Vical Reports 2009 Financial Results and Progress in Key Development Programs
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Press Release Source: Vical Incorporated On Thursday February 11, 2010, 6:30 am EST
SAN DIEGO, Feb. 11, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) today reported financial results for the year ended December 31, 2009. Vical had cash and investments of approximately $53 million at year-end 2009. The company raised approximately $33 million of net proceeds from the sale of equity securities during 2009, and approximately $3 million of additional net proceeds from the sale of equity securities to date in 2010.
Revenues for 2009 were $12.7 million, compared with revenues of $8.0 million for 2008. The net loss for 2009 was $28.6 million, or $0.61 per share, compared with a net loss of $36.9 million, or $0.93 per share, for 2008. The net cash burn for 2009, excluding financing activities, was approximately $22 million, compared with approximately $34 million for 2008. The decline in net cash burn was driven primarily by cost savings resulting from the company's November 2008 restructuring and staff reduction, as well as the increase in revenues. The company is projecting a net cash burn for 2010 of between $20 million and $24 million, including anticipated receipts from new or expanded partnerships not currently contracted.
Recent development highlights included:
Allovectin-7®
* Completion of enrollment of the planned 375 subjects in the company's pivotal Phase 3 AIMM trial of Allovectin-7® in patients with metastatic melanoma; and
* Completion of the AIMM trial's third scheduled safety analysis by an independent Safety Monitoring Board and the recommendation that the trial continue per the protocol.
CMV Vaccines
* Completion of the last scheduled follow-up visit for the final patient enrolled in a Phase 2 trial of the company's TransVax™ cytomegalovirus (CMV) vaccine in hematopoietic stem cell transplant (HCT) recipients;
* Continued overall increase in cellular immune responses for the company's TransVax™ CMV vaccine vs placebo at the seven-month immunogenicity data point in the ongoing Phase 2 HCT trial; and
* Allowance by the U.S. Food and Drug Administration (FDA) of the company's Investigational New Drug (IND) application for a Phase 1 trial of its CyMVectin™ prophylactic vaccine to prevent CMV infection before and during pregnancy, the leading infectious disease cause of congenital birth defects.
H1N1 Influenza Vaccine
* A U.S. Navy contract 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 H1N1 pandemic influenza; and
* Publication of data documenting the successful pilot lot production and initiation of animal immunogenicity testing of a Vaxfectin®-adjuvanted DNA vaccine for H1N1 influenza before conventional vaccine manufacturers even received the seed virus needed to start production.
Collaborations
* The launch by the company's licensee Merial Limited, the animal health subsidiary of sanofi-aventis, of its ONCEPT™ canine melanoma vaccine, a therapeutic DNA vaccine designed to aid in extending survival of dogs with oral melanoma, at the North American Veterinary Conference in January, following full licensure by the U.S. Department of Agriculture (USDA); and
* Approval by the FDA of the Special Protocol Assessment (SPA) agreement for the company's licensee, AnGes MG, Inc., for a Phase 3 clinical trial of its Collategene™ angiogenesis product for patients with advanced peripheral arterial disease (PAD).
Anticipated program highlights for 2010 include:
* Periodic progress reports on the company's Phase 3 AIMM trial of Allovectin-7® in patients with metastatic melanoma;
* Final results in mid-2010 from the Phase 2 trial of the company's TransVax™ CMV vaccine candidate for HCT patients;
* Initiation of a Phase 1 trial of the company's Vaxfectin®-adjuvanted DNA vaccine for H1N1 influenza in the first quarter of 2010 and immunogenicity data within two months of trial initiation; and
* Completion of an ongoing Phase 3 trial in the third quarter of 2010 and presentation of data in the fourth quarter of 2010 by the company's licensee, sanofi aventis Group, for Temusi®, its 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.
Conference Call
Vical will conduct a conference call and webcast today, February 11, 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 (877) 879-6203, or (719) 325-4823 for international participants, and reference confirmation code 4635156. 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 4635156. 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. |
