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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): July 24, 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
July 24, 2023, VBI Vaccines Inc. (the “Company”) issued a press release announcing the closing of the underwriters’
partial exercise of their option to purchase an additional 1,536,363 common shares at a public offering price of $1.64 per share in connection
with the Company’s recent underwritten public offering. 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
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: July 24, 2023 |
By: |
/s/ Jeffrey
R. Baxter |
|
|
Jeffrey R. Baxter |
|
|
President and Chief Executive Officer |
Exhibit 99.1
VBI
Vaccines Announces Closing of Underwriters’ Partial Exercise of Option to Purchase Additional Common Shares
CAMBRIDGE,
Mass. (July 24, 2023) – VBI Vaccines Inc. (NASDAQ: VBIV) (VBI or the Company), a biopharmaceutical company driven by
immunology in the pursuit of powerful prevention and treatment of disease, today announced that the underwriters of its recent underwritten
public offering of common shares and accompanying common warrants to purchase common shares partially exercised their option to
purchase an additional 1,536,363 common shares at a public offering price of $1.64 per common share. The aggregate gross proceeds from
this exercise were approximately $2.5 million, resulting in total gross proceeds of $23.5 million from the underwritten
public offering and the previously completed concurrent registered direct offering, before deducting the underwriting discounts, commissions,
and estimated offering expenses. The partial option exercise closed on July 21, 2023.
Immediately
following the closing of the partial option exercise, the number of outstanding common shares of the Company is 22,872,175.
Raymond
James & Associates, Inc. acted as the sole book-running manager for the underwritten public offering. Newbridge Securities Corporation
acted as the lead manager for the underwritten public offering. The registered direct offering was made without an underwriter or a placement
agent.
VBI
intends to use the net proceeds from the underwritten offering, including the partial option exercise, for the commercialization activities
for PreHevbrio® [Hepatitis B Vaccine (Recombinant)] in the United States, Europe, and Canada; manufacturing of PreHevbrio and clinical
materials for its pipeline programs; and ongoing activities related to its development stage candidates, including VBI-1901 (glioblastoma)
and VBI-2901 (coronaviruses). The net proceeds will also be used for general corporate purposes, including working capital and capital
expenditures.
A
shelf registration statement on Form S-3 (File No. 333-267109) relating to these securities was previously filed with the Securities
and Exchange Commission (“SEC”) on August 26, 2022 and declared effective on September 6, 2022. A final prospectus supplement
and accompanying prospectus relating to the underwritten offering were filed with the SEC and available on the SEC’s website at
www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Raymond James & Associates,
Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail
at prospectus@raymondjames.com.
This
press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale
of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means
of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.
About
PreHevbrio®
PreHevbrio
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 United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. The
brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel).
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, prevailing market conditions; the anticipated use of the proceeds of the offering which could
change as a result of market conditions or for other reasons; 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, and in the final prospectus supplement and accompanying prospectus relating to the underwritten public
offering to be filed with the SEC. 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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