Vaxart Reports Third Quarter 2020 Financial Results and Provides Business Update
Enrollment in Phase 1 for Oral COVID-19 Vaccine Trial Completed
Significant viral load reduction and strong antibody responses in COVID-19 hamster challenge model
Restarting the Norovirus program
“To defeat the COVID-19 epidemic, we need not only effective vaccines, but effective vaccines that are easy to administer, store, and distribute. We need a practical global solution,” said
VXA-CoV2-1 is a single-dose COVID-19 tablet vaccine candidate that we believe can be conveniently distributed and administered without the need for cold-chain storage and distribution.
Unlike injectable vaccines, animal data indicate that VXA-CoV2-1 activates both systemic and mucosal immunity, a broader immune response that has the potential to offer superior protection against SARS-CoV-2. By leveraging over a decade’s worth of work building
Recent Business Highlights:
Pre-Clinical and Clinical Developments:
- Completed enrollment in the Company’s Phase 1 study of VXA-CoV2-1, its oral tablet COVID-19 vaccine candidate.
- Reported COVID-19 Hamster Challenge Study data showing protection against COVID-19 in hamsters receiving two oral doses of Vaxart’s oral vaccine. Animals were protected against systemic weight loss, lung weight gain, showed a 4-5 log reduction in lung viral load, and developed IgG titers above 10,000. Both oral and intranasal delivery of VXA-CoV2-1 (rAd-S-N) conferred similar protection against intranasal viral challenge on all these metrics.
- Posted Preclinical studies of a recombinant adenoviral mucosal vaccine to prevent SARS-CoV-2 infection to Biorxiv, which noted immunization with the vaccine candidate induced strong IgA response in the lungs of animals, indicative of a mucosal immune response.
- Restarted its Norovirus vaccine program with a booster study in subjects that were primed in the previously conducted Phase 1b Norovirus trial.
- Expanded collaboration with Kindred Biosciences for the manufacturing of our COVID-19 oral vaccine. Kindred’s
Californiaplant will be responsible for scaling the COVID-19 clinical trial material into mid-size bioreactors and the Kansasplant will be responsible for manufacturing at 2000L scale in its single use bioreactors.
- Entered into a master services agreement with
Attwill Vascular Technologies, LPfor processing, lyophilizing, and tableting compounds for the Company’s oral COVID-19 vaccine.
Addition to the Board of Directors: In August,
Financial Results for the Fiscal Period Ended September 30, 2020
Vaxartreported a net loss of $8.1 millionfor the third quarter of 2020 compared to $5.3 millionfor the third quarter of 2019. The increase was mainly due to an increase in operating expenses. Net loss per share for the third quarter was $0.08in 2020 compared to $0.32in 2019, in part due to an increase in the number of shares outstanding. Vaxartended the quarter with cash and cash equivalents of $133.4 millioncompared to $44.4 millionas of June 30, 2020. The increase was primarily due to net proceeds of $97.0 millionfor the issuance of common stock, partially offset by $9.3 millionof cash used in operations.
- Revenue for the third quarter was
$265,000compared to $454,000in the third quarter of 2019. The decrease was principally due to a reduction in revenue from our contract with Janssen, for which activities were mostly completed between July 2019and June 2020.
- Research and development expenses were
$4.6 millionfor the third quarter compared to $3.7 millionfor the third quarter of 2019. The increase was mainly due to manufacturing expenses related to the COVID-19 vaccine candidate and higher stock-based compensation costs, partially offset by reductions in the cost of clinical trials for our norovirus vaccine candidate and in personnel costs after we ceased internal manufacturing as part of our December 2019restructuring.
- General and administrative expenses were
$4.2 millionfor the third quarter compared to $1.5 millionfor the third quarter of 2019. The increase was mainly due to higher legal fees and an increase in headcount, with higher stock-based compensation costs.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates, and preclinical and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations relating to Vaxart’s relationship with Emergent, KindredBio and AMS including their ability to produce bulk cGMP vaccines and the timing thereof; and Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and SARS-CoV-2.
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Condensed Consolidated Balance Sheets
|September 30, 2020|
|Cash and cash equivalents||$||133,438||$||13,526|
|Prepaid and other assets||1,975||594|
|Property and equipment, net||662||210|
|Right-of-use assets, net||2,591||1,990|
|Intangible assets, net||15,794||17,093|
|Liabilities and stockholders’ equity|
|Accrued and other liabilities||3,724||4,583|
|Liability related to sale of future royalties||14,706||16,332|
|Operating lease liabilities||2,731||2,313|
|Total liabilities and stockholders’ equity||$||154,710||$||37,032|
(1) Derived from the audited consolidated financial statements of
Condensed Consolidated Statements of Operations
|Three Months Ended September 30,||Nine Months Ended September 30,|
|(in thousands, except share and per share amounts)|
|Research and development||4,616||3,713||11,272||11,249|
|General and administrative||4,190||1,455||10,076||4,856|
|Total operating expenses||7,854||5,168||20,499||16,105|
|Loss from operations||(7,589||)||(4,714||)||(16,809||)||(10,159||)|
|Other income and (expenses), net||(470||)||(515||)||(1,345||)||(1,783||)|
|Provision for income taxes||(26||)||(31||)||(205||)||(294||)|
|Net loss per share, basic and diluted||$||(0.08||)||$||(0.32||)||$||(0.23||)||$||(0.96||)|
|Shares used in computing net loss per share, basic and diluted||107,718,578||16,249,032||81,121,045||12,748,665|
Source: Vaxart, Inc.