Vical Reports Third Quarter 2009 Financial Results and Progress in Key Development...
Vical Reports Third Quarter 2009 Financial Results and Progress in Key
Development Programs
SAN DIEGO, Nov. 4, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL)
today reported financial results for the quarter ended September 30, 2009.
Revenues for the third quarter of 2009 increased to $3.9 million, compared with
revenues of $0.8 million for the third quarter of 2008, primarily as a result of
increased revenue from AnGes MG, Inc., related to funding of the company's Phase
3 Allovectin-7(R) trial, and contract manufacturing revenues for the delivery of
a dengue vaccine to the U.S. Navy. The net loss for the third quarter of 2009
was $7.0 million or $0.14 per share, compared with $9.8 million or $0.24 per
share for the third quarter of 2008.
Revenues for the first nine months of 2009 were $10.1 million, compared with
revenues of $5.3 million for the first nine months of 2008. The net loss for the
first nine months of 2009 was $21.2 million, or $0.47 per share, compared with a
net loss of $27.9 million, or $0.70 per share, for the first nine months of
2008. The decrease in net loss reflected the increased revenues as well as
operational improvements resulting from the strategic restructuring implemented
in November 2008.
The company's third quarter 2009 net cash burn was consistent with the company's
prior guidance of a full-year 2009 net cash burn of between $19 million and $23
million. Vical raised net proceeds of approximately $29 million through
registered direct offerings during the first nine months of 2009, and had cash
and investments of $55 million at September 30, 2009.
Allovectin-7(R) - AnGes
Vical received a $2.5 million cash installment payment in September from AnGes
for the company's pivotal Phase 3 trial of its Allovectin-7(R) immunotherapeutic
as first-line therapy in patients with metastatic melanoma. Vical has now
received the full $22.6 million committed by AnGes prior to trial completion.
The trial is being conducted in accordance with a Special Protocol Assessment
(SPA) completed with the U.S. Food and Drug Administration (FDA), and the
company expects to complete enrollment of the planned 375 subjects by year-end
2009.
Allovectin-7(R) - Teva
Vical entered into an exclusive agreement with Teva Pharmaceutical Industries
Ltd. in August for sales and marketing of the company's Allovectin-7(R)
immunotherapeutic product candidate in Israel. Teva has agreed to pay Vical
upfront and milestone payments in exchange for the rights to an exclusive
license for Israel.
TransVax(TM)
TransVax is a therapeutic DNA vaccine designed to prevent reactivation of
cytomegalovirus (CMV) in patients undergoing transplant procedures, which could
reduce the need for antiviral drugs and the risk of CMV-associated disease.
During the third quarter, Vical reported promising results for TransVax(TM)
compared with placebo across a broad range of clinical efficacy endpoints at the
four-month interim analysis in a double-blind, placebo-controlled Phase 2 trial.
In October, the company reported that the TransVax(TM) vaccine continued to
demonstrate an overall increase in cellular immune responses compared with
placebo at the seven-month immunogenicity data point. The company expects final
data from the trial to be available in the first half of 2010.
H1N1 Pandemic Influenza
Vical announced in early October that the U.S. Navy had awarded the company a
contract for $1.25 million to support large-scale cGMP vaccine manufacturing and
related clinical and regulatory preparations for a Phase 1 clinical trial of the
company's vaccine against A/H1N1 pandemic influenza (swine flu). The trial will
be conducted in collaboration with the U.S. Naval Medical Research Center
(NMRC), a biomedical research organization within the Navy.
The company's DNA vaccine against A/H1N1 pandemic influenza has demonstrated
robust immune responses in 100% of vaccinated mice and rabbits against virus
strains isolated from recent outbreaks in three distinct geographic locations -
California, Texas and Mexico.
U.S. Patent No. 7,582,613 was issued to Vical, providing broad coverage of
Vaxfectin(R)-formulated DNA vaccines for any circulating or potential influenza
viruses, including both seasonal and pandemic strains.
Sanofi-aventis
Vical's licensee, sanofi-aventis, has completed enrollment in a multinational
500-patient pivotal Phase 3 clinical trial of its FGF-1 angiogenesis treatment
for advanced peripheral arterial disease. Sanofi-aventis expects final data from
this trial in late 2010.
