Vaxart, Inc. (NASDAQ: VXRT) issued its business update today
for the third quarter of 2022, during which the Company made
significant progress on its oral vaccine candidates.
“We are encouraged by the growing body of
clinical evidence that supports the transformational potential of
Vaxart’s oral pill vaccine platform with positive data from both
our leading programs, COVID-19 and norovirus,” said Andrei Floroiu,
Vaxart’s Chief Executive Officer.
Dr. James Cummings, Vaxart’s Chief Medical
Officer, said, “During the third quarter, we announced positive
top-line Phase II clinical study results for our Wuhan S-only
COVID-19 pill vaccine candidate. These data are very encouraging,
showing that Vaxart’s vaccine candidate can trigger both serum and
mucosal immunity and can boost responses in those having previously
received mRNA vaccines. These results highlight the potential of
mucosal immunity through remarkable cross-reactive responses. Our
Wuhan vaccine candidate showed equally strong activity towards
Omicron, something not seen with injectable vaccines. Additionally,
we remain confident in our norovirus program, with encouraging
recent data from our trial in elderly adults, which suggests
similar activity as seen in younger adults. This is not often
expected with vaccines and offers another potential source of
differentiation for our oral pill vaccine candidate.”
“Norovirus is a significant opportunity for
Vaxart – with a $10 billion economic burden of disease in the U.S.
alone and no approved vaccine against a disease that
disproportionately affects older and pediatric populations. Vaxart
has generated compelling clinical data across five norovirus
trials. We are eagerly anticipating the upcoming results of our
norovirus human challenge study at the end of the first quarter or
at the start of the second quarter of 2023. We are increasing our
focus on the norovirus program, with two additional clinical trials
planned to start in the next six months,” Mr. Floroiu added.
Vaxart’s oral vaccine platform has the potential
to transform the vaccination paradigm globally, by providing
significant advantages compared to injectable vaccines. One of the
Company’s vaccine candidates was shown to be as protective as a
leading injectable against a pandemic respiratory virus in a human
flu challenge study. In addition, data from multiple programs
suggest that by triggering mucosal immunity the platform could
provide cross-reactivity against variants, reduce viral
transmission, offer long duration of protection and offer a more
tolerable safety profile.
“These potential advantages are in addition to
those offered by the oral pill format, which could allow more
people to be vaccinated painlessly, easily and faster all around
the world. We are in a position to aggressively pursue our two
leading clinical programs and are very excited looking into 2023 at
the significant milestones for both programs – the readouts of two
human challenge studies for norovirus and COVID-19,” Mr. Floroiu
concluded.
Recent Business Highlights
COVID-19 Vaccine
Developments
- In September 2022, Vaxart reported
positive top-line data from its Phase II COVID-19 trial supporting
broad potential of the Company’s COVID-19 vaccine candidates to
tackle the challenges of an evolving virus that continues to
overcome the immune protection provided by approved vaccines.
- Vaxart is the only company with a
mucosal vaccine candidate for COVID-19 that has produced Phase II
clinical data that shows it stimulates mucosal immunity.
- In July 2022, the Company updated
Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N) candidate
stimulated SARS-CoV-2-specific IgA antibodies in saliva and nasal
samples from human subjects and was cross-reactive to many
different coronaviruses that are more divergent than circulating
variants of SARS-CoV-2.
Norovirus Vaccine
Developments
- In June 2022, Vaxart reported
positive top-line data about its norovirus vaccine candidate.
- The 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.
- 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.
Corporate Updates
- Bolstered management and Board with
three significant additions:
- In August, named Ray Stapleton,
Ph.D. as Chief Technology Officer.
- Dr. Stapleton
joins Vaxart from Genocea, where he served as CTO and Executive
Vice President, working to develop next generation personalized
immunotherapies in the forms of vaccines and cell therapies. His
prior experience includes senior manufacturing and technical
operations roles at a number of biotech companies after spending 15
years in positions of increasing responsibility in Merck and
Company’s manufacturing organization.
- Also in August, appointed Elaine J.
Heron, Ph.D. and W. Mark Watson to the Company’s Board of
Directors.
- Dr. Heron currently serves on the
boards of BioMarin Pharmaceutical, Inc., Palvella Therapeutics,
Inc., Visgenx, Inc., and Watershed Medical, Inc. She also serves as
an advisor to Kyto Technology and Life Science, Inc. Dr. Heron has
over 35 years of experience in the life science research and
biotech development sectors.
- Mr. Watson is a Certified Public
Accountant with more than 40 years of experience in public
accounting and auditing, having spent his entire career from
January 1973 to June 2013 at Deloitte Touche Tohmatsu and its
predecessor, most recently as Central Florida Marketplace
Leader.
