Fresh Tracks Therapeutics, Inc.

Fresh Tracks Therapeutics, Inc.

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Fresh Tracks Therapeutics, Inc. (FRTX) Q2 2009 Earnings Call Transcript

Published at 2009-08-07 09:58:20
Executives
Alan Engbring – Executive Director, IR Vijay Samant – President and CEO Jill Broadfoot – SVP, CFO and Secretary
Analysts
Stephen Willey – Thomas Weisel Partners Craig Gordon – Cowen and Company Alan Carr – Needham & Company Ren Benjamin – Rodman
Operator
Good day and welcome ladies and gentlemen to the Vical Incorporated financial results conference call. At this time, I would like to inform you that this conference is being recorded and that all participants are in a listen-only mode. At the request of the company, we will open the conference up for questions and answers from invited participants after the presentation. I would now turn the conference over to Mr. Alan Engbring, Executive Director of Investor Relations. Please go ahead, sir.
Alan Engbring
Hello everyone, welcome to our second quarter 2009 financial results conference call. Participating on the call today are Vical’s President and Chief Executive Officer, Mr. Vijay Samant; and Vical’s Chief Financial Officer, Ms. Jill Broadfoot. I will begin with a brief notice concerning projections and forecast. This call includes forward-looking statements including financial expectations and projections of progress in our research and development programs that are subject to risks and uncertainties that could cause actual results to differ materially from those projected including the risks set forth in Vical’s Annual Report on Form 10-K and quarterly reports on form 10-Q filed with the Securities and Exchange Commission, as well as the specific risks and uncertainties noted in Vical’s news release on second quarter 2009 financial results. These forward-looking statements represent the company’s judgment as of today. The company disclaims, however, any intent or obligation to update these forward-looking statements. Now, I would like to introduce Vical’s President and Chief Executive Officer, Mr. Vijay Samant.
Vijay Samant
Thank you, Alan and welcome everyone. In today's call, I will provide an update on recent progress in our key, independent, and partnered development programs and our outlook for the remainder of 2009. We will then open the call up to questions. But before I do that, I'll ask Jill Broadfoot, our CFO to review our second quarter 2009 financial results. Jill?
Jill Broadfoot
Thank you, Vijay. Following our strategic restructuring in the fourth quarter last year, we have maintained a sharp focus on our key development activities, the Allovectin-7 and the TransVax CMV vaccine programs. Our financial results for the second quarter of 2009 reflected higher revenues and lower expenses than in the same quarter last year and we ended the first half of 2009 with a higher cash balance than we had at year-end 2008. Second quarter 2009 revenues of $4 million included continued funding by our Japanese partner AnGes of our Phase III Allovectin-7 trial. We received a $2.5 million progress payment from AnGes during the second quarter and we also received a $1.5 million milestone payment from Merck during the second quarter in connection with our hTERT cancer vaccine program. Our focus on key programs allowed us to also reduce operating expenses by $1.6 million compared with the second quarter last year from the $11.4 million down to $9.8 million. We also achieved a $2.5 million reduction in net loss for the same period from $8.5 million down to $6 million, which is consistent with our guidance for the full year. We were pleased to raise additional capital in these very challenging economic times. During the second quarter of 2009, we completed an at-market registered direct placement of $20 million of securities with institutional investors. In July, we completed another at-market registered direct placement of $10 million of common stock, which further strengthens our financial position. We ended the second quarter with $49 million in cash and marketable securities. Our second quarter 2009 net cash burn was consistent with our prior projection for full year 2009 net cash burn of between $19 million and $23 million. I will now turn the call back to Vijay.
