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2024-02-14
2024-02-14
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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): February 14, 2024
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
1.01 |
Entry
into a Material Definitive Agreement |
On
February 13, 2024, VBI Vaccines Inc. (the “Company”) entered into (i) an amendment to the Company’s loan agreement
with K2 HealthVentures LLC (“K2HV”), (ii) a Purchase Agreement (“Brii Purchase Agreement”) among
the Company, Variation Biotechnologies Inc., a Canadian federal corporation (“VBI Cda”) and Brii Biosciences Limited,
an exempted company organized under the laws of the Cayman Islands (“Brii Bio”), (iii) a Purchase Agreement (“Rehovot
Purchase Agreement”) among the Company, SciVac Ltd., an Israeli company (“SciVac”), Brii Biosciences,
Inc., a Delaware corporation (“Brii Subsidiary”) and a wholly-owned subsidiary of Brii Bio to be formed in Israel
and joined as a party to the Rehovot Purchase Agreement and (iv) a side letter (“Side Letter”) with Brii Bio.
Amendment
to Loan Agreement
As
previously disclosed, the Company and its subsidiary VBI Cda, as borrowers, entered into a Loan and Guaranty Agreement dated as of May
22, 2020, as amended by the first amendment, dated as of May 17, 2021, that second amendment, dated as of September 14, 2022, and that
third amendment, dated as of July 5, 2023, and as such agreement may be amended from time to time in the future (collectively, the “Loan
Agreement”) with K2HV and any other lenders party thereto from time to time (collectively, the “Loan Parties”)
with the obligations under the Loan Agreement secured on a senior basis by a lien on substantially all of the assets of the Company and
its subsidiaries.
On
February 13, 2024, the Loan Parties entered into an amendment (the “Fourth Amendment”) to the Loan Agreement pursuant
to which the parties have agreed to, among other things, (i) remove a financial covenant requiring the Company to maintain minimum net
revenue of 75% of projections, (ii) the forbearance by K2HV and the other lenders party thereto, prior to the earlier of (A) December
31, 2024, (B) the date the Side Letter ceases to be in full force and effect prior to the completion of the Essential Activities
(as defined below) and (C) the date the Essential Activities are complete (the “Forbearance Expiration Date”)
from exercising their remedies with respect to the occurrence of Events of Default subject to certain exceptions, and (iii) following
the Forbearance Expiration Date, add a financial covenant requiring the Company to maintain a minimum cash amount equal to its obligations
under the Loan Agreement at all times.
The
entry into the Brii Purchase Agreement, the Side Letter, and the Rehovot Purchase Agreement set forth in this this Current Report on
Form 8-K (the “Report”) are conditions to the effectiveness of the Fourth Amendment.
Brii
Purchase Agreement
On
February 13, 2024, the Company and VBI Cda entered into the Brii Purchase Agreement with Brii Bio, pursuant to which, the Company and
VBI Cda will sell, transfer, convey and assign to Brii Bio, substantially all of the intellectual property related to VBI-2601 owned
by the Company and VBI Cda, for a secured promissory note in the principal amount up to $10,000,000 (the “Note”) to
be issued by Brii Bio, which is then required to be assigned to K2HV pursuant to the terms of the Fourth Amendment, in exchange for a
reduction in the Company’s obligations under the Loan Agreement equal to the initial principal amount of the Note. The initial
principal amount of the Note will be $2,500,000, which shall be increased by an aggregate amount equal to $7,500,000 upon the Company
obtaining applicable consents under the License Agreement, dated as of September 1, 2021, by and among Ferring International Center S.A.,
SciVac, and the Company. In the event of certain breaches by VBI of the Brii Purchase Agreement and any such breach is
not cured with 30 days, the aggregate principal amount of the Note shall be reduced by an aggregate amount equal to $2,500,000.
In
addition to the foregoing, the Purchase Agreement contains certain amendments to the Company’s previously announced collaboration
agreements with Brii Bio, which are further described below.
Amendments
to Collaboration and License Agreement
As
previously disclosed on July 5, 2023, the Company and Brii Bio entered into a Collaboration and License Agreement (the “Collaboration
Agreement”), pursuant to which, among other things, subject to the terms and conditions set forth in the Collaboration Agreement,
the Company and Brii Bio agreed to collaborate on the further development of PreHevbri (“Licensed Product”), a three
antigen vaccine for use in the field of the prevention of Hepatitis B in the licensed territory, which consists of the Asia Pacific region
other than Japan.
