Vaxart Announces First Quarter 2020 Financial Results and Provides Corporate Update
Lead Vaccine Candidates for COVID-19 are Highly Immunogenic in Preclinical Testing
COVID-19 Phase 1 Clinical Study Planned for 2H20
“In January we pivoted to COVID-19, and we are now on track to start a first Phase 1 study in the second half of this year with our oral tablet vaccine,” said
“For COVID-19, a key challenge will be to manufacture sufficient vaccine and efficiently vaccinate the millions at risk, and ultimately the entire population. Our vaccines are administered orally using a room temperature-stable tablet, an enormous logistical advantage over injectable vaccines in large vaccination campaigns. The bulk vaccine does not require sterile fill and finish, a significant bottleneck for injectable vaccines, but can be tableted very efficiently using high throughput industrial tableting equipment.”
In preclinical testing, the Company’s lead vaccine candidates generated robust anti-SARS CoV-2 antibodies in all tested animals after both the first and second dose, with a clear boosting effect after the second dose. Antibody responses in all vaccinated groups were statistically significant (p<0.002), with median ELISA IgG antibody titers above 10,000 compared to a median titer of 1 in the untreated controls, a larger than 10,000 fold increase.
- The manufacturing collaboration with Emergent BioSolutions is progressing well and, provided
Vaxartelects to proceed, Emergent is on schedule to produce bulk cGMP vaccine in time for initiation of a Phase 1 clinical study during the second half of 2020.
- The Universal Influenza vaccine collaboration with Janssen remains on schedule to provide results by mid-2020.
- The Company continues to pursue strategic, financial and public-private partnerships to advance its development candidates, including its coronavirus vaccine candidates, norovirus and seasonal influenza vaccine programs.
Financial Results for the Three Months Ended
Vaxartreported a net loss of $1.3 millionfor the first quarter of both 2020 and 2019. Net loss per share was $0.02in 2020 compared to $0.18in 2019 due to an increase in the number of shares outstanding.
Vaxartended the quarter with cash and cash equivalents of $29.9 millioncompared to $13.5 millionat December 31, 2019. The increase was primarily due to $9.2 millionof net proceeds raised in a registered direct offering of common stock and warrants and $10.3 millionfrom the exercise of common stock warrants, partially offset by $3.2 millionof cash used in operations.
- Revenue for the quarter was
$2.9 millioncompared to $5.4 millionin the first quarter of 2019. The $2.5 milliondecrease was principally due to the loss of royalty revenue of $0.7 millionfor Relenza following the expiration of the patent and a decrease of $1.9 millionin royalty revenue for Inavir, partly due to higher sales in the three months ended December 31, 2019.
- Research and development expenses were
$1.5 millionfor the quarter compared to $3.8 millionfor the first quarter of 2019. The decrease was mainly due to a reduction in personnel costs after we ceased internal manufacturing as part of our December 2019restructuring and a reduction in expenditure on our norovirus vaccine candidate.
- General and administrative expenses were
$2.0 millionfor the quarter, substantially unchanged from the first quarter of 2019.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations relating to Vaxart’s relationship with Emergent, including Emergent’s ability to produce bulk cGMP vaccine and the timing thereof; and Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and SARS-CoV-2.
650 550 3500
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||29,859||$||13,526|
|Prepaid and other assets||1,281||594|
|Property and equipment, net||191||210|
|Right-of-use assets, net||1,910||1,990|
|Intangible assets, net||16,660||17,093|
|Liabilities and stockholders’ equity|
|Accrued and other liabilities||4,298||4,583|
|Liability related to sale of future royalties||14,054||16,332|
|Operating lease liabilities||2,126||2,313|
|Total liabilities and stockholders’ equity||$||52,564||$||37,032|
(1) Derived from the audited consolidated financial statements of
Condensed Consolidated Statements of Operations
|Three Months Ended
|(in thousands, except share and per share amounts)|
|Research and development||1,542||3,829|
|General and administrative||1,990||2,026|
|Total operating expenses||3,596||5,855|
|Loss from operations||(694||)||(448||)|
|Other income and (expenses), net||(450||)||(641||)|
|Provision for income taxes||(153||)||(250||)|
|Net loss per share, basic and diluted||$||(0.02||)||$||(0.18||)|
|Shares used in computing net loss per share, basic and diluted||60,677,145||7,301,189|
Source: Vaxart, Inc.