Vijay Samant
Thank you, Jill. In the recent months, there has been a substantial interest in our swine flu vaccine, fueled by the concerns about the availability of vaccines to protect against the continued global spread of this pandemic virus. Investors have rallied around Vical as they have with other companies focused on this serious threat. What sets Vical apart from most others is that we have already demonstrated our ability to move quickly through the vaccine development and production processes. We showed that in H5 previously. Within a week of the initial reports of widespread outbreaks in Mexico, we were the first company to enter into an agreement with the U.S. agreement for the development and testing of a vaccine against H1N1 influenza. Within two months of securing the gene sequence of the H1N1 pandemic strain, we were the first company to report results of immunogenicity testing in animals. Our vaccine elicited robust immune responses, well above the expected protection threshold in 100% of the vaccinated mice and rabbits after a standard two-dose regimen. Our H1 vaccine proved to be very immunogenic and our geometric mean titer is – which is really a measure of how immunogenic the vaccine is, was 1,522 in rabbits and 987 in mice after two doses. Let me repeat, 1,522 in rabbits and 987 in mice after two doses. Just put these numbers in perspective. The seasonal influenza vaccine produced a GMT of 92 versus the 1,522 that we got at rabbits and the live H1 virus challenge of ferrets by the CD produced a titer of 1,280 versus 1,522 we got in the rabbits. So vaccine-generated immune response is in the same range as a live challenge. This is an excellent achievement. We believe these impressive results warrant for the development and the Navy is an idea partner for this effort. They have direct experience working with us on dengue vaccines and are therefore very familiar with our technology. They have the ability to recruit healthy volunteers very quickly for a clinical trial and have access to facilities where such a trial can be conducted rapidly. We are actively working with Navy under our existing CRADA to advance into human clinical testing. At the same time, we are exploring opportunities to work with foreign governments to pursue development of H1 vaccines in areas that maybe underserved by the current conventional vaccine manufacturers. Our lead independent product development program is our Phase III registration trial for Allovectin-7 in patients with advanced metastatic melanoma. This trial is being funded by AnGes MG, our commercialization partner in Asia. AnGes has already made two progress payments to Vical this year, bringing their financial support to this program so far for more than $20 million. Last call, we announced an exclusive sales and marketing agreement with our Turkish partner EIP for the distribution of Allovectin-7 in Turkey. This week, we announced that we have entered into an exclusive agreement with sales and marketing subsidiary of Teva Pharmaceuticals for distribution of Allovectin-7 in Israel. We are actively enrolling patients at more than 90 sites worldwide including our newest sites in Brazil. We expect to complete enrollment of the planned 375 patients in our pivotal Phase III trial by the end of this year. Next, I'll review the progress on our ongoing Phase II TransVax therapeutic CMV vaccine program. Our Phase II TransVax trial is a 1-to-1 randomized double-blind, placebo-controlled, multicenter study in 80 HCT patients. The CMV seropositive transplant recipients enrolled in our study are at higher risk for CMV reactivation. The use of immunosuppressive drugs to prevent transplant rejection in these patients allows their existing, but latent CMV infection to reactivate, complicating their recovery. Our TransVax therapeutic vaccine is intended to help control CMV during this period and reduce the need for toxic and expensive antiviral drugs. We designed our Phase II TransVax trial primarily as an endpoint defining study to determine which of the multiple endpoints maybe the most meaningful as a basis for a pivotal Phase III study. We completed enrollment in the study last November and reported promising interim efficacy results in July. As a reminder, our protocol includes four injections of the transplant recipients, one dose several days before the transplant procedure, and three additional doses at two months, three months, and six months after the transplant. Our interim analysis includes data collected through four-month follow-up visit for each patient before they received their final six-month vaccination. We have posted the results of this interim analysis to our website. So I'll not review them in detail today, but feel free to look at them and call Alan if you have any questions. But we will provide a brief summary of our findings. The primary efficacy data were based on serum levels of CMV through PCR analysis conducted at one central lab at the Mayo Clinic, not at the local hospital labs. We went on the Mayo results. The viral load data favored TransVax vaccine group of placebo across five key measurement points. One, occurrence of CMV infection, which indicated a viral load at or above the minimum detectable level at the central lab. Two, recurrence of CMV infection, which indicated at least two episodes of CMV reactivation. Three, duration of CMV infection, measured as the number of days with detectable viral load as a