Vical Incorporated ( VICL) Credit Suisse Group Healthcare Conference Call Transcript November 9, 2011 9:30 AM ET Executives Adam Cutler – Senior Biotechnology Analyst, Credit Suisse Vijay Samant – President & Chief Executive Officer Presentation Adam Cutler
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We own the CMV vaccine franchise. CMV is a herpes family, which is a problem in both transplant patients and females of child-bearing age. We just did a deal with Astellas, which is a major Japanese company, which is a key player in the transplant market. I will tell you more about that.The second target in the herpes family is Herpes Simplex 2. This is a major problem. It’s a sexually transmitted disease that leads to general lesions. The only antivirals available, we had some very exciting preclinical data in the therapeutic vaccine setting. But these are pipeline programs. We have key validating partnerships with some big pharmaceutical companies. We are one of the few companies by the way which has a GMP manufacturing facility where we have capacity to launch both our CMV and Allovectin programs worldwide. And finally, we have a strong balance sheet. In our recent guidance, we will end the year with about mid-50s million dollars in cash. So, again a quick summary of our product pipeline. Allovectin-7 lead program in melanoma, market commercial opportunity is greater than $0.5 billion. The Phase 3 is fully enrolled, the top line data will be in the middle of the year. TransVax, again our product in lead transplant setting, our Phase 2 is completed. We expect to start a Phase 3 and a cease of Phase 2 trials in the solid organ transplant setting in the first half of next year. Collategene is our program for treatment of peripheral arterial disease of the legs to a Japanese company, AnGes, which is for treatment of blockage of arteries where you inject an angiogenic growth factor. We expect that Phase 3 to be started sometime in 2012, early 2012. Now, CyMVectin is a big opportunity. This is for treatment of prevention of CMV infection of females of child-bearing age. The market is the size of Gardasil. And we have an IND allowed there. So, that’s a very exciting program for us for future product opportunity. I had mentioned the HSV-2 program and product extension applications for Allovectin-7.
With that, I will move on to Allovectin-7. It’s first-in-class systemic immunotherapeutics. Immunotherapy is now something that everybody gets excited, but we have been working on this for a long time. I think people are starting to believe that immunotherapy has really a place in the treatment of cancer. We have dosed several hundred patients, I think 900 patients up to date, from doses ranging from 300 micrograms to 2 milligrams. Allovectin’s advantage is it’s given locally but invokes a systemic response, and I will demonstrate that to you in the next few slides.The other important attribute is it’s very well tolerated. You can see the side-effects of the newly approved therapies and you really understand the contract that Allovectin-7 brings to the table. It has a unique mechanism of action that drives a systemic effect. We have a Fast Track status, we have an Orphan Drug status and we expect the Phase 3 results to be available in the middle of 2012. What’s the commercial opportunity for Allovectin-7? People say, Vijay, well, you have two new products approved. First of all, those two new products are not cure for melanoma. One is the Bristol-Myers drug Yervoy, and the other is Zelboraf from Roche. They have significant toxicities, they have short-lived responses in some cases. There is plenty of room for additional treatments in the field of melanoma, and I think particularly drugs which have good and safety profile and efficacious. And Allovectin falls into that sweet spot. Quality of life is very important. Allovectin has given an outpatient treating with minimal side effects. The mechanism of action by the way is synergistic with other treatments. We believe them and we actually demonstrated in one of those (inaudible), I will show you some of the preclinical data. Read the rest of this transcript for free on seekingalpha.com