Vical Incorporated (Nasdaq:VICL) today reported financial results for the year ended December 31, 2010. Vical had cash and investments of approximately $61 million at year-end 2010. The company received approximately $37 million of net proceeds from the sale of equity securities during 2010.
Revenues for 2010 were $8.7 million, compared with revenues of $12.7 million for 2009. The net loss for 2010 was $30.4 million, or $0.51 per share, compared with a net loss of $28.6 million, or $0.61 per share, for 2009. The net cash burn for 2010, excluding cash received from financings, was approximately $29 million, compared with approximately $22 million for 2009. The company is projecting a net cash burn for 2011 of between $22 million and $27 million, including projected cash from new or expanded partnerships for which we do not currently have contracts.
Development highlights during 2010 included:
- Completion of enrollment in February 2010 in the company’s pivotal Phase 3 trial of Allovectin-7® in patients with metastatic melanoma; and
- Completion of the Phase 3 trial’s fourth scheduled safety analysis by an independent Safety Monitoring Board and the recommendation that the trial continue per the protocol.
TransVax™ CMV Vaccine
- Achievement of key efficacy, immunogenicity and safety results in a Phase 2 trial, establishing the TransVax™ cytomegalovirus (CMV) vaccine as the first to provide evidence of protection in immunocompromised hematopoietic cell transplant (HCT) recipients, and defining a potential pathway for further development.
Prophylactic CMV Vaccine
- A five-year, $4.0 million grant to leading pediatric infectious disease researchers Stuart P. Adler, M.D., and Michael A. McVoy, Ph.D., of Virginia Commonwealth University (VCU) from the National Institutes of Health (NIH), to develop novel vaccine approaches designed to protect women of child-bearing potential from infection with CMV. Vical will produce the DNA vaccines and Vaxfectin® adjuvant, and will conduct the animal studies funded by the grant.
H1N1 Influenza Vaccine
- Initiation of a U.S. government-funded Phase 1 trial of the company’s Vaxfectin®-formulated DNA vaccine against H1N1 swine-origin pandemic influenza in collaboration with the U.S. Naval Medical Research Center (NMRC).
Herpes Simplex Vaccines
- Protection against lethal challenge, sterilizing immunity and inhibition of viral counts at both the primary and latent infection sites in mice with the company’s prophylactic Vaxfectin®-formulated DNA vaccine against herpes simplex virus type 2 (HSV-2). Significant reduction with a related vaccine of the recurrence of HSV-2 lesions in a therapeutic model using guinea pigs with latent infection.
- 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; 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).
- A $2.4 million contract to manufacture plasmid DNA (pDNA) vaccines against HIV for the IPPOX Foundation, a collaborating institution for the Poxvirus Vaccine Regimen Design (PVRD) led by the Centre Hospitalier Universitaire Vaudois (CHUV) under the auspices of the Collaboration for AIDS Vaccine Discovery (CAVD).
Anticipated program highlights for 2011 include:
- Data in the first quarter of 2011 from the Phase 1 trial of the company’s Vaxfectin®-adjuvanted DNA vaccine for H1N1 influenza;
- Database lock in the second half of 2011 in the company’s Phase 3 trial of Allovectin-7® in patients with metastatic melanoma;
- Initiation in the second half of 2011 of a Phase 3 trial of the company’s TransVax™ CMV vaccine candidate for HCT patients; and
- Efforts by AnGes to expedite initiation of a multinational Phase 3 clinical trial of its Collategene™ angiogenesis product for patients with advanced PAD.