Vaxart Announces Third Quarter 2018 Financial Results and Provides Corporate Update
Start of Norovirus Vaccine Trials Delayed to 1H 2019 Due to Manufacturing Issue
“As our first year as a public company comes to a close, Vaxart’s main
focus continues to be the development of our oral tablet vaccine for the
prevention of norovirus infection. Due to a manufacturing issue, our
norovirus GI.1 vaccine tablets failed release testing, and we now expect
to initiate our Phase 1 bivalent study and Phase 2 monovalent challenge
study in the first half of 2019,” said
“Norovirus causes up to 20 million cases of acute gastroenteritis in the
U.S. each year, with significant morbidity and mortality in vulnerable
populations like the very young and elderly,” Dr. Latour continued.
“Norovirus outbreaks are notorious in long-term care facilities,
schools, hospitals, restaurants and cruise ships. In all, norovirus
disease costs society an estimated
Third Quarter 2018 and Recent Highlights:
The Company’s Phase 1 bivalent and Phase 2 challenge norovirus studies
are now expected to begin in the first half of 2019 due to a
manufacturing issue affecting the norovirus GI.1 vaccine tablets.
Vaxartis working diligently to resolve the issue.
October 6, 2018, 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 confirmed that Vaxart’s oral vaccines are uniquely suited to provide protection against mucosal pathogens such as influenza, norovirus and respiratory syncytial virus (RSV). A copy of this presentation can be found on the Investor Relations page on the Company’s website.
October 4, 2018, the Company presented preclinical data on its human papillomavirus (HPV) vaccine trial in a poster presentation at the 32nd International Papillomavirus Conferencein Sydney, Australia. As described in the poster, 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. Preparations to advance the program into the clinic in 2019 are underway. A copy of this presentation can be found on the Investor Relations page on the Company’s website.
Following the completion of the 3-month follow-up assessment of the
Phase 2 clinical trial evaluating teslexivir, a small-molecule
antiviral for the treatment of condyloma that
Vaxartobtained in the acquisition of Aviragen in 2018, analysis of the data showed there was no improvement compared to the topline results reported in June 2019.
Third Quarter 2018 Financial Results
Vaxartreported a net loss of $6.5 millionfor the third quarter of 2018 compared to a net loss of $2.2 millionfor the third quarter of 2017. For the nine months ended September 30, 2018, the net loss was $13.1 millioncompared to a net loss of $8.5 millionfor the same period in 2017. Vaxartended the quarter with cash and cash equivalents of $17.9 millioncompared to $23.9 millionat June 30, 2018. The decrease was primarily due to cash used in operations.
Revenue for the quarter was
$0.3 millioncompared to $0.9 millionin the third quarter of 2017. The decrease was due to lower revenues from the contract with BARDA, which ended on September 30, 2018.
Research and development expenses were
$4.4 millionfor the quarter compared to $2.2 millionfor the third quarter of 2017. The increase was due to higher clinical and manufacturing costs incurred in the Company’s norovirus program, clinical costs incurred in completing the teslexivir trial, and the amortization of intangible assets acquired in the merger with Aviragen, offset by lower expenditures incurred under the BARDA contract.
General and administrative expenses were
$1.7 millionfor the quarter compared to $0.6 millionfor the third quarter of 2017. The increase was a result of a higher headcount and additional expenses relating to operating as a public company, including expenses required for regulatory compliance, additional insurance, director fees and other professional expenses.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this press release regarding
our strategy, prospects, plans and objectives, results from preclinical
and clinical trials, commercialization agreements and licenses, beliefs
and expectations of management are forward-looking statements. These
forward-looking statements may be accompanied by such words as
“believe,” “could,” “potential”, “will” and other words and terms of
similar meaning. Examples of such statements include, but are not
limited to, statements relating to the Vaxart’s ability to develop and
commercialize its product candidates and clinical results and trial
data; the expected timing of the initiation of the Phase 1 bivalent
study and Phase 2 monovalent challenge study; Vaxart’s ability to
resolve a manufacturing issue affecting its norovirus G1.1 vaccine
tablets; the expected timing of an IND filing for its HPV vaccine; and
Vaxart’s expectations with respect to its norovirus vaccine providing
superior protection compared to injectable alternatives.
|Condensed Consolidated Balance Sheets|
|September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||17,922||$||1,571|
|Prepaid and other current assets||989||137|
|Property and equipment, net||1,059||730|
|Intangible assets, net||20,410||40|
|Liabilities and stockholders’ equity (deficit)|
|Accrued and other current liabilities||1,779||1,605|
|Liability related to sale of future royalties||17,580||—|
|Secured promissory note||3,988||4,968|
|Convertible promissory notes, related party||—||35,282|
|Stockholders’ equity (deficit)||15,988||(38,722||)|
|Total liabilities and stockholders’ equity (deficit)||$||40,636||$||4,523|
|(1)||Derived from the audited financial statements of Vaxart Biosciences, Inc. for the year ended December 31, 2017, included on the Form 8-K/A filed with the Securities and Exchange Commission on April 2, 2018.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||4,381||2,247||12,801||10,450|
|General and administrative||1,674||624||5,455||1,955|
|Total operating expenses||6,161||2,871||19,962||12,405|
|Loss from operations||(5,880||)||(1,956||)||(17,570||)||(7,326||)|
|Bargain purchase gain||—||—||6,660||—|
|Other income and expenses, net||(668||)||(217||)||(2,166||)||(1,181||)|
|Provision for income taxes||—||—||(29||)||—|
|Net loss attributable to common shareholders||$||(6,548||)||$||(2,898||)||$||(13,444||)||$||(10,660||)|
|Net loss per common share, basic and diluted||$||(0.92||)||$||(21.36||)||$||(2.23||)||$||(78.58||)|
Shares used in computing net loss per share,
Stern Investor Relations
Carl Mauch, 212-362-1200