percentage of total days on study. Four, the area under a curve, which is measured as the cumulative total amount of detectable CMV virus over a four-month study period. And finally, five, the median peak viral load, which reflected the highest level of detectable CMV virus during the study period. We also analyzed the use of antiviral drugs against TransVax. Vaccine groups performed – outperformed the placebo group on three key measurements. The percent of subjects requiring initial courses of antiviral treatment, the percent of subjects requiring additional courses of antiviral treatment, and the total duration of antiviral treatment. In addition, we completed immunogenicity data between the two groups through the four-month follow-up period. For transplant patients, the scientific literature notes, the importance of T-cell immune responses in providing protection against CMV outbreaks. We found that T-cell responses against both of the CMV antigens encoded by our TransVax vaccine were markedly higher in the vaccine group than in the placebo group. In summary, we are highly encouraged by these interim results, which appear to favor TransVax vaccine, which is placebo plus all relevant clinical endpoints and the immunogenicity data. Although our Phase II protocol does not allow us to report statistical analysis or P-values in this interim data, we look forward to presenting a full statistical analysis when we report the final data in the first half of 2010. I'll remind you that this Phase II trial was the first and foremost an endpoint defining study, to help us with the assistance of CMV and transplant experts to design a pivotal Phase III trial acceptable to the FDA. Let me move on to some of the additional developments. I don’t know, some of you may have forgotten, but the NIH recently started a Phase IIb trial of a prime-boost vaccine regimen for HIV using three doses of DNA vaccine, which are manufactured by Vical, I think in – what 2007, Alan – followed by a single dose of adenoviral vector vaccine. The placebo-controlled study will enroll 1,350 HIV-seronegative men who have sex with men, putting them at high risk of HIV infection. The trial recently opened for enrollment and is recruiting in multiples sites across the country. The trial will evaluate the ability of the prime-boost vaccine regimen to reduce HIV inflection and disease. In our herpes simplex virus program, which is funded by grant by the NIH, we published preclinical data in the Journal of Virology, which identified potential targets for development of a vaccine. We are pursuing development with this vaccine, which will be evaluated with a novel Vaxfectin adjuvant in collaboration with leading experts of the University of Washington. On the intellectual property front, we recently issued a U.S. patent covering the use of influenza virus gene sequences for a universal vaccine that could provide protection against circulating seasonal strains, as well as emerging pandemic strains of influenza viruses. This patent adds to our existing portfolio, which provides broad protection in the field of DNA vaccines. Finally, we expanded the potential uses of our patent estate through our non-exclusive academic license to John Hopkins Bloomberg School of Public Health. We previously granted academic license of the same terms to 10 other leading institutions including Stanford, Harvard, MIT and others. In summary, we have made tremendous progress in both advancing our product development programs and then validating our platform technology through a series of significant accomplishments. The first approvals of products for animal health applications based on our technology have established commercial, as well as technical validation. Our angiogenesis partners have demonstrated success in advanced human clinical trials. And AnGes, our Japanese partner, is awaiting what could be the first approval of a human product application of this technology. We're on track towards completion of enrollment in our Phase III trial of Allovectin-7 in patients with metastatic melanoma. If successful, this trial could lead to the first approval in nearly two decades of a new frontline therapy for this deadly disease. Our TransVax CMV vaccine Phase II interim results have demonstrated that DNA vaccines have the potential to elicit meaningful T-cell immune responses in – even in seriously immunocompromised patient population, which is beyond the scope of conventional vaccines. Last year, we successfully demonstrated the DNA vaccines can elicit robust antibody responses with the completion of our Phase I trial of our H5 pandemic influenza vaccine. The trial also demonstrated that safety and tolerability of our adjuvant Vaxfectin, which is being explored in multiple additional applications. We demonstrated both the speed and the strength of our approach by being first to announce the excellent preclinical immunogenicity results for H1 vaccine and we are working with the Navy to keep that program moving forward. The $30 million we raised over the past few months provides us with sufficient cash to continue development of our most advanced programs with a broadly applicable platform technology with a great list of collaborative partners and a focused portfolio of novel product candidates, Vical is really hitting the stride. That concludes my prepared comments. So operator, we are now ready to open the call for questions from invited participants. Thank you.
