SOUTH SAN FRANCISCO, Calif.,
Aug. 5, 2021 /PRNewswire/
-- Vaxart, Inc. (Nasdaq: VXRT) issued its business update
today for the second quarter of 2021, reporting strong forward
momentum in development of oral tablet vaccines that it believes
can revolutionize public health.
Vaxart, a clinical-stage biotechnology company developing oral
recombinant vaccines that are administered by tablet rather than by
injection, announced its business progress and provided financial
results for the second quarter ended June
30, 2021.
"By any measure, Vaxart showed real forward momentum during the
last quarter," CEO Andrei Floroiu
said. "We strengthened our balance sheet, made major research
advances, deepened our scientific knowledge, grew the company, and
took the company closer to our goal of developing disruptive oral
tablet vaccines that can have a material impact on the world's
public health."
Recent Business Highlights
Corporate Developments
- Vaxart raised $36.2 million in
net proceeds from its $250 million
at-the-market facility in the three months ended June 30, 2021.
- Vaxart signed an exclusive worldwide licensing agreement with
Altesa Biosciences, Inc. to allow Altesa to develop and
commercialize Vaxart's Vapendavir, a clinical-stage broad spectrum
antiviral.
-
- The licensing agreement provides for milestone payments up to
$130 million and royalties for global
Vapendavir sales.
- Building out the infrastructure necessary to support its
groundbreaking research, Vaxart added to its management team and
strengthened its research, clinical, and manufacturing groups and
R&D infrastructure. The number of R&D employees grew by 36%
in the quarter to 49 full-time employees.
Pre-Clinical and Clinical
Platform-Wide Developments
- Vaxart completed its first boosting study, which showed in
clinical trials that its norovirus vaccine built on the VAAST™
platform can successfully boost immune responses in subjects
previously vaccinated with a Vaxart oral vaccine more than a year
earlier.
-
- The research supports the company's thesis that its oral tablet
vaccines have the potential to be used annually for indications
that may require a boost such as flu or COVID-19.
- The data announced that Vaxart's vaccines may not suffer from
certain antibody response challenges that can occur with viral
vector-based vaccines.
COVID-19 Vaccine Developments
While the nation's death and illness tolls have fallen markedly
since the beginning of the last quarter, new variants such as the
Delta strain continue to worry national political and health
leaders. Vaxart broadened its research into the various COVID-19
strains while continuing its development of an oral tablet vaccine.
Among the most significant developments in the second quarter:
- The U.S. Food and Drug Administration cleared Vaxart to move to
its next phase of COVID-19 testing with a study of its next
generation S-1 construct.
-
- Vaxart is manufacturing the vaccine necessary to start the
Phase 2 clinical study of its S-Wuhan construct and expects to begin this
study shortly.
- A Non-Human Primate study of the S&N construct along with
S-Wuhan and S-South Africa constructs showed optimal
performance by the S-Wuhan
construct and also cross reactivity against all variants tested.
The decision was made to the S-Wuhan vaccine construct into Phase 2.
Norovirus Vaccine Developments
Norovirus is a highly infectious illness that affects around 20
million Americans annually, with an annual economic impact of
approximately $10.5 billion in the United
States.
- In addition to its boosting study, Vaxart enrolled the first
subjects in a Phase 1b
placebo-controlled, dose-ranging, repeat dose trial investigating
its oral norovirus vaccine candidate in elderly subjects aged 55 –
80 years.
-
- This study is designed to evaluate the safety and
immunogenicity of Vaxart's candidate, which is the only clinical
stage norovirus oral tablet vaccine actively being developed.
Financial Results for the Three Months Ended June 30,
2021
- Vaxart ended the quarter with cash, cash equivalents, and
available-for-sale debt securities of $198.9 million, compared
to $177.3 million as of March 31, 2021. The increase
was primarily due to net receipts of $36.2 million from
the Company's $250 million at-the-market facility entered
into in October 2020 and $0.9 million from the
exercise of warrants and options, partially offset by $13.2
million of cash used in operations and $2.2
million spent on property and equipment.
- Vaxart reported a net loss of $16.1 million for
the second quarter of 2021 compared to $9.0 million for
the second quarter of 2020. Net loss per share for the second
quarter of 2021 was $0.13, compared to a net loss
of $0.12 in the second quarter of 2020. The small
increase in net loss per share was due to the increase in net loss
being mostly offset by the increase in the weighted average number
of shares outstanding.
- Revenue for the second quarter of 2021
was $112,000 compared to $523,000 in the second
quarter of 2020. The decrease was principally due to the absence of
royalty revenue related to Relenza sales in Japan as a
result of the patent expiring and a reduction in royalty revenue
related to Inavir sales in Japan as a result of lower
incidences of seasonal influenza.
- Research and development expenses were $10.7
million for the second quarter of 2021 compared to $5.1
million for the second quarter of 2020. The increase was
mainly due to manufacturing and clinical trial expenses related to
the COVID-19 and norovirus vaccine candidates.
- General and administrative expenses were $5.2
million for the second quarter of 2021 compared to $3.9
million for the second quarter of 2020. The increase was
mainly due to higher insurance expenses and an increase in
headcount and related costs.
About Vaxart
Vaxart is a clinical-stage biotechnology company developing
a range of oral recombinant vaccines based on its proprietary
delivery platform. Vaxart vaccines are designed to be
administered using tablets that can be stored and shipped without
refrigeration and eliminate the risk of needle-stick
injury. Vaxart believes that its proprietary tablet
vaccine delivery platform is suitable to deliver recombinant
vaccines, positioning the company to develop oral versions of
currently marketed vaccines and to design recombinant vaccines for
new indications. Its development programs currently include tablet
vaccines designed to protect against coronavirus, norovirus,
seasonal influenza, and respiratory syncytial virus (RSV), as well
as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's
first immuno-oncology indication. Vaxart has filed broad
domestic and international patents covering its proprietary
technology and creations for oral vaccination using adenovirus and
TLR3 agonists.
