
|
Vical Reports First Quarter 2008 Financial Results and Updates Key Development Programs
SAN DIEGO (Map) - Vical had cash and investments of Independent Development Program Highlights -- The Phase 3 pivotal trial of the company's Allovectin-7(R) immunotherapeutic is actively enrolling patients at nearly 50 sites in North America and Europe, and completion of enrollment is expected in mid-2009. The trial is being funded by cash payments and equity investments from AnGes MG, Inc. -- The company's Phase 2 trial of a vaccine designed to prevent cytomegalovirus (CMV) disease in patients undergoing hematopoietic cell transplants has exceeded 50% enrollment and is on schedule for release of interim efficacy data in the second half of 2008. -- The company's Phase 1 trial of its Vaxfectin(R)-formulated vaccine for pandemic influenza completed enrollment and final dosing on schedule and results will be released by August. The company's novel Vaxfectin(R) adjuvant has demonstrated efficacy enhancement and dose-sparing ability in a variety of animal models. Vaxfectin(R) is currently being evaluated for additional vaccine applications by several potential partners. -- The company was awarded a two-year, $2.0 million grant from the National Institutes of Health (NIH) to fund the ongoing development of Vical's immunotherapeutic vaccine designed to reduce disease symptoms and viral shedding in patients already infected with herpes simplex virus type 2 (HSV-2), a sexually transmitted virus which is the leading cause of genital herpes. The HSV-2 vaccine will also be evaluated with Vical's proprietary Vaxfectin(R) adjuvant. Partnered Development Program Highlights -- The company's Japanese partner, the biotechnology company AnGes, submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for its hepatocyte growth factor (HGF) angiogenesis product candidate, Collategene, for treatment of critical limb ischemia. AnGes is expected to pursue initiation of a Phase 3 registration trial with Collategene in the United States. -- The company's European partner, the large pharmaceutical company sanofi-aventis, is conducting a 500-patient Phase 3 pivotal trial of its fibroblast growth factor 1 (FGF-1) angiogenesis product candidate in key global markets and anticipates filing for marketing approvals in 2010. 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, 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 Allovectin-7(R), the company's CMV vaccine candidate, the company's
pandemic influenza vaccine candidate, the company's HSV-2 vaccine candidate,
the company's Vaxfectin(R) adjuvant, the angiogenesis product candidates, or
any other product candidates being developed by Vical, its collaborators or
licensees; whether the Allovectin-7(R) Phase 3 trial will complete enrollment
in mid-2009; 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 the
company's Phase 2 CMV vaccine interim efficacy data will be available in the
second half of 2008, if at all; whether the company's Phase 1 pandemic
influenza vaccine safety and immunogenicity data will be available by Contacts: Alan R. Engbring Executive Director, Investor Relations Jill M. Church Vice President and Chief Financial Officer (858) 646-1127 Website: http://www.vical.com VICAL INCORPORATED Selected Condensed Financial Information (Unaudited) Statements of Operations Three Months Ended March 31, (in thousands, except per share amounts) 2008 2007 Revenues: Contract and grant revenue $460 $850 License and royalty revenue 1,480 405 Total revenues 1,940 1,255 Operating expenses: Research and development 6,594 5,875 Manufacturing and production 3,106 3,947 General and administrative 2,335 2,293 Total operating expenses 12,035 12,115 Loss from operations (10,095) (10,860) Net investment income 530 1,263 Net loss $(9,565) $(9,597) Basic and diluted net loss per share $(0.24) $(0.24) Shares used to calculate basic and diluted net loss per share 39,218 39,182 Balance Sheets March 31, December 31, (in thousands) 2008 2007 Assets: Cash, cash equivalents, and marketable securities $51,998 $71,489 Other current assets 1,645 1,261 Total current assets 53,643 72,750 Marketable securities 8,228 - Property and equipment, net 11,868 12,287 Other assets 5,296 5,548 Total assets $79,035 $90,585 Liabilities and stockholders' equity: Current liabilities $5,970 $8,108 Long-term obligations 2,513 2,565 Stockholders' equity 70,552 79,912 Total liabilities and stockholders' equity $79,035 $90,585
More
Cypress Semiconductor Corp
(CY): Seven Summits Research Releases Alerts on IBM, FCX, AMGN, LVS, and CY 3 days ago
Johnson & Johnson
(JNJ): Journal of Clinical Oncology Article Highlights CellSearch(TM) Circulating Tumor Cell Test in Treatment of Metastatic Colorectal Cancer 5 hrs ago
TreeHouse Foods Inc
(THS): TreeHouse Foods Announces Organizational Changes as Planned Part of Bay Valley Foods Integration 5 hrs ago |
Business News
Stocks tumble after sales of existing homes fall
41 mins ago - Wall Street abruptly ended an earnings-driven rally and closed sharply lower Thursday after a steeper-than-expected decline in existing home sales and worries about the financial sector chilled the market's recent optimism. The major indexes fell about 2 percent, including the Dow Jones industrial average, which lost more than 280 points. 31 mins ago - Bleeding cash and with its very survival uncertain, Ford Motor Co., an icon of American automaking, will try to import some of its success from across the Atlantic. 2 hrs 1 min ago - Two cornerstones of the economy - jobs and housing - sank to new depths Thursday, with unemployment claims bolting higher and home prices recording one of their steepest drops on record.
GOP kills effort to release oil from US stockpile
3 hrs ago - House Republicans on Thursday scuttled a bill that Democrats hoped would help lower gasoline prices by forcing the Energy Department to release 70 million barrels of oil - about a three-day supply - from the national stockpile.
NY AG sues banking giant UBS for securities fraud
3 hrs ago - New York Attorney General Andrew Cuomo sued banking giant UBS for fraud Thursday, accusing the company of marketing tens of billions of dollars of auction-rate securities as safe even when they knew the investments were in trouble.
AP told 3 bidders make final cut to buy Cubs
1 hr 17 mins ago - Tribune Co. is inviting at least three potential buyers who each submitted bids for the Chicago Cubs and Wrigley Field near or above $1 billion to participate in a second round of proposals, according to a person involved in the process. 1 hr 51 mins ago - Ford Motor Co. posted its worst quarterly loss ever Thursday in a roiling global auto market that also saw profits fall at Daimler AG, Hyundai Motor Co. and AutoNation Inc. Renault SA reported a profit increase in the first half of the year but still plans to cut jobs and scale back production.
Bristol-Myers, Eli Lilly post strong 2Q results
2 hrs 21 mins ago - Like other major drugmakers, Bristol-Myers Squibb Co. and Eli Lilly & Co. saw benefits from the weak dollar in the second quarter, as sales grew at a faster rate overseas, but both also posted improvements in their U.S. businesses. |
|
Sports
Business |
Real Estate Family Movies and Books Venues, Sports and Music Concerts, Artists and Tickets Be Inspired - Quotes and Stories |