Vical Reports 2010
Financial Results and Progress in Key Development
Programs
SAN DIEGO,
Feb. 10, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported
financial results for the year ended December 31,
2010. Vical had cash and investments
of approximately $61 million at year-end
2010. The company received approximately $37
million of net proceeds from the sale of equity
securities during 2010.
Revenues for 2010 were $8.7 million,
compared with revenues of
$12.7 million for 2009. The net loss for 2010 was $30.4
million, or $0.51 per share,
compared with a net loss of
$28.6 million, or $0.61 per share, for 2009. The
net cash burn for 2010, excluding cash received from
financings, was approximately $29 million,
compared with approximately $22 million
for 2009. The company is projecting a net cash burn for
2011 of between $22 million and $27 million,
including projected cash from new or expanded
partnerships for which we do not currently have
contracts.
Development highlights during 2010 included:
Allovectin-7®
- Completion of enrollment in February 2010
in the company's pivotal Phase 3 trial of
Allovectin-7® in patients with metastatic
melanoma; and
- Completion of the Phase 3 trial's fourth
scheduled safety analysis by an independent Safety
Monitoring Board and the recommendation that the
trial continue per the protocol.
TransVax™ CMV Vaccine
- Achievement of key efficacy, immunogenicity and
safety results in a Phase 2 trial, establishing the
TransVax™ cytomegalovirus (CMV) vaccine as the first
to provide evidence of protection in
immunocompromised hematopoietic cell transplant (HCT)
recipients, and defining a potential pathway for
further development.
Prophylactic CMV Vaccine
- A five-year, $4.0 million grant
to leading pediatric infectious disease researchers
Stuart P. Adler, M.D., and
Michael A. McVoy, Ph.D., of Virginia Commonwealth
University (VCU) from the National
Institutes of Health (NIH), to develop novel
vaccine approaches designed to protect women of
child-bearing potential from infection with CMV. Vical will produce the DNA vaccines and Vaxfectin®
adjuvant, and will conduct the animal studies funded
by the grant.
H1N1 Influenza Vaccine
- Initiation of a U.S. government-funded Phase 1
trial of the company's Vaxfectin®-formulated
DNA vaccine against H1N1 swine-origin pandemic
influenza in collaboration with the U.S. Naval
Medical Research Center (NMRC).
Herpes Simplex Vaccines
- Protection against lethal challenge, sterilizing
immunity and inhibition of viral counts at both the
primary and latent infection sites in mice with the
company's prophylactic Vaxfectin®-formulated
DNA vaccine against herpes simplex virus type 2
(HSV-2). Significant reduction with a related
vaccine of the recurrence of HSV-2 lesions in a
therapeutic model using guinea pigs with latent
infection.
Collaborations
- The launch by the company's licensee Merial
Limited, the animal health subsidiary of
sanofi-aventis, of its ONCEPT™ canine melanoma
vaccine, a therapeutic DNA vaccine designed to aid
in extending survival of dogs with oral melanoma;
and
- Approval by the FDA of the Special
Protocol Assessment (SPA) agreement for the
company's licensee, AnGes MG, Inc., for a
Phase 3 clinical trial of its Collategene™
angiogenesis product for patients with advanced
peripheral arterial disease (PAD).
Manufacturing Contract
- A $2.4 million contract to
manufacture plasmid DNA (pDNA) vaccines against HIV
for the IPPOX Foundation, a collaborating
institution for the Poxvirus Vaccine Regimen Design
(PVRD) led by the Centre Hospitalier Universitaire
Vaudois (CHUV) under the auspices of the
Collaboration for AIDS Vaccine Discovery (CAVD).
Anticipated program highlights for 2011 include:
- Data in the first quarter of 2011 from the Phase
1 trial of the company's Vaxfectin®-adjuvanted
DNA vaccine for H1N1 influenza;
- Database lock in the second half of 2011 in the
company's Phase 3 trial of Allovectin-7®
in patients with metastatic melanoma;
- Initiation in the second half of 2011 of a Phase
3 trial of the company's TransVax™ CMV vaccine
candidate for HCT patients; and
- Efforts by AnGes to expedite initiation of a
multinational Phase 3 clinical trial of its
Collategene™ angiogenesis product for patients with
advanced PAD.
