Vaxart Announces Fourth Quarter and Year-End 2018 Financial Results and Provides Corporate Update
Initiation of Two Norovirus Vaccine Trials Expected in 1H 2019
“As we execute on our objective of building a leading oral vaccine
company, we continue to expand our understanding of the unique
properties of our oral vaccine platform and the important advantages we
believe it can offer over conventional injectable vaccines, particularly
for mucosal pathogens such as norovirus, flu and RSV,” said
Vaxartcommenced trading on the Nasdaq Capital Marketunder the symbol “VXRT” following the closing of its merger with Aviragen Therapeutics.
In October, at ID Week in
San Francisco, the Company presented data from its H1 influenza Phase 2 challenge study demonstrating that its oral H1 flu vaccine, while providing 39% reduction in flu illness compared to 27% for Fluzone®, protected primarily through mucosal immunity, in contrast to Fluzone which primarily protected through serum antibodies. This finding provides evidence that Vaxart’s oral vaccines may deliver better protection against mucosal pathogens than injectable vaccines.
Vaxartannounced the publication of the comprehensive results of the previously disclosed Phase 1 clinical trial with its norovirus oral tablet vaccine in the Journal of Clinical Investigation Insight. As reported in the article, the vaccine generated robust systemic and mucosal immune responses, including mucosal IgA, memory B cells, and serum blocking antibody titers (BT50), all potential correlates of protection.
In October at the 32nd
International Papillomavirus Conference, the Company presented preclinical data on its human papillomavirus (HPV) vaccine trial. The Vaxart HPV vaccine created CD8 tumor-infiltrating T cells and eliminated or significantly reduced the majority of tumors with or without a checkpoint inhibitor.
- In June, the Company announced the publication of preclinical results from its oral F-protein based Respiratory Syncytial Virus (RSV-F) vaccine in Vaccine. As described in the article, the oral RSV-F vaccine candidate provided complete sterilizing protection against RSV infection in the cotton rat challenge model at the target dose.
Financial Results for the Three Months and Year Ended
Vaxartreported a net loss of $4.9 millionfor the fourth quarter of 2018 compared to a net loss of $1.1 millionfor the fourth quarter of 2017. For the year ended December 31, 2018, the net loss was $18.0 millioncompared to a net loss of $9.6 millionfor 2017. Vaxartended the year with cash and cash equivalents of $11.5 millioncompared to $17.9 millionat September 30, 2018. The decrease was primarily due to cash used in operations.
Revenue for the quarter was
$1.8 millioncompared to $0.8 millionin the fourth quarter of 2017. The increase was due to royalty revenue resulting from our merger with Aviragen, offset by lower revenues from the contract with BARDA, which ended on September 30, 2018.
Research and development expenses were
$4.5 millionfor the quarter compared to $1.9 millionfor the fourth quarter of 2017. The increase was mainly due to higher clinical and manufacturing costs incurred in the Company’s norovirus program and amortization of intangible assets acquired in the merger with Aviragen, offset by lower expenditures incurred under the BARDA contract.
General and administrative expenses were
$1.2 millionfor the quarter compared to $1.5 millionfor the fourth quarter of 2017. The decrease was a result of significant one-off costs incurred in the 2017 period in connection with the merger with Aviragen.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this press release regarding
our strategy, prospects, plans and objectives, results from preclinical
and clinical trials, commercialization agreements and licenses, beliefs
and expectations of management are forward-looking statements. These
forward-looking statements may be accompanied by such words as
“believe,” “could,” “potential,” “will” and other words and terms of
similar meaning. Examples of such statements include, but are not
limited to, statements relating to the Vaxart’s ability to develop and
commercialize its product candidates and clinical results and trial
data; the expected timing of the initiation of the Phase 1 bivalent
study and Phase 2 monovalent challenge study; and Vaxart’s expectations
with respect to the important advantages it believes its oral vaccine
platform can offer over injectable alternatives, particularly for
mucosal pathogens such as norovirus, flu and RSV.
Condensed Consolidated Balance Sheets
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||
|Prepaid and other assets||1,446||137|
|Property and equipment, net||1,066||730|
|Intangible assets, net||19,413||40|
|Liabilities and stockholders’ equity (deficit)|
|Accrued and other liabilities||1,675||1,605|
|Liability related to sale of future royalties||17,741||—|
|Secured promissory note||3,611||4,968|
|Convertible promissory notes, related party||—||35,282|
|Stockholders’ equity (deficit)||11,238||(38,722||)|
|Total liabilities and stockholders’ equity (deficit)||$||35,227||$||4,523|
Condensed Consolidated Statements of Operations
|Three Months Ended December 31,||Year Ended December 31,|
|(In thousands, except share and per share amounts)|
|Research and development||4,474||1,905||17,275||12,355|
|General and administrative||1,226||1,544||6,681||3,499|
|Exit and impairment charges||253||—||1,959||—|
|Total operating expenses||5,953||3,449||25,915||15,854|
|Loss from operations||(4,186||)||(2,689||)||(21,756||)||(10,015||)|
|Bargain purchase gain||—||—||6,760||—|
|Other income and expenses, net||(736||)||1,614||(2,902||)||433|
|Provision for income taxes||(80||)||—||(109||)||—|
|Net loss attributable to common shareholders||$||(4,902||)||$||(1,800||)||$||(18,346||)||$||(12,460||)|
|Net loss per common share, basic and diluted||$||(0.69||)||$||(13.16||)||$||(2.90||)||$||(91.65||)|
|Shares used in computing net loss per share, basic and diluted||7,141,189||136,829||6,316,065||135,953|
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