- RSV Phase 3
Prepare(TM) Trial Outcome De-risked by Successful Informational
Analysis
- NanoFlu(TM)
Vaccine Demonstrates Improved Immune Responses Compared to
Egg-Based, High-Dose Flu Vaccine
- John J. Trizzino
Appointed Chief Business Officer and Chief Financial Officer (as
Announced in Separate Press Release)
GAITHERSBURG, Md., March 14, 2018
(GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today provided a
corporate update and announced its financial results for the fourth
quarter and twelve months ended December 31, 2017.
"During this last quarter we
collected our most significant results to date from our two lead
vaccine programs," said Stanley C. Erck, President and CEO,
Novavax, Inc. "This progress gives us enhanced focus and momentum
to execute under these programs for the remainder of 2018 and
beyond."
NanoFlu
Program Update:
In late February 2018, the Company
announced positive top-line results from its Phase 1/2 clinical
trial in 330 older adults of its NanoFlu recombinant influenza
vaccine, which includes its proprietary Matrix-M(TM) adjuvant,
compared to the leading licensed egg-based, high-dose influenza
vaccine for older adults (IIV3-HD). Key findings from the trial
show that Novavax' trivalent NanoFlu vaccine induced significantly
higher hemagglutination inhibition (HAI) antibody responses against
homologous A-type strains as well as against historic and
forward-drifted H3N2 strains. Based on the strength of these trial
results, the Company submitted a related manuscript to a
peer-reviewed medical journal and is planning to present the data
at the World Vaccine Congress meeting on April 4, 2018.
"This influenza season in the
Northern Hemisphere has resulted in a serious public health
epidemic, largely because of the H3N2 flu strain and the inability
of current vaccines to provide adequate protection, particularly to
older adults and other vulnerable populations," said Gregory M.
Glenn, M.D., President of Research and Development. "Our NanoFlu
vaccine's head-to-head performance against IIV3-HD demonstrated
that it has the potential to address two primary confounding
factors related to poor vaccine efficacy: virus drift and vaccine
mutation resulting from egg-based manufacturing. With these
findings, we are able to initiate manufacturing and clinical
operations activities to support our next step, a Phase 2 trial of
a quadrivalent formulation of our NanoFlu vaccine, scheduled to
begin in the third quarter of this year."
RSV F
Vaccine Maternal Immunization Program Update:
In December 2017, the Company
completed a successful informational analysis of the Phase 3
Prepare(TM) clinical trial of its RSV F Vaccine for infants via
maternal immunization. The analysis of data from 1,307 infants in
the per-protocol population indicate an observed vaccine efficacy
in the range of between 45% and 100%. The Company anticipates that
it will reach approximately 4,600 participants, including
approximately 3,000 actively vaccinated mothers, in the second
quarter of 2018, which will enable an interim efficacy analysis
with results reported in early 2019. This program continues to be
funded under an $89 million grant from the Bill and Melinda Gates
Foundation (BMGF), and has been granted Fast Track designation by
the U.S. Food and Drug Administration (FDA).
"The results of our informational analysis this
December significantly increased the likelihood of success of our
RSV F Vaccine program for infants via maternal immunization," added
Mr. Erck. "With over 4,000 current participants, we are very close
to triggering the interim efficacy analysis, the positive results
of which would form the basis of our Biologics License Application
filing with the FDA. Providing protection to newborns from
respiratory syncytial virus, one of the most prevalent and damaging
diseases to which they are exposed during their first months of
life, has important global public health implications."
Financial
Results for the Three and Twelve Months Ended December 31,
2017
Novavax reported a net loss of
$50.8 million, or $0.16 per share, for the fourth quarter of 2017,
compared to a net loss of $57.1 million, or $0.21 per share, for
the fourth quarter of 2016. For the twelve months ended December
31, 2017, the net loss was $183.8 million, or $0.63 per share,
compared to a net loss of $280.0 million, or $1.03 per share, for
the same period in 2016.
Novavax revenue in the fourth
quarter of 2017 was $10.4 million, compared to $5.4 million in the
same period in 2016. This 93% increase was driven by higher revenue
recorded under the BMGF grant of $89 million.
Research and development expenses
decreased 3% to $49.7 million in the fourth quarter of 2017,
compared to $51.1 million for the same period in 2016. The decrease
was primarily due to reduced development activities of our RSV F
Vaccine for older adults, partially offset by increased
developemtnt activities of our RSV F Vaccine for infants via
maternal immunization.
Interest income (expense), net for
the fourth quarter of 2017 and 2016 was ($3.1) million.
As of December 31, 2017, the
company had $157.3 million in cash, cash equivalents and marketable
securities, compared to $235.5 million as of December 31, 2016. Net
cash used in operating activities for the full year 2017 was $138.7
million, compared to $255.5 million for same period in 2016. The
decrease in cash usage was primarily due to decreased costs
relating to our RSV F Vaccine and lower overall employee-related
costs.
