Hancock Jaffe Completes $41 Million Public Offering

Hancock Jaffe完成4100万美元公开募股

2021-02-12 06:31:53 BioSpace


Capital Raise to Fund VenoValve U.S. Pivotal Trial IRVINE, CA / ACCESSWIRE / February 11, 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has successfully completed a public offering of its securities generating approximately $41.4 million of gross proceeds, prior to deducting underwriting discounts and commissions, and expenses. The Company sold 5,914,284 shares of common stock and warrants to purchase 2,971,142 common shares in the public offering. Proceeds from the offering will be used for general working capital purposes, including funding of the company's proposed U.S. pivotal trial for the VenoValve, a novel treatment for lower limb Chronic Venous Insufficiency (CVI) of the deep vein system. "We believe that the capital from this financing should be more than sufficient to fund the VenoValve U.S. pivotal trial, and support the company into 2023," said Hancock Jaffe CEO Robert Berman. "The current standard of care for deep venous CVI sufferers is ineffective and only treats symptoms, rather than the underlying structural valve issues. We developed the VenoValve to fill this large unmet medical need. With this funding, we expect to make substantial progress toward our goal of helping millions of CVI patients throughout the world." CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping and walking extremely difficult for patients. CVI occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and venous hypertension. This results in leg swelling, pain, open sores (venous ulcers) and reduced mobility for patients. The current standard of care for deep venous CVI sufferers consists of compression garments and leg elevation. One-year results from the first-in-man trial for the VenoValve, released in December 2020, demonstrated significant improvement in all study endpoints, including reflux, venous clinical severity scores (disease manifestations), and visual analog scale scoring for chronic pain, with a good safety profile. Interim results from the study were recently published online in the Journal of Vascular Surgery. Last month, Hancock Jaffe had a successful pre-IDE meeting with the U.S. Food and Drug Administration (FDA) about the VenoValve and expects to file its application with the FDA in the first quarter of 2021 seeking IDE approval for commencing the VenoValve U.S. pivotal trial. Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 billion each year. There are currently no FDA-approved devices or effective treatments for deep venous CVI. Ladenburg Thalmann & Co. Inc. acted as sole book-running manager in connection with the public offering. The securities were offered pursuant to a registration statement on Form S-1, as amended (File No. 333- 251528), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 8, 2021 and a registration statement on Form S-1 (File No. 333-252874) filed pursuant to Rule 462(b) of the Securities Act of 1933, as amended, which became effective on February 8, 2021. