积极推进临床试验,并与日本监管机构保持密切沟通,有望在2025年获得首个产品批准 [37] - 公司在生物治疗递送领域拥有丰富的临床经验和广泛的知识产权,有望成为该领域的领导者 [71][72] 问答环节重要的提问和回答 问题1 **Lander Egaña-Gorroño 提问** 询问公司是否会增加CardiAMP CMI项目的前期试验患者数量 [47] **Peter Altman 回答** 公司已停止额外患者的入组,因为前期试验结果已经非常出色,将直接启动随机对照试验阶段 [48][49][50][51] 问题2 **Lander Egaña-Gorroño 提问** 询问公司与日本PMDA的其他讨论重点 [52] **Peter Altman 回答** 公司已与PMDA确认可以使用美国的临床数据支持在日本的申请,正在准备最终数据提交,预计与PMDA还会有进一步沟通 [53][54][55][56][57] 问题3 **Unidentified Analyst 提问** 询问公司在日本获批后的商业化策略 [78] **Peter Altman 回答** 公司正在与多家潜在合作伙伴进行洽谈,希望找到合适的合作伙伴共同推进在日本的商业化,公司自身也有能力在日本建立盈利的子公司 [79][80][81][82][83][84][85]

Exhibit 99.1 BioCardia Reports First Quarter 2024 Business Highlights and Financial Results Sunnyvale, Calif. – May 14, 2024 - BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the first quarter of 2024 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2024 with the Securities and Exchange Commission. The Company will also hold a conference call ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38999 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or another jurisdiction of (I.R.S. Employer incorporation ...

SUNNYVALE, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the first quarter of 2024 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2024 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following ...

SUNNYVALE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will report its financial results for the the three months ended March 31, 2024 and provide a corporate update by conference call on Tuesday, May 14, 2024 at 4:30 PM ET. Following management's formal remarks, there will be a question-and-answer session. Participants can register for the confere ...