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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading symbol
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Name of each exchange on which registered
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Item 8.01
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Other Events.
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●
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Vaxart announced the results from its VXA-CoV2-1 Phase I clinical trial in 35 subjects:
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o
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Generally well-tolerated with no severe adverse events reported.
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Triggered multiple immune responses against SARS-CoV2 antigens, including:
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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.
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An increase in proinflammatory Th1 cytokines, which are responsible for orchestrating the immune response to viral infection.
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Next steps
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Pre-clinical studies:
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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.
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Clinical studies:
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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.
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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.
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Phase I/II studies of two S-only vaccine constructs targeting different variants are planned to begin in 3Q 2021.
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Boosting studies with previously vaccinated or infected subjects are also planned for 2H 2021.
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Trials in India and Latin America are expected to initiate in 2021.
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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.
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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.
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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.
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A Phase 2 challenge study is planned to start later this year.
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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.
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7 in 10 said they would prefer taking a vaccine pill rather than getting injected with a vaccine.
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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.
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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.
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Item 9.01
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Financial Statements and Exhibits.
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Exhibit
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Description
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99.1
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99.2
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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Vaxart, Inc.
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Dated: May 3, 2021
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By:
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/s/ Andrei Floroiu
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Andrei Floroiu
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President and Chief Executive Officer
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Exhibit 99.1
Vaxart, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
March 31, 2021 |
December 31, 2020 |
|||||||
(Unaudited) |
(1) | |||||||
Assets |
||||||||
Cash and cash equivalents |
$ | 157,311 | $ | 126,870 | ||||
Investments in debt securities |
19,939 | — | ||||||
Accounts receivable |
700 | 334 | ||||||
Prepaid and other assets |
4,393 | 1,699 | ||||||
Property and equipment, net |
2,245 | 1,480 | ||||||
Right-of-use assets, net |
6,350 | 6,838 | ||||||
Intangible assets, net |
14,928 | 15,361 | ||||||
Total assets |
$ | 205,866 | $ | 152,582 | ||||
Liabilities and stockholders’ equity |
||||||||
Accounts payable |
$ | 4,638 | $ | 2,133 | ||||
Accrued and other liabilities |
3,298 | 4,908 | ||||||
Liability related to sale of future royalties |
15,061 | 14,929 | ||||||
Operating lease liabilities |
6,634 | 7,208 | ||||||
Total liabilities |
29,631 | 29,178 | ||||||
Stockholders’ equity |
176,235 | 123,404 | ||||||
Total liabilities and stockholders’ equity |
$ | 205,866 | $ | 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)
(in thousands, except share and per share amounts)
Three Months Ended March 31, |
||||||||
2021 |
2020 |
|||||||
Revenue |
$ | 506 | $ | 2,902 | ||||
Operating expenses: |
||||||||
Research and development |
10,073 | 1,542 | ||||||
General and administrative |
5,944 | 1,990 | ||||||
Restructuring costs |
— | 64 | ||||||
Total operating expenses |
16,017 | 3,596 | ||||||
Loss from operations |
(15,511 | ) | (694 | ) | ||||
Other income and (expenses), net |
(458 | ) | (450 | ) | ||||
Provision for income taxes |
(38 | ) | (153 | ) | ||||
Net loss |
$ | (16,007 | ) | $ | (1,297 | ) | ||
Net loss per share, basic and diluted |
$ | (0.14 | ) | $ | (0.02 | ) | ||
Shares used in computing net loss per share, basic and diluted |
115,422,628 | 60,677,145 |
Exhibit 99.2