0001493152-23-021346.txt : 20230615 0001493152-23-021346.hdr.sgml : 20230615 20230615080029 ACCESSION NUMBER: 0001493152-23-021346 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230615 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230615 DATE AS OF CHANGE: 20230615 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: 231015983 BUSINESS ADDRESS: STREET 1: 160 SECOND STREET STREET 2: CAMBRIDGE CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 617-830-3031 MAIL ADDRESS: STREET 1: 160 SECOND STREET STREET 2: CAMBRIDGE 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
0000764195 false VBI Vaccines Inc/BC 0000764195 2023-06-15 2023-06-15 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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): June 15, 2023

 

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.)

 

160 Second Street, Floor 3

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 ☐

 

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. ☐

 

 

 

 
 

 

Item 8.01 Other Events.

 

On June 15, 2023, VBI Vaccines Inc. issued a press release announcing that PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)] is now available in the United Kingdom for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release dated June 15, 2023
104   Cover Page Interactive Data File (formatted as Inline XBRL)

 

 
 

 

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: June 15, 2023 By: /s/ Jeffrey R. Baxter
    Jeffrey R. Baxter
    President and Chief Executive Officer

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

VBI Vaccines Announces PreHevbri® is Now Available in the United Kingdom for the Prevention of Hepatitis B in Adults

 

  ● PreHevbri® is the only approved 3-antigen hepatitis B vaccine for adults in the U.K.
  ● Product to be launched via marketing and distribution partner, Valneva

 

CAMBRIDGE, Mass. (June 15, 2023) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)] is now available in the United Kingdom (“U.K.”) for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunization with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. As part of the marketing and distribution partnership announced in September 2022, PreHevbri will be available in the U.K. through Valneva’s existing commercial infrastructure and distribution networks.

 

Jeff Baxter, President and CEO of VBI, commented: “We are delighted to announce the availability of PreHevbri in the U.K., marking the first European market launch of our 3-antigen hepatitis B vaccine, which builds upon the increasing momentum for use in the U.S. (available under the brand name PreHevbrio®). We believe Valneva’s local commercial capabilities and relationships will be of significant value not only in this initial European launch, but also in the additional European markets where PreHevbri is expected to launch over the next several months.”

 

About Hepatitis B

 

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

 

About PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)]

 

PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, United Kingdom, United States, Canada, and Israel. The brand names for this vaccine are: PreHevbri® (EU/EEA/UK), PreHevbrio® (US/Canada), and Sci-B-Vac® (Israel).

 

Full European Summary of Product Characteristics for PreHevbri is available from the EMA website at www.ema.europa.eu.

 

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio® [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

 

U.S. Indication

 

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

 

U.S. Important Safety Information (ISI)

 

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

 

 
 

 

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

 

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

 

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

 

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

 

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

 

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

 

Please see Full Prescribing Information.

 

About VBI Vaccines Inc.

 

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

 

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

News and Resources: http://www.vbivaccines.com/news-and-resources/

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 forward-looking 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 impact of general economic, industry or political conditions in the United States or internationally; the impact of the COVID-19 pandemic and the continuing effects of the COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; 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 pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory 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 SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 13, 2023, and filed with the Canadian security authorities at sedar.com on March 13, 2023, 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

Director, Corporate Communications & IR

Phone: (617) 830-3031 x124

Email: IR@vbivaccines.com

 

 

 

 

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Cover
Jun. 15, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jun. 15, 2023
Entity File Number 001-37769
Entity Registrant Name VBI Vaccines Inc/BC
Entity Central Index Key 0000764195
Entity Incorporation, State or Country Code A1
Entity Address, Address Line One 160 Second Street
Entity Address, Address Line Two Floor 3
Entity Address, City or Town Cambridge
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02142
City Area Code (617)
Local Phone Number 830-3031
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Shares, no par value per share
Trading Symbol VBIV
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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