In its business update today for the second quarter of 2022,
Vaxart, Inc. (NASDAQ: VXRT) said it has begun working on
vaccine candidate constructs that directly target new omicron
variants of concern and is preparing to release top-line data in
the third quarter of 2022 from its Phase II COVID-19 testing of a
Wuhan strain vaccine construct.
“We continue to be very excited about the
cross-reactivity of our current vaccine candidates, as seen in
preclinical and early clinical studies,” said Andrei Floroiu, Chief
Executive Officer. “The characteristics and prevalence of newer
SARS-CoV-2 strains, along with our plans for a human omicron
challenge study, led us to begin working on clinical vaccine
candidates that directly target omicron variants of concern, which
also conforms to recent Food and Drug Administration (FDA) guidance
that boosters should target omicron BA.4/5.
“We plan to evaluate these new constructs both
as omicron-only monovalent vaccine candidates and bivalent
candidates in combination with our Wuhan constructs, and to compare
the clinical results of our S-only and S+N constructs to determine
the best path forward in developing a vaccine that can hinder viral
infection and transmission for current and emerging variants. Our
expectation is that the omicron vaccine candidates will be
available to evaluate preclinically in the fourth quarter, and
clinically in the first half of 2023. In addition, top-line Phase
II results from our Wuhan S-only construct are expected in the
third quarter of 2022.
“During the second quarter, we also continued to
make progress on our norovirus program,” Floroiu said. “The data
from our trial in elderly adults is very encouraging, as it
suggests similar activity to that in younger adults, which is often
not the case with injectable vaccines. This adds to the already
compelling clinical data on this program and increases our
confidence as we continue our development.”
Recent Business Highlights
COVID-19 Vaccine
Developments
- Reported
multiple data sets supporting the potential of Vaxart’s COVID-19
vaccine candidates to tackle the challenge of an evolving virus
that evades immune protection provided by approved vaccines or
natural infection.
- In May 2022,
announced data from a preclinical hamster study conducted by
researchers at Duke University and published in Science
Translational Medicine, which demonstrated that Vaxart’s S-only
COVID-19 candidate reduced disease and airborne transmission.
- In June 2022,
announced preclinical data demonstrating that two COVID-19 vaccine
candidates targeting either the SARS-CoV-2 spike (S) protein for
Wuhan or S protein for omicron protected hamsters when challenged
with the omicron BA.1 variant.
- In July 2022,
updated Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N)
candidate induced long-lasting mucosal IgA antibodies in saliva and
nasal samples against SARS-CoV-2 and was cross-reactive to many
different coronaviruses that are more divergent than circulating
variants of SARS-CoV-2.
- Earlier this
year, Vaxart released non-human primate data that demonstrated that
administration of Vaxart’s S-only or S+N COVID-19 vaccine
candidates to the nasal mucosa of non-human primates produced
significant increases in serum IgG and IgA and up to 1,000-fold
increases in nasal IgA.
- All vaccinated
animals challenged with SARS-CoV-2 B.1.351 (beta variant) had a
significant reduction in viral titers in the nasal passages
compared to unvaccinated controls.
- In June 2022,
established an agreement with hVIVO Services Limited, a subsidiary
of Open Orphan, a research company specializing in human challenge
clinical trials for infectious and respiratory disease products,
under which hVIVO will conduct a characterization study and, if
successful, develop a human challenge model based on the omicron
variant of SARS-CoV-2, with the intent to conduct a subsequent
Phase II Human Challenge Trial (HCT) of Vaxart’s oral COVID-19
vaccine candidate.
Norovirus Vaccine
Developments
- In June 2022,
Vaxart reported positive top-line data about its norovirus vaccine
candidate. No vaccine exists in the United States to treat
norovirus, a virus that causes up to 21 million cases, 109,000
hospitalizations and 900 deaths annually in the United States.
The June data, from Vaxart’s Phase Ib trial in subjects aged 55-80,
demonstrated that Vaxart’s oral norovirus vaccine candidate
stimulated a robust immune response across all doses, with a
dose-dependent production of IgA antibody secreting cells.
- Results were
consistent with previous studies conducted in younger populations,
which is typically not the case, as the immune system often weakens
with age, and older people tend to have less robust responses to
vaccination than younger people.
- Vaxart also
reported in June 2022 on top-line data from a Phase I trial
evaluating different boosting regimens with Vaxart’s oral norovirus
vaccine candidate. The data showed that the candidate was able to
successfully boost antibody responses, with antibody responses
trending better with administration spread out over three months
versus a shorter interval.This data and previous results support
the continued development of Vaxart’s oral norovirus vaccine
candidate in adult populations, including elderly adults, and add
to the growing body of evidence supporting its clinical
utility.
Planned Clinical Milestones in the
COVID-19 and Norovirus Pipelines
- Selection of COVID-19 vaccine
constructs expected in Q4 2022 with clinical trials to start in 1H
2023.
- After determining which COVID-19
vaccine candidate to advance, Vaxart anticipates updating its plans
for its India trials.
- Planned start of Phase II trial of
Vaxart’s bivalent norovirus vaccine candidate in Q4 2022.
- Top-line data from ongoing Phase II
norovirus challenge study expected at the end of Q1 2023 or early
Q2 2023.
- Omicron Human Challenge Trial in
the UK starting in the 2H 2023 using selected vaccine
construct.