Vaxfectin(R)
Vical presented encouraging results from animal studies of a peptide-based
cancer vaccine formulated with the company's Vaxfectin(R) adjuvant. The data
demonstrated the adjuvant's ability to enhance immune responses of cancer
antigen-based vaccines in addition to a broad variety of DNA- and protein-based
vaccines against infectious diseases.
Conference Call
Vical will conduct a conference call and webcast today, November 4, 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 (888)
505-4347, or (719) 325-2457 for international participants, and reference
confirmation code 8500540. 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 8500540. 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.
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 confirmation of net cash burn
guidance, as well as statements about Vical's Allovectin-7(R), TransVax(TM) and
pandemic influenza vaccine programs, 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(R), TransVax(TM), a vaccine
against H1N1 pandemic influenza or any other Vaxfectin(R)-formulated influenza
vaccine candidates, the sanofi aventis FGF-1 angiogenesis therapy, or any other
independent or collaborative programs; whether Vical and/or the NMRC will
conduct human clinical trials of the H1 vaccine; whether Vical and/or the NMRC
will terminate the CRADA before achievement of its objectives; whether Vical
will complete enrollment of 375 subjects in the Allovectin-7(R) Phase 3 trial by
year-end 2009, if at all; whether Teva will successfully sell and market
Allovectin-7(R) in Israel; whether Vical will achieve any milestones and whether
Teva will pay Vical any upfront or milestone payments under the agreement;
whether final results from the TransVax(TM) CMV vaccine Phase 2 trial will be
available in the first half of 2010, if at all; whether sanofi aventis will
successfully complete its ongoing FGF-1 Phase 3 trial; whether Vical's issued
patents will be challenged and whether such challenges will have an adverse
effect on the scope of the patents; whether Vical will pursue enforcement of its
issued patents or be successful in any such enforcement efforts; whether Vical
will achieve levels of revenues and control expenses to meet its financial
projections; 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.
VICAL INCORPORATED
Selected Condensed Financial Information (Unaudited)
Three Months Ended Nine Months Ended
Sept. 30, Sept. 30,
---------------------- ----------------------
2009 2008 2009 2008
---------- ---------- ---------- ----------
Statements of
Operations
(in thousands, except
per share amounts)
Revenues:
Contract and grant
revenue $ 2,013 $ 711 $ 2,743 $ 1,604
License and
royalty revenue 1,890 133 7,388 3,727
---------- ---------- ---------- ----------
Total revenues 3,903 844 10,131 5,331
---------- ---------- ---------- ----------
Operating expenses:
Research and
development 5,405 6,226 17,281 19,284
Manufacturing
and production 3,779 2,716 8,467 8,772
General and
administrative 1,768 2,087 5,555 6,439
---------- ---------- ---------- ----------
Total operating
expenses 10,952 11,029 31,303 34,495
---------- ---------- ---------- ----------
Loss from operations (7,049) (10,185) (21,172) (29,164)
Net investment and
other income
(expense) 64 360 (77) 1,292
---------- ---------- ---------- ----------
Net loss $ (6,985) $ (9,825) $ (21,249) $ (27,872)
=========== =========== =========== ===========
Basic and diluted
net loss per share $ (0.14) $ (0.24) $ (0.47) $ (0.70)
=========== =========== =========== ===========
Shares used to
calculate basic
and diluted net
loss per share 51,111 40,349 45,361 39,688
========== ========== ========== ==========
Sept. 30, Dec.31,
2009 2008
---------- ----------
Balance Sheets
(in thousands)
Assets:
Cash, cash
equivalents, and
marketable securities,
including restricted $ 49,055 $ 36,266
Other current assets 1,302 1,852
---------- ----------
Total current assets 50,357 38,118
Long-term investments 5,451 5,410
Property and
equipment, net 9,575 10,734
Other assets 4,321 4,795
---------- ----------
Total assets $ 69,704 $ 59,057
========== ==========
Liabilities and
stockholders' equity:
Current liabilities $ 9,467 $ 7,974
Long-term obligations 2,420 2,469
Stockholders' equity 57,817 48,614
Total liabilities and
stockholders' equity $ 69,704 $ 59,057
========== ==========
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CONTACT: Vical Incorporated
Alan R. Engbring, Executive Director, Investor Relations
Jill M. Broadfoot, Senior Vice President and Chief Financial
Officer
(858) 646-1127
www.vical.com
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