Pursuant
to the Brii Purchase Agreement, on February 13, 2024, the Company and Brii Bio agreed to amend the Collaboration Agreement to, among
other things, subject to the terms and conditions set forth in the Collaboration Agreement, (i) amend the terms of the royalty bearing
license granted by the Company to Brii Bio for the global development activities of the Licensed Product to be “perpetual and irrevocable”,
(ii) omit the requirement for Brii Bio to obtain marketing approval for the Licensed Product in certain territories and (iii) omit the
requirement for Brii Bio to make royalty and milestone payments to the Company.
Amendments
to the Amended & Restated Collaboration and License Agreement
As
previously disclosed, on December 4, 2018, the Company and Brii Bio entered into a Collaboration and License Agreement (the “Original
Collaboration Agreement”), pursuant to which the Company and Brii Bio agreed to collaborate on the development of a Hepatitis
B recombinant protein-based immunotherapeutic in the licensed territory, which consists of China, Hong Kong, Taiwan, and Macau (collectively,
the “VBI-2601 Licensed Territory”).
Further,
as previously disclosed, on July 5, 2023, the Company and Brii Bio agreed to amend and restate the Original Collaboration Agreement (the
“A&R Collaboration Agreement”), to, among other things, subject to the terms and conditions set forth in the A&R
Collaboration Agreement, expand the VBI-2601 Licensed Territory to the entire world for Brii Bio’s exclusive rights and licenses
to make, have made, use, sell, offer for sale, and import VBI-2601.
Pursuant
to the Brii Purchase Agreement, on February 13, 2024, the Company and Brii Bio agreed to amend the A&R Collaboration Agreement to,
among other things, subject to the terms and conditions set forth in the A&R Collaboration Agreement, (i) amend the terms the royalty
bearing license granted by the Company to Brii Bio for research studies and development of VBI-2601 to be “perpetual and irrevocable”,
(ii) omit the requirement for Brii Bio to obtain marketing approval and commercialize VBI-2601 in the United States and China, (iii)
revise the indemnity requirements such that Brii Bio indemnifies the Company with respect to certain transferred intellectual property
after the effective date of the Brii Purchase Agreement and the Company indemnifies Brii Bio prior to such date,(iv) omit the requirement
for Brii Bio to make royalty and milestone payments to the Company and (v) omit certain rights of the Company to terminate the A&R
Collaboration Agreement and certain other effects of termination of the A&R Collaboration Agreement.
Side
Letter
On
February 13, 2024, the Company and Brii Bio entered into the Side Letter setting forth certain essential and additional priority activities
to transfer manufacturing responsibility for clinical supply and commercial supply of VBI-2601 and PreHevbri for the Brii Territories
set forth in the Side Letter (the “Essential Activities”) the Company is required to complete as a condition to the
entry into the License Agreement and consummation of the transactions pursuant to the Rehovot Purchase Agreement. The principal amount
of the Note shall increase up to $18,000,000 upon completion of the Essential Activities and the Company’s obligations under the
Loan Agreement shall be reduced by a corresponding amount.
License
Agreement
Upon
completion of the Essential Activities, VBI Cda and Brii Brio will enter into a license agreement (the “License Agreement”)
pursuant to which VBI Cda will grant Brii Bio a perpetual, royalty-free, milestone-free, sublicensable, fully-paid, and exclusive license
to the GBM Program (VBI-1901) for development and commercialization in the Asia-Pacific (APAC) region (excluding Japan), for a secured
promissory note in the principal amount of $5,000,000 to be issued by Brii Bio, which is then required to be assigned to K2HV pursuant
to the terms of the Fourth Amendment, in exchange for a reduction in the Company’s obligations under the Loan Agreement equal to
the initial principal amount of such note.
The
entry by VBI Cda and Brii Brio into the License Agreement is subject to the Company completing the Essential Activities.
