VBI Vaccines Announces First Quarter 2019 Financial Results and Provides Corporate Update
May 01 2019 - 8:00AM
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today reported financial
results for the first quarter ending March 31, 2019, and
highlighted progress of the company’s pipeline.
“2019 has the potential to be a transformative year for VBI,
marked by clinical milestones across all four of our lead programs,
and as such, the first quarter of 2019 was characterized by intense
focus on the execution of our ongoing clinical programs,” said Jeff
Baxter, President and CEO, VBI Vaccines Inc. “In April 2019,
all subjects in the Sci-B-Vac® pivotal Phase 3 PROTECT study
completed clinical visits, including follow-up visits for safety,
which confirms the timeline to top-line data. This data
read-out is the most significant clinical milestone in the history
of VBI and we remain diligently focused and excited as we advance
towards the data read-out, expected mid-year this year,
2019.”
Recent Highlights and Upcoming Milestones
Sci-B-Vac®: Trivalent Prophylactic Hepatitis B
Vaccine
Sci-B-Vac® is currently being evaluated in a global, pivotal
Phase 3 clinical program, the results of which are intended to
support future regulatory and marketing authorization submissions
in the U.S., Europe, and Canada. The program consists of two
concurrent Phase 3 studies – PROTECT and CONSTANT.
PROTECT: 2-arm safety and immunogenicity study in approximately
1,500 adults age 18 and older
- Top-line data, expected mid-year 2019, will include both
co-primary endpoints and key secondary endpoints.
- Co-primary endpoints: After three doses of Sci-B-Vac® vs. three
doses of Engerix-B®, (i) non-inferiority of seroprotection rates in
adults age 18 and older, and (ii) superiority of seroprotection
rates in adults over the age of 45.
- Secondary endpoints: (i) non-inferiority of seroprotection
rates after two doses of Sci-B-Vac® vs. three doses of Engerix-B®,
and (ii) safety and tolerability.
- In April 2019, VBI presented data in a poster presentation at
The International Liver Congress™ (ILC), the Annual Meeting of the
European Association for the Study of the Liver (EASL), which
support the secondary endpoints in PROTECT. The poster
illustrated data from three previously-conducted clinical studies –
two randomized Phase 3 studies comparing Sci-B-Vac® to Engerix-B®
conducted in Vietnam and Russia, and one single-arm Phase 4 study
conducted in Israel – in subjects aged 18 to 45 years. Data
from all three studies demonstrated a clean safety profile for
Sci-B-Vac® and seroprotection rates of more than 98% after two
vaccinations in all subjects receiving Sci-B-Vac®.
CONSTANT: 4-arm lot-to-lot consistency study in approximately
2,850 subjects
- The primary endpoint is to demonstrate consistency of immune
response, measured by geometric mean concentration (GMC), across
three independent, consecutively manufactured lots of
Sci-B-Vac®.
- Top-line CONSTANT data is expected around year-end 2019.
VBI-1901 – Glioblastoma (GBM)
Immunotherapeutic
VBI-1901 is currently being evaluated in a two-part Phase 1/2a
study in recurrent GBM patients.
PART A: Dose-escalation phase designed to evaluate the safety,
tolerability, and to define the optimal therapeutic dose level of
VBI-1901
- Expanded data from Part A of the study was recently selected
for poster presentation at the Annual Meeting of the American
Society of Clinical Oncology (ASCO) in early June, and will feature
expanded immunologic data along with tumor and clinical responses,
based on MRIs and survival data, from all three dose cohorts in
Part A of the study.
- The poster, number 237, will be presented during the Central
Nervous System Tumors session on Sunday, June 2, 2019 from 8:00 AM
ET to 11:00 AM ET.
PART B: Subsequent extension phase with a narrower enrollment
criteria, designed to more clearly assess immunologic responses and
the correlation with tumor and clinical responses, based on MRIs
and survival data
- As announced in April 2019, based on safety and immunogenicity
data, the highest dose tested in Part A of the study, 10mcg, has
been selected as the optimal dose level to test in Part B of the
study.
