Vaxart Announces Second Quarter 2020 Results
Enhanced Leadership – New CEO in Q2
Ample Cash Runway following Financing by
May 20, 2020, Vaxartannounced that it had selected its lead COVID-19 vaccine candidate to move into clinical trials. Vaxartis continuing with its manufacturing collaboration with Emergent BioSolutions Inc. (Emergent) and KindredBio and is currently producing bulk cGMP vaccine in time for initiation of a Phase 1 clinical study during the second half of 2020.
June 25, 2020, Vaxartannounced the signing of a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP(“AMS”) affirming the parties’ intent to establish AMS as a resource for lyophilization development and large-scale manufacturing including tableting and enteric coating for the oral COVID-19 vaccine.
June 26, 2020, Vaxartannounced that its oral COVID-19 vaccine was selected to participate in a non-human primate challenge study, organized and funded by Operation Warp Speed.
- The universal influenza vaccine collaboration study with Janssen has been completed and a report is being compiled for Janssen.
- As of
July 13, 2020, Vaxarthad raised approximately $97 millionin net proceeds through its At-The-Market facility (the ATM Program), which constituted the maximum offering price under the ATM Program.
Financial Results for the Fiscal Period Ended
Vaxartreported a net loss of $9.0 millionfor the second quarter of 2020 compared to $5.6 millionfor the second quarter of 2019. The increase was mainly due to an increase in operating expenses. Net loss per share for the second quarter was $0.12in 2020 compared to $0.39in 2019, in part due to an increase in the number of shares outstanding. Vaxartended the quarter with cash and cash equivalents of $44.4 millioncompared to $29.9 millionat March 31, 2020. The increase was primarily due to $14.4 millionreceived for the exercise of common stock warrants, partially offset by $3.7 millionof cash used in operations.
- Revenue for the second quarter was
$523,000compared to $85,000in the second quarter of 2019. The increase was principally due to the reversal of the reserve for sales returns for Relenza and revenue from our contract with Janssen.
- Research and development expenses were
$5.1 millionfor the second quarter compared to $3.7 millionfor the second 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
$3.9 millionfor the second quarter compared to $1.4 millionfor the second quarter of 2019. The increase was mainly due to higher stock-based compensation costs and severance expenses related to our former Chief Executive Officer.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); Vaxart’s participation in the study organized by Operation Warp Speed, expectations relating to Vaxart’s relationship with Emergent, KindredBio and AMS including their ability to produce bulk cGMP vaccines and the timing thereof; and Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and SARS-CoV-2.
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617 435 6602
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||44,388||$||13,526|
|Prepaid and other assets||1,248||594|
|Property and equipment, net||345||210|
|Right-of-use assets, net||1,755||1,990|
|Intangible assets, net||16,227||17,093|
|Liabilities and stockholders’ equity|
|Accrued and other liabilities||6,396||4,583|
|Liability related to sale of future royalties||14,469||16,332|
|Operating lease liabilities||1,924||2,313|
|Total liabilities and stockholders’ equity||$||64,190||$||37,032|
|(1) Derived from the audited consolidated financial statements of
Condensed Consolidated Statements of Operations
|Three Months Ended
||Six Months Ended
|(in thousands, except share and per share amounts)|
|Research and development||5,114||3,707||6,656||7,536|
|General and administrative||3,896||1,375||5,886||3,401|
|Total operating expenses||9,049||5,082||12,645||10,937|
|Loss from operations||(8,526||)||(4,997||)||(9,220||)||(5,445||)|
|Other income and (expenses), net||(425||)||(627||)||(875||)||(1,268||)|
|Provision for income taxes||(26||)||(13||)||(179||)||(263||)|
|Net loss per share, basic and diluted||$||(0.12||)||$||(0.39||)||$||(0.15||)||$||(0.64||)|
|Shares used in computing net loss per share, basic and diluted||74,675,131||14,597,446||67,676,138||10,969,473|
Source: Vaxart, Inc.