Vaxart Announces First Quarter 2019 Financial Results and Provides Corporate Update
- Norovirus bivalent vaccine Phase 1b clinical study underway with results expected in 2H19 -
“With the Phase 1b study of our bivalent norovirus tablet vaccine
underway and two successful financings behind us, we are well positioned
to advance our lead product candidate, the first oral vaccine against
norovirus, the leading cause of food-borne illness in the U.S.,” said
March 8, Vaxartannounced the initiation of the open label lead-in portion of its Phase 1b bivalent norovirus vaccine clinical trial. On March 27, the Company announced it had completed dosing of the lead-in cohort, and on April 16the first patient in the randomized cohort of the clinical trial was dosed.
March 19, Vaxartannounced the pricing of a registered direct offering of 1,200,000 shares of its common stock at a price of $2.50per share. Total gross proceeds from the offering were $3.0 million.
April 1, at the International Society for Influenzaand other Respiratory Virus Diseases conference in Siena, Italy, and on April 3, at the Influenza Vaccines for the World 2019 conference in Edinburgh, Scotland, Vaxartpresented new data from its Phase 2 influenza challenge study further solidifying the evidence that its oral tablet vaccine protects against influenza infection, primarily through mucosal immunity.
April 9, Vaxartannounced the pricing of an underwritten public offering of a total of 925,455 shares of common stock and 8,165,455 pre-funded warrants with an exercise price of $0.10per share, as well as common warrants for 10,454,546 shares with an exercise price of $1.10per share. The gross proceeds of the offering at close were $9.3 million. As of May 8, 2019, 6,519,091 pre-funded warrants had been exercised, bringing the aggregate gross proceeds up to $10.0 million, and 1,646,364 pre-funded warrants remained outstanding.
April 13, at the 29th European Congress of Clinical Microbiology and Infectious Diseasesin Amsterdam, the Netherlands, Vaxartpresented preclinical data showing that Vaxart’s oral quadrivalent seasonal influenza vaccine conferred 100% protection against a lethal H5N1 pre-pandemic influenza challenge in ferrets, while in the Fluzone group only 62% of the animals survived.
Financial Results for the Three Months Ended
Vaxartreported a net loss of $1.3 millionfor the first quarter of 2019 compared to net income of $2.3 millionfor the first quarter of 2018. The principal reason for the decrease was the absence of a $7.0 millionone-off non-cash bargain purchase gain recorded in the first quarter of 2018, partially offset by an increase in revenue of $3.9 million, primarily from royalties on Inavir and Relenza. Vaxartended the quarter with cash and cash equivalents of $8.4 millioncompared to $11.5 millionat December 31, 2018. The decrease was primarily due to cash used in operations, partially offset by the $2.5 millionnet raised in the registered direct offering in March 2019.
Revenue for the quarter was
$5.4 millioncompared to $1.5 millionin the first quarter of 2018. The $3.9 millionincrease was principally due to royalty revenue resulting from our merger with Aviragen being recorded for the full quarter in 2019, while in 2018 the majority of this revenue was earned pre-merger.
Research and development expenses were
$3.8 millionfor the quarter compared to $3.4 millionfor the first quarter of 2018. 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, partially offset by the discontinuation of the teslexivir program and completion of the BARDA contract.
General and administrative expenses were
$2.0 millionfor the quarter, substantially unchanged from the first quarter of 2018.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this press release regarding
our strategy, prospects, plans and objectives, results from preclinical
and clinical trials, commercialization agreements and licenses, beliefs
and expectations of management are forward-looking statements. These
forward-looking statements may be accompanied by such words as
“believe,” “could,” “potential,” “will” and other words and terms of
similar meaning. Examples of such statements include, but are not
limited to, statements relating to the Vaxart’s ability to develop and
commercialize its product candidates and clinical results and trial
data; the expected timing of the initiation of the Phase 2 monovalent
challenge study; the expected timing of topline results from the Phase
1b bivalent study and Phase 2 monovalent challenge study in the second
half of 2019; the continued advancement of the Company‘s first
therapeutic vaccine for the treatment of HPV associated cervical
dysplasia and cancer toward the clinic; and Vaxart’s expectations with
respect to the important advantages it believes its oral vaccine
platform can offer over injectable alternatives, particularly for
mucosal pathogens such as norovirus, flu and RSV.
|Condensed Consolidated Balance Sheets|
|March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||8,424||$||11,506|
|Prepaid and other assets||1,346||1,446|
|Property and equipment, net||1,559||1,066|
|Right-of-use assets, net||762||—|
|Intangible assets, net||18,634||19,413|
|Liabilities and stockholders’ equity|
|Accrued and other liabilities||1,745||1,675|
|Liability related to sale of future royalties||16,901||17,741|
|Secured promissory note||3,229||3,611|
|Operating lease liabilities||1,009||—|
|Total liabilities and stockholders’ equity||$||36,309||$||35,227|
|(1)||Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2018, included on the Form 10-K filed with the Securities and Exchange Commission on February 6, 2019.|
Condensed Consolidated Statements of Operations
|Three Months Ended March 31,|
|(in thousands, except share and per share amounts)|
|Research and development||3,829||3,408|
|General and administrative||2,026||2,010|
|Total operating expenses||5,855||5,418|
|Loss from operations||(448||)||(3,915||)|
|Bargain purchase gain||—||6,988|
|Other income and (expenses), net||(641||)||(731||)|
|Provision for income taxes||(250||)||(28||)|
|Net (loss) income||
|Net (loss) income attributable to common stockholders||
|Net (loss) income per common share, basic||
|Shares used in computing net (loss) income per share, basic||7,301,189||3,656,360|
|Net (loss) income per common share, diluted||
|Shares used in computing net (loss) income per share, diluted||7,301,189||5,299,751|
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