GAITHERSBURG, Md., Nov. 4, 2016 /PRNewswire/ -- GenVec, Inc.
(NASDAQ: GNVC) today reported financial results for the third
quarter ended September 30, 2016. For
the three months ended September 30,
2016, the company reported a net loss of $1.2 million or $0.05 per share on revenues of $173,000. This compares to a net loss of
$1.5 million or $0.09 per share on revenues of $193,000 for the same period in the prior year.
For the nine months ended September 30,
2016, the company reported a net loss of $4.3 million or $0.21 per share on revenues of $489,000. This compares to a net loss of
$4.9 million or $0.30 per share on revenues of $725,000 for the same period in the prior year.
The company ended the third quarter of 2016 with $8.4 million in cash, cash equivalents, and
investments.
"During the third quarter, the FDA lifted the clinical hold on
the CGF166 Phase 1/2 clinical trial, which allowed the drug to
advance into the next patient cohort at a higher dose level," said
Douglas J. Swirsky, president and
CEO of GenVec. "Patient enrollment is currently underway in the
fourth cohort and we look forward to updating our stockholders as
further progress is made."
"Operationally, we remain focused on business development
activities directed at forming new collaborations to maximize the
value of our AdenoVerse™ platform," Mr. Swirsky continued.
"Recently presented data demonstrate the potential of our
proprietary vectors to deliver genes to immune cells and we believe
our platform may offer unique advantages for applications in
emerging areas such as cellular immunotherapy and gene
editing."
Financial Results for the Three Months and Nine Months Ended
September 30, 2016
Revenues for the three-month and nine-month periods ended
September 30, 2016 were $173,000 and $489,000, respectively, which represent decreases
of 10% and 33% as compared to $193,000 and $725,000 in the comparable prior year
periods.
The decrease in revenue for the three-month period ended
September 30, 2016 is primarily
attributable to a reduced work scope under our hearing loss and
balance disorders program, which resulted in a $42,000 reduction in revenue in the current
period as compared to the same period in 2015. This was
partially offset by an increase of $22,000 in revenue for work performed under our
malaria program.
The decrease in revenue for the nine-month period ended
September 30, 2016 is primarily
attributable to the completion of our contract with the U.S.
Department of Homeland Security related to our animal health
program in February 2015. We
recognized $0.2 million in revenue
under this contract in the nine months of 2015 with no
corresponding revenue associated with this contract in the same
period in 2016. Revenue under our animal health program in 2016 is
related to the second amendment to our license agreement with
Merial Inc. Also contributing to the decrease was a reduced
work scope under our hearing loss and balance disorders program,
which resulted in a $0.1 million
reduction in revenue in the current period as compared to the same
period in 2015. Partially offsetting these decreases was an
increase in revenue from our malaria program of $0.1 million, primarily attributable to our grant
with the NIH. As noted previously, work under this grant was
completed in March 2016.
Operating expenses were $1.7
million and $5.6 million for
the three-month and nine-month periods ended September 30, 2016, respectively, which are
in-line with the comparable prior year periods.
General and administrative expenses for the three-month and
nine-month periods ended September 30,
2016 increased 18% and 4%, respectively, with expenses of
approximately $1.2 million and
$3.8 million in 2016 as compared to
$1.0 million and $3.6 million, respectively, in 2015. The increase
is primarily attributable to higher expenses for professional
services in the three-month period ended September 30, 2016 as compared to the same period
in 2015. For the nine-month period ended September 30, 2016, the increase is primarily
attributable to higher personnel costs due to the expansion of our
workforce by three full-time employees as compared to the same
period in 2015.
Research and development expenses for the three-month and
nine-month periods ended September 30,
2016 decreased 26% and 10%, respectively, with expenses of
approximately $0.5 million and
$1.8 million in 2016 as compared to
$0.7 million and $2.0 million, respectively, in 2015. The
decreases are primarily attributable to lower expenses for
personnel and professional services in both the three- and
nine-month periods ended September 30,
2016 as compared to the same periods in 2015.
Other income, net for the three-month and nine-month periods
ended September 30, 2016 was
$323,000 and $841,000, respectively, as compared to
$6,000 and $19,000, respectively, for the same periods in
2015. The increases in the 2016 periods were due to a $0.3 million and $1.1
million change in the fair value of the warrant liabilities
in connection with our May 10, 2016
registered offering, respectively, for the three- and nine-month
periods ended September 30, 2016,
partially offset by financing expenses of $250,000 related to the offering, in the
nine-month period ended September 30,
2016.
