On August 9, 2016 Vical Incorporated (Nasdaq:VICL) reported financial results for the three and six months ended June 30, 2016 (Press release, Vical, AUG 9, 2016, View Source [SID:1234514566]). Net loss for the second quarter of 2016 was $1.3 million, or $0.14 per share, compared with a net loss of $2.8 million, or $0.30 per share, for the second quarter of 2015. Revenues for the second quarter of 2016 were $4.1 million, compared with revenues of $4.2 million for the second 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.

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Vical had cash and investments of $38.5 million at June 30, 2016. This cash balance does not include the $7.8 million in proceeds received from the Company’s recently completed private placement. The Company’s net cash use for the first six months of 2016 was $3.5 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, which includes the cash burn associated with the planned initiation of the HSV-2 Phase 2 clinical program later this year.

Operational updates include:

ASP0113 CMV Vaccine

Recruitment in the multinational Phase 3 registration trial in 500 hematopoietic cell transplant (HCT) recipients is nearing completion with over 90% of the subjects enrolled. Astellas expects enrollment to be completed during the third quarter of 2016, with the top-line data expected to be available in the fourth quarter of 2017. The primary endpoint of this trial is a composite of overall mortality and CMV end organ disease. Vical and Astellas have made substantial progress in process validation activities for the manufacture of the bulk drug product in anticipation of a potential BLA filing in 2018.

One year follow up in the multinational Phase 2 trial in kidney transplant recipients is now complete. Astellas is completing the final verification of all outstanding data and expects to release the top-line trial results during the third quarter of 2016. 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 1 year after transplantation. The study also includes a key clinically relevant secondary endpoint, incidence of CMV disease.
HSV-2 Therapeutic Vaccine

Vical plans to initiate a Phase 2 trial of its bivalent HSV-2 therapeutic vaccine during the second half of 2016. The randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of the vaccine in approximately 225 otherwise healthy adults aged 18 to 50 years with symptomatic genital HSV-2 infection. Vical is confirming with the FDA the Phase 2 trial design, which is intended to evaluate the vaccine’s efficacy using clinical relevant endpoints rather than virologic endpoints.
VL-2397 Antifungal

Enrollment is ongoing in Vical’s first-in-human Phase 1 trial of its novel antifungal, VL-2397. The randomized, double-blind, placebo-controlled trial is intended to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of VL-2397 in healthy volunteers. The trial is expected to be completed by the end of 2016. Vical is working closely with its expert advisors and the FDA to design a Phase 2 efficacy study for VL-2397 in the treatment of patients with invasive aspergillosis. This fungal infection is associated with a high rate of mortality in immunocompromised patients, and represents a sizeable unmet medical need for new antifungal therapies.
Equity Investment by AnGes

On August 1, 2016, Vical announced an agreement by AnGes, MG, a partner and shareholder in Vical since 2006, to purchase approximately $7.8 million of Vical’s common stock in a private placement. The shares were sold at a price of $4.24 per share, the 90-day volume weighted average price of Vical’s common stock and a premium to the close on the prior trading day. With the new investment, AnGes’ equity position increased to approximately 18.6% of Vical’s outstanding shares. The transaction further strengthens Vical’s relationship with AnGes, which has a strategic interest in DNA vaccines, including one in its own pipeline, and which has demonstrated an appreciation for Vical’s DNA technology, and clinical, regulatory, and manufacturing expertise over the years.