GAITHERSBURG, Md., Feb. 26, 2015 (GLOBE NEWSWIRE)
-- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company
focused on the discovery, development and commercialization of
recombinant nanoparticle vaccines and adjuvants, today announced
its financial results for the fourth quarter and twelve months
ended December 31, 2014.
Corporate
Highlights
Fourth Quarter and
Subsequent Achievements:
RSV
- Initiated a Phase 2 clinical trial of its RSV
F-Protein nanoparticle vaccine candidate (RSV F Vaccine) in 1,600
elderly adults (greater than or equal to 60 years of age);
- Received the U.S. Food and Drug Administration's
(FDA) Fast Track Designation of our RSV F Vaccine for protection of
infants via maternal immunization, which, among other advantages,
provides the potential for priority review (shorter Biologics
License Application review) that could result in improved timeline
to licensure;
- Initiated enrollment in a Phase 1 clinical trial
of our RSV F Vaccine in healthy children, the first study of this
vaccine candidate to be conducted in a pediatric population;
and
- Presented new positive data from the first
clinical study of our RSV F Vaccine in women of childbearing age at
the 8th Vaccine & ISV Congress, showing 50% reduction in
infection in the vaccinated women relative to placebo. This data
suggests that the vaccine may be efficacious in future clinical
testing.
Influenza
- Initiated a randomized, observer-blinded,
dose-ranging Phase 2 clinical trial of our recombinant quadrivalent
seasonal influenza virus-like particle (VLP) vaccine candidate
(Seasonal Influenza VLP) in 400 healthy adults. This trial is being
conducted under our contract with the U.S. Department of Health and
Human Services, Biomedical Advanced Research and Development
Authority (BARDA) (Contract No. HHSO 100201100012C) for the
development of Novavax' recombinant vaccines to address seasonal
influenza and influenza strains with pandemic potential; and
- Received the FDA's Fast Track Designation of our
Pandemic H7N9 Influenza VLP vaccine candidate (Pandemic H7N9 VLP)
with Matrix-M(TM) adjuvant, which recognizes the public health
risks of the H7N9 strain and may allow for an improved timeline to
licensure via the potential for accelerated approval and priority
review.
Ebola
- Initiated a novel Ebola Glycoprotein (GP)
recombinant nanoparticle vaccine candidate (EBOV GP Vaccine)
program based on the currently circulating Makona strain
(previously referred to as the Guinea strain) of Ebola virus;
- Presented positive pre-clinical results at the
8th Vaccine & ISV Congress of our EBOV GP Vaccine with Matrix-M
adjuvant, showing seroprotective antibodies and
cross-neutralization to a previously circulating Ebola virus
strain;
- Announced significant immunogenicity and efficacy
data demonstrating the EBOV GP Vaccine is the first subunit Ebola
GP-based vaccine to provide protection in non-human primates.
Non-human primates received two injections of a 5µg dose of the
EBOV GP Vaccine with Matrix-M adjuvant. As expected, the challenge
was lethal for the control animal whereas, in sharp contrast, 100%
of the immunized animals were protected; and
- Initiated a randomized, observer-blinded,
dose-ranging Phase 1 clinical trial of our EBOV GP Vaccine in
Australia to evaluate the safety and immunogenicity of the vaccine,
with and without Matrix-M adjuvant, in 230 healthy adults between
18 and 50 years of age.
2015 Anticipated
Events:
- Announce top-line data from the Phase 1 clinical
trial our EBOV GP Vaccine in mid-2015;
- Announce top-line data from the Phase 2 clinical
trial of our Seasonal Influenza VLP in the second quarter of
2015;
- Announce top-line data from the Phase 2 clinical
trial of our RSV F Vaccine in healthy women in their third
trimester of pregnancy in the third quarter of 2015;
- Announce top-line data from the Phase 2 clinical
trial of our RSV F Vaccine in elderly adults in the third quarter
of 2015; and
- Announce top-line data from the Phase 1 clinical
trial of our RSV F Vaccine in healthy pediatrics in late 2015 or in
the first half of 2016.
"We have initiated five clinical trials within the
last six months, including advancing both our RSV and seasonal
influenza programs into Phase 2 clinical trials, while introducing
our new Ebola vaccine into the clinic," said Stanley C. Erck,
President and Chief Executive Officer of Novavax. "These
achievements underscore the strength of our vaccine technology,
capability of our manufacturing platform and experience of our
leadership team. We look forward to carrying this momentum through
2015, with important clinical data readouts expected in our RSV,
seasonal influenza and Ebola programs."
Financial Results for the
Three and Twelve Months Ended December 31, 2014
Novavax reported a net loss of $31.5 million, or
$0.13 per share, for the fourth quarter of 2014, compared to a net
loss of $14.1 million, or $0.07 per share, for the fourth quarter
of 2013. For the twelve months ended December 31, 2014, the net
loss was $82.9 million, or $0.37 per share, compared to a net loss
of $52.0 million, or $0.31 per share for 2013.
Novavax revenue in the fourth quarter of 2014
decreased 23% to $6.7 million, compared to $8.7 million for the
same period in 2013. Revenue for the full year 2014 increased 47%
to $30.7 million, compared to $20.9 million in 2013. The increase
in the full year revenue results from the Phase 1/2 clinical trial
of our H7N9 pandemic influenza vaccine candidate with Matrix-M and
activities relating to the preparation and initiation of the Phase
2 clinical trial of our Seasonal Influenza VLP; both programs are
funded under our contract with HHS BARDA.