- Enrollment in Part B will be restricted only to those with a
first tumor recurrence.
- Initiation of enrollment of the 10 patients in Part B of the
study is expected mid-year 2019.
VBI-2601 – Hepatitis B Immunotherapeutic
- In December 2018, VBI announced a license and collaboration
agreement with Brii Biosciences for the development of a functional
cure for chronic hepatitis B using VBI-2601, the company’s novel
immunotherapeutic candidate formulated to target and enhance B- and
T-cell immunity.
- In January 2019, VBI initiated pre-clinical studies required to
enable initiation of a Phase 2 human proof-of-concept study, which
is expected to initiate around year-end 2019.
VBI-1501 – Prophylactic Cytomegalovirus (CMV)
Vaccine
- In December 2018, VBI announced plans for a Phase 2
dose-ranging study following positive discussions with Health
Canada, and the company anticipates similar discussions with the
FDA in 2019.
- The Phase 2 study is expected to assess the safety and
immunogenicity of higher dosages of VBI-1501, up to 20mcg, with
study initiation anticipated around the end of 2019.
- A toxicology study to support the new dose levels is underway,
the results of which are required prior to the start of the Phase 2
study.
First Quarter 2019 Financial Results
- Cash Position: VBI ended the first quarter of
2019 with $43.3 million in cash and cash equivalents compared to
$59.3 million as of December 31, 2018.
- Net Cash Used in Operating Activities: Net
cash used in operations for the three months ended March 31, 2019
was $14.0 million compared to $8.6 million for the same period in
2018.
- Cash Used for Purchase of Property and
Equipment: Cash used for the purchase of property and
equipment was $1.9 million for the three months ended March 31,
2019 compared to $1.0 million for the same period in 2018.
The increase in spend is due to the modernization and capacity
increase of the company’s manufacturing facility in Rehovot,
Israel. The construction and temporary closure of the
facility began in Q2 2018 and is now substantially complete.
We anticipate being able to recommence operations in the facility
by the end of 2019.
- Revenue: Revenue in the first quarter of 2019
was $0.4 million, compared to $0.2 million for the same period in
2018. The increase was primarily due to R&D service revenues
earned pursuant to the therapeutic hepatitis B license and
collaboration agreement with Brii Biosciences, offset by a slight
decrease in named-patient sales of Sci-B-Vac® in Europe.
- Research and Development (R&D): R&D
expenses were $9.2 million for the first quarter of 2019, compared
to $7.0 million for the same period in 2018. The increase was
primarily due to the advancement of the Phase 3 program for
Sci-B-Vac® and the Phase 1/2a clinical study for VBI-1901 in
recurrent GBM patients.
- General and Administrative (G&A): G&A
expenses were $4.0 million for the first quarter of 2019, compared
to $3.4 million for the same period in 2018. The increase was
primarily due to increased human resource expenses, the allocation
of certain cost of revenues related to the temporary Rehovot
facility closure, and pre-commercialization costs for
Sci-B-Vac®.
- Net Loss: Net loss and net loss per share for
the first quarter of 2019 were $14.6 million and $0.15,
respectively, compared to a net loss of $12.3 million and a net
loss per share of $0.19 for the first quarter of 2018.
About VBI Vaccines Inc.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage
biopharmaceutical company developing a next generation of vaccines
to address unmet needs in infectious disease and immuno-oncology.
VBI is advancing the prevention and treatment of hepatitis B, with
the only commercially-approved trivalent hepatitis B vaccine,
Sci-B-Vac®, which is approved for use in Israel and 10 other
countries and is currently in a Phase 3 study in the U.S., Europe,
and Canada, and with an immunotherapeutic in development for a
functional cure for chronic hepatitis B. VBI’s eVLP Platform
technology allows for the development of enveloped virus-like
particle (eVLP) vaccines that closely mimic the target virus to
elicit a potent immune response. Integrating its cytomegalovirus
(CMV) expertise with the eVLP platform technology, VBI’s lead eVLP
vaccine candidates include a prophylactic CMV vaccine candidate and
a therapeutic glioblastoma (GBM) vaccine candidate. VBI is
headquartered in Cambridge, MA with research operations in Ottawa,
Canada and research and manufacturing facilities in Rehovot,
Israel.