Operator
Thank you, Mr. Samant. (Operator instructions). Please standby for your first question. Our first question comes from Stephen Willey with Thomas Weisel Partners. Stephen Willey – Thomas Weisel Partners: Yes, thanks for taking the question.
Vijay Samant
Hi, Stephen. Stephen Willey – Thomas Weisel Partners: Hi, Vijay. I was just wondering if you could maybe just elaborate a little bit on kind of where you are with the Navy right now with respect to working on the H1N1 and do you kind of anticipate some kind of public announcement of I guess hard funding coming in for this program.
Vijay Samant
All I could tell you at this stage is we are in active discussions with them. So this is not just a conference call rhetoric that I'm putting forward to you. I think Navy, as any government organization, has to go through a lot of bureaucratic procedures, but we are in active touch with them and we feel pretty confident that we'll get the funding. Stephen Willey – Thomas Weisel Partners: And maybe just kind of an insight to that as well. There has obviously been kind of a lot of pressure with respect to the poor yields at some of the larger pharmas are getting on their H1 candidates. Has there been any kind of acceleration with respect to Vaxfectin, potential interest, potential partnerships?
Vijay Samant
We normally don't comment on who we are working with, but all I can tell you is yes, we are actively involved with a number of people including people in the field of flu business who are evaluating Vaxfectin and the end of these partnerships take time to develop and they are done on the basis not on – of our own data, but the partner or the collaborator getting data and it's in their own laboratories with their own construct and so, it takes time. The answer is yes, this is done because Vaxfectin is an excellent adjuvant and it's done not in the context of H1N1 swine flu vaccine, but there maybe certainly applications there, okay? I just – to just to follow up on your question about this low yields that we are hearing and we are hearing the same thing. You need to understand that we are not impacted by that low yield productivity issues that the conventional vaccine manufacturers have because we make our vaccine by fermentation, we don't handle the pathogen itself. So if anything, we believe based on our preclinical studies that the H1N1 probably is more immunogenic than the H5N1 vaccine that was previously made. Remember, the H5N1, the conventional vaccine manufacturers were using 19 micrograms times 2. So they were using two doses, 19 micrograms times 2 versus the normal flu vaccine, which is the 15 microgram dose, okay? So – and it remains to be seen how the conventional vaccines are immunogenic. So I know people who have just started some of their clinical trials are just about the clinical trial and the data is not going to be available for at least the next three to six months. So at that time, we will be past the flu season or ready for the next flu season. Stephen Willey – Thomas Weisel Partners: Great, congrats on a good quarter. And I'll jump back in the queue.
Operator
Our next question comes from Craig Gordon of Cowen and Company. Craig Gordon – Cowen and Company: Hello, congratulations. Just a couple of follow-up questions. First, in terms of the H5, where does that development program stand?
Vijay Samant
In the H5N1 program, we completed a Phase I study in humans. That was a 100-patient study. And our data across the three different dose levels were somewhere between 50% and 67% and really with rigorous assays, okay? These are not cockamamie assays that we developed here. These were not functional assays, these were CDC prescribed assays. We actually had some of the serological samples tested by an independent lab. The reason I'm telling you is a lot of people are representing they had 60% responses or 50% response is meaningless. The first question you should ask is, "Did you use the CDC prescribed assays? Are you using the four-fold increase from baseline in counting your seroconversion"? We did that. And we are waiting for funding either through the U.S. government or some other foreign governments to move with the program. I’m a firm believer that this H1N1 is just hors d'oeuvres, an appetizer. The real pandemic is going to be H5. Remember, the fact that H5 is not in the scene doesn’t mean that there is no activity going on in the hotspots around the world in H5. H5 has still a pretty active potential to become a pandemic, okay? And so we are pretty well prepared, we have an IND in place, we have completed Phase I study, we need money to expand the study and repeat that in a larger number of patients to do a Phase II study. And our discussions by the way outside the United States are primarily on the H5. Craig Gordon – Cowen and Company: And do you see something for – do you see this progressing? Is that a 2009 event or do you think that could be more of a 2010 event?
