SOUTH SAN FRANCISCO, Calif., May 12, 2020 (GLOBE NEWSWIRE) – Vaxart, Inc. (“Vaxart” or the “Company”), a clinical biotechnology company developing recombinant oral vaccines that are given by tablet rather than by injection , today announced the financial results for the first quarter ended March 31, 2020 and provided a business update.
“In January, we opted for COVID-19, and we are now well on our way to begin a first phase 1 study in the second half of this year with our vaccine for oral tablets,” said Wouter Latour, MD, president – CEO of Vaxart. “We are developing a state-of-the-art gene-based vaccine using our proprietary vector platform, and the main candidate vaccines have performed well in preclinical testing, generating very high levels of antibodies.”
“For COVID-19, a major challenge will be to make enough vaccines and effectively immunize the millions of people at risk, and ultimately the entire population. Our vaccines are administered orally using a tablet at room temperature, a huge logistical advantage over injectable vaccines in large vaccination campaigns. Bulk vaccine does not require sterile filling and finishing, a major bottleneck for injectable vaccines, but can be tableted very efficiently using industrial high-throughput tablet manufacturing equipment. “
In the preclinical tests, the Company’s main vaccine candidates generated robust anti-SARS CoV-2 antibodies in all the animals tested after the first and second doses, with a clear booster effect after the second dose. Antibody responses in all vaccinated groups were statistically significant (p
- Manufacturing collaboration with Emergent BioSolutions is progressing well and, if Vaxart chooses to continue, Emergent is on schedule to produce a bulk cGMP vaccine in time for the launch of a phase 1 clinical study in the second half of 2020 .
- The universal flu vaccine’s collaboration with Janssen remains on schedule to deliver results by mid-2020.
- The Company continues to seek strategic, financial and public-private partnerships to advance its development candidates, in particular its candidate vaccines against coronavirus, norovirus and seasonal influenza vaccination programs.
www.vaxart.com. “Data-reactid =” 32 “>About Vaxart
Vaxart is a clinical biotechnology company primarily focused on the development of recombinant protein-based oral vaccines based on its exclusive oral vaccine platform. Vaxart vaccines are designed to generate broad and lasting immune responses that protect against a wide range of infectious diseases and can also be useful for the treatment of chronic viral infections and cancer. Vaxart vaccines are given using a handy tablet at room temperature rather than by injection. Vaxart believes that tablet vaccines are easier to distribute and administer than injectable vaccines and have the potential to dramatically increase vaccination rates. Vaxart’s development programs include vaccines for oral tablets designed to protect against coronavirus, norovirus, seasonal flu and respiratory syncytial virus (“RSV”), as well as a therapeutic vaccine against human papillomavirus (“HPV”) ). For more information, please visit www.vaxart.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results of pre-clinical and clinical trials, marketing agreements and licenses, management beliefs and expectations are forward-looking statements. These forward-looking statements may be accompanied by words such as “should”, “believe”, “could”, “potential”, “will”, “planned”, “plan” and other words and terms that have the same meaning. Examples of such statements include, but are not limited to, statements regarding Vaxart’s ability to develop and market its product candidates and its clinical results and test data (including plans for product candidates for the vaccine COVID-19); expectations regarding Vaxart’s relationship with Emergent, including Emergent’s ability to produce bulk cGMP vaccine and when; and Vaxart’s expectations regarding the significant benefits it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, influenza and RSV, as well than coronaviruses such as SARS, MERS and SARS-CoV-2. Vaxart may not actually carry out the plans, realize 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 presented in the forward-looking statements. Various important factors could cause actual results or events to differ materially from Vaxart’s forward-looking statements, including the inherent uncertainties in research and development, including the ability to meet anticipated clinical endpoints, dates of start and / or completion of clinical trials, regulatory submission dates, regulatory approval dates and / or launch dates, as well as the possibility of new adverse clinical data and new analyzes of existing clinical data; the risk that clinical trial data will be subject to different interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design and results of clinical studies; decisions of regulatory authorities having an impact on labeling, manufacturing processes and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart product candidates are not approved by the FDA or non-US regulatory authorities; that, even if approved by the FDA or non-US regulatory authorities, Vaxart’s product candidates may not be widely accepted by the market; that a Vaxart employee may not reach the development and commercial stages; that Vaxart may experience manufacturing issues and delays due to events under or outside Vaxart’s control, including the recent COVID-19 outbreak; that Vaxart may not be able to obtain, maintain and enforce necessary patents and other intellectual property protections; that Vaxart’s capital resources may be insufficient; Vaxart’s ability to obtain sufficient capital to finance its operations on terms acceptable to Vaxart, if any; the impact of government health care 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 assumes no obligation to update any forward-looking statements, except as required by law.
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|March 31, 2020||December 31, 2019|
|Cash and cash equivalents||$||29,859||$||13,526|
|Prepaid and other assets||1,281||594|
|Property and equipment, net||191||210|
|User rights assets, net||1,910||1,990|
|Intangible assets, net||16,660||17,093|
|Liabilities and equity|
|Liabilities payable and other liabilities||4,298||4.583|
|Liabilities related to the sale of future royalties||14,054||16,332|
|Operating lease liabilities||2.126||2,313|
|Total liabilities and equity||$||52,564||$||37,032|
(1) Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2019, included in Form 10-K filed with the Securities and Exchange Commission on March 19, 2020.
|Quarter ended March 31|
|(in thousands, except per share and per share amounts)|
|Research and development||1.542||3,829|
|general and administrative||1,990||2,026|
|Total of the exploitation charges||3,596||5,855|
|Other net income and (expense)||(450||)||(641||)|
|Provision for income taxes||(153||)||(250||)|
|Basic and diluted loss per share||$||(0.02||)||$||(0.18||)|
|Shares used in calculating basic and diluted net loss per share||60,677,145||7,301,189|