Financial Results for the Three Months
Ended June 30, 2022
-
Vaxart ended the second quarter with cash, cash equivalents
and available-for-sale debt securities of $131.5 million,
compared to $157.0 million as of March 31, 2022. The
decrease was primarily due to $25.9 million of cash used in
operations. The Company’s existing funds are expected to be
sufficient to fund its operations into the second half of
2023.
- The
Company reported a net loss of $29.4 million for the
second quarter of 2022, compared to $16.1 million for the
second quarter of 2021. Net loss per share for the second quarter
of 2022 was $0.23, compared to a net loss
of $0.13 per share in the second quarter of 2021. The
increase in net loss was primarily due to a significant increase in
research and development expenses.
- Research and
development expenses were $19.9 million for the second
quarter of 2022, compared to $10.7 million for the second
quarter of 2021. 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 $9.3 million for the second quarter of
2022, compared to $5.2 million for the second quarter of 2021. The
increase was mainly due to the cost of settling shareholder
litigation in June and increases in legal and professional costs
and in headcount and related costs.
Conference CallThe Vaxart
senior management team will host a conference call to discuss the
business update and financial results for the second quarter of
2022 today, beginning at 4:30 p.m. ET.
The conference call can be accessed using the
following information:
Webcast: Click hereDate: Monday, August 8, 2022
– 4:30 p.m. ETDomestic: 877-407-0832International:
201-689-8433Conference ID: 13731641
Investors may submit written questions in
advance of the conference call to ir@vaxart.com. A replay of the
webcast will be available on the Company’s website at
www.vaxart.com following the conclusion of the event.
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.
About NorovirusNorovirus is the
leading cause of acute gastroenteritis that produces vomiting and
diarrhea among people of all ages. The World Health Organization’s
(WHO) Product Development for Vaccines Advisory Committee has
identified norovirus as a priority disease for vaccine development.
The virus contributes up to 21 million cases, 109,000
hospitalizations and 900 deaths annually in the United States.
Children under the age of 5 and adults over the age of 65 years are
especially vulnerable to norovirus infection, with 15% of the
children and 7.5% of the adults infected annually. Norovirus also
has negative health economic impacts, which has been estimated to
cost $10.65 billion annually in the United States alone.
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,"
“anticipate,” "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 |
(646) 871-8486 |
|
Vaxart, Inc.Condensed Consolidated Balance
Sheets |
|
|
|
June 30, 2022 |
|
December 31, 2021 |
|
|
(Unaudited) |
|
(1) |
|
|
(in thousands) |
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
91,468 |
|
$ |
143,745 |
Investments in debt
securities |
|
|
40,018 |
|
|
38,952 |
Accounts receivable |
|
|
— |
|
|
71 |
Prepaid and other assets |
|
|
13,742 |
|
|
3,499 |
Property and equipment,
net |
|
|
9,336 |
|
|
6,601 |
Right-of-use assets, net |
|
|
12,433 |
|
|
13,168 |
Intangible assets, net |
|
|
9,949 |
|
|
10,624 |
Goodwill |
|
|
4,508 |
|
|
4,508 |
Total Assets |
|
$ |
181,454 |
|
$ |
221,168 |
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,007 |
|
$ |
3,872 |
Operating lease
liabilities |
|
|
12,679 |
|
|
13,008 |
Liability related to sale of
future royalties |
|
|
12,033 |
|
|
11,522 |
Accrued and other
liabilities |
|
|
8,641 |
|
|
5,235 |
Total liabilities |
|
|
38,360 |
|
|
33,637 |
Stockholders’ equity |
|
|
143,094 |
|
|
187,531 |
Total liabilities and
stockholders’ equity |
|
$ |
181,454 |
|
$ |
221,168 |
(1) Derived from the audited consolidated financial statements
of Vaxart, Inc. for the year ended December 31, 2021, included on
the Form 10-K filed with the Securities and Exchange Commission on
February 24, 2022.
|
Vaxart, Inc.Condensed Consolidated
Statements of Operations (Unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June
30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
(in thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
— |
|
|
$ |
112 |
|
|
$ |
85 |
|
|
$ |
618 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
19,926 |
|
|
|
10,737 |
|
|
|
38,129 |
|
|
|
20,810 |
|
General and administrative |
|
|
9,321 |
|
|
|
5,150 |
|
|
|
15,979 |
|
|
|
11,094 |
|
Total operating expenses |
|
|
29,247 |
|
|
|
15,887 |
|
|
|
54,108 |
|
|
|
31,904 |
|
Loss from
operations |
|
|
(29,247 |
) |
|
|
(15,775 |
) |
|
|
(54,023 |
) |
|
|
(31,286 |
) |
Other income and (expenses), net |
|
|
(168 |
) |
|
|
(311 |
) |
|
|
(473 |
) |
|
|
(769 |
) |
Loss before income
taxes |
|
|
(29,415 |
) |
|
|
(16,086 |
) |
|
|
(54,496 |
) |
|
|
(32,055 |
) |
Provision for income taxes |
|
|
15 |
|
|
|
30 |
|
|
|
35 |
|
|
|
68 |
|
Net loss |
|
$ |
(29,430 |
) |
|
$ |
(16,116 |
) |
|
$ |
(54,531 |
) |
|
$ |
(32,123 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.27 |
) |
Shares used in computing net
loss per share, basic and diluted |
|
|
126,428,298 |
|
|
|
120,925,570 |
|
|
|
126,111,777 |
|
|
|
118,174,099 |
|
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