Conference Call
Vical
will conduct a conference call and webcast today,
February 10, at noon Eastern Time,
to discuss with invited analysts and institutional
investors the company's financial results and program
updates. 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 (913) 312-1493 (preferred),
or (888) 710-4022 (toll-free), and reference
confirmation code 3159114. A replay of the call will be
available for 48 hours beginning about two hours after
the call. To listen to the replay, dial (719) 457-0820
(preferred) or (888) 203-1112 (toll-free) and enter
replay passcode 3159114. 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
ir@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.
The
Vical Incorporated
logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5768
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. Forward-looking statements include net loss
and net cash burn guidance, as well as statements about Vical's Allovectin-7®, TransVax™,
pandemic influenza vaccine and HSV-2 vaccine programs,
the VCU prophylactic CMV vaccine program, the IPPOX HIV
vaccine program, and other independent and collaborative
programs, as well as anticipated developments in
independent and collaborative programs, and statements
about the scope of coverage of and potential
applications for Vical's patents. Risks and uncertainties include
whether
Vical or others will continue development of
Allovectin-7®, TransVax™, a prophylactic
vaccine against congenital CMV infection, a vaccine
against H1N1 pandemic influenza, prophylactic and
therapeutic vaccines against HSV-2, the AnGes
Collategene™ angiogenesis therapy, the IPPOX HIV
vaccine, or any other independent or collaborative
programs; whether Vical will release data from the H1N1 influenza
vaccine Phase 1 trial in the first quarter of 2011, if
at all; whether Vical will lock the database in
the company's Phase 3 trial of Allovectin-7®
in the second half of 2011, if at all; whether Vical will initiate a Phase 3 trial of TransVax™
for HCT patients in the second half of 2011, if at all;
whether AnGes will expedite initiation of a
multinational Phase 3 trial of Collategene™ for patients
with advanced PAD in 2011, if at all; whether Vical will achieve levels of revenues and control
expenses to meet its financial projections; whether Vical will enter into any new partnerships or
expand any existing partnerships and receive all, if
any, projected cash payments; whether any product
candidates will be shown to be safe and efficacious in
clinical trials; the timing of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market any
product candidates; 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.
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VICAL INCORPORATED |
Selected Condensed Financial Information
(Unaudited) |
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Statements of
Operations |
Three
Months Ended Dec. 31, |
Twelve
Months Ended Dec. 31, |
(in thousands, except per
share amounts) |
2010 |
2009 |
2010 |
2009 |
Revenues: |
|
|
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Contract and grant
revenue |
$ 2,711 |
$ 949 |
$ 6,249 |
$ 3,692 |
License and royalty
revenue |
205 |
1,606 |
2,462 |
8,994 |
Total revenues |
2,916 |
2,555 |
8,711 |
12,686 |
Operating expenses: |
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Research and
development |
4,969 |
6,168 |
19,692 |
23,449 |
Manufacturing and
production |
2,893 |
1,887 |
11,436 |
10,354 |
General and
administrative |
2,325 |
1,914 |
8,798 |
7,469 |
Total operating expenses |
10,187 |
9,969 |
39,926 |
41,272 |
Loss from operations |
(7,271) |
(7,414) |
(31,215) |
(28,586) |
Net investment and
other income |
511 |
105 |
830 |
28 |
Net loss |
$ (6,760) |
$ (7,309) |
$ (30,385) |
$ (28,558) |
Basic and diluted net loss
per share |
$ (0.09) |
$ (0.14) |
$ (0.51) |
$ (0.61) |
Shares used to calculate
basic and diluted net loss per share |
71,716 |
52,192 |
60,084 |
47,086 |
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Balance Sheets |
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December 31, |
December 31, |
(in thousands) |
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2010 |
2009 |
Assets: |
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Cash, cash
equivalents, and marketable securities,
including restricted |
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$ 55,268 |
$ 47,085 |
Other current assets |
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940 |
1,349 |
Total current assets |
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56,208 |
48,434 |
Long-term investments |
|
|
5,434 |
5,477 |
Property and equipment,
net |
|
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7,560 |
9,260 |
Other assets |
|
|
3,705 |
4,201 |
Total assets |
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$ 72,907 |
$ 67,372 |
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Liabilities and
stockholders' equity: |
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Current liabilities |
|
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$ 6,334 |
$ 10,010 |
Long-term obligations |
|
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2,211 |
2,380 |
Stockholders' equity |
|
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64,362 |
54,982 |
Total liabilities and
stockholders' equity |
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$ 72,907 |
$ 67,372 |
CONTACT: Alan R. Engbring
Executive Director, Investor Relations
Jill M. Broadfoot
Senior Vice President and Chief Financial Officer
(858) 646-1127
Website: www.vical.com
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