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to the offering was filed by the company with the SEC on February 10, 2021. Copies of the final prospectus can be obtained at the SEC's website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th floor, New York, NY 10019 or by email at prospectus@ladenburg.com. About Hancock Jaffe Laboratories, Inc. Hancock Jaffe Laboratories (NASDAQ:HJLI) specializes in developing and manufacturing bioprosthetic (tissue-based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI currently has two lead product candidates: the VenoValve ® , a porcine-based valve which is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency, and the CoreoGraft ® , a bovine tissue-based off-the-shelf conduit intended to be used for coronary artery bypass surgery. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of Hancock Jaffe Laboratories, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to our liquidity and future cash position, the timing of filing of our IDE application and beginning patient enrollment, and the VenoValve's ability to fill the unmet medical needs of CVI sufferers) may differ significantly from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. MEDIA CONTACT: Michelle McAdam, Chronic Communications, Inc. michelle@chronic-comm.com (310) 902-1274 SOURCE: Hancock Jaffe Laboratories, Inc.   View source version on accesswire.com: https://www.accesswire.com/629394/Hancock-Jaffe-Completes-41-Million-Public-Offering  
为VenoValve美国关键试验筹集资金 加利福尼亚州欧文/ACCESSWIRE 2021年2月11日讯/汉考克·杰菲实验室公司(纳斯达克代码:HJLI)是一家恢复心脏和血管健康的医疗设备的开发商,该公司今天宣布,它成功地完成了其证券的公开发行,在扣除承销折扣、佣金和费用之前,获得了大约4140万美元的总收益。本公司在公开发行中出售5,914,284股普通股及购买2,971,142股普通股的认股权证。 本次发行的收益将用于一般营运资金用途,包括为该公司拟议的美国VenoValve关键试验提供资金,VenoValve是一种治疗下肢慢性静脉功能不全(CVI)的新型疗法。 Hancock Jaffe公司首席执行官罗伯特·伯曼说:“我们认为,这笔融资的资金应该足以为VenoValve美国关键试验提供资金,并支持公司进入2023年。”“目前对深静脉CVI患者的护理标准是无效的,而且只治疗症状,而不是潜在的瓣膜结构问题。我们开发VenoValve来满足这一巨大的未满足的医疗需求。有了这笔资金,我们希望在帮助全世界数百万CVI患者的目标上取得实质性进展。” CVI是一种使人衰弱的疾病,它会使患者的日常工作如洗澡、睡觉和行走变得极其困难。当腿部静脉内的瓣膜失效,导致血液向错误的方向流动(回流)和静脉高血压时,就会发生CVI。这会导致腿部肿胀、疼痛、开放性溃疡(静脉溃疡)和患者活动能力下降。目前的标准护理深静脉CVI患者包括压缩服装和腿抬高。 2020年12月发布的VenoValve首次在人体内试验的一年结果显示,所有研究终点均有显著改善,包括反流、静脉临床严重程度评分(疾病表现)和慢性疼痛的视觉模拟量表评分,具有良好的安全性。这项研究的中期结果最近在线发表在《血管外科杂志》上。 上个月,Hancock Jaffe与美国食品和药物管理局(FDA)就VenoValve举行了一次成功的IDE前会议,并预计将于2021年第一季度向FDA提交申请,寻求IDE批准VenoValve美国关键试验的开始。 美国大约有240万人由于深静脉系统的回流而患有CVI。据估计,美国CVI每年的直接医疗费用超过380亿美元。目前没有FDA批准的设备或有效的治疗深静脉CVI。 Ladenburg Thalmann公司担任与公开发行有关的唯一簿记管理人。证券是根据经修订的S-1表格登记声明(文件号333-251528)和根据经修订的1933年证券法规则462(b)提交的S-1表格登记声明(文件号333-252874)发售的,该注册声明由美国证券交易委员会(“SEC”)于2021年2月8日宣布生效。 本新闻稿不构成出售要约或征求购买要约,也不会在任何司法管辖区销售这些证券,在该司法管辖区的证券法律规定的注册或资格之前,该要约、征求或出售是非法的。该公司于2021年2月10日向SEC提交了与本次发行相关的最终招股说明书。最终招股说明书的副本可在SEC网站www.sec.gov或从Ladenburg Thalmann&Co.Inc.招股说明书部获得,地址:纽约第五大道640号,第4楼,纽约州10019或通过电子邮件prospectus@Ladenburg.com。 关于Hancock Jaffe Laboratories,Inc. Hancock Jaffe Laboratories(纳斯达克代码:HJLI)专门开发和制造生物修复(基于组织的)医疗设备,以建立治疗心脏和血管疾病的改进的护理标准。HJLI目前有两个主要的候选产品:VenoValve®,这是一种以猪为基础的瓣膜,打算通过外科手术植入腿部深静脉系统,治疗与慢性静脉功能不全相关的反流;以及CoreoGraft®,这是一种以牛组织为基础的现成导管,打算用于冠状动脉旁路手术。 关于前瞻性陈述的警告性说明 本新闻稿以及汉考克·杰菲实验室股份有限公司(以下简称“公司”)的股东、董事、雇员、代表和合伙人的任何与此相关的声明,除其他外,包含或可能包含1995年《私人证券诉讼改革法》所指的某些“前瞻性陈述”。此类前瞻性陈述涉及重大风险和不确定性。这样的陈述可以包括但不限于由诸如“项目”、“可能”、“将要”、“可能”、“将要”、“应该”、“相信”、“预期”、“预期”、“估计”、“打算”、“计划”、“潜在”或类似表述等词语标识的陈述。这些声明基于公司管理层当前的信念和预期,并受到重大风险和不确定性的影响,包括公司向证券交易委员会提交的文件中详述的风险和不确定性。实际结果(包括但不限于我们的流动性和未来现金状况、提交IDE申请和开始患者登记的时间、以及Venovalve满足CVI患者未满足的医疗需求的能力)可能与前瞻性陈述中阐述或暗示的结果有很大差异。这些前瞻性陈述涉及某些风险和不确定因素,这些风险和不确定因素可能会根据各种因素(其中许多因素不在公司的控制范围内)发生变化。公司不承担公开更新任何前瞻性陈述的义务,无论是由于新信息、未来陈述或其他原因,除非适用法律要求。 媒体联系人: Michelle McAdam,慢性通信公司。 电子邮件:michelle@chronic-comm.com (310)902-1274 资料来源:Hancock Jaffe Laboratories,Inc. 在AccessWire.com上查看源版本: https://www.accesswire.com/629394/hancock-jaffe-完成-4100万-公开发行