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Press Release - Vical Incorporated (VICL-NASDAQ) |
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“We can apply our technology for vaccines; we can apply it for proteins, animal health applications, cancer. We are focusing on vaccines because vaccines are now probably the single most important medical advance that is going to be required in the next fifty years to deal with a variety of diseases as well as a variety of cancers. We are focused on one of the most lucrative applications of this technology.” - Vijay B. Samant (VICL) (Interview published February 15, 2007) |
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Vical Reports 2007 Financial Results and
Progress in Product Development Programs
Date: 2/21/2008 6:30:00 AM SAN DIEGO, Feb. 21 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today reported financial results for the year ended December 31, 2007. Vical had cash and investments of approximately $71 million at year-end 2007, which is expected to be sufficient to fund operations at least through 2009. The reported net loss for 2007 was $35.9 million, or $0.92 per share, and the cash burn for 2007 was $29 million, which were both consistent with the company's guidance of a projected net loss of between $32 million and $37 million and cash burn of $27 million to $32 million. The net loss for 2007 reflects the company's investment in advancing the following product development programs: -- The initiation of a Phase 3 clinical trial for the company's
Allovectin-7(R) cancer immunotherapeutic as first-line therapy in
chemotherapy-naive patients with recurrent Stage III or IV metastatic
melanoma, which is being funded through cash payments and equity
investments by AnGes MG, Inc., under a collaborative agreement;
-- Advancement in its Phase 2 clinical trial of a DNA vaccine candidate
for cytomegalovirus (CMV) in donors and recipients undergoing
hematopoietic stem cell transplants, including a new arm targeting
vaccination of recipients only; and
-- Advancement of its DNA vaccine candidate for pandemic influenza from
preclinical development to initiation of a Phase 1 clinical trial.
The company is projecting a net loss for 2008 of between $32 million and $37 million. Including anticipated cash payments and equity investments from AnGes in support of the Allovectin-7(R) Phase 3 trial, the company is projecting an effective cash burn for 2008 of between $27 million and $32 million. Anticipated program highlights for 2008 include:
-- Submission of a filing for marketing approval in Japan by the
company's licensee, AnGes MG, Inc., based on previously announced
positive results from a Phase 3 angiogenesis trial involving DNA-based
delivery of Hepatocyte Growth Factor (HGF), an angiogenic growth
factor, in patients with advanced peripheral arterial disease;
-- Update by the company's licensee, sanofi aventis Group, on an ongoing
Phase 3 trial for the DNA-based delivery of Fibroblast Growth Factor 1
(FGF-1), an angiogenic growth factor, intended to promote the growth
of blood vessels in patients with reduced blood flow to the limbs to
reduce the need for amputations;
-- Pandemic influenza DNA vaccine candidate Phase 1 safety and
immunogenicity data in the first half of 2008;
-- CMV vaccine candidate Phase 2 interim efficacy analysis in the second
half of 2008;
-- Accelerating patient enrollments and completion of geographic
expansion of clinical sites in the company's Phase 3 trial of
Allovectin-7(R); and
-- Publication of data from a DNA vaccine clinical trial conducted by the
NIH for Severe Acute Respiratory Syndrome (SARS).
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, February 21, 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 5814630. 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 5814630. 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 the company will achieve levels of revenues and control expenses to meet projected financial performance; whether Vical or others will continue development of Allovectin-7(R), the company's CMV vaccine candidate, the company's pandemic influenza vaccine candidate, the angiogenesis product candidates, or any other product candidates being developed by Vical, its collaborators or licensees; whether Vical, its collaborators or licensees will be able to recruit patients into clinical trials as planned, if at all; whether Vical will receive all of the clinical trial funding from AnGes under the collaborative agreement, which will depend on continued development of Allovectin-7(R) and certain other conditions, as well as AnGes' compliance with its contractual obligations under the agreement; whether AnGes MG will file for Japanese marketing approval of its HGF angiogenesis product candidate, and if so, whether such approval will be granted; whether Sanofi Aventis will complete its Phase 3 trial of its FGF-1 angiogenesis product, and if so, whether it will successfully reduce the need for amputations; whether the company's Phase 1 pandemic influenza vaccine safety and immunogenicity data will be available in the first half of 2008 as anticipated; whether the company's Phase 2 CMV vaccine interim efficacy data will be available in the second half of 2008 as anticipated; whether the NIH will publish data from its SARS vaccine trial; whether Allovectin-7(R), the company's CMV vaccine candidate, the company's pandemic influenza vaccine candidate, the angiogenesis product candidates, 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; 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 Twelve Months Ended
Statements of Operations December 31, December 31,
(in thousands, except per 2007 2006 2007 2006
share amounts)
Revenues:
Contract and grant revenue $580 $1,122 $4,574 $14,213
License and royalty revenue 191 181 938 527
Total revenues 771 1,303 5,512 14,740
Operating expenses:
Research and development 5,620 5,661 22,934 18,514
Manufacturing and production 2,728 2,638 13,762 13,588
General and administrative 2,253 2,303 9,078 9,055
Total operating expenses 10,601 10,602 45,774 41,157
Loss from operations (9,830) (9,299) (40,262) (26,417)
Net investment income 969 1,377 4,368 3,269
Net loss $(8,861) $(7,922) $(35,894) $(23,148)
Basic and diluted
net loss per share $(0.23) $(0.21) $(0.92) $(0.74)
Shares used to calculate
basic and diluted net loss
per share 39,195 37,819 39,190 31,434
Balance Sheets December 31,
(in thousands) 2007 2006
Assets:
Cash, cash equivalents, and marketable securities $71,489 $100,393
Other current assets 1,261 5,049
Total current assets 72,750 105,442
Property and equipment, net 12,287 13,500
Other assets 5,548 6,307
Total assets $90,585 $125,249
Liabilities and stockholders' equity:
Current liabilities $8,108 $8,153
Long-term obligations 2,565 2,973
Stockholders' equity 79,912 114,123
Total liabilities and stockholders' equity $90,585 $125,249
Contacts: Alan R. Engbring Jill M. Church
Executive Director, Vice President and
Investor Relations Chief Financial Officer
(858) 646-1127
Website: http://www.vical.com
SOURCE Vical Incorporated
-0- 02/21/2008
/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 BIO MTC
SU: ERN ERP CCA
ED-DW
-- LATH019 --
8569 02/21/2008 06:30 EST http://www.prnewswire.com
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