Item 2.02 Results of Operations and Financial Condition.
Vaxart, Inc. ("Vaxart" or the "Company") estimates that its cash and cash
equivalents as of June 30, 2021, was approximately $198.9 million, compared to
$177.3 million as of March 31, 2021. The increase was primarily due to net
receipts of $36.2 million from the Company's $250 million at-the-market facility
entered into in October 2020 and $0.9 million from the exercise of warrants and
options, partially offset by $13.2 million of cash used in operations and $2.2
million spent on property and equipment.
The Company estimates that its revenue for the three and six months ended June
30, 2021 was approximately $112,000 and $618,000, respectively, compared to
$523,000 and $3.4 million for the three and six months ended June 30, 2020,
respectively. The decrease was due primarily to reduction in royalty revenue
related to Inavir sales in Japan as a result of lower incidences of seasonal
influenza.
The Company's consolidated financial statements as of June 30, 2021 and results
of operations for the three and six months ended June 30, 2021, are not yet
available. Accordingly, the information presented above reflects the Company's
preliminary estimates, subject to the completion of the Company's financial
closing procedures and review of its financial statements by its auditors. As a
result, these preliminary estimates may differ from the actual results that will
be reflected in the Company's consolidated financial statements as of June 30,
2021 and results of operations for the three and six months ended June 30, 2021
when they are completed and publicly disclosed. These preliminary estimates may
change, and those changes may be material.
Because these financial results are only preliminary estimates and are based on
information available to management as of the date of this report, these
expectations could change. The Company's actual financial results as of any
particular date or for any particular period are not indicative of future
performance. The Company's independent registered public accountants have not
audited, reviewed or performed any procedures with respect to such preliminary
estimates and accordingly do not express an opinion or any other form of
assurance with respect thereto.
Item 8.01 Other Events.
Preliminary Financial Information
The preliminary financial information disclosed under Item 2.02 above is
incorporated herein by reference.
Recent Business Highlights
Booster Study Results
On July 29, 2021, the Company announced that it has shown for the first time in
clinical trials that its oral tablet vaccine platform successfully boosted
immune responses in subjects previously vaccinated with a Vaxart oral vaccine
more than a year earlier. The data came from Vaxart's 12-subject Phase 1b
blinded study evaluating the ability of its norovirus vaccine to boost
immunogenicity. Study participants were initially vaccinated with Vaxart's oral
norovirus vaccine in late 2019 and were vaccinated again between February and
April 2021. All seven participants who had been previously immunized with the
oral norovirus vaccine elicited a similar broad range of immune responses to
norovirus as the five subjects that had not received a prior oral vaccine dose.
Key metrics identified in the boosting study were as follows:
? Serum antibody blocking titer 50, a surrogate neutralizing antibody
measurement, increased in both previously vaccinated and unvaccinated subjects
by similar amounts.
? Antibody secreting B cell (ASC) responses to norovirus VP1 measured seven days
post-boost were no different than those in subjects receiving the vaccine for
the first time.
? Serum IgG and IgA antibody responses were significantly elevated 29 days
post-boost immunization, with no difference in titer between subjects that had
received a prior oral norovirus vaccine and those who had not previously been
vaccinated.
--------------------------------------------------------------------------------
IND Clearance
On August 2, 2021, the Company announced that the U.S. Food and Drug
Administration ("FDA") has cleared Vaxart's Investigational New Drug ("IND")
application for an S protein-only oral tablet SARS-CoV-2 vaccine candidate.
Vaxart announced in February that it had completed a Phase 1 clinical trial for
its oral S+N COVID-19 vaccine. The results from that study found that the
investigational oral vaccine triggered multiple immune responses against
SARS-CoV-2 antigens, while reaching primary and secondary endpoints of safety
and immunogenicity, respectively.
European Patent
Recently, Vaxart's European Patent No. 3307239, which has claims directed to
vaccine compositions for norovirus and Respiratory Syncytial Virus ("RSV"), was
opposed in the European Patent Office. The ultimate outcome of the opposition
remains uncertain. If Vaxart is not ultimately successful in the proceedings, it
may not be able to prevent others from copying its norovirus and RSV products in
some or all European countries for as long as it otherwise might be able to if
the patent's validity is upheld in the opposition. If the opposed European
patent is partially or fully revoked by the European Patent Office, competitors
may be able to sell competing vaccines for norovirus or RSV earlier without
Vaxart being able to assert patents against them. Vaxart has another patent in
Europe that covers its norovirus and RSV products, but lack of success in the
opposition would prevent us from extending that patent protection out to 2036.
Barker Lawsuit Resolution and Dismissal
On February 4, 2021, Stephen Barker, a purported stockholder of Vaxart, filed a
class action in the Delaware Court of Chancery, captioned Barker v. Vaxart,
Inc., C.A. No. 2021-0098-MTZ (the "Action"), against the Company and the
Company's board of directors (the "Board") alleging that a provision of Article
VI, Section 2 of the Company's bylaws violated Section 141(k) of the Delaware
General Corporation Law ("DGCL"). This section of the bylaws provided that the
Company's directors could only be removed by the affirmative vote of the holders
of at least 75% of the voting power of all the then-outstanding shares of
capital stock of the corporation entitled to vote generally in the election of
directors. The Action sought to lower that threshold voting requiring to a
simple majority of the voting power of the Company's outstanding common stock.
On April 7, 2021, the Board approved and adopted the Amended and Restated Bylaws
of Vaxart, Inc., effective immediately as of that date (the "Bylaws"), which
included an amendment to Article VI, Section 2 of the Bylaws that, subject to
the Certificate of Incorporation and applicable law, lowered the threshold
voting requirement for the removal of any director from 75% to the affirmative
vote of a majority of the voting power of the outstanding capital stock of the
Company entitled to vote in the election of such director. This amendment
effectively mooted the Action.
On May 5, 2021, plaintiff Barker filed a notice and proposed order voluntarily
dismissing the Action as moot and providing that jurisdiction would be retained
solely to resolve an anticipated application for attorneys' fees and expenses,
which proposed order was entered by the Court of Chancery on June 14, 2021. The
parties to the Action subsequently agreed to a payment by Vaxart to plaintiff
Stephen Barker's counsel of $49,000, in full satisfaction of his claim for
attorneys' fees and expenses in connection with the Action. The Court of
Chancery has not been asked to review or approve, and will pass no judgment on,
this payment.
--------------------------------------------------------------------------------
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 and its vaccine booster product candidates); 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
104 Cover Page Interactive Data File
(embedded within the Inline XBRL
document)
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses