Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced its financial results and operational
highlights for the first quarter ended March 31, 2020.
“Our accomplishments to-date in 2020, including
significant progress in our influenza and COVID‑19 vaccine
programs, are the most impressive in the company’s history,” said
Stanley C. Erck, President and Chief Executive Officer of Novavax.
“We shared successful pivotal Phase 3 results for NanoFlu that
demonstrated both efficacy and safety in a pivotal trial, a
significant milestone towards bringing this innovative product to
an influenza market in need of new options. We also reacted quickly
to the coronavirus pandemic by developing and quickly advancing
NVX‑CoV2373, our COVID‑19 vaccine candidate, which shows strong
potential to have a positive impact on this global health crisis.
Looking ahead, with a strengthened balance sheet and CEPI’s
substantial funding, we will focus on scaling up manufacturing and
delivering clinical data for NVX‑CoV2373, while simultaneously
completing the necessary actions needed to prepare our BLA filing
for NanoFlu.”
First Quarter 2020 and Subsequent
Operational Highlights
NanoFlu™ Program
- Novavax announced in March that
NanoFlu, its recombinant quadrivalent seasonal influenza vaccine
candidate with Matrix‑M™ adjuvant, achieved all primary objectives
in its pivotal Phase 3 clinical trial in older adults. As required
by the FDA’s accelerated approval pathway, the trial’s primary
objectives were to demonstrate non-inferior immunogenicity of
NanoFlu compared to a licensed vaccine (Fluzone® Quadrivalent),
using the day 28 ratio of geometric mean titers (GMT) and the
difference in seroconversion rates (SCR), as well as the overall
safety of NanoFlu. These endpoints were met for all four strains
included in NanoFlu. Immunogenicity was measured by
hemagglutination inhibition (HAI) assays using egg-derived
reagents. NanoFlu was well-tolerated, with a safety profile
comparable to Fluzone Quadrivalent with a modest increase in local
adverse events (AEs).
- NanoFlu also achieved statistical
significance for key secondary endpoints. These key endpoints
assessed GMT and SCR, but with an HAI assay based on wild-type
reagents. NanoFlu demonstrated significantly higher GMT and SCR
than Fluzone Quadrivalent across all four strains included in the
vaccine and, importantly, for four tested drifted H3N2 strains not
included in the vaccine but circulating this year.
- Results from this Phase 3 clinical
trial will support a U.S. biologics license application (BLA) and
licensure of NanoFlu using the U.S. Food and Drug Administration’s
(FDA) accelerated approval pathway.
COVID-19 Program
- As announced today, the Coalition
for Epidemic Preparedness Innovations (CEPI) will invest up to an
additional $384 million to advance clinical development of
NVX‑CoV2373. Novavax will use the CEPI funds to advance NVX‑CoV2373
into clinical testing. With its earlier $4 million commitment in
March, the extended collaboration brings CEPI’s total investment in
NVX‑CoV2373 to $388 million.
- In January, Novavax identified its
coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion
protein made using its proprietary nanoparticle technology.
Novavax’ proprietary Matrix‑M adjuvant is included in NVX‑CoV2373,
to enhance immune responses and stimulate high levels of
neutralizing antibodies.
- NVX‑CoV2373 was highly immunogenic
in animal models measuring spike protein-specific antibodies, with
ACE‑2 human receptor binding domain blocking activity and
SARS‑CoV‑2 wild-type virus neutralizing antibodies observed.
Blocking of the binding of the spike protein to the receptor as
well as wild-type virus neutralizing antibodies was also observed,
with high levels of spike protein-specific antibodies after a
single immunization. The already high microneutralization titers
seen after one dose increased eight fold with a second dose. High
titer microneutralizing antibodies are generally accepted evidence
that a vaccine is likely to be protective in humans.
- The NVX‑CoV2373 clinical
development plan combines a Phase 1/Phase 2 approach to allow rapid
advancement during the current coronavirus pandemic. The Phase 1
portion of this trial will be placebo-controlled and observer
blinded in ~130 healthy adults and will include assessment of
dosage and vaccination. Recruiting for the trial began this month
with preliminary immunogenicity and safety results expected in
July.
- Novavax entered into an agreement
with Emergent BioSolutions to provide contract development and
manufacturing services, supplying Novavax with GMP vaccine product
for use in its clinical trials. This agreement offers the potential
to leverage Emergent’s rapid deployment capabilities and expertise
that provide Novavax scalability and capacity to produce vaccine
product.
ResVax™ Program
- Novavax is currently discussing the
opportunity to bring ResVax to market globally with multiple
potential commercial partners. In addition, Novavax continues to
define regulatory licensure requirements and pathways in the U.S.,
the European Union and other geographies.
Matrix-M Partnership
- In March, Novavax announced a
commercial license agreement related to its Matrix‑M vaccine
adjuvant. Matrix‑M is a key component of Serum Institute of India’s
malaria vaccine candidate, which it licensed from Jenner Institute
at Oxford University. The vaccine candidate is currently in a Phase
2b clinical trial being conducted in Burkina Faso with top-line
data expected in the second quarter of 2020.
Corporate
- Through utilization of
At-the-market (ATM) offerings during the first quarter of 2020,
Novavax raised net proceeds of $186 million. Subsequent to
quarter-end, through May 8, 2020, Novavax raised additional net
proceeds of $74 million, for a total of $260 million since the
beginning of the year.
Financial Results for the Three Months
Ended March 31, 2020
Novavax reported a net loss of $25.9 million, or
$0.58 per share, for the first quarter of 2020, compared to a net
loss of $43.2 million, or $2.11 per share, for the first quarter of
2019.
