* |
Merial
Limited received conditional approval of a DNA vaccine designed to
treat
melanoma in dogs -- the first-ever U.S. approval of a therapeutic
cancer
vaccine. Vical's licensee, a joint venture of Merck & Co., Inc. and
sanofi aventis, will distribute the vaccine initially through veterinary
cancer specialists.
|
* |
Vical
began its Phase 3 pivotal Allovectin-7(R) Immunotherapeutic for Metastatic
Melanoma (AIMM) trial in chemotherapy-naive patients with recurrent
Stage
III or IV disease. The trial was designed under a Special Protocol
Assessment (SPA) with the U.S. Food and Drug Administration (FDA),
and the
trial cost is being funded through cash payments and equity investments
by
partner AnGes MG, Inc. The primary endpoint of the trial is objective
response rate after 24 weeks or
more.
|
* |
The
company's licensee, AnGes MG, Inc., is conducting an interim efficacy
evaluation in its Japanese Phase 3 angiogenesis trial in patients
with
advanced peripheral arterial disease (PAD). Positive data from patients
already enrolled, which has been unblinded as each patient completes
the
treatment follow-up, could lead directly to a filing for accelerated
marketing approval in Japan and initiation of a Phase 3 registration
trial
in the United States.
|
* |
The
sanofi aventis group, Vical's other angiogenesis licensee, plans
to
initiate a pivotal Phase 3 trial in the second quarter of 2007 in
approximately 500 PAD patients in 32 countries with a goal of reducing
the
need for amputations. If the trial is successful, multinational filings
for marketing approval are anticipated in
2009-2010.
|
* |
The
U.S. Navy agreed to explore the use of Vical's patented Vaxfectin(TM)
adjuvant with experimental DNA vaccines against
malaria.
|
* |
Vical's
patents cover the use of Vaxfectin(TM) with conventional vaccines
as well
as DNA vaccines. In a recently completed study in mice, a commercial
seasonal influenza vaccine formulated with Vaxfectin(TM) generated
up to
60-fold higher antibody responses than unformulated vaccine at the
same
dose and allowed a nearly 10-fold reduction in vaccine dose. Results
from
the study suggest that Vaxfectin(TM) has the potential to be used
as a
dose-sparing agent with conventional vaccines against seasonal or
possibly
pandemic influenza strains.
|
* |
Vical
anticipates initiation in the second half of 2007 of a Phase 1 trial
with
the company's Vaxfectin(TM)-formulated pandemic influenza DNA
vaccine.
|
* |
The
11th International Betaherpes Virus Workshop (Toulouse, France, May
13-17),
|
* |
The
DNA Vaccines 2007 conference (Malaga, Spain, May
23-25),
|
* |
The
annual meeting of the American Society of Gene Therapy (Seattle,
May
30-June 3), and
|
* |
The
annual meeting of the American Society of Clinical Oncology (Chicago,
June
1-5).
|
Statements
of Operations
|
|||||||
(in
thousands, except per share amounts)
|
|||||||
Three
Months Ended
|
|||||||
March
31,
|
|||||||
2007
|
2006
|
||||||
Revenues:
|
|||||||
Contract
and grant revenue
|
$
|
850
|
$
|
5,579
|
|||
License
and royalty revenue
|
405
|
36
|
|||||
Total
revenues
|
1,255
|
5,615
|
|||||
Operating
expenses:
|
|||||||
Research
and development
|
5,875
|
4,644
|
|||||
Manufacturing
and production
|
3,947
|
3,552
|
|||||
General
and administrative
|
2,293
|
2,442
|
|||||
Total
operating expenses
|
12,115
|
10,638
|
|||||
Loss
from operations
|
(10,860
|
)
|
(5,023
|
)
|
|||
Net
investment income
|
1,263
|
550
|
|||||
Net
loss
|
$
|
(9,597
|
)
|
$
|
(4,473
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.24
|
)
|
$
|
(0.16
|
)
|
|
Shares
used to calculate basic and diluted net loss per share
|
39,182
|
28,290
|
Balance
Sheets
|
March
31,
|
December
31,
|
|||||
(in
thousands)
|
2007
|
2006
|
|||||
Assets:
|
|||||||
Cash,
cash equivalents, and marketable securities
|
$
|
90,665
|
$
|
100,393
|
|||
Other
current assets
|
4,375
|
5,049
|
|||||
Total
current assets
|
95,040
|
105,442
|
|||||
Property
and equipment, net
|
13,394
|
13,500
|
|||||
Other
assets
|
5,985
|
6,307
|
|||||
Total
assets
|
$
|
114,419
|
$
|
125,249
|
|||
Liabilities
and stockholders' equity:
|
|||||||
Current
liabilities
|
$
|
6,703
|
$
|
8,153
|
|||
Long-term
obligations
|
2,830
|
2,973
|
|||||
Stockholders'
equity
|
104,886
|
114,123
|
|||||
Total
liabilities and stockholders' equity
|
$
|
114,419
|
$
|
125,249
|
Contacts:
|
Alan
R. Engbring
|
Executive
Director, Investor Relations
|
|
(858)
646-1127
|
|
Jill
M. Church
|
|
Vice
President and Chief Financial Officer
|
|
Website:
www.vical.com
|