- FDA and EMA regulatory review of VBI’s 3-antigen HBV vaccine
candidate ongoing – U.S. PDUFA target action date November 30,
2021
- Initiation of the first Phase 1/2 study of VBI-2902, VBI’s
monovalent COVID-19 vaccine candidate, expected in Q1 2021, with
the anticipated start of a Phase 1/2 study of VBI-2901, VBI’s
pan-coronavirus vaccine candidate, expected later in 2021
- Following continued positive Phase 2a data in recurrent GBM
patients, expected initiation of randomized study of VBI-1901 in H2
2021, with potential to yield registrational data
- Based on the initial therapeutic HBV data presented, partner
Brii Biosciences expects to initiate a combination Phase 2 study of
VBI-2601 in Q1 2021
- $119.1 million in cash, cash equivalents, and short-term
investments at year-end 2020
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today announced financial results for the
fourth quarter and twelve months ended December 31, 2020. The
Company also provided a corporate update and its outlook for
2021.
Annual Note from Jeff Baxter, President and CEO:
“2020 was, unfortunately, a historic year, marked by
unprecedented disruption, with severe public health, societal, and
economic consequence. Every single person, worldwide, felt the
devastating effects of the ongoing COVID-19 pandemic. Industries
and companies went through extraordinary change and, amidst the
temporary adjustments, new normals were established. The impact of
this pandemic is likely to be felt for years, if not decades, to
come.
The events of 2020 led to impressive collaboration, progress,
and transformation across the biotechnology industry, governments,
and foundations. We added two new vaccine candidates to our
pipeline in 2020 – a multivalent pan-coronavirus vaccine candidate,
VBI-2901, and a monovalent COVID-19 vaccine candidate, VBI-2902. To
support the advancement of these candidates, we received an award
from the Strategic Innovation Fund of the Government of Canada and
partnered with both the National Research Council of Canada (NRC),
Canada’s largest federal R&D organization, and Resilience
Biotechnologies, a Contract Development and Manufacturing
Organization. The preclinical results of these two candidates
continue to excite us and we are working hard to get these
candidates into the clinic in forms that are optimized both for
clinical outcome and long-term commercial viability. We recognize
the possibility that COVID-19, in some form, may be here to stay,
especially with the recent emergence of additional variants, and we
are committed to the long-term control of known and emerging
coronaviruses.
Our 2020 achievements and progress, however, extend well beyond
our coronavirus programs. We successfully completed the pivotal
Phase 3 program for our 3-antigen prophylactic hepatitis B (HBV)
vaccine candidate and submitted applications for approval in the
U.S. and Europe. We believe this vaccine candidate has the
potential to be a meaningful intervention for adults in the fight
against HBV and we look forward to working with both the U.S. Food
and Drug Administration (FDA) and the European Medicines Agency
(EMA) throughout 2021 as they conduct their review.
In addition to the advancement of these prophylactic vaccine
candidates, we continue to see meaningful data generated by the
clinical studies of our therapeutic vaccine candidates targeting
both chronic HBV infection, VBI-2601, and recurrent glioblastoma
(GBM), VBI-1901. With both of these candidates, we are seeking to
address diseases that are challenging and aggressive, with few, if
any, effective treatment options available to patients. Based on
the positive data seen to-date, we and our partners expect to
initiate subsequent clinical studies in both indications in
2021.
These achievements are a result of the continued hard work,
dedication, and flexibility of every member of the VBI team. Our
team remains united across the US, Canada, and Israel in our
mission to protect and enhance human life, and we thank our
shareholders and partners for their support. With $119.1 million in
cash, cash-equivalents, and short-term investments on-hand at the
end of 2020, we entered 2021 well-positioned to achieve meaningful
milestones across all of our lead pipeline programs over the next
12 months, and beyond.”
