Vical Incorporated (
Citi 2012 Global Health Care Conference Call
February 27, 2012 3:30 pm EST
Vijay B. Samant – President and Chief Executive Officer
Vijay B. Samant
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People in the audience. So, first of all, I want to thank Citi for inviting us to this conference. They just did a recent financing, so it’s appropriate that they invite us to this conference. Before I begin my formal presentation, let me refer to your Safe Harbor Statements. We may be looking some forward-looking statements. Please refer to our filed SEC documents to fully understand the risk associated in investing with Vical.
For a number of members in the audience, may not know what Vical does? Vical is a biotechnology company, which has a broad pipeline and a substantial commercial opportunity. I think the lead program is Allovectin-7; I am going to spend some time talking about it. It’s a program for cancer immunotherapy. We have Phase 3 pivotal study which is complete, the one-year follow-up and the patient completed by the end of this month, so I will talk more about that timeline, I am sure in the breakout session, there will be a lot of questions in the timeline.
We are very excited about this program by the way, in terms of how this has come about and how we have executed this program. Allovectin-7 dose has been used for melanoma, if I go through the mechanism of the action you will clearly understand; it is applications of all the solid tumor applications. Our next application would be head and neck cancer, so keep your eyes open, as we talk about our data from our melanoma study, so you fully understand how that translates to other solid tumors.
The next franchise that we really have which is CMV, Cytomegalovirus is a herpes family virus, the apartment that with Astellas, we’ve completed a Phase 2 study we’ll be starting a Phase 3 study in the first half of this year, but Astellas has two indications, one is for the treatment of transplant patient, the second is treatment for females of child-bearing age who get CMV during pregnancy, first time [after] pregnancy.
I will talk more about that in terms of what the opportunity there, and then we announced in the last earnings call that we are embarking in herpes simplex 2 program, which is a therapeutic vaccine for treatment for patients, who have HSV-2 positive, will get lesion recurrences, given idea what size that market is, the big commercial opportunity, a ability to run that trial very quickly. We have a number of key validating partnerships, and the uniqueness about Vical is we do everything in-house.
And you may say why you do in-house because you need to be in control of your destiny, people who don’t do things in-house in fact apart those things out to third-parties, in the end realize that the devil is in the details in this business. We even have our own manufacturing facility, we are one of the few companies in Southern California, which has a biological manufacturing facility, and we have a strong balance sheet. We raised some money now, we have $100 million plus in cash, a burn rate guidance is about $20 million plus.
So there is only upside in terms of what we are doing. So Allovectin-7 the lead program, it’s a first-in-class immunotherapy, before immunotherapy was enrolled, we’ve been working on it for a long time, it’s licensed originally from University of Michigan from Gary Nabel Lab, it has gone in about 900 patients, so far in a variety of dosage forms, the dose that we are using currently is 2 milligrams, okay, which is the highest dose that we’ve used in clinical applications.
As I said before it has variety of applications in solid tumors, it’s well tolerated it’s given in a local study. The way it’s given, if you give one injection per week, for six weeks in a row followed by two week of observation period, for a cycle of treatment is eight weeks, okay. And it’s given into tumor release, so you inject the same lesions through the entire therapy, not all the people think by giving it locally that mean some local therapy it’s not a systematic therapy.
I am just flab a guess, if somebody comes and says, well you mean the injected lesion shrinking is how you measure response rate. Well in the RECIST criteria, you measure response rate by identifying a series of up to 10 target lesions and you follow those lesions through the course of the disease in which you base the response rate. Here we’re injecting only one single lesion, we follow all the 10 lesions, so that’s very important thing that everybody needs to recognize.
It has a unique mechanism of action, it drives a systemic effects, it’s a local therapy that drives systemic effect, and I think I am reemphasizing that point, because it’s so important as this therapy it’s completion, coming to a completion of the pivotal trial. It has potential synergy with other therapies, I will talk more about that, it is an Orphan Drug status, it has a Fast Track designation, we have retained U.S. and EU rights and [then the] SPA. So I will talk more about what the design of the studies in a minute.
Well two drugs have been approved for melanoma in the recent times, Yervoy and Zelboraf one is by Roche drug and the other is by Bristol Myers Squibb, those are not cures for melanoma, so there is plenty of room and particularly there’s plenty of room for drug, which can offer a safe efficacious pathway for patients which then exist today, including chemotherapy. Our drugs hopefully if it gets approved and the safety profile bears out, as we have seen in Phase 2 would be a perfect solution for patients.