Vical Analyst And Investor Day Transcript
Vical Incorporated (
)
Analyst and Investor Day Transcript
November 9, 2010 5:00 pm ET
Executives
Vijay Samant – President and CFO
Sanjiv Agarwala – Chief, Medical Oncology & Hematology and Director of Melanoma and Immunotherapy Program
Alain Rolland – EVP, Product Development
Mark Pescovitz – Professor of Surgery and Microbiology & Immunology
Rick Kenney – VP, Clinical Development
Presentation
Vijay Samant
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Welcome to Vical’s Unidentified Analyst Day. We have our Senior Members from Vical’s staffs here along with some distinguished speakers, so – and both members from the buy side and the sell side community.
First of fall, I want to thank all of you for coming for this Analyst Day. I want to walk you briefly to the agenda, but before I do that, I need to remind you of the Safe Harbor statements, you know, the presentation that both the outside speakers, as well as the inside speakers will be making – it may contain statements which are forward-looking statement. Please refer to our filed SEC document to fully understand the risk associated than investing in Vical or any of the biotech company for that matter.
Brief overview of the agenda. I’ll give you a brief overview. The last time we did this quite a few people came that we directly went into the programmatic review and not giving a Vical overviews. So I’ll take about five minutes going to our broad programs that Vical has undertaken, beyond the two programs that we are focusing on.
Dr. Sanjiv Agarwala, Sanjiv raise your hand please. He’s a distinguish melanoma expert. And he also is from Mumbai, which I just found out today. And he’s going to be giving us a little update on the state of melanoma, what’s going on. And obviously you'll have opportunity to ask him questions, as it relates to some of the competitive activities that are going on in the feet of melanoma.
Followed that Alain Rolland our Executive VP of Development. Alain, is going to give a specific presentation on Allovectin-7, which will contrast some of the things that Sanjiv is going to be presenting, but will give you a real idea of what our program is and how the clinical trial is being conducted.
Mark Pescovitz, is a leading transplant expert, solid organ transplant expert. And some of you may be familiar with him because he has been on some of our conference calls on the back stand, he’ll be talking about CMV, the State of Art of CMV and how important viral node in terms of predicting CB [ph] disease among other things.
And Rick Kenney our VP of Clinical will be talking about our TransVax program, specifically how the clinical trial that we conducted recently, to summarize the data in what our plans for the future are. And then we’ll end the presentation with certain Q&As, okay, so which I would be moderating.
So briefly quickly looking at Vical at a glance, it’s a late stage buyback company. 0We have multiple programs, cancer being the lead program, programs in infection disease, PAD. And established platform to be able to retain commercial rights to most of our program, we have several validating partnership, big pharma, small pharma.
We are one of the few companies which has a State of the Art manufacturing facility and a strong balance sheet. The key program of Allovectin-7, big commercial opportunity, market greater than $500 million, CMV is the only company working in that field. Temusi, you will see the top line data on November 16, but that did not mean the primarily end-point and then emerging to this platform.
Allovectin-7 is a first in class the systemic immunotherapy. We have dose about 800 patients to date. It has applications in variety of solid tumor. It’s well tolerated. Given an outpatient setting, it has unique mechanism of action. It’s synergistic with current program that are under development.
And we have significant capacity to commercially launch this product, as I told you we are the only company we has to my knowledge of biological. The 13, San Diego, it is an often drug status. It has a fast track designation and it has – we have retained all the U.S. and EU rights for this program.
TransVax to my knowledge, we are the only company working in the field of 90% to 40% of transplant with the safety vaccine, this is the therapeutic vaccine to prevent CMV reactivation, we have demonstrated group of concept in the phase II study that Rick is going to cover in details, all the clinical data which is presented at recently at AGAC.
Again, we have sufficient capacity to commercially launch this product, we have often drug designation this is application of a both solid organ transplant and hematopoietic cell transplant. And it gets the rise both for U.S. and EU and you got to hear more about the clinical trial designs for both the programs, then Alain and Rick presents their respective presentation.
Our key collaborations on AnGes is a second largest biotech company in Japan, they funded our melanoma program for Allovectin-7, pay us about $23 million for which we give them rise in Asia. And the goal really is use to Allovectin-7 in head and neck cancer in that part of the world. We have retained U.S. and European rights. I mentioned Collategene, which is the program for PAD, similar to the program that Sanofi is doing for PAD and they expect to start the trial sometime in 2011.
Sanofi-Aventis obviously, will be very disappointed with the failure of that study; more of the data will be presented at the America Heart Association next week. And then Merck which has been a big partner for us has stated about $30 million for the last seven year has hTERT cancer vaccine which is a telomerase gene license from John [ph].