The cost of government contracts revenue in the
fourth quarter of 2014 increased 9% to $2.8 million, compared to
$2.6 million for the same period in 2013. For the full year 2014,
cost of government contracts revenue increased 82% to $15.0
million, compared to $8.2 million in 2013. The increase in costs
for the full year 2014 were associated with the Phase 1/2 clinical
trial of our H7N9 pandemic influenza candidate with Matrix-M
adjuvant and activities relating to the preparation and initiation
of the Phase 2 clinical trial of our Seasonal Influenza VLP; both
programs are funded under our contract with HHS BARDA.
Research and development expenses increased 87% to
$30.5 million in the fourth quarter of 2014, compared to $16.3
million for the same period in 2013. For the full year 2014,
research and development expenses increased 58% to $79.4 million,
compared to $50.3 million in 2013. The increase in research and
development expenses for the full year 2014 is driven by activities
relating to the preparation and initiation of three RSV F Vaccine
candidate clinical trials in 2014, the initiation of our Ebola
vaccine candidate program and higher employee-related expenses tied
to the continued growth of the company.
General and administrative expenses increased 24%
to $5.1 million in the fourth quarter of 2014, compared to $4.1
million for the same period in 2013. For the full year 2014,
general and administrative expenses increased 34% to $19.9 million,
compared to $14.8 million in 2013. The increase in general and
administrative expenses for the full year 2014 resulted from
increased employee-related expenses tied to the continued growth of
the company.
As of December 31, 2014, the company had $168.1
million in cash and cash equivalents and marketable securities
compared to $133.1 million as of December 31, 2013. Net cash used
in operating activities for 2014 was $67.0 million, compared to
$45.4 million for 2013. The factors contributing to the change in
cash usage were primarily due to increased costs relating to our
RSV F Vaccine candidate and higher employee-related costs, as well
as the timing of vendor payments.
Conference Call
Novavax management will host its quarterly
conference call today at 4:30 p.m. EDT. The dial-in number for the
conference call is 877-212-6076 (U.S. or Canada) or 707-287-9331
(International). A webcast of the conference call can also be
accessed via a link on the home page of the Novavax website
(novavax.com) or through the "Investor Info"/"Events" tab on the
Novavax website.
A replay of the conference call will be available
starting at 7:30 p.m. on February 26, 2015 until midnight March 5,
2015. To access the replay by telephone, dial 855-859-2056
(Domestic) or 404-537-3406 (International) and use passcode
89629680. The replay will also be available as a webcast and can be
found on the "Investor Info"/"Events" on the Novavax website.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
vaccine company committed to delivering novel products to prevent a
broad range of infectious diseases. Our recombinant nanoparticles
and Matrix-M(TM) adjuvant technology are the foundation for
groundbreaking innovation that improves global health through safe
and effective vaccines. Additional information about Novavax is
available on the company's website, novavax.com.
Forward-Looking
Statements
Statements herein relating to the
future of Novavax and the ongoing development of its vaccine and
adjuvant products are forward-looking statements. Novavax cautions
that these forward looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include those identified under the
heading "Risk Factors" in the Novavax Annual Report on Form 10-K
for the year ended December 31, 2014, to be filed with the
Securities and Exchange Commission (SEC). We caution investors not
to place considerable reliance on the forward-looking statements
contained in this press release. You are encouraged to read our
filings with the SEC, available at sec.gov, for a discussion of
these and other risks and uncertainties. The forward-looking
statements in this press release speak only as of the date of this
document, and we undertake no obligation to update or revise any of
the statements. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
|
NOVAVAX,
INC. |
CONDENSED STATEMENTS OF
OPERATIONS |
(in thousands, except
per share information) |
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
Twelve Months
Ended |
|
December 31, |
December 31, |
|
2014 |
2013 |
2014 |
2013 |
|
(unaudited) |
|
|
Revenue |
$ 6,724 |
$ 8,748 |
$ 30,659 |
$ 20,915 |
|
|
|
|
|
Costs and expenses: |
|
|
|
|
Cost of government contracts revenue |
2,837 |
2,602 |
14,987 |
8,222 |
Research and development |
30,495 |
16,319 |
79,435 |
50,308 |
General and administrative |
5,056 |
4,080 |
19,928 |
14,819 |
Total costs and expenses |
38,388 |
23,001 |
114,350 |
73,349 |
Loss from operations |
(31,664) |
(14,253) |
(83,691) |
(52,434) |
Interest income (expense), net |
118 |
10 |
129 |
27 |
Other income, net |
-- |
192 |
-- |
182 |
Realized gains on marketable securities |
-- |
-- |
615 |
-- |
Change in fair value of warrant liability |
-- |
-- |
-- |
267 |
Loss from operations before income tax expense |
(31,546) |
(14,051) |
(82,947) |
(51,958) |
Income tax expense |
-- |
3 |
-- |
25 |
Net loss |
$
(31,546) |
$ (14,054) |
$
(82,947) |
$ (51,983) |
|
|
|
|
|
Basic and diluted net loss per share |
$ (0.13) |
$ (0.07) |
$ (0.37) |
$ (0.31) |
Basic and diluted weighted average number of common shares
outstanding |
238,519 |
208,538 |
225,848 |
169,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED BALANCE SHEET
DATA |
(in
thousands) |
|
|
|
|
December 31, |
December 31, |
|
2014 |
2013 |
|
|
|
Cash and cash equivalents |
$ 32,335 |
$ 119,471 |
Marketable securities |
135,721 |
13,597 |
Total current assets |
188,158 |
145,001 |
Working capital |
154,042 |
126,879 |
Total assets |
276,002 |
235,125 |
Total notes payable and capital lease obligations |
1,173 |
2,184 |
Total stockholders' equity |
229,618 |
203,234 |
|
|
|
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Novavax, Inc. via Globenewswire
HUG#1897887
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Apr 2023 to Apr 2024