GAITHERSBURG, Md., Nov. 09, 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 third quarter and nine months ended
September 30, 2015.
Novavax Third Quarter and
Subsequent Achievements
- Announced positive top-line data from a Phase 2
clinical trial of its RSV F-protein recombinant nanoparticle
vaccine candidate (RSV F Vaccine) in older adults (60 years of age
and older). The vaccine was well-tolerated and fulfilled the
Company's expectations on the primary, secondary and exploratory
objectives of the trial. The trial is the first to demonstrate
efficacy of an active RSV immunization in any clinical trial
population.
- Announced positive top-line data from a Phase 2
clinical trial of its RSV F Vaccine to protect infants via maternal
immunization. Significant anti-F, PCA and microneutralizing
antibody responses were elicited in mothers and efficient antibody
transfer from mothers to infants was observed.
- Announced that it has been awarded a grant of up
to $89 million by the Bill & Melinda Gates Foundation to
support development of the RSV F Vaccine Phase 3 clinical trial in
pregnant women. This grant will also support regulatory licensing
efforts, providing a path to WHO prequalification. Upon
licensure, Novavax has agreed to make the RSV F Vaccine
affordable and accessible to people in the developing
world.
- Announced positive top-line data from a Phase 1
clinical trial of its RSV F Vaccine in healthy children two to six
years of age. All RSV F Vaccine formulations and regimens were
well-tolerated and highly immunogenic.
- Commenced enrollment in a Phase 2 rollover
clinical trial of its RSV F Vaccine in older adults. The trial is a
randomized, observer-blinded, placebo-controlled rollover trial
designed to enroll the same 1600 older adults who participated in
the recently concluded prior Phase 2 trial.
- Announced positive top-line data from a Phase 2
trial of its recombinant quadrivalent seasonal influenza virus-like
particle candidate (Quadrivalent Seasonal Influenza VLP). The
trial, funded in whole or part with Federal funds from the
Company's contract with the Department of Health and Human
Services, Biomedical Advanced Research and Development Authority
(HHS BARDA) (Contract No. HHSO 100201100012C), demonstrated that
the Quadrivalent Seasonal Influenza VLP vaccine candidate was
well-tolerated with no vaccine-related serious adverse events. The
trial met its immunogenicity targets and demonstrated potential to
meet the Center for Biological Evaluation and Research (CBER)
criteria for accelerated approval.
- Delivered positive top-line data from a Phase 1
clinical trial of its Ebola virus glycoprotein (GP) recombinant
nanoparticle vaccine (Ebola GP Vaccine) candidate adjuvanted with
Matrix-M(TM). The trial demonstrated that the adjuvanted Ebola GP
Vaccine was highly immunogenic, well-tolerated and resulted in
significant antigen dose-sparing.
- Hosted its 3rd Annual
Analyst and Investor Meeting.
Today's Announcement
- Initiation of a Phase 3 trial of the RSV F
Vaccine in older adults
Near-term Anticipated
Events
- Initiation of a Phase 3 trial of the RSV F
Vaccine to protect infants via maternal immunization, contingent
upon discussions with regulatory authorities
Summary
"The initiation of the first Phase 3 trial of our
RSV F Vaccine in older adults underscores our accomplishments to
date and positions the company to bring the first RSV vaccine to
market. Our recent data announcements demonstrate the safety and
robust immunogenicity of the RSV F Vaccine across all three target
populations: older adults; infants via maternal immunization; and
pediatrics," said Gregory Glenn, M.D., Senior Vice President,
Research and Development. "Our Phase 2 trial of the RSV F Vaccine
in older adults was the first to demonstrate efficacy of an active
RSV immunization in any clinical trial population. In addition,
data from pregnant women in their third trimester provided an
important safety data and proof-of-concept for maternal
immunization, with a high level of transplacental antibody
transfer."
"During the third quarter, we delivered positive
results from five key clinical programs including our RSV F Vaccine
for older adults, infants via maternal immunization and pediatrics,
as well as our Seasonal Influenza Vaccine, and our Ebola GP
Vaccine. These results, coupled with today's initiation of our
Phase 3 trial of our RSV F Vaccine in older adults, demonstrate
Novavax' ability to successfully advance our clinical stage
programs along aggressive timelines," said Stanley C. Erck,
President and CEO. "With successful phase 2 results, and consistent
execution, the Company is well-positioned to begin our second phase
3 trial in pregnant women in the first quarter of 2016."
Financial Results for the Three
and Nine Months Ended September 30, 2015
Novavax reported a net loss of $33.1 million, or
$0.12 per share, for the third quarter of 2015, compared to a net
loss of $19.7 million, or $0.08 per share, for the third quarter of
2014. For the nine months ended September 30, 2015, the net loss
was $78.1 million, or $0.30 per share, compared to a net loss of
$51.4 million, or $0.23 per share, for the same period in 2014.
