GAITHERSBURG, Md., May 09, 2018
(GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced
its financial results for the first quarter ended March 31,
2018.
First
Quarter and Subsequent Achievements:
RSV F
Vaccine
- In May 2018, Novavax reached enrollment of
approximately 4,600 pregnant women in its Prepare(TM) Phase 3
clinical trial of its RSV F Vaccine for infants via maternal
immunization. This milestone enables Novavax to initiate a
prespecified interim efficacy analysis after approximately six
months of follow-up of the last infant born to the approximately
4,600 women enrolled (including 3,000 actively vaccinated women).
Completion of this analysis is expected in the first quarter of
2019. Since 2015, the Prepare trial is supported by an $89 million
grant from the Bill & Melinda Gates Foundation
(BMGF).
- In April 2018, Novavax presented at the World
Vaccine Congress on the status of its Phase 3 clinical trial
of its RSV F Vaccine.
NanoFlu(TM)
- In April 2018, Novavax presented clinical data at
the World Vaccine Congress from the Phase 1/2 clinical trial in
older adults comparing trivalent formulations of NanoFlu to the
market-leading licensed egg-based, high-dose influenza vaccine for
older adults.
- In February 2018, Novavax reported positive
top-line results from its Phase 1/2 clinical trial of its trivalent
NanoFlu.
Corporate
- In April 2018, Novavax completed an underwritten
public offering of approximately 34.8 million shares of its common
stock, including 4.5 million shares pursuant to the underwriters'
option to purchase additional shares. The shares resulted in net
proceeds of $54 million.
- Effective on March 14, 2018, John J. Trizzino,
former Senior Vice President, Commercial Operations since 2014, was
promoted to Senior Vice President, Chief Business Officer and Chief
Financial Officer.
Anticipated
Events:
- Initiation of the Phase 2 clinical trial of
quadrivalent formulations of NanoFlu scheduled to begin in the
third quarter of 2018.
- Top-line data from the Phase 2 NanoFlu trial and
End of Phase 2 meeting with the FDA expected in the first quarter
of 2019.
- Results of the Prepare Phase 3 interim efficacy
analysis for our RSV F Vaccine expected in the first quarter of
2019.
Summary
"We had an extremely productive
first quarter, including making important advances in our two lead
clinical vaccine programs. We are pleased to have reached the
enrollment target for our Prepare Phase 3 RSV F Vaccine trial,
which clears the path for following these most recent participants
and their babies, and subsequently announcing top-line results of
our planned interim efficacy analysis in the first quarter of
2019," said Stanley C. Erck, President and CEO of Novavax, Inc. "We
also continue to make significant progress on NanoFlu and plan to
initiate a Phase 2 clinical trial in the third quarter of
2018."
Financial
Results for the First Quarter Ended March 31, 2018
Novavax reported a net loss of
$46.4 million, or $0.14 per share, for the first quarter of 2018,
compared to a net loss of $43.9 million, or $0.16 per share, for
the first quarter of 2017.
Novavax revenue in the first
quarter of 2018 was $9.7 million, compared to $5.7 million in the
same period in 2017. This 70% increase was driven by higher revenue
recorded under the BMGF grant corresponding to the increased
enrollment in the Prepare trial.
Research and development expenses
increased 18% to $44.5 million in the first quarter of 2018,
compared to $37.7 million for the same period in 2017. The increase
was primarily due to increased development activities of the RSV F
Vaccine for infants via maternal immunization.
Interest income (expense), net for
the first quarter of 2018 was ($2.9) million, compared to ($3.0)
million for the same period of 2017.
As of March 31, 2018, Novavax had
$164.2 million in cash, cash equivalents, marketable securities and
restricted cash, compared to $186.4 million as of December 31,
2017. Net cash used in operating activities for the first quarter
of 2018 was $66.1 million, compared to $44.5 million for same
period in 2017. The increase in cash usage was primarily due to
approximately $16 million of one-time payments, as well as the
adoption of a new accounting standard that requires restricted cash
to be included in the beginning and ending balances on the
statements of cash flows, thus increasing Novavax' cash usage in
the first quarter of 2018 and 2017 by approximately $9 million and
$6 million, respectively. We expect our cash used in operating
activities to significantly decrease for the subsequent quarters of
2018 as compared to the first quarter of 2018.
Conference
Call
Novavax management will host its
quarterly conference call today at 4:30 p.m. ET. The dial-in number
for the conference call is (877) 212-6076 (Domestic) or (707)
287-9331 (International), passcode 3687883. A replay of the
conference call will be available starting at 7:30 p.m. ET on May
9, 2018 until 7:30 p.m. ET on May 16, 2018. To access the replay by
telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406
(International) and use passcode 3687883.
A webcast of the conference call
can also be accessed via a link on the home page of the Novavax
website at www.novavax.com or through the "Investor Info"/"Events"
tab on the Novavax website. A replay of the webcast will be
available on the Novavax website until August 9, 2018.