Planned Clinical Milestones in the
COVID-19 and Norovirus Pipelines
Vaxart continues to make progress on its
expected milestones:
- Start of Phase II trial of Vaxart’s
bivalent norovirus vaccine candidate in Q4 2022 or Q1 2023.
- Top-line data from ongoing Phase II
norovirus challenge study expected at the end of Q1 2023 or early
Q2 2023.
- Selection of COVID-19 vaccine
construct to be used in the UK human challenge study expected in Q4
2022.
- After determining which COVID-19
vaccine candidate to advance, Vaxart anticipates updating its plans
for its India trials.
- Omicron Human Challenge Trial in
the UK starting in 2H 2023 using selected vaccine construct.
Financial Results for the Three Months
Ended September 30, 2022
-
Vaxart ended the third quarter with cash, cash equivalents and
available-for-sale debt securities of $114.8 million, compared
to $131.5 million as of June 30, 2022. The decrease was
primarily due to $14.6 million of cash used in operations.
- The
Company reported a net loss of $29.3 million for the
third quarter of 2022, compared to $17.6 million for the third
quarter of 2021. Net loss per share for the third quarter of 2022
was $0.23, compared to a net loss of $0.14 per share
in the third quarter of 2021. The increase in net loss was
primarily due to a significant increase in research and development
costs.
- Research and
development expenses were $22.5 million for the third
quarter of 2022, compared to $12.4 million for the third
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 $7.0 million for the third
quarter of 2022, compared to $5.0 million for the third
quarter of 2021. The increase was mainly due to increases in
headcount and related costs and in legal and professional
costs.
Conference CallThe Vaxart
senior management team will host a conference call to discuss the
business update and financial results for the third quarter of 2022
today, beginning at 4:30 p.m. ET.
The conference call can be accessed using the
following information:
Webcast: Click hereDate: Tuesday, November 8,
2022 – 4:30 p.m. ETDomestic: 888-437-3179International:
862-298-0702Conference ID: 13733692
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.
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
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
(Unaudited) |
|
(1) |
|
|
(in thousands) |
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
50,768 |
|
$ |
143,745 |
Investments in debt
securities |
|
63,999 |
|
38,952 |
Accounts receivable |
|
- |
|
71 |
Prepaid and other assets |
|
7,536 |
|
3,499 |
Property and equipment,
net |
|
12,280 |
|
6,601 |
Right-of-use assets, net |
|
26,607 |
|
13,168 |
Intangible assets, net |
|
9,611 |
|
10,624 |
Goodwill |
|
4,508 |
|
4,508 |
Total assets |
|
$ |
175,309 |
|
$ |
221,168 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
Accounts payable |
|
$ |
7,916 |
|
$ |
3,872 |
Operating lease
liabilities |
|
22,168 |
|
13,008 |
Liability related
to sale of future royalties |
12,358 |
|
11,522 |
Accrued and other
liabilities |
|
10,560 |
|
5,235 |
Total liabilities |
|
53,002 |
|
33,637 |
Stockholders’ equity |
|
122,307 |
|
187,531 |
Total liabilities and stockholders’ equity |
$ |
175,309 |
|
$ |
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 September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
(in thousands, except share and per share
amounts) |
|
|
Revenue |
|
$ |
- |
|
|
$ |
200 |
|
|
$ |
85 |
|
|
$ |
818 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
22,466 |
|
|
12,409 |
|
|
60,595 |
|
|
33,219 |
|
General and administrative |
|
6,960 |
|
|
5,042 |
|
|
22,939 |
|
|
16,136 |
|
Total operating expenses |
|
29,426 |
|
|
17,451 |
|
|
83,534 |
|
|
49,355 |
|
Loss from
operations |
|
(29,426 |
) |
|
(17,251 |
) |
|
(83,449 |
) |
|
(48,537 |
) |
Other income and (expense), net |
|
133 |
|
|
(311 |
) |
|
(340 |
) |
|
(1,080 |
) |
Loss before income
taxes |
|
(29,293 |
) |
|
(17,562 |
) |
|
(83,789 |
) |
|
(49,617 |
) |
Provision for income taxes |
|
16 |
|
|
21 |
|
|
51 |
|
|
89 |
|
Net loss |
|
$ |
(29,309 |
) |
|
$ |
(17,583 |
) |
|
$ |
(83,840 |
) |
|
$ |
(49,706 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.66 |
) |
|
$ |
(0.41 |
) |
Shares used in computing net loss per share, basic and
diluted |
|
126,889,718 |
|
|
123,984,141 |
|
|
126,374,424 |
|
|
120,110,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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