Item 8.01 Other Events.
Financial Information and Corporate Update
On May 3, 2021, Vaxart, Inc. (the "Company" or "Vaxart") reported financial
results for the first quarter ended March 31, 2021 and provided a corporate
update. As part of this update, the Company announced that it plans to initiate
several clinical and pre-clinical COVID-19 vaccine studies as it continues the
development of its multivariant COVID-19 vaccine candidate portfolio.
Recent Business Highlights
Clinical and Pre-Clinical
COVID-19
? Vaxart announced the results from its VXA-CoV2-1 Phase I clinical trial in 35
subjects:
o Generally well-tolerated with no severe adverse events reported.
o Triggered multiple immune responses against SARS-CoV2 antigens, including:
? Inducing a high percentage of responding CD8+ T cells against both Spike (S)
and Nucleoprotein (N) proteins, which may provide long-lasting cross-reactive
protection against current and future strains of the virus due to the
vaccine's more conserved target.
? An increase in proinflammatory Th1 cytokines, which are responsible for
orchestrating the immune response to viral infection.
? Next steps
o Pre-clinical studies:
? Several studies with our S and N and S-only constructs in multiple animal
models are ongoing or will begin soon, testing attributes of our vaccine
candidates such as impact on infection, illness, shedding, transmission, and
cross-variant protection.
o Clinical studies:
? A Phase II trial of VXA-CoV2-1, our vaccine encoding both the S and the N
proteins, is expected to start mid-year 2021 instead of 2Q. The delay is due
to manufacturing issues at the Baltimore contract manufacturing facility, the
same facility where other COVID-19 vaccine manufacturers have also reported
issues.
? Manufacturing of our vaccines is currently underway at the Company's other
manufacturing partner, and at our own GMP facility. We are also evaluating
additional manufacturing partners both in the U.S. and abroad.
? Phase I/II studies of two S-only vaccine constructs targeting different
variants are planned to begin in 3Q 2021.
? Boosting studies with previously vaccinated or infected subjects are also
planned for 2H 2021.
? Trials in India and Latin America are expected to initiate in 2021.
Norovirus
Norovirus is a highly infectious illness that affects around 20 million
Americans annually, and it has an annual economic impact of approximately $10.5
billion in the United States. Vaxart plans to progress its oral norovirus
vaccine program with the initiation of four clinical trials in 2021:
? A booster dose in a subset of subjects who participated in the prior Phase 1b
bivalent study will assess the safety, tolerability and immunogenicity of this
dose approximately 18 months after initial dosing. Dosing is completed, and
results will be reported by mid-year 2021.
? A booster ranging trial designed to assess the safety, tolerability,
immunogenicity, and efficacy of 2-dose vaccination schedule (4, 8, and 12
weeks apart) started recently.
? An age escalation trial in subjects over 65 years old designed to assess the
safety, tolerability, immunogenicity, and efficacy of 2 dose levels of vaccine
with a 2-dose vaccination schedule (4 weeks apart) planned to start in 3Q
2021.
? A Phase 2 challenge study is planned to start later this year.
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Vaxart also released data from a poll it commissioned, which surveyed 1,500
subjects and found that as many as an additional 19 million Americans would
decide to get vaccinated against COVID-19 if they had an oral tablet option.
? The poll suggested as many as an additional 4 million Black, 3 million rural,
2 million Hispanic and 1.5 million Asian Americans would take a pill COVID-19
vaccine.
? 7 in 10 said they would prefer taking a vaccine pill rather than getting
injected with a vaccine.
Corporate
? Vaxart appointed David Wheadon, M.D., to its Board of Directors. Dr. Wheadon
is a health policy leader and physician with more than three decades of global
experience in the pharmaceutical industry coordinating the interests of public
companies, trade groups, and regulators.
? Dr. Rajesh Kapoor joined Vaxart as the SVP Quality. Dr. Kapoor brings 30 years
of domestic and international experience with small and large companies
covering aseptic and non-aseptic Quality Operations encompassing vaccines,
biologics, drugs, APIs, clinical Quality Assurance, and radiopharmaceuticals.
Cash, Cash Equivalents, and Marketable Securities Balance
Vaxart ended the quarter with cash, cash equivalents, and available-for-sale
debt securities of $177.3 million, compared to $126.9 million as of December 31,
2020. The increase was primarily due to receipts of $65.7 million from the
Company's $250 million at-the-market facility entered into in October 2020 and
$1.9 million from the exercise of warrants and options, partially offset by
$16.6 million of cash used in operations and $0.6 million spent on property and
equipment.
Financial Results for the Three Months Ended March 31, 2021
Vaxart reported a net loss of $16.0 million for the first quarter of 2021
compared to $1.3 million for the first quarter of 2020. Net loss per share for
the first quarter of 2021 was $0.14, compared to a net loss of $0.02 in the
first quarter of 2020. The increase in net loss per share was due to the
increase in net loss partially offset by the increase in the weighted average
number of shares outstanding.
Revenue for the first quarter of 2021 was $506,000 compared to $2.9 million in
the first quarter of 2020. The decrease was principally due to a reduction in
royalty revenue related to Inavir sales in Japan as a result of abnormally low
incidences of seasonal influenza.
Research and development expenses were $10.1 million for the first quarter of
2021 compared to $1.5 million for the first 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 $5.9 million for the first quarter of
2021 compared to $2.0 million for the first quarter of 2020. The increase was
mainly due to higher legal and insurance expenses, and an increase in headcount
and related costs.
Vaxart's Unaudited Condensed Consolidated Balance Sheets as of March 31, 2021
and Condensed Consolidated Statements of Income for the Three Months ended March
31, 2021 are filed as Exhibit 99.1 to this Current Report on Form 8-K and are
incorporated herein by reference.
New Phase 1 Data and Corporate Presentation
On May 3, 2021, the Company will present new Phase 1 data from its COVID-19
clinical trial suggesting that VaX-CoV2-1, the Company's first COVID-19 oral
vaccine, has broad cross-variant and cross-coronavirus activity. Data obtained
from the Phase 1 study were compared to data from volunteers vaccinated with the
Moderna or Pfizer mRNA vaccine distributed under emergency use authorizations
(EUAs). The Company measured the T-cell responses in 9 volunteers vaccinated
with the mRNA vaccines under EUAs and compared them in the same assays at the
same timepoints to T-cell responses induced in subjects participating in the
Company's clinical trial (N=26 paired samples, or N=7 in the sub-study). This
was not a direct head-to-head study. A copy of the Company's updated Corporate
Presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and is
incorporated herein by reference. The corporate presentation will also be
available on the Company's website.
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Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than statements of
historical facts, included herein regarding Vaxart's strategy, prospects, plans
and objectives, results from pre-clinical 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 "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 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; 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Description
99.1 Vaxart, Inc. Unaudited
Condensed Consolidated Balance
Sheets as of March 31, 2021 and
December 31, 2020 and Condensed
Consolidated Statements of
Operations for the Three Months
ended March 31, 2021 and 2020
99.2 Vaxart, Inc. Corporate
Presentation, dated May 3,
2021
104 Cover Page Interactive Data File
(embedded within the Inline XBRL
document)
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