Vijay Samant
No, no. I mean, you don’t know. At the end of this conference call, you may hear that there is an H5N1 outbreak. This is a pretty dynamic situation. So, hard to predict what the timing of that is going to be. But I think we are in a great shape with H5N1 and we are getting in a better shape with H1N1 because we got most of the work done on H1N1 from a preclinical perspective. Craig Gordon – Cowen and Company: Great. And two other questions if I may. On the AnGes, they – last we had heard they might be consulting in the Collategene into a Phase III program in the U.S. Is that so on table? Have you gotten any updates in terms of their intentions for that program?
Vijay Samant
The answer to that question is yes. They are in active discussions with the FDA in a design of Phase III study. We – and hopefully they are successful and once they are successful and they come with that announcement, that will be the point to move. But we expect that to occur sometime this year. Craig Gordon – Cowen and Company: Great. And then on the Sanofi, since the trial will be completing, do you anticipate data in Q1 or is that more of a Q2 2010 event?
Vijay Samant
We do not have a specific date from them, but our expectation is going to be in the first half. So they – and if you go to their website and what they have publicly stated that they are going to file in the second half of next year and if that's going to occur, my guess is with a six-month follow-up, the data should be available early next year. But we have not heard when they are formally going to release or what conference they are going to release this data at. Craig Gordon – Cowen and Company: Great. And congratulations on your progress again.
Operator
Next, we will go to Alan Carr of Needham & Company. Alan Carr – Needham & Company: Hi, good morning, everyone. One of the – one follow-up question on the flu program. Is there any particular extra data that these potential funding agencies are looking for or is it just a matter of – trying to get a sense of what the challenge is in terms of getting some funding for this program.
Vijay Samant
Well, the data that we wanted to show to our funding partner is the Navy, who is negotiating on our behalf. Remember, we are not directly negotiating with the government to secure funding. Navy is a surrogate partner who has seen the data, they are happy with the data, they are working with us on dengue. So they are the ones who are negotiating with the appropriate government authorities to get funding for this program. And remember, Navy has a special access to the fund because Navy does a lot of vaccine research, okay, The Naval Medical Research Center. Alan Carr – Needham & Company: Okay, thank you. And then around the melanoma trial, what – do you have any access to data from that trial ongoing that you can share with us or is this essentially going to be a black box until we see results next year?
Vijay Samant
First of all, I am absolutely impressed, Alan, that you are asking what Allovectin-7 (inaudible). So this is a turning point, I got you convinced now. Remember, nothing has been approved for melanoma for a very long period of time. There are a lot of skeletons on the melanoma highway. I think we are pretty excited because the trial is recruiting well. I think – I have visited almost a dozen centers as I told in the last six months and I feel that the nurse coordinators, the doctors are pleased with the progress of the trial. There is no interim analysis of the trial, to answer your question. It's going to be a – the P-values are going to come out once the trial is closed out and all the data is collected and we have gone through all of – I mean, the database is locked, okay? Remember, there is no DSMB; there is only a safety board that looks at safety perspective. And remember, the trial is not a double-blinded study. It's not blinded to the physicians, it's blinded to us because one, it's an intratumoral therapy, which is the treatment arm; and the control arm is an intravenous and an oral therapy, depending on whether you get dacarbazine or temozolomide. So the answer is no, we have no interim analysis. Alan Carr – Needham & Company: Anything in the blinded data of interest that you can share with us?
