SAN DIEGO, Aug. 1, 2013 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today reported financial results for the three months and six months ended June 30, 2013. Revenues were $1.5 million for the second quarter of 2013 compared with $1.6 million for the second quarter of 2012, reflecting ongoing reimbursements from Astellas Pharma Inc. for expenses related to the development of ASP0113 (TransVax™), Vical's therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients. The net loss was $9.9 million, or $0.11 per share, for the second quarter of 2013, compared with $7.9 million, or $0.09 per share, for the second quarter of 2012. Revenues were $3.0 million for the first half of 2013 compared with $13.0 million for the first half of 2012. The 2012 revenue includes the recognition of a $10 million milestone payment from Astellas for progress with ASP0113 which occurred in the first quarter of 2012. The net loss was $19.2 million, or $0.22 per share, for the first half of 2013, compared with $7.6 million, or $0.09 per share, for the first half of 2012. Vical had cash and investments of approximately $70 million at June 30, 2013. The company's net cash uses in the first half of 2013 were slightly below the company's forecast range. The company expects to provide net cash use guidance for the second half of 2013 after analyzing the financial implications of results from its Phase 3 registration trial of Allovectin ®. Program highlights include: Allovectin®
- Top-line results from the company's Phase 3 registration trial of Allovectin®, previously projected for release in the third quarter of 2013, are now expected to be released in August.
- Following today's scheduled conference call, as described below, and extending until the release of top-line results, the company will enter a self-imposed quiet period during which time company management will not be interacting substantively with the investment community.
- Astellas initiated a 500-patient Phase 3 trial of ASP0113 for hematopoietic cell transplant (HCT) recipients in June and expects to initiate a Phase 2 trial of ASP0113 for solid organ transplant (SOT) recipients later this year. Details of the Phase 3 trial design will be discussed in today's scheduled conference call, as described below.
- The company is planning to initiate a Phase 1/2 clinical trial of its Vaxfectin®-formulated therapeutic vaccine against herpes simplex virus type 2 (HSV-2) in the second half of 2013.
|Selected Condensed Financial Information (Unaudited)|
|Statements of Operations||Three Months Ended June 30,||Six Months Ended June 30,|
|(in thousands, except per share amounts)||2013||2012||2013||2012|
|Contract and grant revenue||$ 1,170||$ 1,364||$ 2,306||$ 2,585|
|License and royalty revenue||286||201||724||10,440|
|Research and development||3,930||3,791||7,580||10,219|
|Manufacturing and production||3,891||2,933||7,604||5,405|
|General and administrative||3,478||2,778||6,996||5,478|
|Total operating expenses||11,299||9,502||22,180||21,102|
|Loss from operations||(9,843)||(7,937)||(19,150)||(8,077)|
|Net investment and other income (expense)||(38)||69||(13)||453|
|Net loss||$ (9,881)||$ (7,868)||$ (19,163)||$ (7,624)|
|Basic and diluted net loss per share||$ (0.11)||$ (0.09)||$ (0.22)||$ (0.09)|
|Weighted average shares used in computing basic and diluted net loss per share||86,730||86,282||86,623||85,412|
|Balance Sheets||June 30,||December 31,|
|Cash, cash equivalents, and marketable securities, including restricted||$ 67,498||$ 83,857|
|Other current assets||2,083||2,152|
|Total current assets||69,581||86,009|
|Property and equipment, net||4,735||5,284|
|Total assets||$ 79,285||$ 96,522|
|Liabilities and stockholders' equity:|
|Current liabilities||$ 6,059||$ 5,779|
|Total liabilities and stockholders' equity||$ 79,285||$ 96,522|
CONTACT: Alan R. Engbring (858) 646-1127 Website: www.vical.com