About
RSV
RSV is the most common cause of
lower respiratory tract infections and the leading viral cause of
severe lower respiratory tract disease in infants and young
children worldwide, with estimated annual infection and mortality
rates of 64 million and 160,000, respectively.1 In
the U.S., RSV is the leading cause of hospitalization of
infants.2 Despite
the induction of post-infection immunity, repeat infection and
lifelong susceptibility to RSV is common.3 Currently,
there is no approved RSV vaccine available.
About RSV F
Vaccine for Infants via Maternal Immunization
Novavax is developing a vaccine
that targets the fusion protein, or F protein, of the RSV virus.
The F protein has highly conserved amino acid sequences, called
antigenic sites, which are the target of neutralizing antibodies
and are believed to be ideal vaccine targets. Novavax' genetically
engineered novel F protein antigen exposes a range of these
antigenic sites, and can evoke immune responses to them in human
vaccine recipients. In a previous Phase 2 clinical trial of the RSV
F Vaccine, which assessed the transplacental transfer of maternal
antibodies induced by the vaccine, immunized women demonstrated
meaningful fold rises in anti-F IgG, palivizumab-competing
antibodies and microneutralization titers. In addition, infants'
antibody levels at delivery averaged 90-100% of the mothers'
levels, indicating efficient transplacental transfer of antibodies
from mother to infant.
About
Influenza
Influenza is a world-wide
infectious disease that causes illness in humans with symptoms
ranging from mild to life-threatening or even death. Serious
illness occurs not only in susceptible populations such as infants,
young children and older adults, but also in the general population
largely because of infection by continuously evolving strains of
influenza which can evade the existing protective antibodies in
humans. An estimated one million deaths each year are attributed to
influenza.4 Current
estimates for seasonal influenza vaccine growth in the top seven
markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a
potential increase from approximately $3.2 billion in 2015 to $5.3
billion by 2025.5
About
NanoFlu(TM)
NanoFlu is a recombinant
hemagglutinin (HA) protein nanoparticle influenza vaccine candidate
produced by Novavax in its SF9 insect cell baculovirus system.
NanoFlu uses HA amino acid protein sequences that are the same as
the recommended wild-type circulating virus HA sequences. NanoFlu
contains Novavax' patented saponin-based Matrix-M adjuvant, which
has demonstrated a potent and well-tolerated effect by stimulating
the entry of antigen-presenting cells into the injection site and
enhancing antigen presentation in local lymph nodes.
About
Novavax
Novavax, Inc. (Nasdaq:NVAX) is a
clinical-stage biotechnology company committed to delivering novel
products to prevent infectious diseases. Its RSV and influenza
nanoparticle vaccine candidates are Novavax' most advanced clinical
programs and are at the forefront of Novavax' efforts to improve
global health. For more information, please
visit www.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, 2017 as 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.
1 https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
2 Leader
S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
3 PLOS.
"How immunity to respiratory syncytial virus develops in childhood,
deteriorates in adults." ScienceDaily. 21 April
2016. https://www.sciencedaily.com/releases/2016/04/160421145747.htm
4 Resolution
of the World Health Assembly (2003) WHA56.19.28
5 Influenza
Vaccines Forecasts. Datamonitor (2013)
|
|
NOVAVAX,
INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in
thousands, except per share information) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended |
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
$ |
9,653 |
|
|
$ |
5,680 |
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
44,514 |
|
|
|
37,654 |
|
|
General and administrative |
|
|
|
|
|
8,652 |
|
|
|
8,852 |
|
|
|
Total
expenses |
|
|
|
|
|
53,166 |
|
|
|
46,506 |
|
Loss from operations |
|
|
|
|
|
(43,513 |
) |
|
|
(40,826 |
) |
Interest income (expense), net |
|
|
|
|
|
(2,872 |
) |
|
|
(3,039 |
) |
Other income (expense) |
|
|
|
|
|
33 |
|
|
|
11 |
|
Net loss |
|
|
|
|
$ |
(46,352 |
) |
|
$ |
(43,854 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
|
|
|
$ |
(0.14 |
) |
|
$ |
(0.16 |
) |
Basic and diluted weighted average |
|
|
|
|
|
|
|
|
number of common shares outstanding |
|
|
|
|
|
336,972 |
|
|
|
274,178 |
|
|
|
|
|
|
|
|
|
|
|
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA |
(in
thousands) |
|
|
March
31,
2018 |
|
December 31,
2017 |
|
(unaudited) |
|
|
Cash
and cash equivalents |
$ |
113,402 |
|
|
$ |
106,307 |
|
Marketable securities |
|
30,358 |
|
|
|
50,996 |
|
Total
restricted cash |
|
20,439 |
|
|
|
29,124 |
|
Total
current assets |
|
181,034 |
|
|
|
203,311 |
|
Working capital |
|
136,130 |
|
|
|
129,636 |
|
Total
assets |
|
276,067 |
|
|
|
302,493 |
|
Notes
payable |
|
318,119 |
|
|
|
317,763 |
|
Total
stockholders' deficit |
|
(99,369 |
) |
|
|
(101,732 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:
Investors
Novavax, Inc.
Erika Trahan
ir@novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Sam Brown
Mike Beyer
mikebeyer@sambrown.com
312-961-2502
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq 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
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