VBI Vaccines公布2018年第二季度财务业绩并提供公司更新

StephenW

VBI Vaccines Announces Second Quarter 2018 Financial Results and Provides Corporate Update
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July 26, 2018 07:00 ET | Source: VBI Vaccines, Inc.

-- Pivotal Phase 3 program for Sci-B-Vac® Hepatitis B vaccine continues to advance towards topline data expected mid-year 2019 --

-- Positive safety and immunogenicity data from Phase 1 study of VBI-1501 for Congenital Cytomegalovirus (CMV) reported in May 2018 --

-- Initial data from Phase 1/2a study of VBI-1901 for the treatment of recurrent glioblastoma (GBM) expected H2 2018 --

CAMBRIDGE, Mass., July 26, 2018 (GLOBE NEWSWIRE) -- VBI Vaccines Inc. (NASDAQ:VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today reported financial results for the second quarter ending June 30, 2018, and provided a corporate update.

“We continue to make strong progress in all three of our lead clinical programs,” said Jeff Baxter, President and CEO of VBI. “Our pivotal Phase 3 program of Sci-B-Vac®, our hepatitis B vaccine, is advancing well towards topline data from the PROTECT study expected mid-year 2019.  Our eVLP technology-based pipeline showed exciting results in the clinic in May, when we reported positive final safety and immunogenicity data from our Phase 1 randomized study of VBI-1501 for CMV. This study was the first in-human study of a vaccine developed with our eVLP technology. We were excited to be able to demonstrate a robust immunologic response at a dose that is one-tenth the amount of other organizations’ CMV vaccine candidates. For our immuno-oncology pipeline, also developed with our eVLP technology, we look forward to reporting initial immunologic data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients, which we expect in the second half of this year.”

Recent Highlights and Upcoming Milestones

Sci-B-Vac® for Hepatitis B

    Sci-B-Vac®, the Company’s Hepatitis B vaccine, is currently being studied in a pivotal Phase 3 clinical program in the U.S., Europe, and Canada. This program consists of two concurrent Phase 3 studies, the PROTECT study and the CONSTANT study.
        Topline data from the PROTECT study are expected mid-year 2019, with topline data from the CONSTANT study expected in the second half of 2019.
        The results from this pivotal Phase 3 program are intended to support future regulatory filings in the U.S., Europe, and Canada.

VBI-1501 for Congenital Cytomegalovirus (CMV)

    In May 2018, VBI reported positive safety and immunogenicity data from a Phase 1 randomized, observer-blind, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of VBI-1501 in 128 CMV-negative, healthy adults aged 18-40 years.
        Subjects were randomized into five arms to receive various dose levels of a modified form of the CMV gB antigen, gB-g, with or without the adjuvant alum, or to receive placebo.  The highest does of antigen tested was 2.0μg of gB-g content with alum (VBI-1501A 2.0μg).
        The final Phase 1 study results demonstrated that VBI-1501A was safe and well-tolerated at all doses.
        VBI-1501A 2.0μg elicited CMV-neutralizing antibodies against fibroblast cell infection in 100% of subjects after the third vaccination (85% after two vaccinations), inducing titers comparable to those observed in patients protected as a result of natural infection (CMV-positive controls).
        In epithelial cells, which have historically been the much harder cell type to protect against infection, VBI-1501A 2.0μg demonstrated a 31% neutralizing antibody seroconversion rate after three vaccinations, up from 17% after two vaccinations.
        Discussions with regulatory bodies are planned for the second half of 2018 to discuss the next stage of development for VBI-1501A.

VBI-1901 for Glioblastoma Multiforme (GBM)

    A Phase 1/2a Clinical Study of VBI-1901 for the treatment of recurrent glioblastoma (rGBM) is ongoing.
        The multi-center, open-label, two-part study will enroll up to 28 patients and is designed to evaluate safety, tolerability, and the optimal therapeutic dose level of VBI-1901.
        Extensive biomarker testing and tumor imaging is built into this clinical protocol to enable the Company to assess the robustness of the immune response induced by VBI-1901.
        In the second half of 2018, VBI hopes to be able to correlate this immunologic and biomarker data with initial clinical outcomes from the low and mid dose cohorts, and expects 6-month overall survival (OS) and progression-free survival (PFS) data in the first half of 2019.            