Conference
Call
Novavax management will host its
quarterly conference call today at 5:00 p.m. ET. The dial-in number
for the conference call is (877) 212-6076 (Domestic) or (707)
287-9331 (International), passcode 6472939. A replay of the
conference call will be available starting at 7:30 p.m. ET on March
14, 2018 until 8:30 pm ET on March 21, 2018. To access the replay
by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406
(International) and use passcode 6472939.
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 webcast will be available on the
Novavax website until June 14, 2018.
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.1 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 2025.2
About the Phase 1/2 Clinical
Trial
Novavax conducted a randomized, observer-blind,
comparator-controlled trial of NanoFlu vaccine (in two trivalent
formulations: 45µg or 180µg total HA) against IIV3-HD in 330
healthy adults aged 60 years or older. Vaccine immunogenicity was
measured by HAI and neutralization antibody responses against a
panel of vaccine-homologous, and historically and forward-drifted,
influenza virus strains.
About NanoFlu(TM) and Matrix
M(TM)
NanoFlu vaccine is a recombinant hemagglutinin
(HA) protein nanoparticle influenza vaccine candidate produced by
Novavax in its SF9 insect cell baculovirus system. NanoFlu vaccine
uses HA amino acid protein sequences that are substantially the
same as wild-type circulating virus HA sequences. NanoFlu vaccine
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
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.3 In
the US, RSV is the leading cause of hospitalization of
infants.4 Despite
the induction of post-infection immunity, repeat infection and
lifelong susceptibility to RSV is common.5 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 the
U.S. Food and Drug Administration's (FDA) Fast Track
Program
The Fast Track Drug Development
Program was established under the FDA Modernization Act of 1997. A
Fast Track designation is intended for products that treat serious
or life-threatening diseases or conditions, and that demonstrate
the potential to address unmet medical needs for such diseases or
conditions. The program is intended to facilitate development and
expedite review of drugs to treat serious and life-threatening
conditions so that an approved product can reach the market
expeditiously. Specifically, Fast Track designation facilitates
meetings to discuss all aspects of development to support licensure
and it provides the opportunity to submit sections of a BLA on a
rolling basis as data become available, which permits the FDA to
review modules of the BLA as they are received instead of waiting
for the entire BLA submission. In addition, priority review (six
month review versus standard ten month review) is a potential
benefit that may be available to Novavax' RSV F vaccine in the
future.
About
Novavax
Novavax, Inc. (Nasdaq:NVAX) is a
clinical-stage biotechnology company committed to delivering novel
products to prevent infectious diseases. Our RSV and influenza
nanoparticle vaccine candidates are Novavax' most advanced clinical
programs and are at the forefront of the Company's efforts to
improve global health. 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, 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.
NOVAVAX,
INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in
thousands, except per share information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended |
|
Twelve
Months Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ 10,412 |
|
$ 5,399 |
|
$ 31,176 |
|
$ 15,353 |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
49,657 |
|
51,100 |
|
168,435 |
|
237,939 |
|
General and administrative |
8,540 |
|
8,344 |
|
34,451 |
|
46,527 |
|
|
Total
expenses |
58,197 |
|
59,444 |
|
202,886 |
|
284,466 |
Loss from operations |
(47,785) |
|
(54,045) |
|
(171,710) |
|
(269,113) |
Interest income (expense), net |
(3,105) |
|
(3,066) |
|
(12,126) |
|
(10,822) |
Other income (expense) |
47 |
|
2 |
|
67 |
|
(31) |
Net loss |
$
(50,843) |
|
$ (57,109) |
|
$
(183,769) |
|
$ (279,966) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$
(0.16) |
|
$ (0.21) |
|
$
(0.63) |
|
$ (1.03) |
Basic and diluted weighted average |
|
|
|
|
|
|
|
|
number of common shares outstanding |
316,119 |
|
271,200 |
|
292,669 |
|
270,802 |
|
|
|
|
|
|
|
|
|
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA |
(in
thousands)
|
|
December
31,
2017 |
|
December 31, 2016 |
|
|
|
|
Cash
and cash equivalents |
$ |
106,307 |
|
|
$ |
144,353 |
|
Marketable securities |
|
50,996 |
|
|
|
91,126 |
|
Total
current assets |
|
203,311 |
|
|
|
287,830 |
|
Working capital |
|
129,636 |
|
|
|
221,424 |
|
Total
assets |
|
302,493 |
|
|
|
394,301 |
|
Total
notes payable and capital lease obligation |
|
317,763 |
|
|
|
316,376 |
|
Total
stockholders' deficit |
|
(101,732 |
) |
|
|
(5,546 |
) |
Contact:
Investors
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Sam Brown
Mike Beyer
mikebeyer@sambrown.com
312-961-2502
1 Resolution
of the World Health Assembly (2003) WHA56.19.28
2 Influenza
Vaccines Forecasts. Datamonitor (2013)
3 https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
4 Leader
S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
5 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
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
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Apr 2024 to May 2024
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From May 2023 to May 2024