- Phase 1b Bivalent Norovirus Study Fully
Enrolled -
- Research Collaboration with Janssen for
Universal Flu Vaccine Underway -
Vaxart, Inc., a clinical-stage biotechnology company developing
oral recombinant vaccines that are administered by tablet rather
than by injection, today announced financial results for the second
quarter ended June 30, 2019.
“We have made significant progress this quarter, achieving a
number of important milestones. We completed enrollment in our
Phase 1b bivalent norovirus vaccine study and we expect to have
topline results by October of this year,” said Wouter Latour, M.D.,
chief executive officer of Vaxart. “Norovirus causes $60 billion in
global healthcare related costs annually, and our oral tablet
vaccine would be ideal to help protect vulnerable populations such
as older adults and the very young. We remain committed to
developing the norovirus vaccine, and we are now preparing to start
a Phase 2 study with our bivalent norovirus vaccine in 2020,
assuming we achieve positive results in the current Phase 1b
trial.”
“With regard to universal flu, the collaboration with Janssen is
an important endorsement of our oral vaccine platform and could
position us as a key player in the future of influenza vaccine
development. In parallel, we continue our efforts to advance our
own oral seasonal flu vaccine, which demonstrated the potential to
provide better protection than currently marketed injectable
vaccines, such as FluzoneTM, in a human challenge study. Given our
focus on the bivalent norovirus and universal flu vaccine programs,
we have deprioritized the monovalent norovirus vaccine challenge
study and now plan to file our human papilloma virus (HPV)
Investigational New Drug application (IND) in 2020,” continued Dr.
Latour.
Recent Corporate Highlights:
● Completed enrollment in the Phase 1b
bivalent norovirus vaccine clinical trial. The vaccine consists of
an oral norovirus GI.1 vaccine tablet and an oral norovirus GII.4
vaccine tablet administered concurrently. The trial is designed to
evaluate safety and immunogenicity and Vaxart expects to report
topline data in early Q4 2019.
● Entered into a research collaboration
agreement with Janssen Vaccines & Prevention B.V. (Janssen) to
evaluate Vaxart’s proprietary oral vaccine platform for the Janssen
universal influenza vaccine program.
● Priced an underwritten public offering
which closed in April. As of June 30, 2019, the aggregate gross
proceeds were $10.0 million.
● Entered into an agreement with Lonza
Houston to supply vaccine for the planned Phase 2 bivalent
norovirus study in 2020.
● Presented preclinical data at the 29th
European Congress of Clinical Microbiology and Infectious Diseases
in Amsterdam which showed that Vaxart’s oral quadrivalent seasonal
influenza vaccine conferred 100% protection against a lethal H5N1
pre-pandemic influenza challenge in ferrets, while in the Fluzone
group only 62% of the animals survived.
● Published the comprehensive results from
a preclinical trial of Vaxart’s chikungunya vaccine in the peer
reviewed journal, Vaccine. The preclinical results demonstrated
that Vaxart’s vaccine candidate induced significant neutralizing
antibodies against chikungunya virus as well as protective efficacy
against virus-induced pathologic changes.
● Presented preclinical results of
Vaxart’s oral Respiratory Syncytial Virus (RSV) vaccine in a poster
presentation at the American Society of Microbiology 2019,
demonstrating the Vaxart vaccine induces respiratory mucosal memory
and protection against RSV infection in cotton rats.
Following a review of the development strategy for norovirus,
Vaxart has deprioritized the monovalent GI.1 challenge study.
Consequently, the Company is preparing to initiate a Phase 2 safety
and immunogenicity study with Vaxart’s bivalent norovirus vaccine
in 2020, to be followed by a Phase 3 efficacy study, assuming FDA
concurrence.
Financial Results for the Three Months Ended June 30,
2019
● Vaxart reported a net loss of $5.6
million for the second quarter of 2019 compared to $8.9 million for
the second quarter of 2018. The principal reasons for the decrease
were the absence of a $1.6 million one-off non-cash impairment
charge recorded in the second quarter of 2018 and a reduction in
research and development expenditure.
● Vaxart ended the quarter with cash and
cash equivalents of $16.3 million compared to $8.4 million at March
31, 2019. The increase was primarily due to the $8.7 million net
raised as a result of the underwritten offering in April 2019,
partially offset by cash used in operations.
● Revenue for the quarter was $85,000
compared to $608,000 in the second quarter of 2018. The decrease
was almost entirely due to the absence of revenue of $520,000 from
the BARDA contract which ended in 2018.
● Research and development expenses were
$3.7 million for the quarter compared to $5.0 million for the
second quarter of 2018. The decrease was mainly due to the absence
of clinical trials costs for teslexivir and costs incurred for the
now-completed BARDA contract, partially offset by higher clinical
trial and manufacturing costs incurred in the Company’s norovirus
program.
● General and administrative expenses were
$1.4 million for the quarter compared to $1.8 million for the
second quarter of 2018. The decrease was mainly due to lower legal
costs and a reduction in personnel costs.