Second Quarter 2018 Financial Results

    VBI ended the second quarter of 2018 with $41.1 million in cash and cash equivalents compared with $67.7 million as of December 31, 2017.  Net cash used in operations for the six months ended June 30, 2018 was $24.5 million.
     
    Revenue for the second quarter of 2018 was $0.2 million and was primarily attributable to sales of Sci-B-Vac in Israel and in Europe, on a named-patient basis.  Revenue for the second quarter of 2017 was $0.3 million and was primarily attributable to sales of Sci-B-Vac in Israel and to a services agreement that was completed during that timeframe.
     
    Research and development expenses were $10.9 million for the second quarter of 2018, as compared to $4.5 million for the same period in 2017. The increase was primarily due to the continuation of the Phase 3 program for Sci-B-Vac® and the Phase 1/2a clinical study for VBI-1901 in recurrent GBM patients, but was partially offset by the reduction in research expenses due to the advancement of VBI-1901 into clinical development from pre-clinical development.
     
    General and administrative expenses were $4.0 million for the second quarter of 2018, as compared to $2.8 million for the same period in 2017. The increase was primarily due to human resources expenses, stock-based compensation expenses, and impairment related to leasehold improvements and manufacturing equipment no longer being utilized in the business as a result of the renovation and capacity increases of our manufacturing facility in Rehovot, Israel.
     
    Net loss and net loss per share for the second quarter of 2018 were $16.7 million and $0.26, respectively, compared to a net loss of $9.0 million and a net loss per share of $0.22 for the second quarter of 2017.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac®, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac® is approved for use in Israel and 10 other countries. VBI’s eVLP Platform technology enables the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma (GBM). VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

StephenW

VBI Vaccines公布2018年第二季度财务业绩并提供公司更新
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2018年7月26日07:00 ET |资料来源：VBI Vaccines，Inc。

- Sci-B-Vac®乙型肝炎疫苗的Pivotal第3阶段计划继续向2019年中期的最高数据发展 -

- 2018年5月报告的VBI-1501先天性巨细胞病毒（CMV）1期研究的阳性安全性和免疫原性数据 -

- 用于治疗复发性胶质母细胞瘤（GBM）的VBI-1901阶段1 / 2a研究的初步数据预计H2 2018年 -

马萨诸塞州剑桥市，2018年7月26日（GLOBE NEWSWIRE） - VBI疫苗公司（纳斯达克股票代码：VBIV）（“VBI”），一家开发下一代传染病和免疫肿瘤疫苗的商业阶段生物制药公司，今天报道截至2018年6月30日的第二季度财务业绩，并提供了企业更新。

“我们在所有三个主要临床项目中都继续取得长足进步，”VBI总裁兼首席执行官杰夫巴克斯特说。 “我们的乙型肝炎疫苗Sci-B-Vac®的关键性第3阶段计划正在朝着2019年中期预期的PROTECT研究的最佳数据发展。我们基于eVLP技术的管道在5月份在诊所取得了令人振奋的成果，当我们报告我们用于CMV的VBI-1501的第1阶段随机研究中的阳性最终安全性和免疫原性数据时。这项研究是第一项使用我们的eVLP技术开发的疫苗的人体内研究。我们很高兴能够以其他组织的CMV候选疫苗数量的十分之一的剂量证明强大的免疫反应。对于我们的免疫肿瘤学管道，也是用我们的eVLP技术开发的，我们期待报告在复发的GBM患者中进行VBI-1901的1 / 2a期研究的初始免疫学数据，我们预计在今年下半年。“

最近的亮点和即将到来的里程碑

Sci-B-Vac®用于乙型肝炎

    公司的乙型肝炎疫苗Sci-B-Vac®目前正在美国，欧洲和加拿大的关键性3期临床项目中进行研究。该计划包括两个同时进行的3期研究，即PROTECT研究和CONSTANT研究。
        PROTECT研究的最高数据预计在2019年中期，CONSTANT研究的最高数据预计在2019年下半年。
        该关键阶段3计划的结果旨在支持美国，欧洲和加拿大未来的监管备案。