2016 Guidance
For 2016, GenVec continues to anticipate a cash burn between
$6.0 million and $6.5 million,
exclusive of our May 2016
financing. We believe our existing resources are sufficient
to fund operations into 2018.
About GenVec
GenVec is a clinical-stage gene delivery company focused on
developing a pipeline of cutting-edge therapeutics and vaccines
using its proprietary AdenoVerse™ gene delivery platform. The
company is a pioneer in the design, testing and manufacture of
adenoviral-based product candidates that can deliver on the promise
of gene-based medicine. GenVec's lead product candidate, CGF166, is
licensed to Novartis and is currently in a Phase 1/2 clinical study
for the treatment of hearing loss and balance disorders. In
addition to its internal and partnered pipeline, the company is
also focused on opportunities to license its proprietary technology
platform, including vectors and production cell lines, for the
development and manufacture of therapeutics and vaccines to the
biopharmaceutical industry. Additional information about GenVec is
available at www.genvec.com and in the company's various filings
with the Securities and Exchange Commission.
Statements herein relating to future financial or business
performance, conditions or strategies and other financial and
business matters, including with respect to GenVec's hearing loss
and balance disorders program, business strategy, expansion of the
reach of GenVec's technology platform, and expectations regarding
cash burn, are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act. GenVec cautions
that these forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time.
Factors that may cause actual results to differ materially from the
results discussed in, or implied by, the forward-looking statements
or historical experience include risks and uncertainties, such as
the failure of Novartis to advance GenVec's hearing loss and
balance disorders program or of the interest or success of other
potential or existing third-party collaborators, as well as
unexpected business expenses or opportunities. Further
information on the factors and risks that could affect GenVec's
business, financial condition and results of operations, are
contained in GenVec's filings with the U.S. Securities and Exchange
Commission (SEC), which are available at www.sec.gov. These
forward-looking statements speak only as of the date of this press
release, and GenVec assumes no duty to update forward-looking
statements.
Contact:
Rena Cohen
(240) 632-5501
ir@genvec.com
(Tables to follow)
GenVec,
Inc.
|
Condensed
Statements of Operations
|
(in thousands,
except per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues
|
$173
|
|
$193
|
|
$489
|
|
$725
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
General and
administrative
|
1,181
|
|
999
|
|
3,765
|
|
3,619
|
Research and
development
|
522
|
|
705
|
|
1,827
|
|
2,028
|
Total operating expenses
|
1,703
|
|
1,704
|
|
5,592
|
|
5,647
|
|
|
|
|
|
|
|
|
Operating
Loss
|
(1,530)
|
|
(1,511)
|
|
(5,103)
|
|
(4,922)
|
|
|
|
|
|
|
|
|
Other
income/(expense):
|
|
|
|
|
|
|
|
Change in fair value
of warrant
liabilities
|
314
|
|
-
|
|
1,079
|
|
-
|
Financing
expense
|
-
|
|
-
|
|
(250)
|
|
-
|
Interest and other
income, net
|
9
|
|
6
|
|
12
|
|
19
|
Total other
income, net
|
323
|
|
6
|
|
841
|
|
19
|
|
|
|
|
|
|
|
|
Net
loss
|
$(1,207)
|
|
$(1,505)
|
|
$(4,262)
|
|
$(4,903)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss
per share
|
$(0.05)
|
|
$(0.09)
|
|
$(0.21)
|
|
$(0.30)
|
Shares used in
computation of basic
and diluted net loss per share
|
22,736
|
|
16,760
|
|
20,149
|
|
16,614
|
|
|
|
GenVec,
Inc.
Selected Balance
Sheet Information
(in
thousands)
|
|
|
|
|
September 30,
2016
(unaudited)
|
|
December 31,
2015
|
Cash, cash
equivalents and
investments
|
$8,396
|
|
$8,676
|
Working
capital
|
7,450
|
|
7,393
|
Total
assets
|
9,268
|
|
9,463
|
Stockholders'
equity
|
6,045
|
|
7,680
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/genvec-reports-third-quarter-2016-financial-results-300357428.html
SOURCE GenVec, Inc.