0001493152-19-014865.txt : 20191002 0001493152-19-014865.hdr.sgml : 20191002 20191002090017 ACCESSION NUMBER: 0001493152-19-014865 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20191002 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20191002 DATE AS OF CHANGE: 20191002 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VBI Vaccines Inc/BC CENTRAL INDEX KEY: 0000764195 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37769 FILM NUMBER: 191130896 BUSINESS ADDRESS: STREET 1: 222 THIRD STREET STREET 2: SUITE 2241 CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-830-3031 MAIL ADDRESS: STREET 1: 222 THIRD STREET STREET 2: SUITE 2241 CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: SciVac Therapeutics Inc. DATE OF NAME CHANGE: 20150717 FORMER COMPANY: FORMER CONFORMED NAME: LEVON RESOURCES LTD. DATE OF NAME CHANGE: 20100910 FORMER COMPANY: FORMER CONFORMED NAME: LEVON RESOURCES LTD DATE OF NAME CHANGE: 19850305 8-K 1 form8-k.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 2, 2019

VBI VACCINES INC.

(Exact name of registrant as specified in its charter)

British Columbia, Canada

001-37769

N/A

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

222 Third Street, Suite 2241

Cambridge, Massachusetts

02142

(Address of principal executive offices)

(Zip Code)

(617) 830-3031

(Registrant’s telephone number, including area code)

N/A

(Former Name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[ ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ]	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of exchange on which registered
Common Shares, no par value per share		VBIV		The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company [X]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [X]

Item 8.01 Other Events.

On October 2, 2019, VBI Vaccines Inc. issued a press release announcing that its abstract titled, “Trivalent hepatitis B (HepB) vaccine yields superior seroprotection rates in adults: results from the phase 3 double-blind, randomized study comparing immunogenicity and safety of a 3-Dose regimen of Sci-B-Vac™ and Engerix B® (PROTECT),” has been selected for a late-breaker oral presentation at IDWeek 2019™, in Washington, D.C., on Friday, October 4, 2019. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description

99.1		Press Release dated October 2, 2019

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	VBI Vaccines Inc.

Date: October 2, 2019	By:	/s/ Jeff Baxter
		Jeff Baxter
		President and Chief Executive Officer

EX-99.1 2 ex99-1.htm

VBI Vaccines Announces Late-Breaker Oral Presentation at IDWeek 2019™

CAMBRIDGE, Mass. (October 2, 2019) – VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the company’s abstract titled, “Trivalent hepatitis B (HepB) vaccine yields superior seroprotection rates in adults: results from the phase 3 double-blind, randomized study comparing immunogenicity and safety of a 3-Dose regimen of Sci-B-Vac™ and Engerix B^® (PROTECT),” has been selected for a late-breaker oral presentation at IDWeek 2019™, in Washington, D.C., on Friday, October 4, 2019.

Dr. Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study, will deliver the oral presentation. Dr. Langley will discuss the top-line data from the PROTECT study, a pivotal Phase 3 study designed to evaluate the efficacy and safety of a 10µg dose of Sci-B-Vac^®, VBI’s trivalent hepatitis B vaccine, compared with a 20µg dose of the comparator vaccine, Engerix-B^®. Notably, Dr. Langley will highlight the two successfully-met co-primary endpoints and detailed seroprotection data in key patient subgroups, including by age group, gender, diabetic status, body mass index, and smoking status.

Presentation Details

-	Abstract #: 717615
-	Session: 184 - Late Breaker Oral Abstract Session 2
-	Location: Walter E. Washington Convention Center, Room 209 ABC
-	Date: Friday, October 4, 2019
-	Time: 2:35 – 2:45 PM ET
-	Event Website: https://idweek.org

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/

- 2 -

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

Email: info@vbivaccines.com

VBI Investor Contact

Nell Beattie

Chief Business Officer

Email: ir@vbivaccines.com

VBI Media Contact

Burns McClellan, Inc.

Ryo Imai

Phone: (212) 213-0006

Email: rimai@burnsmc.com

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