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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Vaxart Inc | NASDAQ:VXRT | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.749 | 0.73 | 0.75 | 0 | 01:00:00 |
“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
Norovirus Vaccine Developments
Corporate Updates
Planned Clinical Milestones in the COVID-19 and Norovirus Pipelines
Vaxart continues to make progress on its expected milestones:
Financial Results for the Three Months Ended September 30, 2022
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 | ||||||||||||
1 Year Vaxart Chart |
1 Month Vaxart Chart |
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