Vaxart Announces First Quarter 2020 Financial Results and Provides Corporate Update
May 12 2020 - 4:01PM
Vaxart, Inc. (“Vaxart” or the “Company”), 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, 2020 and
provided a corporate update.
“In January we pivoted to COVID-19, and we are
now on track to start a first Phase 1 study in the second half of
this year with our oral tablet vaccine,” said Wouter Latour, MD,
chief executive officer of Vaxart. “We are developing a
state-of-the-art gene-based vaccine utilizing our proprietary
vector platform, and the lead candidate vaccines performed well in
preclinical testing, generating very high levels of
antibodies.”
“For COVID-19, a key challenge will be to
manufacture sufficient vaccine and efficiently vaccinate the
millions at risk, and ultimately the entire population. Our
vaccines are administered orally using a room temperature-stable
tablet, an enormous logistical advantage over injectable vaccines
in large vaccination campaigns. The bulk vaccine does not require
sterile fill and finish, a significant bottleneck for injectable
vaccines, but can be tableted very efficiently using high
throughput industrial tableting equipment.”
Corporate Highlights:
In preclinical testing, the Company’s lead
vaccine candidates generated robust anti-SARS CoV-2 antibodies in
all tested animals after both the first and second dose, with a
clear boosting effect after the second dose. Antibody responses in
all vaccinated groups were statistically significant (p<0.002),
with median ELISA IgG antibody titers above 10,000 compared to a
median titer of 1 in the untreated controls, a larger than 10,000
fold increase.
- The manufacturing collaboration with Emergent BioSolutions is
progressing well and, provided Vaxart elects to proceed, Emergent
is on schedule to produce bulk cGMP vaccine in time for initiation
of a Phase 1 clinical study during the second half of 2020.
- The Universal Influenza vaccine collaboration with Janssen
remains on schedule to provide results by mid-2020.
- The Company continues to pursue strategic, financial and
public-private partnerships to advance its development candidates,
including its coronavirus vaccine candidates, norovirus and
seasonal influenza vaccine programs.
Financial Results for the Three Months
Ended March 31, 2020
- Vaxart reported a net loss of $1.3 million for the first
quarter of both 2020 and 2019. Net loss per share was $0.02 in 2020
compared to $0.18 in 2019 due to an increase in the number of
shares outstanding.
- Vaxart ended the quarter with cash and cash equivalents of
$29.9 million compared to $13.5 million at December 31, 2019. The
increase was primarily due to $9.2 million of net proceeds raised
in a registered direct offering of common stock and warrants and
$10.3 million from the exercise of common stock warrants, partially
offset by $3.2 million of cash used in operations.
- Revenue for the quarter was $2.9 million compared to $5.4
million in the first quarter of 2019. The $2.5 million decrease was
principally due to the loss of royalty revenue of $0.7 million for
Relenza following the expiration of the patent and a decrease of
$1.9 million in royalty revenue for Inavir, partly due to higher
sales in the three months ended December 31, 2019.
- Research and development expenses were $1.5 million for the
quarter compared to $3.8 million for the first quarter of 2019. The
decrease was mainly due to a reduction in personnel costs after we
ceased internal manufacturing as part of our December 2019
restructuring and a reduction in expenditure on our norovirus
vaccine candidate.
- General and administrative expenses were $2.0 million for the
quarter, substantially unchanged from the first quarter of
2019.
About VaxartVaxart is a
clinical-stage biotechnology company primarily 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 coronavirus, 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 Vaxart’s strategy, prospects, plans
and objectives, results from pre-clinical 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 “should,” “believe,”
“could,” “potential,” “will,” “expected,” “plan” and other words
and terms of similar meaning. Examples of such statements include,
but are not limited to, statements relating to Vaxart’s ability to
develop and commercialize its product candidates and clinical
results and trial data (including plans with respect to the
COVID-19 vaccine product candidates); expectations relating to
Vaxart’s relationship with Emergent, including Emergent’s ability
to produce bulk cGMP vaccine and the timing thereof; 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,
as well as coronaviruses such as SARS, MERS and SARS-CoV-2. Vaxart
may not actually achieve the plans, carry out the intentions or
meet the expectations or projections disclosed in the
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,
including uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from the clinical studies; decisions by regulatory
authorities impacting labeling, manufacturing processes, and safety
that could affect the availability or commercial potential of any
product candidate, including the possibility 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 a Vaxart collaborator may not attain
development and commercial milestones; that Vaxart may experience
manufacturing issues and delays due to events within, or outside
of, Vaxart’s control, including the recent outbreak of COVID-19;
that Vaxart may not be able to obtain, maintain and enforce
necessary patent and other intellectual property protection; that
Vaxart’s capital resources may be inadequate; Vaxart’s ability to
obtain sufficient capital to fund its operations on terms
acceptable to Vaxart, if at all; the impact of government
healthcare proposals and policies; competitive factors; 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.
ContactBrant Biehn Vaxart, Inc. 650 550
3500IR@vaxart.com
Vaxart, Inc.Condensed
Consolidated Balance Sheets
|
March 31, 2020 |
|
December 31, 2019 |
|
(Unaudited) |
|
(1) |
|
(In thousands) |
Assets |
|
|
|
Cash and cash equivalents |
$ |
29,859 |
|
$ |
13,526 |
|
Accounts receivable |
|
2,663 |
|
|
3,619 |
|
Prepaid and other assets |
|
1,281 |
|
|
594 |
|
Property and equipment, net |
|
191 |
|
|
210 |
|
Right-of-use assets, net |
|
1,910 |
|
|
1,990 |
|
Intangible assets, net |
|
16,660 |
|
|
17,093 |
|
Total assets |
$ |
52,564 |
|
$ |
37,032 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Accounts payable |
$ |
793 |
|
$ |
852 |
|
Accrued and other liabilities |
|
4,298 |
|
|
4,583 |
|
Liability related to sale of future royalties |
|
14,054 |
|
|
16,332 |
|
Operating lease liabilities |
|
2,126 |
|
|
2,313 |
|
Total liabilities |
|
21,271 |
|
|
24,080 |
|
Stockholders’ equity |
|
31,293 |
|
|
12,952 |
|
Total liabilities and stockholders’ equity |
$ |
52,564 |
|
$ |
37,032 |
|
|
(1) Derived from the audited consolidated financial statements
of Vaxart, Inc. for the year ended December 31, 2019, included on
the Form 10-K filed with the Securities and Exchange Commission on
March 19, 2020.
Vaxart, Inc.Condensed
Consolidated Statements of Operations
(Unaudited)
|
Three Months Ended March 31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
(in thousands, except share and per share amounts) |
|
|
|
|
Revenue |
$ |
2,902 |
|
|
$ |
5,407 |
|
Operating expenses: |
|
|
|
Research and development |
|
1,542 |
|
|
|
3,829 |
|
General and administrative |
|
1,990 |
|
|
|
2,026 |
|
Restructuring costs |
|
64 |
|
|
|
— |
|
Total operating expenses |
|
3,596 |
|
|
|
5,855 |
|
Loss from
operations |
|
(694 |
) |
|
|
(448 |
) |
Other income and (expenses), net |
|
(450 |
) |
|
|
(641 |
) |
Provision for income taxes |
|
(153 |
) |
|
|
(250 |
) |
Net loss |
$ |
(1,297 |
) |
|
$ |
(1,339 |
) |
Net loss per share, basic and diluted |
$ |
(0.02 |
) |
|
$ |
(0.18 |
) |
Shares used in computing net
loss per share, basic and diluted |
|
60,677,145 |
|
|
|
7,301,189 |
|
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Apr 2023 to Apr 2024