Vical had cash and investments of about $42 million at year-end 2008, including about $5 million invested in long-term auction rate securities.
For the fourth quarter of 2008, company reported revenues of $2.6 million, compared with revenues of $0.8 million for the fourth quarter of 2007. The net loss for the fourth quarter of 2008 was $9.0 million or $0.22 per share, against $8.9 million or $0.23 per share for the fourth quarter of 2007.
The company is forecasting a net loss for 2009 of between $24 million and $28 million and a net cash burn for 2009 of between $19 million and $23 million, and expects to have cash and investments of $19 million to $23 million at year-end 2009.
Significant developments during the fourth quarter of 2008 included:
Completion of enrollment in a Phase 2 trial of Vical’s therapeutic DNA vaccine designed to prevent cytomegalovirus (CMV) reactivation and disease in immunosuppressed bone marrow or stem cell transplant recipients, and an interim analysis of immunogenicity data for the first 33 transplant recipients in the recipient-only arm of the study showing significant (p less than 0.05) post-transplant enhancement of CMV-specific T-cell responses in subjects receiving vaccine compared with subjects receiving placebo.
A $1.0 million milestone payment from Merck & Co., Inc. related to initiation of a Phase 1 clinical trial of an investigational DNA cancer vaccine encoding human telomerase reverse transcriptase (hTERT);
A $1.3 million contract with the Naval Medical Research Center for manufacturing, regulatory and clinical support for preclinical and Phase 1 evaluation by the U.S. Navy and the US Army of a Vaxfectin(r)-formulated DNA vaccine to protect against dengue, a tropical disease spread by mosquitoes that infects up to 100 million people each year and causes tens of thousands of deaths;
Expanded data from a Phase 1 clinical trial of the company’s Vaxfectin(r)-formulated H5N1 pandemic influenza DNA vaccines showing sustained antibody responses, T-cell responses against a matching strain of influenza virus and cross-clade antibody responses against a different strain; and
Publication of data from a Phase 1 clinical trial conducted by the NIH of a DNA vaccine for Severe Acute Respiratory Syndrome (SARS) demonstrating that the vaccine was well-tolerated and induced both neutralizing antibody responses and T-cell immune responses.