Vaxart Announces First Quarter 2019 Financial Results and Provides Corporate Update

May 9, 2019 Off By BusinessWire

– $13 million raised in 1H19 –

– Norovirus bivalent vaccine Phase 1b clinical study underway with
results expected in 2H19 –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Vaxart, Inc., a clinical-stage biotechnology company developing oral
recombinant vaccines that are administered by tablet rather than by
injection, today announced financial results for the first quarter ended
March 31, 2019.

“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
Wouter Latour, M.D., chief executive officer of Vaxart. “We expect to
initiate the Phase 2 monovalent norovirus challenge study in the first
half of 2019, and we expect topline results from both the Phase 1b and
Phase 2 studies in the second half of 2019. In addition, we are
advancing our first therapeutic vaccine for the treatment of HPV
associated cervical dysplasia and cancer toward the clinic.”

2019 Highlights:

Corporate:

  • On March 8, Vaxart announced 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 16 the first patient in the randomized cohort of
    the clinical trial was dosed.
  • On March 19, Vaxart announced the pricing of a registered direct
    offering of 1,200,000 shares of its common stock at a price of $2.50
    per share. Total gross proceeds from the offering were $3.0 million.
  • On April 1, at the International Society for Influenza and other
    Respiratory Virus Diseases conference in Siena, Italy, and on April 3,
    at the Influenza Vaccines for the World 2019 conference in Edinburgh,
    Scotland, Vaxart presented 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.
  • On April 9, Vaxart announced 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 $0.10 per share, as well
    as common warrants for 10,454,546 shares with an exercise price of
    $1.10 per 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.
  • On April 13, at the 29th European Congress of Clinical Microbiology
    and Infectious Diseases in Amsterdam, the Netherlands, Vaxart
    presented 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 March 31, 2019

  • Vaxart reported a net loss of $1.3 million for the first quarter of
    2019 compared to net income of $2.3 million for the first quarter of
    2018. The principal reason for the decrease was the absence of a $7.0
    million one-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.
  • Vaxart ended the quarter with cash and cash equivalents of $8.4
    million compared to $11.5 million at December 31, 2018. The decrease
    was primarily due to cash used in operations, partially offset by the
    $2.5 million net raised in the registered direct offering in March
    2019.
  • Revenue for the quarter was $5.4 million compared to $1.5 million in
    the first quarter of 2018. The $3.9 million increase 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 million for the quarter
    compared to $3.4 million for 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 million for the quarter,
    substantially unchanged from the first quarter of 2018.

About Vaxart

Vaxart is a clinical-stage biotechnology company focused on developing
oral recombinant protein vaccines based on its proprietary oral vaccine
platform. Vaxart’s vaccines are designed to generate broad and durable
immune responses that protect against a wide range of infectious
diseases and may also be useful for the treatment of chronic viral
infections and cancer. Vaxart’s vaccines are administered using a
convenient room temperature-stable tablet, rather than by injection.
Vaxart believes that tablet vaccines are easier to distribute and
administer than injectable vaccines and have the potential to
significantly increase vaccination rates. Vaxart’s development programs
include oral tablet vaccines that are designed to protect against
norovirus, seasonal influenza and respiratory syncytial virus (RSV), as
well as a therapeutic vaccine for human papillomavirus (HPV). For more
information, please visit www.vaxart.com.

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. Vaxart may not
actually achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in our forward-looking statements
and you should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from the
plans, intentions, expectations and projections disclosed in the
forward-looking statements. Various important factors could cause actual
results or events to differ materially from the forward-looking
statements that Vaxart makes, that Vaxart’s product candidates may not
be approved by the FDA or non-U.S. regulatory authorities; that, even if
approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product
candidates may not achieve broad market acceptance; that Vaxart may
experience manufacturing issues and delays; and other risks described in
the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports
filed with the SEC. Vaxart does not assume any obligation to update any
forward-looking statements, except as required by law.

   
Vaxart, Inc.
Condensed Consolidated Balance Sheets
 
March 31, 2019 December 31, 2018
(Unaudited) (1)
(In thousands)
Assets
Cash and cash equivalents $ 8,424 $ 11,506
Accounts receivable 5,584 1,796
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
Total assets $ 36,309 $ 35,227
 
Liabilities and stockholders’ equity
Accounts payable $ 849 $ 962
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 23,733 23,989
Stockholders’ equity   12,576   11,238
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.
 
   

Vaxart, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 
Three Months Ended March 31,
2019 2018
(in thousands, except share and per share amounts)
 
Revenue

$

5,407

  $ 1,503  
Operating expenses:
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

$

(1,339

) $ 2,314  
Net (loss) income attributable to common stockholders

$

(1,339

) $ 1,975  
Net (loss) income per common share, basic

$

(0.18

) $ 0.54  
Shares used in computing net (loss) income per share, basic   7,301,189     3,656,360  
Net (loss) income per common share, diluted

$

(0.18

) $ 0.49  
Shares used in computing net (loss) income per share, diluted   7,301,189     5,299,751  
 

Contacts

Daniella Funaro
Stern Investor Relations
212-362-1200
[email protected]