VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today announced it has entered into a
refinanced and upsized debt facility of up to $100 million with its
existing lender, K2 HealthVentures (K2HV), a healthcare-focused
specialty finance company.
Under the terms of the agreement, $50 million is immediately
available to VBI upon closing, comprised of $30 million to
refinance the outstanding facility the Company held with K2HV, and
an incremental $20 million of non-dilutive funding. Future tranches
of up to $25 million are committed and will be made available to
VBI upon the achievement of certain clinical and financial
milestones, and a further tranche of $25 million is available at
the discretion of K2HV.
“Through our successful partnership with K2HV, this refinancing
and access to additional capital further enables important
financial flexibility as we continue our commercial launch of
PreHevbrio™ and advance our prophylactic and therapeutic vaccine
pipeline,” said Jeff Baxter, VBI’s President and CEO. “The K2HV
team has proven to have a deep understanding of our business and
the science driving VBI, and we are grateful for their support of
and investment in VBI’s future.”
“We are pleased to be able to maintain and increase our support
of VBI’s commercialization and pipeline development efforts, and we
look forward to continuing to work with the VBI team in their
mission to address significant unmet needs in infectious disease
and oncology,” said Anup Arora, Founding Managing Director and
Chief Investment Officer of K2HV.
About PreHevbrio™ [Hepatitis B Vaccine (Recombinant)]
VBI’s hepatitis B vaccine 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, and Israel. The brand names for this vaccine are:
PreHevbrio™ (US), 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/
About K2 HealthVentures
K2 HealthVentures is an alternative investment firm focused on
providing flexible, long-term financing solutions to innovative
private and public companies in the life sciences and healthcare
industries. The investment team comprises collaborative,
experienced professionals with diverse backgrounds in finance and
operations, as well as deep domain knowledge across various
healthcare sectors. A uniquely flexible, permanent capital
structure enables the firm to provide creative, adaptive financing
solutions and meet the evolving capital needs of its portfolio
companies as they grow. K2HV is driven by dual goals of Profit and
Purpose—aiming to fuel the growth of innovative companies that will
ultimately improve the lives of patients and giving a percentage of
investment profits back to underserved areas in healthcare.
www.k2hv.com
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 impact of general economic, industry or political
conditions in the United States or internationally; the impact of
the ongoing 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 7, 2022, and filed with the
Canadian security authorities at sedar.com on March 7, 2022, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220915005635/en/
VBI Nicole Anderson Director, Corporate Communications
& IR Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
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