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10390
Pacific Center Court, San Diego, CA 92121-4340
858·646·1100,
FAX: 858·646·1150
www.vical.com
|
News
Release
|
Contacts:
|
Alan
R. Engbring
Executive
Director, Investor Relations
(858)
646-1127
Website:
www.vical.com
|
Jill
M. Church
Vice
President and Chief Financial
Officer
|
·
|
Sanofi-aventis
initiated a 500-patient pivotal Phase 3 clinical trial of its NV1FGF
angiogenesis therapy, which is based on Vical’s non-viral DNA delivery
technology. Assuming successful completion of the trial, sanofi-aventis
expects to file for marketing approval in
2010.
|
·
|
The
company’s other angiogenesis licensee, AnGes MG, Inc. (AnGes), is
preparing an application for Japanese marketing approval based
on positive
results following an interim efficacy evaluation in its Japanese
Phase 3
trial of its gene-based Hepatocyte Growth Factor (HGF) product
candidate
in patients with advanced peripheral arterial disease
(PAD).
|
·
|
In
October, an
independent data safety monitoring board (DSMB) found no safety
issues and
recommended continuation of the company’s Phase 2 trial of a DNA vaccine
against cytomegalovirus (CMV) in patients receiving hematopoietic
stem
cell transplants. The DSMB completed an interim evaluation of safety
data
after the two-month follow-up visits for the first 20 transplant
recipients enrolled in the study.
|
·
|
In
August, Vical initiated a Phase 1 trial of the company’s
Vaxfectin™-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The
double-blind, placebo-controlled trial is evaluating safety, tolerability
and immune responses in up to 60 healthy volunteers. Vaccination
of the
first dose cohort has been completed with no safety issues, and
the second
dose cohort has been fully enrolled. Trial results are expected
in the
first half of 2008.
|
·
|
In
October, the protein-based H5N1 pandemic influenza vaccine currently
stockpiled by the U.S. government was shown to derive dose-sparing
benefit
from the company’s patented Vaxfectin™ adjuvant in a study in
mice.
|
·
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The
company also reported that a measles DNA vaccine formulated with
the
company’s Vaxfectin™ adjuvant completely protected infant nonhuman
primates following challenge one year after intradermal vaccination,
with
no clinical signs of disease and no culturable virus after
challenge.
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VICAL
INCORPORATED
|
|||||||||||
Selected
Condensed Financial Information
(Unaudited)
|
Statements
of Operations
|
Three
Months Ended Sept. 30,
|
Nine
Months Ended Sept. 30,
|
|||||||||||
(in
thousands, except per share amounts)
|
2007
|
2006
|
2007
|
2006
|
|||||||||
Revenues:
|
|||||||||||||
Contract
and grant revenue
|
$
|
164
|
$
|
412
|
$
|
3,994
|
$
|
13,091
|
|||||
License
and royalty revenue
|
211
|
154
|
747
|
346
|
|||||||||
Total
revenues
|
375
|
566
|
4,741
|
13,437
|
|||||||||
Operating
expenses:
|
|||||||||||||
Research
and development
|
5,580
|
4,038
|
17,314
|
12,853
|
|||||||||
Manufacturing
and production
|
2,871
|
2,899
|
11,034
|
10,950
|
|||||||||
General
and administrative
|
2,192
|
1,904
|
6,825
|
6,752
|
|||||||||
Total
operating expenses
|
10,643
|
8,841
|
35,173
|
30,555
|
|||||||||
Loss
from operations
|
(10,268
|
)
|
(8,275
|
)
|
(30,432
|
)
|
(17,118
|
)
|
|||||
Net
investment income
|
1,029
|
766
|
3,399
|
1,892
|
|||||||||
Net
loss
|
$
|
(9,239
|
)
|
$
|
(7,509
|
)
|
$
|
(27,033
|
)
|
$
|
(15,226
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.24
|
)
|
$
|
(0.24
|
)
|
$
|
(0.69
|
)
|
$
|
(0.52
|
)
|
|
Shares
used to calculate basic and diluted net loss per
share
|
39,193
|
30,714 | 39,189 | 29,282 |
Balance
Sheets
|
Sept.
30,
|
December
31,
|
|||||||||||
(in
thousands)
|
2007
|
2006
|
|||||||||||
Assets:
|
|||||||||||||
Cash,
cash equivalents, and marketable securities
|
$
|
76,906
|
$
|
100,393
|
|||||||||
Other
current assets
|
1,328
|
5,049
|
|||||||||||
Total
current assets
|
78,234
|
105,442
|
|||||||||||
Property
and equipment, net
|
12,808
|
13,500
|
|||||||||||
Other
assets
|
5,665
|
6,307
|
|||||||||||
Total
assets
|
$
|
96,707
|
$
|
125,249
|
|||||||||
|
|||||||||||||
Liabilities
and stockholders' equity:
|
|||||||||||||
Current
liabilities
|
$
|
5,768
|
$
|
8,153
|
|||||||||
Long-term
obligations
|
2,649
|
2,973
|
|||||||||||
Stockholders'
equity
|
88,290
|
114,123
|
|||||||||||
Total
liabilities and stockholders' equity
|
$
|
96,707
|
$
|
125,249
|