Vical's CEO Discusses Q4 2011 Results - Earnings Call Transcript

We are projecting a net cash burn for 2012 of $17 million to $22 million, this includes the $10 million milestone payment from Astellas, along with contract services, revenues offset by plans pre-commercialization, preparations for (inaudible). It also includes pre-clinical studies and manufacturing of our HSB2 vaccine in preparation for a phase one slash two clinical trial.

Vijay will describe these efforts in more detail. With that, I’ll turn the call back to Vijay.

Vijay Samant

Thank you, Jill. I will start today with our Phase III Allovectin Program and the timing guidance we updated this morning. As a reminder, this physical trial for patients with metastatic melanoma was scattered out in – on SBA. It enrolled 390 subjects from Jan 2007 to Feb 2010, and the enrollment is not complete.

They were randomized two to one to receive either Allovectin or the physician choice of (inaudible) or tyrosinamide which are the standard chemotheraphy drugs used for melanoma.

We enrolled subjects with Stage III or Stage IV disease up to M1b, excluding lower and (inaudible) with no prior chemotherapy, and normal levels of LDH. These factors reflect the fair – experience gained from our Phase II study.

We have two efficacy end-points of this trial, the primary end-point is object response rate at 24 weeks or more after randomization, and the secondary end-point if overall survival.

The databases for these two-end points can be processed separately, but wide [ph] will remain unblended until both are finished, this is a very important point, will reach the end of the maximum two-year period later this month for the last subjects enrolled in the study.

After the last subjects go off the study, they’ll complete the side audits and log the data base for the primary end-point which is overall survival which is our object response rate. An independent committee of radiologists and oncologists will then review the data in a blinded fashion with no enrolment or access by Vical.

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