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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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FOR
IMMEDIATE RELEASE
August
5, 2008
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Contacts:
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Alan
R. Engbring
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Jill
M. Church
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| |
Executive
Director,
Investor Relations
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Vice
President and
Chief Financial Officer
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(858)
646-1127
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Website:
www.vical.com
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Vical
Reports Second Quarter and First Six Months 2008 Financial
Results
And
Highlights in Product Development Programs
SAN
DIEGO—August 5, 2008—Vical Incorporated (Nasdaq:VICL) today reported financial
results for the quarter and six months ended June 30, 2008. Revenues for
the
second quarter of 2008 were $2.5 million, compared with revenues of $3.1
million
for the second quarter of 2007. The net loss for the second quarter of
2008 was
$8.5 million, or $0.21 per share, compared with a net loss of $8.2 million,
or
$0.21 per share, for the second quarter of 2007.
Revenues
for the first six months of 2008 were $4.5 million, compared with revenues
of
$4.4 million for the first six months of 2007. The net loss for the first
six
months of 2008 was $18.0 million, or $0.46 per share, compared with a net
loss
of $17.8 million, or $0.45 per share, for the first six months of
2007.
Vical
had
cash and investments of $58 million at June 30, 2008. The company’s second
quarter 2008 financial results were consistent with its projection for
a full
year net loss of $32 million to $37 million and a net cash burn of $27
million
to $32 million.
Independent
Development Program Highlights
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· |
Preliminary
data from a Phase 1 trial of the company's Vexfectin®-formulated
H5N1
pandemic
influenza DNA vaccines demonstrated
for the first time that DNA vaccines have achieved potentially
protective
levels of antibody responses in humans with no significant safety
issues.
These results support further development of pandemic influenza
DNA
vaccines and advancement of additional Vaxfectin®-formulated
DNA vaccines. The Vaxfectin®
adjuvant is currently being evaluated by potential partners for
a variety
of additional vaccine applications.
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·
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In
June, Vical received $6.3 million of cash payments and equity investments
from AnGes MG, Inc., for continued funding of the company's ongoing
Allovectin-7®
Phase 3 metastatic melanoma trial. Vical is conducting the Phase
3 pivotal
trial multinationally at nearly 50 sites to evaluate
Allovectin-7®
as
first-line therapy in chemotherapy-naïve patients with Stage III or IV
metastatic melanoma.
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·
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In
an editorial commentary in the June 15 issue of The Journal of Infectious
Diseases, independent experts on cytomegalovirus (CMV)
said the vaccine under development by Vical, at the optimal dose
and
regimen tested, “holds promise” based on its ability to elicit persistent
immune responses in a majority of CMV-seronegative subjects, and
warrants
further evaluation for its potential to prevent infection and disease.
The
commentary accompanied the issue's lead article, which expanded on
previously reported immunogenicity data from a Phase 1 study of Vical’s
DNA vaccine. The company’s Phase 2 trial of the CMV vaccine in patients
undergoing hematopoietic cell transplants is on schedule for release
of
interim efficacy data in the second half of
2008.
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·
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The
company successfully completed first-year milestones under a three-year,
$6.0 million grant awarded in 2007, and is advancing with the development
of the RapidResponse™ DNA vaccine manufacturing process, which is designed
to allow extremely rapid and large-scale production of DNA vaccines
with
low capital requirements.
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Partnered
Development Program Highlights
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·
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In
July, Vical received a
$1.0 million cash payment from its Japanese
partner, the biotechnology company AnGes
MG, Inc.,
reflecting continued progress of its Collategene™ angiogenesis program.
Vical
received an initial upfront payment of $1.0 million under
an exclusive license agreement in
2005, and further advancement may lead to additional milestones and
royalty payments. In March 2008, AnGes filed for marketing approval
with
the Japanese Ministry of Health, Labor and Welfare for the use of
Collategene™ as a treatment for critical limb ischemia, an advanced form
of peripheral arterial disease, and for Buerger’s disease. The
Collategene™ application in Japan is the first for an angiogenesis product
based on Vical’s patented DNA delivery
technology.
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·
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The
company’s European partner 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.
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Conference
Call
Vical
will conduct a conference call and webcast to discuss the financial results
and
program updates with invited analysts and institutional investors today, August
5, at noon Eastern Time. The call and webcast are open on a listen-only basis
to
any interested parties. To listen to the conference call, dial in approximately
ten minutes before the scheduled call to (888) 600-4883, or (913) 312-6683
for
international participants, and reference confirmation code 4962317. A replay
of
the call will be available for 48 hours beginning about two hours after the
call. To listen to the replay, dial (888) 203-1112, or (719) 457-0820 for
international participants, and enter replay passcode 4962317. The call also
will be available live and archived through the events page at www.vical.com.
For
further information, contact Vical’s Investor Relations department by phone at
(858) 646-1127 or by e-mail at info@vical.com.