VBI-1501用于先天性巨细胞病毒（CMV）

    在2018年5月，VBI报告了1期随机，观察者盲，安慰剂对照研究的阳性安全性和免疫原性数据，该研究旨在评估VBI-1501在128名CMV阴性，18岁健康成年人中的安全性，耐受性和免疫原性。 40年。
        将受试者随机分成五个臂以接受各种剂量水平的CMV gB抗原的修饰形式，gB-g，有或没有佐剂明矾，或接受安慰剂。测试的抗原的最高值是2.0μg的含有明矾的gB-g含量（VBI-1501A2.0μg）。
        最终的1期研究结果表明，VBI-1501A在所有剂量下都是安全且耐受良好的。
        VBI-1501A2.0μg在第三次接种后100％受试者中引发了针对成纤维细胞感染的CMV中和抗体（两次接种后为85％），诱导效价与在自然感染保护的患者中观察到的相当（CMV阳性）控制）。
        在历史上一直是更难以抵抗感染的细胞类型的上皮细胞中，VBI-1501A2.0μg在三次疫苗接种后表现出31％的中和抗体血清转换率，高于两次接种后的17％。
        计划于2018年下半年与监管机构进行讨论，讨论VBI-1501A的下一个发展阶段。

VBI-1901用于多形性胶质母细胞瘤（GBM）

    用于治疗复发性胶质母细胞瘤（rGBM）的VBI-1901的1 / 2a期临床研究正在进行中。
        这项多中心，开放标签，两部分研究将招募多达28名患者，旨在评估VBI-1901的安全性，耐受性和最佳治疗剂量水平。
        广泛的生物标志物测试和肿瘤成像已纳入该临床方案，使公司能够评估VBI-1901诱导的免疫应答的稳健性。
        在2018年下半年，VBI希望能够将这些免疫学和生物标志物数据与来自中低剂量队列的初始临床结果相关联，并期望6个月的总生存期（OS）和无进展生存期（PFS）数据在2019年上半年。

2018年第二季度财务业绩

    截至2017年12月31日，VBI以20110万美元的现金和现金等价物结束了2018年第二季度的结果，而截至2017年12月31日为止，截至2010年6月30日的六个月的运营净现金为2450万美元。
2018年第二季度的收入为20万美元，主要归因于以色列和欧洲的Sci-B-Vac在指定患者基础上的销售额。 2017年第二季度的收入为30万美元，主要归因于以色列Sci-B-Vac的销售以及在此期间内完成的服务协议。
     
    2018年第二季度的研发费用为1090万美元，而2017年同期为450万美元。这一增长主要是由于Sci-B-Vac®和第1阶段的第3阶段计划的继续/ 2a在复发性GBM患者中进行VBI-1901的临床研究，但由于VBI-1901从临床前开发进展为临床开发，研究费用的减少部分抵消了这一研究。
     
    2018年第二季度的一般和管理费用为400万美元，而2017年同期为280万美元。这一增长主要是由于人力资源开支，股票补偿费用以及与租赁权益改善和制造相关的减值所致。由于我们在以色列雷霍沃特的制造工厂的翻新和产能增加，设备不再用于业务。
     
    2018年第二季度的净亏损和每股净亏损分别为1670万美元和0.26美元，而2017年第二季度的净亏损为900万美元，每股净亏损为0.22美元。

关于VBI Vaccines Inc.

VBI Vaccines Inc.（“VBI”）是一家商业阶段的生物制药公司，开发下一代疫苗，以解决传染病和免疫肿瘤学方面的未满足需求。 VBI的第一个上市产品是Sci-B-Vac®，一种乙型肝炎（HBV）疫苗，模仿乙型肝炎病毒的所有三种病毒表面抗原; Sci-B-Vac®已获准在以色列和其他10个国家使用。 VBI的eVLP平台技术可以开发包膜病毒样颗粒（eVLP）疫苗，该疫苗可以模拟目标病毒，从而引发强效的免疫反应。 VBI正在推进eVLP疫苗的推广，其中包括巨细胞病毒（CMV）和胶质母细胞瘤（GBM）的主要项目。 VBI总部位于马萨诸塞州剑桥，在加拿大渥太华设有研究机构，在以色列雷霍沃特设有研究和制造工厂。