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Biotech / Medical : VICL (Vical Labs)

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From: bob zagorin5/2/2006 9:16:18 AM
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Vical Reports First Quarter 2006 Financial Results
Tuesday May 2, 7:30 am ET

SAN DIEGO, May 2 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL - News) today reported financial results for the quarter ended March 31, 2006. Revenues for the first quarter of 2006 were $5.6 million, compared with revenues of $2.7 million for the first quarter of 2005. The net loss for the first quarter of 2006 was $4.5 million, or $0.16 per share, compared with a net loss of $7.6 million, or $0.32 per share, for the first quarter of 2005. The increase in revenues and decrease in net loss were primarily a result of the timing of contract manufacturing shipments for the National Institutes of Health (NIH), and of NIH research and development grant funding.

The reported first quarter 2006 net loss included non-cash, stock-based compensation expense of $0.5 million for the first quarter of 2006, compared with $0.1 million for the first quarter of 2005. The company confirmed its projection for an adjusted full-year net loss for 2006 of between $22 million and $26 million. This projection excludes non-cash, stock-based compensation expense and, as a result, is not calculated in accordance with U.S. generally accepted accounting principles (GAAP). See "Use of Non-GAAP Financial Measure" below. Vical had cash and investments of $57 million at March 31, 2006.

Recent Events

* Vical announced today that the company's lead three-component influenza
(flu) DNA vaccine candidate provided 100% protection in mice and
ferrets against lethal challenges with a highly virulent H5N1 avian
influenza virus in studies conducted by Richard J. Webby, Ph.D., at
St. Jude Children's Research Hospital. Additionally, in these and
earlier studies in mice, simplified versions of Vical's vaccine
candidate using only two of the three components provided high levels
of protection against multiple human flu strains and against the H5N1
avian flu strain. Based on the results, the company is continuing to
advance toward human testing of the pandemic flu DNA vaccine candidate.

* Vical's licensee, Sanofi-Aventis, presented encouraging data from a
Phase 2b trial of its angiogenesis product candidate NV1FGF, using
Vical's patented DNA delivery technology. The data were released at
the 55th Annual Scientific Session of the American College of
Cardiology (ACC) in Atlanta, Georgia. In a separate presentation to
analysts, Sanofi-Aventis disclosed plans to advance to Phase 3 testing
of the product candidate in the fourth quarter of 2006.

* An Ebola vaccine candidate administered using Vical's proprietary DNA
delivery technology was safe and well tolerated, and produced both
antibody and T-cell Ebola-specific responses in all healthy volunteers
who received the full 3 doses of vaccine in a Phase 1, randomized,
placebo-controlled, dose-escalation study sponsored by the National
Institute of Allergy and Infectious Diseases, NIH. The data were
presented at the American Society for Microbiology (ASM) 2006
Biodefense Research Meeting in Washington, D.C.

* Enrollment opened in Vical's Phase 2 trial of a DNA vaccine against
cytomegalovirus (CMV), which will be conducted at leading U.S.
transplant centers in 80 pairs of donors and recipients undergoing stem
cell transplants. After the first 20 donor-recipient pairs have
completed scheduled follow-up visits approximately two months after the
transplant procedures, an independent Data Safety and Monitoring Board
will evaluate interim safety data. Success in this patient population
would support Vical's expansion of studies of its CMV vaccine into
other transplant settings and into the general population.

* Vical's licensee, Corautus Genetics, announced that it has terminated
its Phase 2b angiogenesis trial based on the recommendation of an
independent Data Monitoring Committee.

* Vical granted non-exclusive, academic licenses for its broad DNA
delivery technology patent estate to four of the nation's top research
institutions: Stanford University, Harvard University, Yale University,
and the Massachusetts Institute of Technology (MIT). In exchange,
Vical will have the option to exclusively license from the universities
potential commercial applications stemming from the technology on terms
to be negotiated.

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, May 2, 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 (888) 224-3260, or (913) 905-1086 for international participants. 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 conference identification number 2477734. The call also will be available live and archived through the webcast center 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 has retained all rights to its internally developed product candidates. 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 serve significant unmet medical needs. Additional information on Vical is available at www.vical.com.
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