Second Half 2020 Key Program Achievements and Projected
Upcoming Milestones
3-Antigen Hepatitis B Vaccine Candidate
- November 2020: Biologics License Application (BLA) and
Marketing Authorization Application (MAA) submitted to U.S. Food
and Drug Administration (FDA) and the European Medicines Agency
(EMA), respectively
- December 2020 and February 2021: EMA acceptance of MAA filing,
and FDA acceptance of BLA filing, initiating the review
process
- December 2020: Announcement of Syneos Health (Syneos) and VBI
partnership for commercialization in the U.S., Europe, and Canada,
pending regulatory approvals
- November 30, 2021: U.S. Prescription Drug User Fee Act (PDUFA)
target action date set by FDA
VBI-2900: Coronavirus Vaccine Program
- August 2020: Two clinical candidates selected with the goal of
bringing forward candidates that add meaningful clinical and
medical benefit to those already approved – be it as a one-dose
administration, more durable responses, and/or providing broader
protection against known and future mutated strains of COVID-19
- VBI-2901 : a trivalent candidate, expressing SARS-CoV-2,
SARS-CoV, and MERS-CoV spike proteins
- VBI-2902 : a monovalent candidate, expressing the SARS-CoV-2
spike protein
- September 2020: Through its Strategic Innovation Fund, the
Canadian Government agreed to contribute up to CAD$56 million to
support VBI-2900 clinical development through Phase 2 studies, to
be contributed as expenses are incurred
- December 2020 : Broadened collaboration with NRC to include
additional support for pre-clinical evaluation, optimization, and
scale-up
- March 2021: Phase 1/2 clinical study of VBI-2902 in adults
expected to initiate in Canada
- 2021: Phase 1/2 clinical study of VBI-2901 expected to
initiate
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate
- November 2020: Positive interim Phase 1b/2a proof-of-concept
data announced suggesting restoration of antibody and T cell
responses
- Q1 2021: Partner, Brii Biosciences, expected to initiate Phase
2 combination study to assess VBI-2601 (BRII-179) and BRII-835
(VIR-2218), a novel RNAi therapeutic, as potential functional cure
in chronically infected patients
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate
- November 2020: Positive data announcement from ongoing Phase
1/2a clinical study of VBI-1901 in recurrent GBM patients,
including 2 partial responses (PRs), observed with tumor reduction
of more than 50%, and 7 stable disease (SD) observations
- H2 2021: Expected initiation of a randomized, controlled
clinical study with the potential to yield registrational data
Financing
- Throughout the fourth quarter of 2020, VBI raised total gross
proceeds of $15.9 million, issuing 4.8 million shares at an average
price of $3.32 through its Open Market Sales AgreementSM,
established July 31, 2020 with Jefferies LLC
Financial Results for the Three and Twelve Months Ended
December 2020
- Cash Position: VBI ended the fourth quarter of 2020 with
$119.1 million cash, cash equivalents, and short-term investments
compared with $44.2 million as of December 31, 2019.
- Net Cash Used in Operating Activities: Net cash used in
operating activities for the full year 2020 was $47.1 million,
compared to $48.7 million for the same period in 2019.
- Cash Used for Purchase of Property and Equipment: The
purchase of property and equipment in 2020 was $1 million, compared
to $3.7 million in 2019. The decrease is a result of the completion
of the modernization and capacity increase at the manufacturing
facility in Rehovot, Israel.
- Revenue: Revenue for the three months ended December 31,
2020 and for the full year 2020 was $0.2 million and $1.1 million,
respectively, compared to $0.6 million and $2.2 million for the
same time periods in 2019, respectively. There was a decrease in
product revenue due to limited product availability as we prepared
for our U.S. and Europe regulatory submissions for our 3-antigen
HBV vaccine candidate, which occurred in Q4 2020. Additionally,
there was a decrease as a result of the license revenue earned as
part of the License Agreement with Brii Bio in 2020 compared to
2019.
