– $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
vaxart@sternir.com