Vaxart Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
March 19 2020 - 4:01PM
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 fourth
quarter and full year ended December 31, 2019, and provided a
corporate update.
“SARS CoV-2, the coronavirus that causes COVID-19, is primarily
transmitted by viral particles that enter through the nose, mouth
or eyes, and cause a respiratory infection,” said Wouter Latour,
MD, chief executive officer of Vaxart Inc. “Unlike injectable
vaccines, our oral vaccines have been shown to protect against
respiratory infection based on mucosal immunity, the first line of
defense for such infections. This could be essential for an
effective vaccine that protects the population from COVID-19. In
addition, the Vaxart vaccine would be administered using a room
temperature-stable tablet, an enormous logistical advantage in
large vaccination campaigns.”
“This outbreak is a call to duty for all of us here at Vaxart
and we are highly focused on the development of the COVID-19
vaccine,” Dr. Latour continued. “Accordingly, we have put
several vaccine programs on hold, including the norovirus vaccine
program for which we recently successfully completed a Phase 1
study and for which we are actively seeking a development partner,
as well as our therapeutic HPV vaccine program. The
Janssen-partnered Universal Flu program is fully active and on
track to be completed in the coming weeks.”
All Vaxart vaccines are based on its oral Vector-Adjuvant
platform, VAASTTM. In a recent clinical study published in the
Lancet Infectious Diseases, the Company demonstrated that the
Vaxart oral H1 influenza tablet vaccine primarily protected against
infection based on mucosal immunity, in contrast to the injectable
flu vaccine that protected primarily through systemic immunity.
In January, Vaxart initiated a program to develop a coronavirus
vaccine candidate based on its VAASTTM platform and is currently
producing multiple research grade COVID-19 vaccine candidates to be
evaluated in a preclinical model. In addition, Vaxart announced
this week that it had entered into an agreement with Emergent
BioSolutions Inc. Per the agreement, development
services are to begin immediately and upon Vaxart’s election,
Emergent is expected to produce bulk cGMP vaccine in time for a
Phase 1 clinical study to begin early in the second half of
2020.
Other Corporate Updates:
- The Universal Influenza vaccine collaboration with Janssen is
proceeding as planned and remains on schedule to provide results in
1H 2020, barring delays due to the Coronavirus outbreak.
- Published results from the H1 seasonal influenza oral tablet
vaccine challenge study in the Lancet Infectious Diseases. The
study demonstrated that Vaxart’s oral tablet influenza vaccine
generated a 39 percent reduction in clinical disease relative to
placebo, compared to a 27 percent reduction by Fluzone. It
also reduced infection rates by 47 percent, compared to 43 percent
by Fluzone.
- Restructured the manufacturing and process development
departments resulting in, among other things, a reduction in
headcount.
- Raised approximately $9.8 million in net proceeds from the
exercise of Warrants during the first quarter of 2020 to date.
- Completed a registered direct offering in March 2020, through
which Vaxart raised aggregate gross proceeds of $10.0 million from
the sale of 4.0 Million shares of common stock and warrants to
purchase 2.0 million shares of common stock that are exercisable
for $2.50 per share.
- Regained compliance with the continuing listing standards of
The Nasdaq Capital Market.
Financial Results for the Three Months Ended December
31, 2019
- Vaxart reported a net loss of $6.4 million for the fourth
quarter of 2019 compared to $4.9 million for the fourth quarter of
2018. The principal reason for the increase was a charge of $4.9
million for restructuring, partially offset by an increase in
revenue and a reduction in research and development
expenditure.
- Revenue for the quarter was $3.9 million compared to $1.8
million in the fourth quarter of 2018. The increase was mostly due
to non-cash royalty revenue related to the sale of future
royalties.
- For the quarter ended December 31, 2019, royalty revenue from
Inavir increased by $2.2 million, or 148%, compared to the quarter
ended December 31, 2018.
Financial Results for the Full Year 2019
- Vaxart reported a net loss of $18.6 million for 2019 compared
to $18.3 million for 2018. The principal reason for the increase
was the absence of a bargain purchase gain of $6.8 million,
partially offset by an increase in revenue of $5.7 million.
- Revenue for the year was $9.9 million compared to $4.2 million
in 2018. The increase was mostly due to $3.5 million of 2018
revenue having been recorded in the pre-Merger period of January
1-February 13, 2018 and increased royalty revenue from Inavir in
the fourth quarter of 2019.
- Research and development expenses were $14.5 million for 2019
compared to $17.3 million for 2018. The decrease was mainly due to
the absence of clinical trials costs for teslexivir and HHS BARDA
contract costs and a reduction in pre-clinical research costs,
partially offset by higher manufacturing and clinical trial costs
incurred in Vaxart’s norovirus program.
