Vical Incorporated (NASDAQ:VICL) announced its second-quarter results on Thursday. For the record, the biotech reported revenue of $1.5 million with a net loss of $9.9 million, or $0.11 per share. With Vical, though, these numbers aren’t very important at this stage in the game. Here are the key points from the company’s announcement that you need to know.
1. Allovectin announcement in August
Vical Incorporated (NASDAQ:VICL) expects to announce top-line results from its phase 3 study of melanoma cancer vaccine Allovectin later this month. It’s been a long time coming.
Two years ago, the company stated that it would provide these results in the second quarter of 2012. When the second quarter of 2012 arrived, Vical said that the results would be announced in the latter part of the year. By November 2012, Vical had revised the time frame to the third quarter of 2013.
There were several reasons for the delays, but the pertinent fact now is that the top-line results are close at hand. Vical Incorporated (NASDAQ:VICL) CEO Vijay Samant has used the analogy of driving across the country with the destination of downtown Manhattan to describe the Allovectin phase 3 process thus far. Three months ago, he said that Vical was in Central New Jersey. Samant now says that after a detour they’re “in the city [New York City] and headed to the southern section of Manhattan.”
2. Pipeline pushing forward
It’s not all about Allovectin for Vical. The company also provided updates on a couple of drugs in its pipeline.
Vical Incorporated (NASDAQ:VICL) announced in June the initiation of a phase 3 trial of latent cytomegalovirus, or CMV, vaccine ASP0113. The biotech licensed ASP0113, formerly known as TransVax, to Astellas Pharma in 2011.
CMV is a common virus that often doesn’t show any symptoms. The study that Astellas is conducting, though, focuses on use of the ASP0113 vaccine for hematopoietic cell transplant, or HCT, patients who are at high risk for CMV. Acquiring the virus can lead to serious complications for these patients.
This phase 3 study for ASP0113 will consist of two parts. The first part will compare the overall mortality one year after transplant between patients taking the vaccine and patients on placebo. This comparison will help Astellas and Vical Incorporated (NASDAQ:VICL) determine the best primary endpoint to use for the second part of the study, which will include another 400 patients. The study is expected to be completed by the end of 2016.
Vical’s other pipeline update related to its herpes simplex virus type 2, or HSV-2, vaccine. The company plans to initiate a phase 1/2 trial for the vaccine later this year.
3. Playing the quiet game
Don’t expect to hear any news from Vical Incorporated (NASDAQ:VICL) until the Allovectin phase 3 results are announced. That’s because the company is now operating under a self-imposed quiet period. Samant noted that Vical has canceled all scheduled public presentations through the end of August.