Vijay Samant
No. We are not snooping around in the data. I mean, the fact that the trial is going well and the fact that physicians who are not blinded to the study are recruiting patients that tells us that they are happy with the study. Alan Carr – Needham & Company: Okay. And then –
Vijay Samant
Remember, most of the studies, which are double-blinded but recruitment rates are meaningless, okay? Here, the docs know in their own hospitals that this thing is working for them or not. Alan Carr – Needham & Company: Okay. And then one last one, if I may, around the CMV program. Any updates on partnering strategy around that program?
Vijay Samant
We are in active discussions with a variety of companies. Some of them are in the process of reviewing the data; some of them have looked at the data. So I can't comment on where it stands, but there is a lot of interest in the data because universally most of the CMV experts who have looked at the data, and we have reached out to most of them because we are friends with most of them, feel that the data is great. To quote one of the senior investigators from the U.K., his comment was, "Vijay, if this data was seen in HIV patients who have basically the same kind of immune status, you would be in the front page of the New York Times." Unfortunately, people don't understand CMV. So I hope you guys write about it. Alan Carr – Needham & Company: Do you plan to partner this before starting Phase III or you are still entertaining the possibility of doing a Phase III program yourself for this particular indication?
Vijay Samant
Well, I think we – as we have said always, the real opportunity for partnering is really the CyMVectin, which is our program for females of childbearing age. I think that's a great opportunity, a huge opportunity. This is a program that we can manage on our own. However, if we find a partner who is willing to fund it, we are open to the idea. But I think that's really the focus of the partnership. Alan Carr – Needham & Company: I see. All right. Well, thank you very much.
Vijay Samant
Thanks.
Operator
(Operator instructions). Our next question comes from Ren Benjamin with Rodman. Ren Benjamin – Rodman: Hi, good afternoon and thanks for taking the question.
Vijay Samant
Hi, Ren. Ren Benjamin – Rodman: Hi. I guess most of mine have been answered, but just to dig in a little bit more, maybe starting off with the H1N1 program, are there any more studies that are ongoing preclinical studies, maybe a challenge study or any other data that we might get? Or is the next milestone really the funding from the Navy?
Vijay Samant
The next milestone is funding. We are not going to tell you that we made the material and things like that. It's all meaningless, okay? The fact that we made material – we have made this several times, we have the cell banks, we have – we have made the prototype, and the next milestone is funding. Everything is irrelevant after that, okay? You got to get the funding to get into the humans. That's really the key milestone. Ren Benjamin – Rodman: And just to understand the next trial, once the funding is obtained, how big is the next study and when do you see results coming?
Vijay Samant
I think it's big right now. We are in discussions with the Navy in terms of what dose ranging, if any, we need to do; what size we do; what age group of patients do we go into and I think a little bit of that trial design is a little bit dynamic in terms of what people on the conventional side are doing and what hurdles they are facing. I think we are in a much better shape because all these people have gotten out of the barn and running and they are going to run and trip and fall. And we want to make sure that we learn from what their lessons are, quickly. So the study – trial design is dynamic. Having said that, it's not going to be a huge study. We want to quickly demonstrate that this vaccine is immunogenic. If anything more immunogenic than our prior H5 data, and much better and if hopefully we can even show that it has some better cross-protecting – has a much broader utilizing capability than conventional vaccines. If we show that in small number of patients, we've had our home run. Ren Benjamin – Rodman: Okay. And then just regarding the government and sort of the chatter there, since you are in constant contact with the Navy and have an idea as to what's happening, what is – do you have a good sense as to what is the chatter, the – any sort of talks that are coming out from Navy regarding stockpiling or moving forward into the fall, as far as the government is concerned?
Vijay Samant
It's all – nobody knows. The school of thought is that this may kind of go away, but I don’t know whether you are keeping an eye. I get the SOSes from the World Health Organization and others. Today North of Bombay – in Mumbai, in the City of Pune, there was a riot where thousands of people are lining up in the hospitals to get their H1N1 status tested, people who are sick with flu because a couple of young children have died at that city and there is a panic in the city. So is this a lot of media hype and people panicking or this pandemic is for real? We don’t know. And so, the – to answer your question, the intensity of how the money flows towards this program is directly proportional to what the (inaudible) death and morbidity is with this particular studies. Right now, everything seems to be under reasonable control, at least in the Northern Hemisphere. Ren Benjamin – Rodman: Got it. Just moving on to the CMV, the TransVax program, what are the current thoughts regarding prevention? Is the IND still on schedule and did you learn anything from this interim analysis that has made you change your thoughts regarding the prevention indication?