About Vaxart
Vaxart is a clinical-stage biotechnology company focused on
developing oral recombinant protein vaccines based on its
proprietary oral vaccine platform. Vaxart’s vaccines are designed
to generate broad and durable immune responses that protect against
a wide range of infectious diseases and may also be useful for the
treatment of chronic viral infections and cancer. Vaxart’s vaccines
are administered using a convenient room temperature-stable tablet,
rather than by injection. Vaxart believes that tablet vaccines are
easier to distribute and administer than injectable vaccines and
have the potential to significantly increase vaccination rates.
Vaxart’s development programs include oral tablet vaccines that are
designed to protect against norovirus, seasonal influenza and
respiratory syncytial virus (RSV), as well as a therapeutic vaccine
for human papillomavirus (HPV). For more information, please visit
www.vaxart.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. All statements, other
than statements of historical facts, included in this press release
regarding our strategy, prospects, plans and objectives, results
from preclinical and clinical trials, commercialization agreements
and licenses, beliefs and expectations of management are
forward-looking statements. These forward-looking statements may be
accompanied by such words as “believe,” “could,” “potential,”
“will” and other words and terms of similar meaning. Examples of
such statements include, but are not limited to, statements
relating to the Vaxart’s ability to develop and commercialize its
product candidates and clinical results and trial data; Vaxart’s
plans to start a phase 2 study with its bivalent norovirus vaccine
in 2020; Vaxart’s expectations with respect to its collaboration
with Janssen; Vaxart’s intention to continue its efforts to advance
its oral tablet seasonal flu vaccine; the expected timing of
topline results from its Phase 1b bivalent norovirus vaccine study
in early Q4 2019; the ability of Lonza Houston to supply vaccine
for Vaxart’s planned Phase 2 bivalent norovirus vaccine study in
2020; and Vaxart’s expectations with respect to the important
advantages it believes its oral vaccine platform can offer over
injectable alternatives, particularly for mucosal pathogens such as
norovirus, flu and RSV. Vaxart may not actually achieve the plans,
carry out the intentions or meet the expectations or projections
disclosed in our forward-looking statements and you should not
place undue reliance on these forward-looking statements. Actual
results or events could differ materially from the plans,
intentions, expectations and projections disclosed in the
forward-looking statements. Various important factors could cause
actual results or events to differ materially from the
forward-looking statements that Vaxart makes, that Vaxart’s product
candidates may not be approved by the FDA or non-U.S. regulatory
authorities; that, even if approved by the FDA or non-U.S.
regulatory authorities, Vaxart’s product candidates may not achieve
broad market acceptance; that Vaxart may experience manufacturing
issues and delays; and other risks described in the “Risk Factors”
sections of Vaxart’s Quarterly and Annual Reports filed with the
SEC. Vaxart does not assume any obligation to update any
forward-looking statements, except as required by law.
Vaxart, Inc. Condensed
Consolidated Balance Sheets
June 30, 2019
December 31, 2018
(Unaudited)
(1)
(in thousands)
Assets
Cash and cash equivalents
$
16,258
$
11,506
Accounts receivable
35
1,796
Prepaid and other assets
916
1,446
Property and equipment, net
1,517
1,066
Right-of-use assets, net
565
—
Intangible assets, net
17,959
19,413
Total Assets
$
37,250
$
35,227
Liabilities and stockholders’
equity
Accounts payable
$
610
$
962
Accrued and other liabilities
1,503
1,675
Liability related to sale of future
royalties
15,669
17,741
Secured promissory note
2,842
3,611
Operating lease liabilities
781
—
Total liabilities
21,405
23,989
Stockholders’ equity
15,845
11,238
Total liabilities and stockholders’
equity
$
37,250
$
35,227
(1) Derived from the audited consolidated financial statements
of Vaxart, Inc. for the year ended December 31, 2018, included on
the Form 10-K filed with the Securities and Exchange Commission on
February 6, 2019.
Vaxart, Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2019
2018
2019
2018
(in thousands, except share and
per share amounts)
Revenue
$
85
$
608
$
5,492
$
2,111
Operating expenses:
Research and development
3,707
5,012
7,536
8,420
General and administrative
1,375
1,771
3,401
3,781
Exit and impairment charges
—
1,600
—
1,600
Total operating expenses
5,082
8,383
10,937
13,801
Loss from operations
(4,997)
(7,775)
(5,445)
(11,690)
Bargain purchase gain
—
(328)
—
6,660
Other income and (expenses), net
(627)
(767)
(1,268)
(1,498)
Provision for income taxes
(13)
(1)
(263)
(29)
Net loss
$
(5,637)
$
(8,871)
$
(6,976)
$
(6,557)
Net loss attributable to common
stockholders
$
(5,637)
$
(8,871)
$
(6,976)
$
(6,896)
Net loss per share, basic and
diluted
$
(0.39)
$
(1.24)
$
(0.64)
$
(1.26)
Shares used in computing net loss per
share, basic and diluted
14,597,446
7,141,189
10,969,473
5,477,265
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version on businesswire.com: https://www.businesswire.com/news/home/20190808005581/en/
Daniella Funaro Stern Investor Relations 212-362-1200
vaxart@sternir.com
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