Alan
R. Engbring
|
Jill
M. Church
|
|
Executive
Director, Investor Relations
|
Vice
President and Chief Financial Officer
|
|
(858)
646-1127
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||
Website:
www.vical.com
|
·
|
The
Phase 3 pivotal trial of the company’s Allovectin-7®
immunotherapeutic is actively enrolling patients at nearly 50 sites
in
North America and Europe, and completion of enrollment is expected
in
mid-2009. The trial is being funded by cash payments and equity
investments from AnGes
MG, Inc.
|
·
|
The
company’s Phase 2 trial of a vaccine designed to prevent cytomegalovirus
(CMV)
disease in patients undergoing hematopoietic cell transplants has
exceeded
50% enrollment and is on schedule for release of interim efficacy
data in
the second half of 2008.
|
·
|
The
company’s Phase 1 trial of its Vaxfectin®-formulated
vaccine for pandemic influenza completed enrollment and final dosing
on
schedule and results will be released by August. The company’s novel
Vaxfectin®
adjuvant has demonstrated efficacy enhancement and dose-sparing ability
in
a variety of animal models. Vaxfectin®
is
currently being evaluated for additional vaccine applications by
several
potential partners.
|
·
|
The
company was awarded a two-year, $2.0 million grant from the National
Institutes of Health (NIH) to fund the ongoing development of Vical’s
immunotherapeutic vaccine designed to reduce disease symptoms and
viral
shedding in patients already infected with herpes simplex virus type
2
(HSV-2), a sexually transmitted virus which is the leading cause
of
genital herpes. The HSV-2 vaccine will also be evaluated with Vical’s
proprietary Vaxfectin®
adjuvant.
|
·
|
The
company’s Japanese partner, the biotechnology company AnGes, submitted a
New Drug Application (NDA) to the Japanese Ministry of Health, Labor
and
Welfare for its hepatocyte growth factor (HGF) angiogenesis product
candidate, Collategene,
for treatment of critical limb ischemia. AnGes is expected to pursue
initiation of a Phase 3 registration trial with Collategene
in
the United States.
|
·
|
The
company’s European partner, the large pharmaceutical company sanofi-aventis,
is conducting a 500-patient Phase 3 pivotal trial of its fibroblast
growth
factor 1 (FGF-1) angiogenesis product candidate in key global markets
and
anticipates filing for marketing approvals in
2010.
|
Statements
of Operations
|
Three
Months Ended
March
31,
|
||||||
(in
thousands, except per share amounts)
|
2008
|
2007
|
|||||
Revenues:
|
|||||||
Contract
and grant revenue
|
$
|
460
|
$
|
850
|
|||
License
and royalty revenue
|
1,480
|
405
|
|||||
Total
revenues
|
1,940
|
1,255
|
|||||
Operating
expenses:
|
|||||||
Research
and development
|
6,594
|
5,875
|
|||||
Manufacturing
and production
|
3,106
|
3,947
|
|||||
General
and administrative
|
2,335
|
2,293
|
|||||
Total
operating expenses
|
12,035
|
12,115
|
|||||
Loss
from operations
|
(10,095
|
)
|
(10,860
|
)
|
|||
Net
investment income
|
530
|
1,263
|
|||||
Net
loss
|
$
|
(9,565
|
)
|
$
|
(9,597
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.24
|
)
|
$
|
(0.24
|
)
|
|
Shares
used to calculate basic and diluted net loss per
share
|
39,218
|
39,182
|
Balance
Sheets
|
March
31,
|
December
31,
|
|||||
(in
thousands)
|
2008
|
2007
|
|||||
Assets:
|
|||||||
Cash,
cash equivalents, and marketable securities
|
$
|
51,998
|
$
|
71,489
|
|||
Other
current assets
|
1,645
|
1,261
|
|||||
Total
current assets
|
53,643
|
72,750
|
|||||
Marketable
securities
|
8,228
|
-
|
|||||
Property
and equipment, net
|
11,868
|
12,287
|
|||||
Other
assets
|
5,296
|
5,548
|
|||||
Total
assets
|
$
|
79,035
|
$
|
90,585
|
|||
Liabilities
and stockholders' equity:
|
|||||||
Current
liabilities
|
$
|
5,970
|
$
|
8,108
|
|||
Long-term
obligations
|
2,513
|
2,565
|
|||||
Stockholders'
equity
|
70,552
|
79,912
|
|||||
Total
liabilities and stockholders' equity
|
$
|
79,035
|
$
|
90,585
|