Vijay Samant
No, I think if anything, it has reinforced that A, this is a – this vaccine is immunogenic. It does impact – directly impact the amount of virus that circulates in the body when there is a reactivation. We now need to work with the experts and particularly, some of the CMV experts and the transplant experts, to come with two or three primary endpoints and maybe a composite endpoint, and then present the white paper to the FDA, have a Type 2C meeting with them before we have the end of Phase II meeting, which should occur earlier next year and then go from there. I think – no, the thought process has not changed at all. But we can do – or have an end of Phase II meeting till the final fourth injection data is in our hand, okay? Ren Benjamin – Rodman: And so that's for the prevention protocol as well?
Vijay Samant
It is. It's – oh, you are talking about the CyMVectin? Ren Benjamin – Rodman: Yes, yes.
Vijay Samant
Nothing has changed. I think you remember that vaccine is formulated with Vaxfectin and it encodes only GB. So it's an antibody-mediated response. I think we have good – there is a paper that Bob Fass recently published in the New England Journal of Medicine, okay, with using GB protein. So it tells you that GB indeed does have an impact on prevention. And so that has given us a good frame of reference in terms of how our vaccine is going to be effective. I'll send you the article, okay? Ren Benjamin – Rodman: Okay. Just one final question. Milestones for the remainder of the year that as investors we should be looking out for and just any thoughts on – I think it was Merial that just got acquired by some other pharma?
Vijay Samant
No. It was a 50-50 joint venture between Merck and Sanofi and it's a part of the Sanofi Schering – Merck-ScheringPlough merger, Merck having some animal health – ScheringPlough having some animal business I think to prevent any intervention by FTC. They kind of sold their share of that animal health business to prevent any antitrust issues to Sanofi Pasteur. So Sanofi, which was a 50-50 owner, is now a 100% owner of Merial, okay? Ren Benjamin – Rodman: Okay.
Vijay Samant
It was not acquired by any other company. We expect – to answer your question, we expect that in the next few months they – well, we have not heard recently in the last one month or so, but Merial or the – that animal health company is very optimistic of that drug getting full approval. And if that gets full approval, you will see ads in your local TV channel advertising – that product being advertised. As we told you, it's going to be priced at $1,000 per therapy. In terms of your question on what terms the immediate – the milestone payment – the milestones that are going to come, we expect the completion of the enrollment of the Allovectin-7 trial. The follow-up will be collecting data after the fourth injection of the CMV TransVax vaccine and we should have data in the first half of 2010, which will be complete data after four injections and we – that will be really – this data that we take to the FDA in finalizing the design of Phase III study. That doesn’t mean we are going to wait for that data, we'll be working on the design of Phase III in advance of that. We expect our approval of our AnGes license sometime by this year. That's what our Japanese partner is telling us. This is for Collategene, which is for angiogenesis. As somebody had asked before, that the Sanofi data should be available sometime or in the first half of year. We hope it's available in the first quarter of next year. The Merial vaccine, we think you should get data. Potentially, pandemic flu funding either for H5N1 or H1N1. Hopefully, some more technical data on Vaxfectin with some other constructs that we've been working up with our collaborators. So quite a lot of news flow. Ren Benjamin – Rodman: Terrific, guys. Thank you very much and congratulations.
Vijay Samant
Thanks, Ren.
Operator
If there are no further questions, I will now turn the call back over to Mr. Samant.
Vijay Samant
Well, this concludes our session today. I thank you all for participating. We look forward to seeing in the near future. Thank you.
Operator
Ladies and gentlemen, this concludes our conference for today. You may now disconnect.