- General and administrative expenses were $6.2 million for the
year compared to $6.7 million for 2018. The decrease was mainly due
to reductions in legal fees and other costs associated with
becoming a public company.
- Other operating expenses were $4.9 million for 2019 due to
restructuring costs related to the suspension of Vaxart’s
manufacturing operations, compared to $2.0 million for 2018, which
related to the impairment of intangible assets related to
teslexivir and the sublease of Vaxart’s premises in Georgia.
- Vaxart ended the year with cash and cash equivalents of $13.5
million compared to $11.5 million at December 31, 2018. The
increase was primarily due to funds raised via issuances of equity
totaling $19.87 million during 2019, partially offset by cash used
in operations totaling $13.1 million and the repayment of debt for
$3.8 million.
About Vaxart
Vaxart 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 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 (including
plans with respect to the proposed coronavirus vaccine program);
Vaxart’s intention to continue its efforts to advance its oral
tablet seasonal flu vaccine; 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 the virus that recently
emerged in China. 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, 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 due to events within, or outside of, Vaxart’s
control, including the recent outbreak of COVID-19; 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
Brant Biehn Vaxart Inc 650 550 3500 IR@vaxart.com
Vaxart, Inc.Condensed
Consolidated Balance Sheets
|
|
December 31, 2019 |
|
|
December 31, 2018 |
|
|
|
(Unaudited) |
|
|
|
(1) |
|
|
|
|
(in thousands) |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,526 |
|
|
$ |
11,506 |
|
|
Accounts receivable |
|
|
3,619 |
|
|
|
1,796 |
|
|
Prepaid and other assets |
|
|
594 |
|
|
|
1,446 |
|
|
Property and equipment, net |
|
|
210 |
|
|
|
1,066 |
|
|
Right-of-use assets, net |
|
|
1,990 |
|
|
|
— |
|
|
Intangible assets, net |
|
|
17,093 |
|
|
|
19,413 |
|
|
Total Assets |
|
$ |
37,032 |
|
|
$ |
35,227 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
852 |
|
|
$ |
962 |
|
|
Accrued and other liabilities |
|
|
4,583 |
|
|
|
1,675 |
|
|
Liability related to sale of future royalties |
|
|
16,332 |
|
|
|
17,741 |
|
|
Secured promissory note |
|
|
— |
|
|
|
3,611 |
|
|
Operating lease liabilities |
|
|
2,313 |
|
|
|
— |
|
|
Total liabilities |
|
|
24,080 |
|
|
|
23,989 |
|
|
Stockholders’ equity |
|
|
12,952 |
|
|
|
11,238 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
37,032 |
|
|
$ |
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 December 31, |
|
|
Year Ended December 31, |
|
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
2018 |
|
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
(1) |
|
|
|
|
(in thousands,
except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
3,916 |
|
|
$ |
1,767 |
|
|
$ |
9,862 |
|
|
$ |
4,159 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,291 |
|
|
|
4,474 |
|
|
|
14,540 |
|
|
|
17,275 |
|
|
General and administrative |
|
|
1,331 |
|
|
|
1,226 |
|
|
|
6,187 |
|
|
|
6,681 |
|
|
Restructuring and impairment charges |
|
|
4,920 |
|
|
|
253 |
|
|
|
4,920 |
|
|
|
1,959 |
|
|
Total operating expenses |
|
|
9,542 |
|
|
|
5,953 |
|
|
|
25,647 |
|
|
|
25,915 |
|
|
Loss from
operations |
|
|
(5,626 |
) |
|
|
(4,186 |
) |
|
|
(15,785 |
) |
|
|
(21,756 |
) |
|
Bargain purchase gain |
|
|
— |
|
|
|
100 |
|
|
|
— |
|
|
|
6,760 |
|
|
Other income and expenses, net |
|
|
(587 |
) |
|
|
(736 |
) |
|
|
(2,370 |
) |
|
|
(2,902 |
) |
|
Provision for income taxes |
|
|
(196 |
) |
|
|
(80 |
) |
|
|
(490 |
) |
|
|
(109 |
) |
|
Net loss |
|
$ |
(6,409 |
) |
|
$ |
(4,902 |
) |
|
$ |
(18,645 |
) |
|
$ |
(18,007 |
) |
|
Net loss attributable
to common stockholders |
|
$ |
(6,409 |
) |
|
$ |
(4,902 |
) |
|
$ |
(18,645 |
) |
|
$ |
(18,346 |
) |
|
Net loss per share,
basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.86 |
) |
|
$ |
(2.90 |
) |
|
Shares used in computing net
loss per share, basic and diluted |
|
|
47,744,463 |
|
|
|
7,141,189 |
|
|
|
21,569,523 |
|
|
|
6,316,065 |
|
|
|
(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.
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