Vaxart, Inc. (NASDAQ: VXRT) issued its business update today
for the third quarter of 2021, reporting strong forward momentum in
developing its oral vaccine platform consisting of tablet vaccines
that it believes may revolutionize public health.
During the third quarter, Vaxart started the first Phase II
trial of its investigational COVID-19 oral tablet vaccine and dosed
its first subjects. Vaxart expects the full data set from this
study to be available in Q1 2022.
Duke University published the results of its study of Vaxart’s
COVID-19 vaccine candidate, finding that Vaxart’s oral tablet
vaccine reduced the airborne transmission of SARS-CoV-2 virus in a
hamster preclinical model.
The Company also expanded its research and manufacturing
capabilities, enhancing its ability to advance its pipeline of
vaccine candidates.
“Vaxart made significant progress this quarter toward its goal
of developing a next-generation oral tablet COVID-19 vaccine,” said
Andrei Floroiu, Vaxart’s Chief Executive Officer. “We have started
our United States Phase II trial and anticipate beginning
international trials in the near future. This is an important
milestone, as our candidate is the only oral COVID-19 vaccine to
progress to Phase II trials in the U.S.”
“Our view has been that an oral tablet vaccine could transform
how the world is protected from COVID-19 and other infections
because they are easy to distribute and administer. Now we added
evidence suggesting the differentiated mucosal mechanism of action
could be yet another improvement over injectable alternatives,”
added Mr. Floroiu.
“The progress we made in our vaccine research this quarter was
significant,” said Dr. Sean Tucker, Vaxart’s founder and Chief
Scientific Officer. “We already learned from an earlier human
influenza challenge study that our oral flu vaccine candidate
inhibited the shedding of viral RNA better than injectable
vaccines. Our published hamster study showed that our vaccine
candidate can reduce transmission of SARS-CoV-2, even when there is
infection breakthrough in a vaccinated subject.”
“The implications are significant because existing injected
vaccines do not always protect against viral shedding and
transmission to other people. A vaccine that reduces shedding and
reduces the probability of infection could make a big difference in
protecting lives and public health.”
Recent Business Highlights
Corporate Developments
- Vaxart recently brought online its
own GMP manufacturing facility and is now producing vaccines at two
GMP plants. This has allowed the Company to manufacture all of the
COVID-19 vaccine oral tablets for the clinical trials started and
planned to start this year, and to begin manufacturing vaccines for
its upcoming norovirus Phase II trials.
- Vaxart scaled up its research,
quality and manufacturing capabilities, increasing its R&D
employee headcount by more than 35% during the quarter.
- The Company created two advisory
boards, the Scientific and Clinical Advisory Board and the
Manufacturing and Quality Advisory Board, to provide
expertise as the Company grows its scientific and manufacturing
capabilities.
- Vaxart named Dr. James F. Cummings
as its Chief Medical Officer. Dr. Cummings is a board-certified
infectious disease physician with extensive experience in vaccine,
drug and diagnostics development, and will help guide the Company’s
development of its vaccines.
- Widely respected biotech executive
Dr. Julie Cherrington joined Vaxart’s Board of Directors, deepening
the pool of expertise on its board.
Preclinical and Clinical
Clinical COVID-19 Vaccine Developments
Vaxart made significant progress in Q3 2021 to advance its
transformative approach to vaccines.
- Vaxart began dosing subjects in
October for its Phase II clinical trial in the United States, which
is expected to enroll 96 subjects.
- The Company expects data from this
study to be available during Q1 2022.
- The study will be conducted with
subjects split evenly between COVID-19 naïve and mRNA
vaccinated subjects.
- During Q4 2021, Vaxart expects to
start Phase Ib clinical testing in India.
- The Company expects to launch
additional international clinical trials in 1H 2022.
Preclinical COVID-19 Vaccine Developments
- A Duke University-led
study published in bioRxiv in October showed
that Vaxart’s investigational oral tablet vaccine candidate
reduced the airborne transmission of SARS-CoV-2 virus in a hamster
model.
- These results are consistent with
those from Vaxart’s Phase II human flu challenge study,
which showed that Vaxart’s oral tablet flu vaccine was
better at reducing shedding than the injectable flu vaccine
comparator.
- Vaxart’s preclinical study also
demonstrated that the Company’s oral vaccine platform
induces robust systemic and mucosal responses.
- The study suggested that mucosal
vaccines may protect not only vaccinated, but also unvaccinated
animals.
- Vaxart will submit the results of
its nonhuman primate study for publication in Q4 2021. Results from
that study prompted Vaxart to move forward with its S-only vaccine
candidate in Phase II clinical trials. This S-only vaccine
candidate produced better antibody responses and cross-reactivity
against all variants tested than Vaxart’s S+N vaccine
candidate.
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.
- Vaxart has almost completed
enrollment in its Phase Ib placebo-controlled, dose-ranging, repeat
dose trial investigating its oral norovirus vaccine candidate in
elderly subjects aged 55 to 80 years. This study is designed to
evaluate the safety and immunogenicity of Vaxart's vaccine
candidate.
- The Company anticipates completing
enrollment in its norovirus VXA-G1.1-104 study in Q4 2021.
- Vaxart is also conducting an
additional norovirus vaccine study to evaluate the optimal timing
for boost administration under VXA-NVV-105. This study has
completed enrollment.
- The Company expects initial data to
be available from these studies in Q1 2022 and more complete data
by Q2 2022.
- Vaxart is preparing to launch its
norovirus challenge study in Q1 2022 to evaluate the safety and
clinical efficacy of its oral vaccine candidate.