Novavax revenue in the third quarter of 2015
decreased 21% to $6.5 million, compared to $8.2 million for the
same period in 2014. This decrease results from a lower level of
development activities under the HHS BARDA contract in the third
quarter of 2015 as compared to the same period in 2014.
The cost of government contracts revenue in the
third quarter of 2015 decreased 32% to $2.7 million, compared to
$4.0 million for the same period in 2014. The decrease in cost of
government contracts revenue was associated with a lower level of
development activities under the HHS BARDA contract in the third
quarter of 2015 as compared to the same period in 2014.
Research and development expenses increased 45% to
$27.9 million in the third quarter of 2015, compared to $19.2
million for the same period in 2014. The increase in research and
development expenses was driven by activities relating to the RSV
Vaccine and higher employee-related expenses, including non-cash
stock-based compensation, tied to the continued growth of the
company.
General and administrative expenses increased 90%
to $9.1 million in the third quarter of 2015, compared to $4.8
million for the same period in 2014. The increase in general and
administrative expenses resulted from increased employee-related
expenses, including non-cash stock-based compensation, tied to the
continued growth of the company and professional fees for
pre-commercialization activities.
As of September 30, 2015, the company had $290.2
million in cash and cash equivalents and marketable securities
compared to $168.1 million as of December 31, 2014. Net cash used
in operating activities for the nine months of 2015 was $71.3
million, compared to $47.2 million for the same period in 2014. The
factors contributing to the change in operating cash usage were
primarily due to increased costs relating to our RSV F Vaccine,
Ebola GP Vaccine and higher employee-related expenses, as well as
the timing of customer and vendor payments.
Conference Call
Novavax management will host its quarterly
conference call today at 8:00 a.m. EST. 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 11:00 a.m. on November 9, 2015 until midnight November
16, 2015. To access the replay by telephone, dial 855-859-2056
(Domestic) or 404-537-3406 (International) and use passcode
70778771. 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 and our Quarterly Reports on
Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015,
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 CONSOLIDATED
STATEMENTS OF OPERATIONS |
(in thousands, except per
share information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
(unaudited) |
|
(unaudited) |
Revenue |
$ |
6,525 |
|
|
$ |
8,214 |
|
|
$ |
30,397 |
|
|
$ |
23,935 |
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
Cost of
government contracts revenue |
|
2,747 |
|
|
|
4,027 |
|
|
|
8,054 |
|
|
|
12,150 |
|
|
Research
and development |
|
27,917 |
|
|
|
19,219 |
|
|
|
78,686 |
|
|
|
48,940 |
|
|
General
and administrative |
|
9,060 |
|
|
|
4,757 |
|
|
|
21,991 |
|
|
|
14,871 |
|
|
|
Total costs and
expenses |
|
39,724 |
|
|
|
28,003 |
|
|
|
108,731 |
|
|
|
75,961 |
|
Loss from
operations |
|
(33,199 |
) |
|
|
(19,789 |
) |
|
|
(78,334 |
) |
|
|
(52,026 |
) |
Interest
income (expense), net |
|
130 |
|
|
|
81 |
|
|
|
324 |
|
|
|
10 |
|
Other
income (expense) |
|
(51 |
) |
|
|
(19 |
) |
|
|
(121 |
) |
|
- |
Realized
gains on marketable securities |
- |
|
- |
|
- |
|
|
615 |
|
Net
loss |
$ |
(33,120 |
) |
|
$ |
(19,727 |
) |
|
$ |
(78,131 |
) |
|
$ |
(51,401 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.23 |
) |
Basic and
diluted weighted average |
|
|
|
|
|
|
|
|
number of
common shares outstanding |
|
269,554 |
|
|
|
238,304 |
|
|
|
259,703 |
|
|
|
221,578 |
|
SELECTED CONSOLIDATED BALANCE
SHEET DATA |
(in thousands) |
|
|
September 30,
2015 |
|
December 31,
2014 |
|
(unaudited) |
|
|
Cash and
cash equivalents |
$ |
138,144 |
|
|
$ |
32,335 |
|
Marketable securities |
|
152,042 |
|
|
|
135,721 |
|
Total
current assets |
|
310,102 |
|
|
|
188,158 |
|
Working
capital |
|
285,229 |
|
|
|
154,042 |
|
Total
assets |
|
404,634 |
|
|
|
276,002 |
|
Total
notes payable and capital lease obligation |
|
664 |
|
|
|
1,173 |
|
Total
stockholders' equity |
|
367,016 |
|
|
|
229,618 |
|
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
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#1965453
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