- $13 million raised in 1H19 -
- Norovirus bivalent vaccine Phase 1b clinical
study underway with results expected in 2H19 -
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 first
quarter ended March 31, 2019.
“With the Phase 1b study of our bivalent norovirus tablet
vaccine underway and two successful financings behind us, we are
well positioned to advance our lead product candidate, the first
oral vaccine against norovirus, the leading cause of food-borne
illness in the U.S.,” said Wouter Latour, M.D., chief executive
officer of Vaxart. “We expect to initiate the Phase 2 monovalent
norovirus challenge study in the first half of 2019, and we expect
topline results from both the Phase 1b and Phase 2 studies in the
second half of 2019. In addition, we are advancing our first
therapeutic vaccine for the treatment of HPV associated cervical
dysplasia and cancer toward the clinic.”
2019 Highlights:
Corporate:
- On March 8, Vaxart announced the
initiation of the open label lead-in portion of its Phase 1b
bivalent norovirus vaccine clinical trial. On March 27, the Company
announced it had completed dosing of the lead-in cohort, and on
April 16 the first patient in the randomized cohort of the clinical
trial was dosed.
- On March 19, Vaxart announced the
pricing of a registered direct offering of 1,200,000 shares of its
common stock at a price of $2.50 per share. Total gross proceeds
from the offering were $3.0 million.
- On April 1, at the International
Society for Influenza and other Respiratory Virus Diseases
conference in Siena, Italy, and on April 3, at the Influenza
Vaccines for the World 2019 conference in Edinburgh, Scotland,
Vaxart presented new data from its Phase 2 influenza challenge
study further solidifying the evidence that its oral tablet vaccine
protects against influenza infection, primarily through mucosal
immunity.
- On April 9, Vaxart announced the
pricing of an underwritten public offering of a total of 925,455
shares of common stock and 8,165,455 pre-funded warrants with an
exercise price of $0.10 per share, as well as common warrants for
10,454,546 shares with an exercise price of $1.10 per share. The
gross proceeds of the offering at close were $9.3 million. As of
May 8, 2019, 6,519,091 pre-funded warrants had been exercised,
bringing the aggregate gross proceeds up to $10.0 million, and
1,646,364 pre-funded warrants remained outstanding.
- On April 13, at the 29th European
Congress of Clinical Microbiology and Infectious Diseases in
Amsterdam, the Netherlands, Vaxart presented preclinical data
showing 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.
Financial Results for the Three Months Ended March 31,
2019
- Vaxart reported a net loss of $1.3
million for the first quarter of 2019 compared to net income of
$2.3 million for the first quarter of 2018. The principal reason
for the decrease was the absence of a $7.0 million one-off non-cash
bargain purchase gain recorded in the first quarter of 2018,
partially offset by an increase in revenue of $3.9 million,
primarily from royalties on Inavir and Relenza.
- Vaxart ended the quarter with cash and
cash equivalents of $8.4 million compared to $11.5 million at
December 31, 2018. The decrease was primarily due to cash used in
operations, partially offset by the $2.5 million net raised in the
registered direct offering in March 2019.
- Revenue for the quarter was $5.4
million compared to $1.5 million in the first quarter of 2018. The
$3.9 million increase was principally due to royalty revenue
resulting from our merger with Aviragen being recorded for the full
quarter in 2019, while in 2018 the majority of this revenue was
earned pre-merger.
- Research and development expenses were
$3.8 million for the quarter compared to $3.4 million for the first
quarter of 2018. The increase was mainly due to higher clinical and
manufacturing costs incurred in the Company’s norovirus program and
amortization of intangible assets acquired in the merger with
Aviragen, partially offset by the discontinuation of the teslexivir
program and completion of the BARDA contract.
- General and administrative expenses
were $2.0 million for the quarter, substantially unchanged from the
first quarter of 2018.
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 2 monovalent
challenge study; the expected timing of topline results from the
Phase 1b bivalent study and Phase 2 monovalent challenge study in
the second half of 2019; the continued advancement of the Company‘s
first therapeutic vaccine for the treatment of HPV associated
cervical dysplasia and cancer toward the clinic; 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 March 31, 2019 December 31, 2018
(Unaudited) (1) (In thousands)
Assets Cash and
cash equivalents $ 8,424 $ 11,506 Accounts receivable 5,584 1,796
Prepaid and other assets 1,346 1,446 Property and equipment, net
1,559 1,066 Right-of-use assets, net 762 — Intangible assets, net
18,634 19,413 Total assets $ 36,309 $ 35,227
Liabilities and stockholders’ equity Accounts payable $ 849
$ 962 Accrued and other liabilities 1,745 1,675 Liability related
to sale of future royalties 16,901 17,741 Secured promissory note
3,229 3,611 Operating lease liabilities 1,009 — Total
liabilities 23,733 23,989 Stockholders’ equity 12,576
11,238 Total liabilities and stockholders’ equity $ 36,309 $ 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 March 31, 2019 2018
(in thousands, except share and per share amounts)
Revenue
$
5,407
$ 1,503 Operating expenses: Research and development
3,829 3,408 General and administrative 2,026
2,010 Total operating expenses 5,855
5,418
Loss from operations (448 ) (3,915 ) Bargain
purchase gain — 6,988 Other income and (expenses), net (641 ) (731
) Provision for income taxes (250 ) (28 )
Net
(loss) income
$
(1,339
) $ 2,314
Net (loss) income attributable to common
stockholders
$
(1,339
) $ 1,975
Net (loss) income per common share, basic
$
(0.18
) $ 0.54 Shares used in computing net (loss) income per
share, basic 7,301,189 3,656,360
Net
(loss) income per common share, diluted
$
(0.18
) $ 0.49 Shares used in computing net (loss) income per
share, diluted 7,301,189 5,299,751
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005805/en/
Daniella FunaroStern Investor
Relations212-362-1200vaxart@sternir.com
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