Website Home: http://www.vbivaccines.com/
News and Insights: http://www.vbivaccines.com/wire/
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 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 Securities and Exchange Commission and
the Canadian securities authorities, including its Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
February 25, 2019, and filed with the Canadian security authorities
at sedar.com on February 25, 2019, 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 |
(In
Thousands) |
|
March 31, 2019 |
|
December 31, 2018 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
43,308 |
|
$ |
59,270 |
Inventory, net |
|
1,083 |
|
|
911 |
Prepaid expenses and other current
assets |
|
1,405 |
|
|
1,550 |
Total current assets |
|
45,796 |
|
|
61,731 |
Property and equipment, net |
|
9,944 |
|
|
8,525 |
Intangible assets, net |
|
59,465 |
|
|
58,249 |
Goodwill |
|
8,438 |
|
|
8,265 |
Other non-current assets |
|
2,600 |
|
|
835 |
Total non-current assets |
|
80,447 |
|
|
75,874 |
Total assets |
|
126,243 |
|
|
137,605 |
|
|
|
|
Liabilities and stockholder’s
equity |
|
|
|
Accounts payable |
$ |
5,654 |
|
$ |
6,055 |
Other current liabilities |
|
17,339 |
|
|
17,322 |
Total current liabilities |
|
22,993 |
|
|
23,377 |
Total non-current liabilities |
|
16,555 |
|
|
16,095 |
Total liabilities |
|
39,548 |
|
|
39,472 |
Total stockholders' equity |
|
86,695 |
|
|
98,133 |
Total liabilities and stockholders'
equity |
|
126,243 |
|
|
137,605 |
|
|
|
|
|
|
|
VBI
Vaccines Inc. and Subsidiaries |
Condensed Consolidated Statement of Operations and
Comprehensive Loss |
(In
Thousands Except Per Share Amounts) |
|
For the Three Months Ended March
31 |
|
2019 |
|
2018 |
|
(Unaudited) |
Revenues |
$ |
360 |
|
|
$ |
178 |
|
Operating expenses |
|
|
|
Cost of revenue |
|
988 |
|
|
|
1,413 |
|
Research and development |
|
9,227 |
|
|
|
6,964 |
|
General and administrative |
|
3,964 |
|
|
|
3,425 |
|
Total operating expenses |
|
14,179 |
|
|
|
11,802 |
|
Loss from operations |
|
(13,819 |
) |
|
|
(11,624 |
) |
Interest income (expense), net |
|
(480 |
) |
|
|
(539 |
) |
Foreign exchange gain (loss) |
|
(307 |
) |
|
|
(88 |
) |
Loss before income taxes |
|
(14,606 |
) |
|
|
(12,251 |
) |
Income tax benefit |
|
- |
|
|
|
- |
|
Net Loss |
$ |
(14,606 |
) |
|
$ |
(12,251 |
) |
Basic and diluted net loss per share |
$ |
(0.15 |
) |
|
$ |
(0.19 |
) |
Weighted-average number of shares used to compute
basic and diluted net loss per share |
|
97,481,625 |
|
|
|
64,179,605 |
|
Other comprehensive income (loss) -
currency translation adjustments |
|
1,727 |
|
|
|
(1,902 |
) |
Comprehensive Loss |
$ |
(12,879 |
) |
|
$ |
(14,153 |
) |
|
|
|
|
|
|
|
|
VBI Contact
Nicole Anderson, Communications ExecutivePhone: (617) 830-3031
x124Email: info@vbivaccines.com
VBI Investor Contact
Nell BeattieChief Business OfficerEmail: IR@vbivaccines.com
VBI Media Contact
Burns McClellan, Inc. Robert Flamm, Ph.D. Phone: (212)
213-0006Email: rflamm@burnsmc.com
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