Rehovot
Purchase Agreement
On
February 13, 2024, the Company and SciVac (the “Seller”) entered into the Rehovot Purchase Agreement with a
wholly-owned subsidiary of Brii Bio to be formed in Israel prior to the closing and joined as a party to the agreement prior to the closing
as the purchaser (the “Purchaser”) and Brii Subsidiary, pursuant to which, upon closing of the transactions
contemplated by the Rehovot Purchase Agreement, the Seller will sell to the Purchaser certain assets including Seller and
its affiliates’ interest and rights in and to certain assets and leases with respect to a vaccine manufacturing facility
in Israel, for an aggregate purchase price of $10,000,000, which is then required to be paid to K2HV pursuant to the terms of the Fourth
Amendment.
The
Rehovot Purchase Agreement contains representations and warranties of the Seller and Purchaser that are typical for transactions of
this type. The Rehovot Purchase Agreement also contains covenants on the part of the Company that are typical for transactions of this
type.
The
closing of the transactions pursuant to the Rehovot Purchase Agreement are subject to closing conditions that are typical for transactions
of this type, including the Company completing the Essential Activities and closing will not occur prior to June 30, 2024.
| Item
2.03 |
Creation
of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant. |
The
information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference in this Item 2.03.
| Item
3.03 |
Material
Modification to Rights of Security Holders. |
The
information required by this Item 3.03 is contained in Item 1.01 and is incorporated by reference herein.
On
February 14, 2024, the Company issued a press release announcing its entry into the Brii Purchase Agreement, amendment to the Collaboration
Agreements, amendment to A&R Collaboration Agreement, Rehovot Purchase Agreement and the Fourth Amendment. 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
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:
February 14, 2024 |
By: |
/s/
Jeffrey R. Baxter |
| |
|
Jeffrey
R. Baxter |
| |
|
President
and Chief Executive Officer |
Exhibit 99.1
VBI
Announces Agreement to Sell Manufacturing Capabilities, Certain Related Assets, and Enter Into New License Agreement with Brii Biosciences
| ● | VBI
to receive up to $33 million in consideration, subject to achievement of certain activities,
for: |
| ◌ | VBI’s
manufacturing capabilities and certain related assets at Rehovot manufacturing facility |
| ◌ | Intellectual
property for VBI-2601, VBI’s hepatitis B immunotherapeutic candidate |
| ◌ | Exclusive
Asia Pacific (APAC), excluding Japan, license for development and commercialization of VBI-1901,
VBI’s glioblastoma immunotherapeutic candidate |
| ● | Following
completion of the full transaction, VBI expects its total debt principal under its current
facility with K2 HealthVentures to be significantly reduced to $17 million |
CAMBRIDGE,
Mass. (February 14, 2024) – 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 agreements whereby Brii
Biosciences (“Brii Bio”), subject to certain activities, is expected to: (i) acquire the intellectual property for VBI-2601,
VBI’s HBV immunotherapeutic development program, and eliminate payment obligations from the July 2023 agreements between VBI and
Brii Bio, (ii) acquire manufacturing capabilities and certain related assets at VBI’s Rehovot, Israel manufacturing facility, and
(iii) enter into an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate,
in the Asia Pacific region (APAC), excluding Japan. Additionally, subject to certain approvals, VBI and Brii Bio will work together to
transfer the manufacturing technologies of VBI-2601 to a site designated by Brii Bio. VBI received $2.5 million of consideration upon
signing of definitive documents and is expected to receive up to an additional $30.5 million of consideration, subject to achievement
of certain activities, with a target completion date of June 30, 2024.
Jeff
Baxter, President and CEO of VBI, stated: “We believe that this transaction improves the financial stability of VBI and balances
the potential value creation within our development and commercial portfolio with a streamlined and focused resource deployment. Upon
successful completion of all transactions, we anticipate that we will have reduced the long-term burn of the company, and reduced our
debt overhang by about 70%. We remain steadfast in our belief that our pipeline can have a meaningful impact on patients, providers,
and public health, and we believe this deal better positions us to deliver on this mission.”
The
proceeds from these agreements will be used for reduction of debt under the Company’s current facility with K2 HealthVentures.
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 Company’s ability to satisfy all of the conditions to the consummation of the transactions
with Brii described above, the Company’s ability to comply with its obligations under its loan agreement with K2 HealthVentures,
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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