Novavax revenue in the first quarter of 2020 was
$3.4 million, compared to $4.0 million in the same period in 2019.
This 15% decrease was primarly due to the conclusion of the
Prepare™ trial in 2019, partially offset by revenue from CEPI’s
funding.
Research and development expenses decreased 52%
to $16.9 million in the first quarter of 2020, compared to $35.5
million in the same period in 2019. This decrease was primarily due
to decreased development activities of ResVax, lower
employee-related costs and other cost savings due to the Catalent
transaction in 2019.
General and administrative expenses increased to
$9.4 million in the first quarter of 2020, compared to $8.7 million
for the same period in 2019.
Interest income (expense), net for the first
quarter of 2020 and 2019 was ($3.0) million.
As of March 31, 2020, Novavax had $244.7 million
in cash, cash equivalents, marketable securities and restricted
cash, compared to $82.2 million as of December 31, 2019. Net cash
used in operating activities for the first quarter of 2020 was
$23.1 million, compared to $50.6 million for same period in
2019.
Share and per share data have been restated to
reflect the reverse stock split that was completed in May 2019.
Conference Call
Novavax will host its quarterly conference call
today at 4:30 p.m. ET. The dial-in numbers for the conference call
are (877) 212-6076 (Domestic) or (707) 287-9331 (International),
passcode 1274143. A replay of the conference call will be available
starting at 7:30 p.m. ET on May 11, 2020 until 7:30 p.m. ET on May
18, 2020. To access the replay by telephone, dial (855) 859-2056
(Domestic) or (404) 537-3406 (International) and use passcode
1274143.
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 August 11, 2020.
About NanoFlu™
NanoFlu is a recombinant hemagglutinin (HA)
protein nanoparticle influenza vaccine 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. Top-line data from Novavax’
ongoing Phase 3 clinical trial of NanoFlu is expected late in the
first quarter of 2020.
About NVX-CoV2373
NVX‑CoV2373 is a vaccine candidate engineered
from the genetic sequence of SARS‑CoV‑2, the virus that causes
COVID-19 disease. NVX‑CoV2373 was created using Novavax’
recombinant nanoparticle technology to generate antigen derived
from the coronavirus spike (S) protein and contains Novavax’
patented saponin-based Matrix-M™ adjuvant to enhance the immune
response and stimulate high levels of neutralizing antibodies. In
preclinical trials, NVX‑CoV2373 demonstrated efficient binding with
receptors targeted by the virus, a critical aspect for effective
vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 will
initiate in May 2020 with preliminary immunogenicity and safety
results expected in July 2020. The Coalition for Epidemic
Preparedness Innovations (CEPI) is investing up to $388 million of
funding to advance clinical development of NVX‑CoV2373.
About Matrix-M™
Novavax’ patented saponin-based Matrix-M
adjuvant 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, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a late-stage
biotechnology company that promotes improved health globally
through the discovery, development, and commercialization of
innovative vaccines to prevent serious infectious diseases and
address urgent, global health needs. Novavax recently initiated
development of NVX-CoV2373, its vaccine candidate against
SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical
trial results expected in July of 2020. NanoFlu™, its quadrivalent
influenza nanoparticle vaccine, met all primary objectives in its
pivotal Phase 3 clinical trial in older adults. Both vaccine
candidates incorporate Novavax’ proprietary saponin-based Matrix-M™
adjuvant in order to enhance the immune response and stimulate high
levels of neutralizing antibodies. Novavax is a leading innovator
of recombinant vaccines; its proprietary recombinant technology
platform combines the power and speed of genetic engineering to
efficiently produce highly immunogenic nanoparticles in order to
address urgent global health needs.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
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, 2019, 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)(unaudited)
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
March 31 |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
3,377 |
|
|
$ |
3,982 |
|
|
|
|
|
Expenses: |
|
|
|
Research and development |
|
16,895 |
|
|
|
35,473 |
|
General and administrative |
|
9,379 |
|
|
|
8,732 |
|
Total expenses |
|
26,274 |
|
|
|
44,205 |
|
Loss from operations |
|
(22,897 |
) |
|
|
(40,223 |
) |
Interest income (expense),
net |
|
(2,967 |
) |
|
|
(2,983 |
) |
Other income (expense) |
|
-- |
|
|
|
(12 |
) |
Net loss |
$ |
(25,864 |
) |
|
$ |
(43,218 |
) |
|
|
|
|
Basic and diluted net loss per
share |
$ |
(0.58 |
) |
|
$ |
(2.11 |
) |
Basic and diluted weighted
average number of common shares outstanding |
|
44,421 |
|
|
|
20,442 |
|
|
|
|
|
|
|
|
|
SELECTED CONSOLIDATED BALANCE SHEET
DATA(in thousands)
|
March 31, 2020 |
|
December 31,2019 |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
179,881 |
|
|
$ |
78,823 |
|
Marketable securities |
|
57,474 |
|
|
|
-- |
|
Total restricted cash |
|
7,311 |
|
|
|
3,357 |
|
Total current assets |
|
255,232 |
|
|
|
97,247 |
|
Working capital |
|
236,250 |
|
|
|
71,452 |
|
Total assets |
|
328,068 |
|
|
|
172,957 |
|
Notes payable |
|
320,967 |
|
|
|
320,611 |
|
Total stockholders’ deficit |
|
(23,971 |
) |
|
|
(186,017 |
) |
|
|
|
|
|
|
|
|
Contacts:
InvestorsNovavax, Inc.Erika Trahanir@novavax.com240-268-2022
WestwickeJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaBrandzone/COGS CommunicationEdna
Kaplankaplan@kogspr.com617-974-8659
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