Vical Incorporated (Nasdaq:VICL) today reported financial results for the quarter ended March 31, 2010. Revenues were $1.5 million for the first quarter of 2010 compared with $2.3 million for the first quarter of 2009, reflecting lower revenues under the company’s license agreement with AnGes MG, Inc. Operating expenses were $10.1 million for the first quarter of 2010 compared with $10.6 million for the first quarter of 2009.
The net loss was $8.5 million, or $0.15 per share, for the first quarter of 2010, compared with $8.2 million, or $0.20 per share, for the first quarter of 2009. Vical had cash and investments of approximately $48 million at March 31, 2010. The company’s first quarter 2010 net cash use was consistent with the company’s prior guidance for the full year.
Development highlights to date in 2010 included:
- Completion of enrollment in February with 390 total subjects in the company’s pivotal Phase 3 trial of Allovectin-7® in patients with metastatic melanoma;
- Enhanced cellular and antibody immune responses for the company’s TransVax™ cytomegalovirus (CMV) vaccine vs placebo through the final 12-month immunogenicity data point in the ongoing Phase 2 trial in hematopoietic cell transplant (HCT) recipients;
- Initiation of a Phase 1 clinical trial of the company’s vaccine against H1N1 pandemic influenza with U.S. Navy funding;
- 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;
- Presentation of encouraging results from a Phase 1/2a clinical trial of a prime-boost vaccine regimen and publication of preclinical data demonstrating enhancement of immune responses with the company’s Vaxfectin® adjuvant, both in collaboration with the U.S. military on DNA vaccines for malaria; and
- Publication of Phase 1 results highlighting safety and tolerability, antibody responses in the same range as conventional vaccines, sustained immunogenicity, and cross-clade antibody responses for the company’s H5N1 pandemic influenza vaccine.
Anticipated program highlights for the remainder of 2010 include:
- Results of independent safety monitoring board review of the company’s Phase 3 trial of Allovectin-7® in patients with metastatic melanoma;
- Final results in the third quarter of 2010 from the Phase 2 trial of the company’s TransVax™ CMV vaccine candidate for HCT patients;
- Immunogenicity data from a Phase 1 trial of the company’s Vaxfectin®-adjuvanted DNA vaccine for H1N1 influenza; and
- Data in the fourth quarter of 2010 from the company’s licensee, sanofi aventis Group, from the ongoing TAMARIS Phase 3 trial of Temusi®, intended to promote the growth of blood vessels to reduce the need for amputations in patients with reduced blood flow to the limbs.