Start of Norovirus Vaccine Trials Delayed to 1H
2019 Due to Manufacturing Issue
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 third
quarter ended September 30, 2018 and provided a corporate
update.
“As our first year as a public company comes to a close,
Vaxart’s main focus continues to be the development of our oral
tablet vaccine for the prevention of norovirus infection. Due to a
manufacturing issue, our norovirus GI.1 vaccine tablets failed
release testing, and we now expect to initiate our Phase 1 bivalent
study and Phase 2 monovalent challenge study in the first half of
2019,” said Wouter Latour, M.D., chief executive officer of Vaxart.
“Besides our norovirus program, we are also advancing our first
therapeutic vaccine for the treatment of human papillomavirus
(HPV)–associated cancer and dysplasia and we are on track to file
an IND for our HPV vaccine in 2019.”
“Norovirus causes up to 20 million cases of acute
gastroenteritis in the U.S. each year, with significant morbidity
and mortality in vulnerable populations like the very young and
elderly,” Dr. Latour continued. “Norovirus outbreaks are notorious
in long-term care facilities, schools, hospitals, restaurants and
cruise ships. In all, norovirus disease costs society an estimated
$5.5 billion annually in the United States, according to a
prominent health economics study published in 2012. At IDWeek in
October of this year, we presented breakthrough data demonstrating
that our oral H1 flu vaccine primarily protected through mucosal
immunity. Our oral norovirus vaccine is based on the same platform,
and we expect it to provide superior protection compared to
injectable alternatives.”
Third Quarter 2018 and Recent Highlights:
Corporate:
- The Company’s Phase 1 bivalent and
Phase 2 challenge norovirus studies are now expected to begin in
the first half of 2019 due to a manufacturing issue affecting the
norovirus GI.1 vaccine tablets. Vaxart is working diligently to
resolve the issue.
- On October 6, 2018, the Company
presented data from its H1 influenza Phase 2 challenge study
demonstrating that its oral H1 flu vaccine, while providing 39%
reduction in flu illness compared to 27% for Fluzone®, protected
primarily through mucosal immunity, in contrast to Fluzone which
primarily protected through serum antibodies. This finding
confirmed that Vaxart’s oral vaccines are uniquely suited to
provide protection against mucosal pathogens such as influenza,
norovirus and respiratory syncytial virus (RSV). A copy of this
presentation can be found on the Investor Relations page on the
Company’s website.
- On October 4, 2018, the Company
presented preclinical data on its human papillomavirus (HPV)
vaccine trial in a poster presentation at the 32nd
International Papillomavirus Conference in Sydney, Australia. As
described in the poster, the Vaxart HPV vaccine created CD8
tumor-infiltrating T cells and eliminated or significantly reduced
the majority of tumors with or without a checkpoint inhibitor.
Preparations to advance the program into the clinic in 2019 are
underway. A copy of this presentation can be found on the Investor
Relations page on the Company’s website.
- Following the completion of the 3-month
follow-up assessment of the Phase 2 clinical trial evaluating
teslexivir, a small-molecule antiviral for the treatment of
condyloma that Vaxart obtained in the acquisition of Aviragen in
2018, analysis of the data showed there was no improvement compared
to the topline results reported in June 2019.
Third Quarter 2018 Financial Results
- Vaxart reported a net loss of $6.5
million for the third quarter of 2018 compared to a net loss of
$2.2 million for the third quarter of 2017. For the nine months
ended September 30, 2018, the net loss was $13.1 million compared
to a net loss of $8.5 million for the same period in 2017.
- Vaxart ended the quarter with cash and
cash equivalents of $17.9 million compared to $23.9 million at June
30, 2018. The decrease was primarily due to cash used in
operations.
- Revenue for the quarter was $0.3
million compared to $0.9 million in the third quarter of 2017. The
decrease was due to lower revenues from the contract with BARDA,
which ended on September 30, 2018.
- Research and development expenses were
$4.4 million for the quarter compared to $2.2 million for the third
quarter of 2017. The increase was due to higher clinical and
manufacturing costs incurred in the Company’s norovirus program,
clinical costs incurred in completing the teslexivir trial, and the
amortization of intangible assets acquired in the merger with
Aviragen, offset by lower expenditures incurred under the BARDA
contract.
- General and administrative expenses
were $1.7 million for the quarter compared to $0.6 million for the
third quarter of 2017. The increase was a result of a higher
headcount and additional expenses relating to operating as a public
company, including expenses required for regulatory compliance,
additional insurance, director fees and other professional
expenses.
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; the
expected timing of the initiation of the Phase 1 bivalent study and
Phase 2 monovalent challenge study; Vaxart’s ability to resolve a
manufacturing issue affecting its norovirus G1.1 vaccine tablets;
the expected timing of an IND filing for its HPV vaccine; and
Vaxart’s expectations with respect to its norovirus vaccine
providing superior protection compared to injectable alternatives.
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 Reports filed on Form
10-Q and of Vaxart’s other periodic 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 (In thousands) September 30,
2018 December 31, 2017 (Unaudited) (1)
Assets Cash and cash equivalents $ 17,922 $ 1,571 Short-term
investments — 1,415 Accounts receivable 256 630 Prepaid and other
current assets 989 137 Property and equipment, net 1,059 730
Intangible assets, net 20,410 40 Total assets
$ 40,636 $ 4,523
Liabilities and stockholders’
equity (deficit) Accounts payable $ 1,301 $ 1,390 Accrued and
other current liabilities 1,779 1,605 Liability related to sale of
future royalties 17,580 — Secured promissory note 3,988 4,968
Convertible promissory notes, related party — 35,282
Total liabilities 24,648 43,245 Stockholders’ equity
(deficit) 15,988 (38,722 ) Total liabilities and
stockholders’ equity (deficit) $ 40,636 $ 4,523 (1)
Derived from the audited financial statements of Vaxart
Biosciences, Inc. for the year ended December 31, 2017, included on
the Form 8-K/A filed with the Securities and Exchange Commission on
April 2, 2018.
Vaxart, Inc. Condensed Consolidated
Statements of Operations (In thousands, except share and per
share amounts) Three Months Ended September
30, Nine Months Ended September 30, 2018
2017 2018 2017 (Unaudited)
(Unaudited) (Unaudited) (Unaudited)
Revenue $ 281 $ 915 $ 2,392 $ 5,079
Operating expenses: Research and development 4,381 2,247
12,801 10,450 General and administrative 1,674 624 5,455 1,955
Impairment charges 106 — 1,706
— Total operating expenses 6,161
2,871 19,962 12,405
Loss from operations (5,880 ) (1,956 ) (17,570 ) (7,326 )
Bargain purchase gain — — 6,660 — Other income and expenses, net
(668 ) (217 ) (2,166 ) (1,181 ) Provision for income taxes —
— (29 ) —
Net loss
$ (6,548 ) $ (2,173 ) $ (13,105 ) $ (8,507 )
Net loss
attributable to common shareholders $ (6,548 ) $ (2,898 ) $
(13,444 ) $ (10,660 )
Net loss per common share, basic and
diluted $ (0.92 ) $ (21.36 ) $ (2.23 ) $ (78.58 )
Shares used in computing net loss per
share,basic and diluted
7,141,189 135,658 6,038,001
135,658
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181109005207/en/
Stern Investor RelationsCarl Mauch,
212-362-1200vaxart@sternir.com
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Apr 2024 to May 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From May 2023 to May 2024