- Recruitment in the multinational Phase 3 registration trial in hematopoietic cell transplant (HCT) recipients met its target enrollment of 500 subjects in September and is now fully enrolled. The primary endpoint of the trial is a composite of overall mortality and CMV end organ disease which will be assessed one year after transplantation. Astellas now expects top-line data to be available in the first quarter of 2018. Vical and Astellas continue to make substantial progress in process validation activities for the manufacture of the bulk drug product in anticipation of a potential BLA filing in 2018.
SAN DIEGO, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the three and nine months ended September 30, 2016. Net loss for the third quarter of 2016 was $2.5 million, or $0.24 per share, compared with a net loss of $0.3 million, or $0.03 per share, for the third quarter of 2015. Revenues for the third quarter of 2016 were $2.6 million, compared with revenues of $5.0 million for the third quarter of 2015, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under the ASP0113 collaborative agreements. ASP0113 is Vical's therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients. Vical had cash and investments of $43.0 million at September 30, 2016. The Company's net cash use for the first nine months of 2016 was $6.8 million, which was consistent with the Company's guidance for the full year. The Company is projecting net cash burn for 2016 between $8 million and $11 million. Operational updates include: ASP0113 CMV Vaccine