CAMBRIDGE, Mass., June 16, 2019 (GLOBE NEWSWIRE) -- VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, will host a conference call and webcast tomorrow morning, June 17, 2019, at 8:00 AM ET. Management looks forward to reviewing top-line data from PROTECT, one of two pivotal Phase 3 studies for Sci-B-Vac®, the company’s trivalent hepatitis B vaccine.

Conference Call and Webcast Details

The live webcast and slide presentation can be accessed via the Events/Presentations page in the investors section of the company’s website, https://www.vbivaccines.com/investors/events-presentations/, or by clicking this link: https://edge.media-server.com/m6/p/7ryhzgu2.

A replay of the webcast will be archived on the company’s website for 90 days following the live conference call.

To listen to the live conference call, please dial:

      - Toll-free U.S. & Canada Dial-In: (866) 602-1050
      - International Dial-In: (409) 231-2052
      - Conference ID: 7639339

About Sci-B-Vac®

Sci-B-Vac® is a trivalent hepatitis B vaccine, which is approved for use in Israel and 10 other countries and is currently in a pivotal Phase 3 program in the U.S., Europe, and Canada. This pivotal Phase 3 program consists of two studies, the PROTECT study and the CONSTANT study.  Top-line data from the CONSTANT study is expected around year-end 2019. Commercial product distribution data estimates that over 500,000 infants and adults have been safely vaccinated with Sci-B-Vac® in Israel and other markets where the vaccine is approved.  In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen) of the hepatitis B virus, Sci-B-Vac® is a trivalent vaccine that contains the S antigen and the pre-S1 and pre-S2 surface antigens.  Published data demonstrates that T cell responses to pre-S1 and pre-S2 antigens can further boost responses to the S antigen, resulting in a more immunogenic response.   

About Hepatitis B

Hepatitis B is an infection of the liver caused by the Hepatitis B virus (HBV), and is characterized by liver inflammation, injury, and cell death. The disease can present acutely and resolve on its own, or it can progress to a chronic state. According to the World Health Organization (“WHO”), more than 880,000 people die each year due to HBV-related complications, including cirrhosis and liver cancer, as currently available treatments generate a functional cure in less than 20 percent of those treated. Primary prevention by vaccination, therefore, is considered the best way to control hepatitis B infection.

About VBI Vaccines Inc.

VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with the only commercially-approved trivalent hepatitis B vaccine, Sci-B-Vac®, which is approved for use in Israel and 10 other countries and is currently in a Phase 3 program in the U.S., Europe, and Canada, and with an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. Integrating its cytomegalovirus (CMV) expertise with the eVLP platform technology, VBI’s lead eVLP program candidates include a prophylactic CMV vaccine candidate and a glioblastoma (GBM) vaccine immunotherapeutic candidate. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

Website Home: http://www.vbivaccines.com/ 

News and Insights: http://www.vbivaccines.com/wire/

Investors: http://www.vbivaccines.com/investors/ 

Cautionary Statement on Forward-looking Information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The company cautions that such statements involve risks and uncertainties that may materially affect the company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the company's products. A discussion of these and other factors, including risks and uncertainties with respect to the company, is set forth in the Company's filings with the Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2019, and filed with the Canadian security authorities at sedar.com on February 25, 2019, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

VBI Contact

Nicole Anderson
Associate, Corporate Communications
Phone: (617) 830-3031 x124
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VBI Investor Contact

Nell Beattie
Chief Business Officer
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VBI Media Contact

Burns McClellan, Inc.
Robert Flamm, Ph.D.
Phone: (212) 213-0006
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NEW YORK, June 16, 2019 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of RCI Hospitality Holdings, Inc. (Nasdaq: RICK) between August 10, 2017 and May 10, 2019 (the “Class Period”) of the important July 22, 2019 lead plaintiff deadline in the securities class action lawsuit. The lawsuit seeks to recover damages for RCI investors under the federal securities laws.

To join the RCI class action, go to http://www.rosenlegal.com/cases-register-1570.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it. for information on the class action.

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) RCI engaged in numerous transactions with Eric Langan, RCI’s CEO, including lending him large amounts of money; (2) these practices were likely to lead to investigations of RCI by regulators; (3) investigations into RCI’s corporate governance would harm RCI’s prospects by, among other things, causing it to be unable to timely file its financial statements; and (4) as a result, Defendants’ statements about RCI’s business, operations and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than July 22, 2019. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1570.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it..

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney advertising. Prior results do not guarantee future outcomes.

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Contact Information:
      Laurence Rosen, Esq.
      Phillip Kim, Esq.
      The Rosen Law Firm, P.A.
      275 Madison Avenue, 34^th Floor
      New York, NY  10016
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Final Results Presented in Late-Breaking Session
at Society for Vascular Surgery 2019 Vascular Annual Meeting

NATIONAL HARBOR, Md., June 15, 2019 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced positive final results for the company’s ROADSTER-2 post-marketing study evaluating real world use of the ENROUTE® Neuroprotection and Stent Systems in TransCarotid Artery Revascularization (TCAR) procedures.

In the late-breaking session at the Society for Vascular Surgery 2019 Vascular Annual Meeting (VAM), Dr. Vikram Kashyap, Chief of Vascular Surgery and Endovascular Therapy at University Hospitals Case Medical Center (Cleveland, OH) and National Co-Principal Investigator of ROADSTER-2, reported that the study demonstrated compelling patient outcomes with low stroke and combined stroke and death rates of 0.6% and 0.8%, respectively, in 632 high surgical risk patients enrolled across 42 sites. Seventy percent (70%) of patients enrolled in the study were from physicians new to TCAR.

“The results of ROADSTER-2 continue to demonstrate the safety, effectiveness and clinical advantages of TCAR, especially given that a majority of the TCAR procedures were performed by a broad group of physicians with no previous TCAR experience,” Dr. Kashyap said. “The study results highlight the short learning curve of the TCAR procedure and its remarkable consistency and reproducibility, and, I believe, will further encourage physicians to broadly adopt the TCAR procedure.”

Designed as a follow-on study to the pivotal ROADSTER trial, ROADSTER-2 is a prospective, multi-center study designed to assess the real-world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the TCAR procedure. The study met its primary endpoint of procedural success, defined as acute device and technical success in the absence of stroke, death or myocardial infarction (MI) at 30 days, at 97.9%.

Significant findings from the study showed TCAR to have low rates of 30-day major adverse events, including:

• 1.7% stroke, death and MI
• 0.8% stroke and death
• 0.6% stroke, including 0.6% in symptomatic patients, 0.5% in females, and 1.1% in patients age greater than 75

In addition, ROADSTER-2 showed lower rates of acute (1.3%) and permanent (0.5%) cranial nerve injury than is typically observed for patients receiving carotid endarterectomy (CEA), the current standard of care.

“The mounting clinical evidence base demonstrates the compelling patient benefits of TCAR, which we believe will further support physician confidence and adoption. The data from ROADSTER-2, taken together with recent updated results from the TCAR Surveillance Project, supports the case for TCAR as the standard of care in high surgical risk patients,” said Erica Rogers, Silk Road Medical’s Chief Executive Officer.

About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
TCAR (TransCarotid Artery Revascularization) is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The ENROUTE Transcarotid Stent is intended to be used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The ENROUTE Transcarotid NPS is a first in class device used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE Transcarotid Stent.

About Silk Road Medical
Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.

ENROUTE is a registered trademark of Silk Road Medical, Inc.

INVESTOR CONTACT
Lynn Lewis or Carrie Mendivil
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MEDIA CONTACT
Joni Ramirez
Merryman Communications
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323-532-0746