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, and 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 and
norovirus vaccine product candidates); expectations relating to
Vaxart's relationship with Emergent BioSolutions, Inc., Kindred
Biosciences and Attwill Medical Solutions Sterilflow, LP,
including their ability to produce cGMP vaccines and the timing
thereof; expectations relating to future license royalties
(including forecasts in connection with Vaxart's license agreement
with Altesa Biosciences, Inc.); Vaxart's expectations with respect
to the important advantages it believes its oral vaccine platform
can offer over injectable alternatives, particularly for
coronaviruses such as SARS, MERS and SARS-CoV-2; expectations
regarding Vaxart's ability to develop effective vaccines against
new and emerging variant strains; expectations regarding the timing
and nature of future developments and announcements, including
those related to trials and studies; the potential applicability of
results seen in our preclinical studies or trials to those that may
be seen in humans or clinical trials; the expected role of mucosal
immunity in blocking transmission of COVID-19; and Vaxart's
expectations with respect to the effectiveness of its product
candidates, including Vaxart's potential role in mitigating the
impact of COVID-19. 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 or its partners may experience manufacturing
issues and delays due to events within, or outside of, Vaxart's or
its partners' control, including the ongoing COVID-19 pandemic;
difficulties in production, particularly in scaling up initial
production, including difficulties with production costs and
yields, quality control, including stability of the product
candidate and quality assurance testing, shortages of qualified
personnel or key raw materials, and compliance with strictly
enforced federal, state, and foreign regulations;
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 resolve pending legal matters; 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.
Contact
Vaxart Media Relations:
Mark Herr
Vaxart, Inc.
(203) 517-8957
mherr@vaxart.com
Vaxart,
Inc.
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
June 30,
2021
|
|
|
December 31,
2020
|
|
|
|
(Unaudited)
|
|
|
|
(1)
|
|
|
|
(in
thousands)
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
165,266
|
|
|
$
|
126,870
|
|
Investments in debt
securities
|
|
|
33,657
|
|
|
|
—
|
|
Accounts
receivable
|
|
|
107
|
|
|
|
334
|
|
Prepaid and other
assets
|
|
|
5,172
|
|
|
|
1,699
|
|
Property and
equipment, net
|
|
|
4,339
|
|
|
|
1,480
|
|
Right-of-use assets,
net
|
|
|
5,808
|
|
|
|
6,838
|
|
Intangible assets,
net
|
|
|
14,495
|
|
|
|
15,361
|
|
Total
Assets
|
|
$
|
228,844
|
|
|
$
|
152,582
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,702
|
|
|
$
|
2,133
|
|
Accrued and other
liabilities
|
|
|
4,279
|
|
|
|
4,908
|
|
Liability related to
sale of future royalties
|
|
|
14,927
|
|
|
|
14,929
|
|
Operating lease
liabilities
|
|
|
6,154
|
|
|
|
7,208
|
|
Total
liabilities
|
|
|
29,062
|
|
|
|
29,178
|
|
Stockholders'
equity
|
|
|
199,782
|
|
|
|
123,404
|
|
Total liabilities and
stockholders' equity
|
|
$
|
228,844
|
|
|
$
|
152,582
|
|
|
(1) Derived from the
audited consolidated financial statements of Vaxart, Inc. for the
year ended December 31, 2020, included on the Form 10-K filed with
the Securities and Exchange Commission on February 25,
2021.
|
Vaxart,
Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
|
|
|
|
Three Months Ended
June 30,
|
|
|
Six Months
Ended June 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
112
|
|
|
$
|
523
|
|
|
$
|
618
|
|
|
$
|
3,425
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
10,737
|
|
|
|
5,114
|
|
|
|
20,810
|
|
|
|
6,656
|
|
General and
administrative
|
|
|
5,150
|
|
|
|
3,896
|
|
|
|
11,094
|
|
|
|
5,886
|
|
Restructuring
costs
|
|
|
—
|
|
|
|
39
|
|
|
|
—
|
|
|
|
103
|
|
Total operating
expenses
|
|
|
15,887
|
|
|
|
9,049
|
|
|
|
31,904
|
|
|
|
12,645
|
|
Loss from
operations
|
|
|
(15,775)
|
|
|
|
(8,526)
|
|
|
|
(31,286)
|
|
|
|
(9,220)
|
|
Other income and
(expenses), net
|
|
|
(311)
|
|
|
|
(425)
|
|
|
|
(769)
|
|
|
|
(875)
|
|
Loss before income
taxes
|
|
|
(16,086)
|
|
|
|
(8,951)
|
|
|
|
(32,055)
|
|
|
|
(10,095)
|
|
Provision for income
taxes
|
|
|
30
|
|
|
|
26
|
|
|
|
68
|
|
|
|
179
|
|
Net
loss
|
|
$
|
(16,116)
|
|
|
$
|
(8,977)
|
|
|
$
|
(32,123)
|
|
|
$
|
(10,274)
|
|
Net loss per
share, basic and diluted
|
|
$
|
(0.13)
|
|
|
$
|
(0.12)
|
|
|
$
|
(0.27)
|
|
|
$
|
(0. 15)
|
|
Shares used in
computing net loss per share, basic
and diluted
|
|
|
120,925,570
|
|
|
|
74,675,131
|
|
|
|
118,174,099
|
|
|
|
67,676,138
|
|
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SOURCE Vaxart, Inc.