- Research and Development (R&D): R&D expenses for
the fourth quarter and full year 2020 were $4.8 million and $14.9
million, respectively, compared to $4.3 million and $26.3 million
for the same periods in 2019, respectively. The decrease in R&D
spend in 2020 was primarily due to a decrease in costs related to
the Phase 3 clinical studies of our 3-antigen prophylactic HBV
vaccine candidate, which were both completed in 2020, but were
ongoing in 2019. The decrease in R&D expenses was offset by
increased analytical development, manufacturing, and clinical costs
associated with our eVLP vaccine candidates.
- General and Administrative (G&A): G&A expenses
for the fourth quarter and full year 2020 were $7.1 million and
$20.7 million, respectively, compared to $3.8 million and $14.1
million for the same periods in 2019, respectively. The increase in
G&A expense in 2020 was primarily due to an increase in
pre-commercialization activities related to our 3-antigen
prophylactic hepatitis B vaccine, increased insurance costs, and
increased people costs.
- Impairment Charge: There were no impairment charges in
2020, compared to a charge of $6.3 million in 2019 related to
goodwill.
- Net Loss: Net Loss and net loss per share for the year
ended December 31, 2020 were $46.2 million and $0.21, respectively,
compared to a net loss of $54.8 million and a net loss per share of
$0.46 for the year ended December 31, 2019. The decrease in net
loss resulted primarily from decreased R&D expenses offset by
the increased cost of revenues and G&A expenses.
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 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 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 SEC and the Canadian securities authorities, including its
Annual Report on Form 10-K filed with the SEC on March 2, 2021, and
filed with the Canadian security authorities at sedar.com on March
2, 2021, 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 Vaccines Inc. and
Subsidiaries
Selected Condensed
Consolidated Balance Sheet
(Unaudited, In Thousands)
December 31, 2020
December 31, 2019
Assets
Cash and cash equivalents
$
93,825
$
44,213
Short-term investments
25,276
-
Accounts receivable, net
77
201
Inventory, net
2,152
1,075
Prepaid expenses and other
current assets
10,711
1,474
Total current assets
132,041
46,963
Property and equipment, net
10,721
10,195
Intangible assets, net
62,156
60,756
Goodwill
2,261
2,208
Other non-current assets
2,193
2,079
Total Assets
$
209,372
$
122,201
Liabilities and stockholder’s
equity
Accounts payable
$
3,734
$
1,127
Other current liabilities
12,415
12,261
Deferred revenues
255
882
Current portion of lease
liability
944
642
Current portion of long-term
debt
-
14,845
Total current liabilities
17,348
29,757
Total non-current liabilities
20,319
4,189
Total liabilities
37,667
33,946
Total stockholders' equity
171,705
88,255
Total liabilities and
stockholders' equity
$
209,372
$
122,201
VBI Vaccines Inc. and
Subsidiaries
Condensed Consolidated
Statement of Operations and Comprehensive Loss
(Unaudited, in Thousands Except
Share and Per Share Amounts)
For the Years Ended December
31
2020
2019
Revenues
$
1,061
$
2,221
Operating expenses
Cost of revenue
9,168
7,904
Research and development
14,859
26,332
General and administrative
20,651
14,092
Impairment charges
-
6,292
Total operating expenses
44,678
54,620
Loss from operations
(43,617
)
(52,399
)
Interest (expense), net
(2,708
)
(2,196
)
Foreign exchange gain (loss)
95
(218
)
Loss before income taxes
(46,230
)
(54,813
)
Income tax benefit
-
-
Net Loss
$
(46,230
)
$
(54,813
)
Basic and diluted net loss per
share
$
(0.21
)
$
(0.46
)
Weighted-average number of shares
used to compute basic and diluted net loss per share
218,268,979
119,446,377
Other comprehensive income (loss)
- currency translation adjustments
2,017
3,406
Comprehensive Loss
$
(44,213
)
$
(51,407
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210302005285/en/
VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com
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