Stock Monitor: KemPharm Post Earnings Reporting

LONDON, UK / ACCESSWIRE / April 23, 2018 / Active-Investors.com has just released a free research report on VBI Vaccines Inc. (NASDAQ: VBIV). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=VBIV as the Company's latest news hit the wire. On April 19, 2018, the Cambridge-based biopharmaceutical Company announced that it has completed the enrollment in the ongoing PROTECT Phase-3 study assessing the Company's third-generation hepatitis B vaccine, Sci-B-Vac®. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for KemPharm, Inc. (NASDAQ: KMPH), which also belongs to the Healthcare sector as the Company VBI Vaccines. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, VBI Vaccines most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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The first patient was dosed in the PROTECT study in December 2017. More than 1,600 adults have now been enrolled in the study at 27 sites across the US, Europe, and Canada.

Data from the PROTECT Study will Inform Positioning and Differentiation of Sci-B-Vac®

Jeff Baxter, President and Chief Executive Officer of VBI Vaccines, stated that the completion of enrollment in the PROTECT study is a significant milestone in this pivotal Phase-III program. According to him, Data from this head-to-head immunogenicity study will inform the positioning and differentiation of Sci-B-Vac®.

Jeff added that the Company looks forward to reporting the topline data and remain dedicated to advancing Sci-B-Vac® through phase-3 development as quickly as possible.

Top-line Data from the PROTECT Study are Expected Mid-Year 2019

PROTECT is a double-blind, two-arm, randomized, controlled study, and is one of two ongoing global studies that form the Phase-3 program for Sci-B-Vac®. It is designed to evaluate the safety and immunogenicity of Sci-B-Vac® compared to the control vaccine, Engerix-B®, in support of future regulatory filings in the US, Europe, and Canada. More than 1,600 subjects, 18 years of age and older, have been randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac® 10?g or a three-dose course of the control vaccine, Engerix-B® 20?g.

The co-primary objective of the study is to demonstrate non-inferiority of the seroprotection rate induced by Sci-B-Vac® versus Engerix-B® four weeks after the third vaccination in adults age 18 and older. The other co-primary objective is to demonstrate superiority of the seroprotection rate induced by Sci-B-Vac® versus Engerix-B® four weeks after the third vaccination in adults older than 45 years of age. Top-line data from the PROTECT study are expected mid-year 2019.

FDA Accepted Investigational New Drug Application for Sci-B-Vac® Phase-3 Clinical Program

On August 30, 2017, the US Food and Drug Administration (FDA) accepted the Company's Investigational New Drug Application (IND) for a Phase-3 clinical program evaluating Sci-B-Vac®. VBI Vaccines had previously received a No Objection Letter (NOL) from Health Canada in response to its Clinical Trial Application (CTA) as well. Acceptance of the IND and CTA enabled the Company to initiate the Phase-3 clinical study in both the US and Canada.

About Hepatitis B Infection

Hepatitis B is an infectious disease caused by the hepatitis B virus (HBV) that affects the liver. It can cause both acute and chronic infections. Many people have no symptoms during the initial infection, some develop a rapid onset of sickness with vomiting, yellowish skin, tiredness, dark urine, and abdominal pain. It may take 30 to 180 days for symptoms to begin. Most of those with chronic disease have no symptoms; however, cirrhosis and liver cancer may eventually develop. These complications result in the death of 15% to 25% of those with chronic disease. The virus is transmitted by exposure to infectious blood or body fluids.

About Sci-B-Vac®

Sci-B-Vac® is a licensed third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 500,000 patients. Sci-B-Vac® is currently approved for use in Israel and in 14 other countries. In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac® contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac® may prove more immunogenic in subjects that currently do not respond optimally to second-generation vaccines.

About VBI Vaccines Inc.

Founded in 2001 and headquartered in Massachusetts, VBI Vaccines is a commercial-stage biopharmaceutical company developing next generation 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.

Stock Performance Snapshot

April 20, 2018 - At Friday's closing bell, VBI Vaccines' stock fell 3.93%, ending the trading session at $3.18.

Volume traded for the day: 277.20 thousand shares, which was above the 3-month average volume of 120.82 thousand shares.

After last Friday's close, VBI Vaccines' market cap was at $221.49 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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