Manufacturing Updates
- As noted above, Vaxart is now
producing vaccines at two GMP manufacturing plants in California,
including its own GMP manufacturing facility.
- As a result, Vaxart has produced
the tablets for its Phase II and Phase Ib COVID-19 studies and is
starting to produce norovirus vaccine for additional clinical
studies.
Financial Results for the Three Months
Ended September 30, 2021
- Vaxart ended the quarter with
cash, cash equivalents and available-for-sale debt securities
of $204.0 million, compared to $198.9 million as
of June 30, 2021. The increase was primarily due to net
receipts of $20.3 million from the Company’s $250
million at-the-market facility entered into in October
2020 and $0.3 million from the exercise of warrants
and options, partially offset by $14.2 million of cash
used in operations and $1.3 million spent on property and
equipment.
- The Company reported a net loss
of $17.6 million for the third quarter of 2021, compared
to $8.1 million for the third quarter of 2020. Net loss
per share for the third quarter of 2021 was $0.14, compared to
a net loss of $0.08 per share in the third quarter of
2020. The increase in net loss per share was primarily due to the
increase in net loss, resulting from a significant increase in
research and development expenses.
- Revenue for the third quarter of
2021 was $200,000, compared to $265,000 in the third
quarter of 2020. The decrease was due to lower royalty revenue from
sales of Inavir in Japan.
- Research and development expenses
were $12.4 million for the third quarter of 2021,
compared to $4.6 million for the third quarter of 2020.
The increase was mainly due to increases in headcount and related
costs and in manufacturing and clinical trial expenses related to
our COVID-19 and norovirus vaccine candidates.
- General and administrative expenses
were $5.0 million for the third quarter of 2021, compared
to $4.2 million for the third quarter of 2020. The
increase was mainly due to 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. Vaxart’s 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 immune-oncology indication. Vaxart has filed broad domestic
and international patent applications 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 preclinical 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, including its vaccine
booster products; Vaxart's expectations regarding clinical results
and trial data; and Vaxart's expectations with respect to the
effectiveness of its product candidates. 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;
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. Contacts
Vaxart Media
Relations: |
Investor
Relations: |
Mark Herr |
Andrew Blazier |
Vaxart,
Inc. |
Finn Partners |
mherr@vaxart.com |
IR@Vaxart.com |
(203) 517-8957 |
|
Vaxart, Inc.Condensed
Consolidated Balance Sheets
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
|
(Unaudited) |
|
|
|
(1) |
|
|
|
(in thousands) |
Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
167,231 |
|
|
$ |
126,870 |
|
Investments in debt
securities |
|
|
36,720 |
|
|
|
— |
|
Accounts receivable |
|
|
190 |
|
|
|
334 |
|
Prepaid and other assets |
|
|
5,269 |
|
|
|
1,699 |
|
Property and equipment,
net |
|
|
5,427 |
|
|
|
1,480 |
|
Right-of-use assets, net |
|
|
12,237 |
|
|
|
6,838 |
|
Intangible assets, net |
|
|
14,062 |
|
|
|
15,361 |
|
Total assets |
|
$ |
241,136 |
|
|
$ |
152,582 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,745 |
|
|
$ |
2,133 |
|
Accrued and other
liabilities |
|
|
4,543 |
|
|
|
4,908 |
|
Liability related to sale of
future royalties |
|
|
15,158 |
|
|
|
14,929 |
|
Operating lease
liabilities |
|
|
12,742 |
|
|
|
7,208 |
|
Total liabilities |
|
|
36,188 |
|
|
|
29,178 |
|
Stockholders’ equity |
|
|
204,948 |
|
|
|
123,404 |
|
Total liabilities and
stockholders’ equity |
|
$ |
241,136 |
|
|
$ |
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 September 30, |
|
|
Nine Months Ended September
30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
(in thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
200 |
|
|
$ |
265 |
|
|
$ |
818 |
|
|
$ |
3,690 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
12,409 |
|
|
|
4,616 |
|
|
|
33,219 |
|
|
|
11,272 |
|
General and administrative |
|
|
5,042 |
|
|
|
4,190 |
|
|
|
16,136 |
|
|
|
10,076 |
|
Restructuring costs |
|
|
— |
|
|
|
(952 |
) |
|
|
— |
|
|
|
(849 |
) |
Total operating expenses |
|
|
17,451 |
|
|
|
7,854 |
|
|
|
49,355 |
|
|
|
20,499 |
|
Loss from
operations |
|
|
(17,251 |
) |
|
|
(7,589 |
) |
|
|
(48,537 |
) |
|
|
(16,809 |
) |
Other income and (expenses), net |
|
|
(311 |
) |
|
|
(470 |
) |
|
|
(1,080 |
) |
|
|
(1,345 |
) |
Loss before income
taxes |
|
|
(17,562 |
) |
|
|
(8,059 |
) |
|
|
(49,617 |
) |
|
|
(18,154 |
) |
Provision for income taxes |
|
|
21 |
|
|
|
26 |
|
|
|
89 |
|
|
|
205 |
|
Net loss |
|
$ |
(17,583 |
) |
|
$ |
(8,085 |
) |
|
$ |
(49,706 |
) |
|
$ |
(18,359 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.14 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.23 |
) |
Shares used in computing net loss per share, basic and diluted |
|
|
123,984,141 |
|
|
|
107,718,578 |
|
|
|
120,110,780 |
|
|
|
81,121,045 |
|
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