Vical Reports 2012 Financial Results and Progress in Key Development Programs
SAN DIEGO, Feb. 6, 2013 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL)
today reported financial results for the year ended December 31, 2012.
Revenues for 2012 were $17.5 million, compared with revenues of $30.0 million
for 2011, reflecting lower payments from Astellas Pharma Inc. under an
exclusive worldwide license of TransVax™, Vical's therapeutic vaccine designed
to control cytomegalovirus (CMV) reactivation in transplant recipients. In
2011, Vical received a $25.0 million upfront license payment from Astellas. In
2012, Vical received a $10.0 million milestone license payment and increased
contract revenues from Astellas driven by delivery of clinical trial material
for planned TransVax™ trials.
The net loss for 2012 was $22.9 million, or $0.27 per share, compared with a
net loss of $7.3 million, or $0.10 per share, for 2011. The increase in net
loss for 2012 was primarily a result of the lower license revenue partially
offset by higher net contract revenue under the Astellas agreements.
Vical had cash and investments of approximately $86 million at year-end 2012.
The net cash burn of approximately $19 million for 2012, excluding cash from
financing activities, was within the projected range. The company is
projecting net cash burn for the first half of 2013, excluding cash from
financing activities, of between $18 million and $20 million.
The projected net cash burn includes spending for long-lead-time activities
such as manufacturing, validation and others that the company believes will
allow timely filing of a Biologics License Application (BLA) assuming success
in its lead development program, Allovectin^® immunotherapy for patients with
metastatic melanoma. The company intends to provide net cash burn guidance for
the remainder of the year after the release of Phase 3 results.
Program highlights include:
*In the company's Phase 3 registration trial of Allovectin^® vs.
chemotherapy in patients with metastatic melanoma, the company conducted a
comprehensive sweep in September 2012 of all active clinical sites to
eliminate any time lag in death event reporting. The sweep confirmed that
the target number of events had not been reached. It also confirmed the
steady progress towards that goal.
*An independent Safety Monitoring Board (SMB) for the Phase 3 trial
completed its final review of comprehensive trial safety data in the third
quarter and reported "no basis for any concern that there is undue risk"
associated with Allovectin^®.
*The company is tracking progress toward the Phase 3 secondary endpoint
(overall survival) for both arms together in a blinded fashion.
Independent assessment and adjudication of patient-by-patient data for the
primary endpoint (response rate at 24 weeks or more after randomization)
is approaching completion. Upon reaching the target number of death
events, the databases for both endpoints will be unblinded simultaneously
and top-line results for both endpoints are expected to be released in
TransVax™ CMV Vaccine
*Astellas is planning to initiate a Phase 3 trial of TransVax™ for
hematopoietic stem cell transplant (HSCT) recipients and to initiate a
Phase 2 trial of TransVax™ for solid organ transplant (SOT) recipients in
the first half of 2013.
Herpes Simplex Vaccine
*The company is planning to initiate a Phase 1/2 clinical trial of its
Vaxfectin^®-formulated therapeutic vaccine against herpes simplex virus
type 2 (HSV-2) in the second half of 2013.
*At the 15th Annual Meeting of the American Society of Gene & Cell Therapy
in May 2012, Vical presented results from multiple animal studies with the
company's Vaxfectin^®-formulated vaccines against HSV-2 demonstrating
proof of concept.
*Results from the company's completed mouse studies with the HSV-2 vaccines
were published in The Journal of General Virology.
*Results from the company's completed guinea pig studies with the HSV-2
vaccines were published in Vaccine.
*During the first quarter of 2012, the Naval Medical Research Center (NMRC)
initiated a Phase 1 clinical trial of a tetravalent dengue DNA vaccine
formulated with Vaxfectin^®. Vical manufactured the vaccine and the
adjuvant for both the preclinical and clinical studies, and is providing
regulatory and clinical expertise to NMRC for the dengue program.
*Researchers at Ehime University in Japan and their collaborators developed
a Vaxfectin^®-formulated DNA vaccine candidate with the potential to
prevent transmission of malaria and published encouraging initial results
in Vaccine. Vical provided the DNA vaccine plasmid backbone and the
adjuvant used in the research.
*In September 2012, Vical entered into a worldwide, nonexclusive license
with Bristol-Myers Squibb Company of Vical's patented platform DNA
immunization technology and its Vaxfectin^® adjuvant for use in the
production of antibodies.
*In December 2012, Vical entered into a worldwide, nonexclusive license of
the Vaxfectin^® adjuvant to Cyvax, Inc., a privately held vaccine
development company, for use in malaria vaccines.
Vical will conduct a conference call and webcast today, February 6, 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)
312-0696 (preferred), or (888) 282-4056 (toll-free), and reference
confirmation code 4549145. 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
4549145. 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 email@example.com.
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
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 cash burn guidance as well
as statements about anticipated developments and timelines in the
Allovectin^®, TransVax™ and HSV-2 vaccine programs, the Vaxfectin^® adjuvant,
and other independent and collaborative programs. Risks and uncertainties
include whether Vical will achieve levels of revenues and control expenses to
meet its financial projections; whether Vical or others will continue
development of Allovectin^®, TransVax™, HSV-2 vaccines, Vaxfectin^® adjuvant,
or any other independent or collaborative programs; whether Vical will release
top-line data from the company's Phase 3 trial of Allovectin^® in mid-2013, if
at all; whether spending for long-lead-time activities will allow timely
filing of a BLA for Allovectin^®; whether the trial will achieve all, if any,
of the defined endpoints; whether Astellas will initiate a Phase 3 trial of
TransVax™ for HSCT patients and/or a Phase 2 trial of TransVax™ for SOT
recipients in the first half of 2013, if at all; whether Vical will initiate a
Phase 1/2 clinical trial of its therapeutic HSV-2 vaccine in the second half
of 2013, if at all; 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
Selected Condensed Financial Information (Unaudited)
Statements of Three Months Ended Dec. 31, Twelve Months Ended Dec. 31,
(in thousands, except 2012 2011 2012 2011
per share amounts)
Contract and grant $1,909 $1,616 $6,176 $4,223
License and royalty 410 316 11,343 25,795
Total revenues 2,319 1,932 17,519 30,018
Research and 3,439 3,971 17,340 17,975
Manufacturing and 3,797 2,570 13,055 10,267
General and 2,659 2,437 10,557 9,598
Total operating 9,895 8,978 40,952 37,840
Loss from operations (7,576) (7,046) (23,433) (7,822)
Net investment and 27 432 534 539
Net loss $(7,549) $(6,614) $(22,899) $(7,283)
Basic and dilutednet $(0.09) $(0.09) $(0.27) $(0.10)
loss per share
Shares used to
calculate basic and 86,504 72,126 85,966 72,031
diluted net loss per
Balance Sheets December 31, December 31,
(in thousands) 2012 2011
Cash, cash equivalents, and
marketable securities, including $83,857 $50,427
Other current assets 2,152 3,130
Total current assets 86,009 53,557
Long-term investments 2,225 5,928
Property and equipment, net 5,284 6,226
Other assets 3,004 3,062
Total assets $96,522 $68,773
Liabilities and stockholders'
Current liabilities $5,779 $6,461
Long-term liabilities 1,657 1,964
Stockholders' equity 89,086 60,348
Total liabilities and stockholders' $96,522 $68,773
CONTACT: Alan R. Engbring
Executive Director, Investor Relations
Jill M. Broadfoot
Senior Vice President and Chief Financial Officer
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