About
Vical
Vical
researches and develops biopharmaceutical products based on its patented DNA
delivery technologies for the prevention and treatment of serious or
life-threatening diseases. Potential applications of the company’s DNA delivery
technology include DNA vaccines for infectious diseases or cancer, in which
the
expressed protein is an immunogen; cancer immunotherapeutics, in which the
expressed protein is an immune system stimulant; and cardiovascular therapies,
in which the expressed protein is an angiogenic growth factor. The company
is
developing certain infectious disease vaccines and cancer therapeutics
internally. In addition, the company collaborates with major pharmaceutical
companies and biotechnology companies that give it access to complementary
technologies or greater resources. These strategic partnerships provide the
company with mutually beneficial opportunities to expand its product pipeline
and address significant unmet medical needs. Additional information on Vical
is
available at www.vical.com.
Forward-Looking
Statements
This
press release contains forward-looking statements subject to risks and
uncertainties that could cause actual results to differ materially from those
projected, including: whether Vical or others will continue development of
the
company’s Vaxfectin®
adjuvant, the company’s H5N1 pandemic influenza or CMV vaccine candidates,
Allovectin-7®,
the
RapidResponse™ DNA vaccine platform, Collategene™, the FGF-1 angiogenesis
product candidate, or any other product candidates being developed by Vical,
its
collaborators or licensees; whether Vical or others will pursue further
development of pandemic influenza DNA vaccines, advancement of additional
Vaxfectin®-formulated
DNA vaccines, or additional Vaxfectin®
applications; whether any product candidates being developed by Vical, its
collaborators or licensees will be shown to be safe and effective in clinical
trials; whether Vical will release interim efficacy data from the Phase 2 CMV
vaccine trial in the second half of 2008, if at all; whether AnGes will provide
all, if any, additional funding for the Allovectin-7®
Phase 3
trial; whether the RapidResponse™ platform will allow extremely rapid and
large-scale production of DNA vaccines with low capital requirements; whether
the company will receive all, if any additional RapidResponse™ grant funding;
whether AnGes will receive marketing approval of Collategene™ in Japan; whether
AnGes will initiate a Phase 3 registration trial of Collategene™ in the United
States; whether sanofi-aventis will successfully complete its Phase 3 pivotal
trial of ist FGF-1 angiogenesis product candidate and file for marketing
approvals in 2010, if at all; the timing, nature and cost of clinical trials;
whether the company will achieve levels of revenues and control expenses to
meet
projected financial performance; and additional risks set forth in the company’s
filings with the Securities and Exchange Commission. These forward-looking
statements represent the company’s judgment as of the date of this release. The
company disclaims, however, any intent or obligation to update these
forward-looking statements.
VICAL
INCORPORATED
Selected
Condensed Financial Information (Unaudited)
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Statements of Operations
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Three Months Ended June 30,
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Six Months Ended June 30,
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(in thousands, except per share amounts)
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2008
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2007
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2008
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2007
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Revenues:
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|
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Contract
and grant revenue
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$
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433
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$
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2,980
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$
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893
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$
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3,830
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License
and royalty revenue
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2,114
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131
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3,594
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536
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Total
revenues
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2,547
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3,111
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4,487
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4,366
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Operating
expenses:
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|
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Research
and development
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6,464
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5,859
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13,058
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11,734
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Manufacturing
and production
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2,950
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4,216
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6,056
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8,163
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General
and administrative
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2,017
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2,340
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4,352
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4,633
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Total
operating expenses
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11,431
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12,415
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23,466
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24,530
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Loss
from operations
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|
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(8,884
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)
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(9,304
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)
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(18,979
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)
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(20,164
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)
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Net
investment income
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|
402
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|
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1,107
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932
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|
2,370
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Net
loss
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$
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(8,482
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)
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$
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(8,197
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)
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$
|
(18,047
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)
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$
|
(17,794
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)
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|
Basic
and diluted
|
|
|
|
|
|
|
|
|
|
|
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net
loss per share
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$
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(0.21
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)
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$
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(0.21
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)
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$
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(0.46
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)
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$
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(0.45
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)
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Shares
used to calculate basic
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|
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|
|
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|
|
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|
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and
diluted net loss per share
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39,488
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39,191
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39,353
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|
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39,186
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Balance Sheets
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June 30,
|
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December 31,
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(in thousands)
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2008
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|
2007
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Assets:
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Cash,
cash equivalents, and marketable securities
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$
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51,323
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$
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71,489
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Other
current assets
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2,271
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|
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1,261
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Total
current assets
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53,594
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72,750
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Marketable
securities
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6,208
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-
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Property
and equipment, net
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11,494
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12,287
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Other
assets
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5,143
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5,548
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Total
assets
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$
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76,439
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$
|
90,585
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|
|
|
|
|
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Liabilities
and stockholders' equity:
|
|
|
|
|
|
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Current
liabilities
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$
|
7,573
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$
|
8,108
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Long-term
obligations
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2,494
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|
|
2,565
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Stockholders'
equity
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66,372
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|
|
79,912
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Total
liabilities and stockholders' equity
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$
|
76,439
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$
|
90,585
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#
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