How do you define validation of this technology? A lot of people ask, the two important validation that have occurred of for – in the animal health space, one is Merial lead of license incept which is the melanoma vaccine for dog. And this is really the first therapeutic vaccine approved before Dendreon’s Provench [ph] got approved either in human kind or fat kind.
And it’s a – despite at $1000 per treatment, it was launched in Jan of 2010 is being short supply, but we expect this particular opportunity further validating the application of Vical’s technology.
Novartis is a vaccine for stem and approved $3 million efficient clinical trial and all the salmon, and if you had salmon, you had salmon tonight for dinner. Unfortunately, we’re not going to have salmon tonight. Salmon coming from Canada is vaccinated with more extreme vaccine. And then we have several programs if you have collaborated with IHN.
For peace simplex we presented some very exciting data, HIV Ebola, WNV, SARS in the intercept time will not be touching those programs today, you can do to our websites, but those programs have got in funding to the total $240 [ph] to $50 million for the last several years.
Financially, we raised about $32 million in September 2010, we have sufficient cash now to last through 2012 and we have milestone – potential milestone in royalty payments which have potential to fund further R&D. Since, summary the upcoming milestone that the full data of that fail through C-trail will be presented at the American Heart Association.
The Swine Flu data which has come out sometime in the first quarter of 2011, by the way that study was funded by the U.S. maybe the database log for Allovectin-7 Phase III for melanoma is sometime in the second half of 2011, I’m hedging the exact timing because we need to have the appropriate man create and make sure the patients have progressed.
TransVax Phase III HCT trial and the SOT trial, our goal is to start those in the second half of 2011. And AnGes our partner which is going to do a PAD study in critical (inaudible) in sometime in 2011.
So if you’re looking for investing in Vical what are the important value drivers, it’s a proven technology platform there are two animal health products that would be approved right now. We have a phase III program, which is the more advance immunotherapy asset is available for licensing.
A phase II study in TransVax, the first time somebody have shown in such an immune compromise spacious, that we can mould in and response and Rick is going to cover some of that data very shortly. A phase I dynamic influence of vaccine program, why is that program important, this could be an opportunity, forgetting money for department with decent for further validations of the technology and potential starts oiling from very specific users.
The phase I CyMVectin program, this is really a big opportunity. We’re collecting for vaccine for female of child-bearing age, this is the last big target for our female of child
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bearing age. Female will see me negative, who get CMV infection defrayment is a leading cause of birth defects due to an infection raising to U.S. cytologist.
Just – the way (inaudible) use to be in the 50s and 60s, we owned a lot of intellectual property around both TransVax and CMV, we had an IND approved and hopefully we’ll get funding from a partner to start the study in the near future, to approve animal health program and fiscal responsibility. If you look in the last seven, eight years, we have managed our cash very effectively both in terms of programmatic usage, as well as bringing revenues from other sources.
So with that, I’ll stop and pass the turnover to Dr. Agarwala. Sanjiv.
Sanjiv Agarwala
Thank you, Vijay. It’s a pleasure to be here. And I just want to, that you all know that I am Medical Oncologist that specializes in melanoma a very unique disease that I’ll try show you tonight.
I’ll give you one note that I am an Investigator on Vical phase III trial, which is being completed of course and I have done Ad-hoc consulting for Vical in the past and have received research support and honor form Vical I did not own any stock in this company.
So let’s talk about melanoma and this is really an overview of the disease, I don’t have any specific data obviously with Allovectin-7 to show you. But what I want to do is put in perspective in terms of this disease what are the un-net needs, how important is it and where things are going into seal, this is being very exciting time for melanoma actually with a lot of new things going on.
So 2010 these numbers go up every year, the U.S. incidence is now about 68,000 cases with almost 9,000 death and as I’ll show you, unfortunately the death rates for melanoma, approximates pretty much the number of stage four patient.
The lifetime risk of developing melanoma is 155, which means if you know 55 people one of them will get melanoma, so this is a disease that although not as common as long and breath cancer so on, is very important and indeed by the way is the fastest growing cancer in both man and women today.
These are some slides looking at some data that is some old and some relatively new. You see that the incident in melanoma is rising quite dramatically. And some of this is because we are looking for it more, obviously the more you look for something the more you find it.
However, the debt rate has risen as well and it’s not just an artificial incidence because of increase awareness. This is now what we are projecting in 2015 that there will be one in 50 lifetime risk in the United State of melanoma in Caucasians and I got a feeling that that’s going to be exceeded, actually the way things are going. So we’re seeing much more this disease and we use to.
Now, I do a lot of teaching for fellows and residents and so on. And of course, you have the stage cancers and I think just to make it as simple as possible as I do for them. I tell everyone that there are four stages of all cancer.
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