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10390
Pacific Center Court, San Diego, CA 92121-4340
858·646·1100,
FAX: 858·646·1150
www.vical.com
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News
Release
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Contacts: | Alan R. Engbring | Jill M. Church | |
Executive Director, Investor Relations | Vice President and | ||
(858) 646-1127 | Chief Financial Officer | ||
Website: www.vical.com |
· |
Vical
has received notification of Investigational New Drug (IND) allowance
for
its Phase 1 trial of the company’s Vaxfectin™-formulated pandemic
influenza DNA vaccine, and now expects to initiate the trial earlier
than
originally planned during the second half of
2007.
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· |
The
company’s licensee, AnGes MG, Inc. (AnGes), reported positive results
following an interim efficacy evaluation in its Japanese Phase 3
angiogenesis trial of its gene-based Hepatocyte Growth Factor (HGF)
product candidate in patients with advanced peripheral arterial disease
(PAD). Based on the recommendation of an Independent Data Monitoring
Committee, AnGes ended the trial early and is preparing an application
for
Japanese marketing approval.
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· |
Vical
announced in July the enrollment of the 20th
hematopoietic stem cell transplant recipient in the company’s Phase 2
trial of a DNA vaccine against cytomegalovirus (CMV). After the
20th
recipient’s two-month follow-up visit, an independent data safety
monitoring board will conduct an interim evaluation of safety data
for all
subjects enrolled in the trial.
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· |
The
company has initiated 30 of up to 60 planned clinical sites for
the
AIMM (Allovectin-7®
Immunotherapeutic for Metastatic Melanoma)
Phase 3
pivotal trial of the Allovectin-7®
cancer immunotherapeutic as first-line therapy in chemotherapy-naïve
patients with recurrent Stage III or IV metastatic melanoma. The
trial is
being funded by AnGes under a collaborative agreement with
Vical.
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· |
During
the second quarter, the company completed the final contract manufacturing
and shipment of HIV vaccine bulk DNA under a $12 million production
order
for the National Institutes of Health (NIH) for a planned Phase 2b
efficacy proof-of-concept trial expected to begin this year with
the
support of the Partnership for AIDS Vaccine Evaluation (PAVE). The
PAVE
trial will test a vaccine regimen combining a DNA prime based on
Vical’s
technology with an adenoviral vector boost in up to 8,500 volunteers
at
sites in the United States, Africa, the Caribbean and South America
to
determine its potential to prevent infection or disease
progression.
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· |
Vical
was awarded a three-year, $6.0 million grant from the National Institute
of Allergy and Infectious Diseases (NIAID), part of the NIH, for
further
development of a DNA vaccine manufacturing process with the potential
to
produce several million doses of vaccines in a matter of days. By
using a
cell-free manufacturing process, the company believes that the
RapidResponse™ DNA platform can overcome the time, capacity and cost
challenges of manufacturing conventional vaccines for diseases such
as
influenza, which use killed or disabled viruses grown in chicken
eggs or
via cell culture, requiring months of production time in large, dedicated
facilities.
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Statements
of Operations
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Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
||||||||||
(in
thousands, except per share amounts)
|
2007
|
|
2006
|
2007
|
2006
|
||||||||
Revenues:
|
|||||||||||||
Contract
and grant revenue
|
$
|
2,980
|
$
|
7,100
|
$
|
3,830
|
$
|
12,679
|
|||||
License
and royalty revenue
|
131
|
156
|
536
|
192
|
|||||||||
Total
revenues
|
3,111
|
7,256
|
4,366
|
12,871
|
|||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
5,859
|
4,171
|
11,734
|
8,815
|
|||||||||
Manufacturing
and production
|
4,216
|
4,499
|
8,163
|
8,051
|
|||||||||
General
and administrative
|
2,340
|
2,406
|
4,633
|
4,848
|
|||||||||
Total
operating expenses
|
12,415
|
11,076
|
24,530
|
21,714
|
|||||||||
Loss
from operations
|
(9,304
|
)
|
(3,820
|
)
|
(20,164
|
)
|
(8,843
|
)
|
|||||
Net
investment income
|
1,107
|
576
|
2,370
|
1,126
|
|||||||||
Net
loss
|
$
|
(8,197
|
)
|
$
|
(3,244
|
)
|
$
|
(17,794
|
)
|
$
|
(7,717
|
)
|
|
Basic
and diluted
|
|||||||||||||
net
loss per share
|
$
|
(0.21
|
)
|
$
|
(0.11
|
)
|
$
|
(0.45
|
)
|
$
|
(0.27
|
)
|
|
Shares
used to calculate basic
|
|||||||||||||
and
diluted net loss per share
|
39,191
|
28,817 | 39,186 | 28,555 |
Balance
Sheets
|
|
June
30,
|
|
December
31,
|
|||
(in
thousands)
|
2007
|
2006
|
|||||
Assets:
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|||||||
Cash,
cash equivalents, and marketable securities
|
$
|
82,153
|
$
|
100,393
|
|||
Other
current assets
|
4,340
|
5,049
|
|||||
Total
current assets
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86,493
|
105,442
|
|||||
Property
and equipment, net
|
13,031
|
13,500
|
|||||
Other
assets
|
5,899
|
6,307
|
|||||
Total
assets
|
$
|
105,423
|
$
|
125,249
|
|||
Liabilities
and stockholders' equity:
|
|||||||
Current
liabilities
|
$
|
5,500
|
$
|
8,153
|
|||
Long-term
obligations
|
2,735
|
2,973
|
|||||
Stockholders'
equity
|
97,188
|
114,123
|
|||||
Total
liabilities and stockholders' equity
|
$
|
105,423
|
$
|
125,249
|