Vical Incorporated (NASDAQ:VICL) reported financial results for the three and nine months ended September 30, 2015. Net loss for the third quarter of 2015 was $0.3 million, or $0.00 per share, compared with a net loss of $4.4 million, or $0.05 per share, for the third quarter of 2014. Revenues for the third quarter of 2015 were $5.0 million, compared with revenues of $3.4 million for the third quarter of 2014, reflecting increased revenues from Astellas Pharma Inc. for manufacturing services performed under our ASP0113 collaborative agreements. ASP0113 is Vical’s therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients.
Vical generated positive cash flow for the third quarter of 2015 of $0.2 million. The Company had cash and investments of $43.9 million atSeptember 30, 2015 compared to $49.1 million at December 31, 2014. The Company is updating its 2015 full year cash burn guidance to a range of between $7 million and $9 million, a reduction in cash burn from its previous forecast of between $9 million and $12 million.
Program updates include:
ASP0113 CMV Vaccine
- Enrollment in the multinational Phase 3 registrational trial in approximately 500 hematopoietic cell transplant recipients is ongoing. Astellas has finalized the primary endpoint as a composite of overall mortality and CMV end organ disease and has decided to forego the adaptive trial design. Astellas is in active discussions with regulatory agencies to obtain their concurrence on the selected endpoint. Astellas expects enrollment in the trial to be completed by the third quarter of 2016, with the top-line data being available in the fourth quarter of 2017.
- Enrollment in the multinational Phase 2 trial in kidney transplant recipients is complete. The primary endpoint of this trial is the incidence of CMV viremia and the study is powered to show an approximately 50% reduction in CMV viremia at one year after transplantation. Top-line trial data are expected to be available in the third quarter of 2016.
- The subjects in the ongoing Phase 1/2 HSV-2 study will continue to be followed for a period of twelve months for safety and nine months for efficacy following their last dose. Vical expects that additional efficacy data will be available for analysis in December and will enableVical to determine the next steps for the HSV-2 program by early next year.
- In August 2015, Vical’s novel antifungal, VL-2397, received a qualified infectious disease product, or QIDP, designation from the FDA for the treatment of invasive aspergillosis. Vical is targeting initiation of a Phase 1 trial in the first half of 2016. This will be a randomized, double-blind study to determine the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VL-2397 administered by infusion in healthy volunteers. (Original Source)
Shares of Vical closed yesterday at $0.39. VICL has a 1-year high of $1.55 and a 1-year low of $0.37. The stock’s 50-day moving average is $0.47 and its 200-day moving average is $0.74.
Vical Inc is engaged in researching and developing biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.