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Title: Vical Reports Third
Quarter 2007 Financial Results and Progress in Product Development
Programs
Date:
10/31/2007 6:30:00 AM
SAN DIEGO, Oct. 31 /PRNewswire-FirstCall/ -- Vical
Incorporated
(Nasdaq: VICL) today reported financial results for
the quarter ended
September
30, 2007. The net loss for the third quarter of 2007 was
$9.2
million or $0.24 per share, compared with $7.5 million or $0.24 per
share
for the third quarter of 2006.
Financial results were consistent
with the company's guidance of a
projected
net loss for the full year 2007 of between $32 million and
$37
million, and a net cash burn for the full year, excluding equity
investments, of $27 million to $32 million.
Vical had cash and investments of
$77 million at September 30, 2007.
Angiogenesis Programs -- Sanofi-aventis initiated a 500-patient pivotal Phase 3 clinical trial of its NV1FGF angiogenesis therapy, which is based on Vical's non-viral DNA delivery technology. Assuming successful completion of the trial, sanofi-aventis expects to file for marketing approval in 2010. -- The company's other angiogenesis licensee, AnGes MG, Inc. (AnGes), is preparing an application for Japanese marketing approval based on positive results following an interim efficacy evaluation in its Japanese Phase 3 trial of its gene-based Hepatocyte Growth Factor (HGF) product candidate in patients with advanced peripheral arterial disease (PAD). CMV Phase 2 Trial -- In October, an independent data safety monitoring board (DSMB) found no safety issues and recommended continuation of the company's Phase 2 trial of a DNA vaccine against cytomegalovirus (CMV) in patients receiving hematopoietic stem cell transplants. The DSMB completed an interim evaluation of safety data after the two-month follow-up visits for the first 20 transplant recipients enrolled in the study. Pandemic Influenza Phase 1 Trial -- In August, Vical initiated a Phase 1 trial of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The double-blind, placebo-controlled trial is evaluating safety, tolerability and immune responses in up to 60 healthy volunteers. Vaccination of the first dose cohort has been completed with no safety issues, and the second dose cohort has been fully enrolled. Trial results are expected in the first half of 2008. Vaxfectin(TM) Adjuvant -- In October, the protein-based H5N1 pandemic influenza vaccine currently stockpiled by the U.S. government was shown to derive dose-sparing benefit from the company's patented Vaxfectin(TM) adjuvant in a study in mice. -- The company also reported that a measles DNA vaccine formulated with the company's Vaxfectin(TM) adjuvant completely protected infant nonhuman primates following challenge one year after intradermal vaccination, with no clinical signs of disease and no culturable virus after challenge. 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, October 31, 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 1036247. 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
1036247.
The call also will be available live and archived through the events
page at http://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 http://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 CMV or pandemic influenza vaccine candidates, the company's
Vaxfectin(TM) adjuvant, the sanofi-aventis NV1FGF angiogenesis therapy, the
NIH HIV
vaccine candidate, or any other product candidates being developed by
Vical, its collaborators or
licensees; whether the CMV vaccine will achieve
the
safety and efficacy endpoints in the Phase 2 trial for stem cell
transplant
donors and recipients; whether the pandemic influenza vaccine will
achieve
the safety and immunogenicity endpoints in
the Phase 1 trial; whether
sanofi-aventis will complete the Phase 3 trial
of its NV1FGF angiogenesis
therapy
and file for marketing approval in 2010, if at all; whether the
company's
CMV or pandemic influenza vaccine candidates, the Vaxfectin(TM)
adjuvant,
the NV1FGF product candidate, the HIV vaccine candidate, or any
other
product candidates being developed by Vical,
its collaborators or
licensees
will be shown to be safe and effective in clinical trials; 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.
Contacts: Alan R. Engbring Jill M. Church Executive Director, Vice President Investor Relations and Chief Financial Officer (858) 646-1127 Website: http://www.vical.com VICAL INCORPORATED Selected Condensed Financial Information (Unaudited) Three Months Ended Nine Months Ended Sept. 30, Sept. 30, Statements of Operations (in thousands, except per share amounts) 2007 2006 2007 2006 Revenues: Contract and grant revenue $164 $412 $3,994 $13,091 License and royalty revenue 211 154 747 346 Total revenues 375 566 4,741 13,437 Operating expenses: Research and development 5,580 4,038 17,314 12,853 Manufacturing and production 2,871 2,899 11,034 10,950 General and administrative 2,192 1,904 6,825 6,752 Total operating expenses 10,643 8,841 35,173 30,555 Loss from operations (10,268) (8,275) (30,432) (17,118) Net investment income 1,029 766 3,399 1,892 Net loss $(9,239) $(7,509) $(27,033) $(15,226) Basic and diluted net loss per share $(0.24) $(0.24) $(0.69) $(0.52) Shares used to calculate basic and diluted net loss per share 39,193 30,714 39,189 29,282 Balance Sheets Sept. 30, December 31, (in thousands) 2007 2006 Assets: Cash, cash equivalents, and marketable securities $76,906 $100,393 Other current assets 1,328 5,049 Total current assets 78,234 105,442 Property and equipment, net 12,808 13,500 Other assets 5,665 6,307 Total assets $96,707 $125,249 Liabilities and stockholders' equity: Current liabilities $5,768 $8,153 Long-term obligations 2,649 2,973 Stockholders' equity 88,290 114,123 Total liabilities and stockholders' equity $96,707 $125,249 SOURCE Vical Incorporated -0- 10/31/2007 /CONTACT: Alan R. Engbring, Executive Director, Investor Relations, or Jill M. Church, Vice President and Chief Financial Officer, both of Vical Incorporated, +1-858-646-1127/ /Web site: http://www.vical.com / (VICL) CO: Vical Incorporated ST: California IN: HEA MTC BIO SU: ERN CCA KK-BJ -- LAW022 -- 9639 10/31/2007 06:30 EDT http://www.prnewswire.com |