Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)

Vical Incorporated (NASDAQ:VICL)

Q4 2011 Earnings Conference Call

February 8, 2012 12:00 PM ET

Executives

Vijay Samant – President and Chief Executive Officer

Alan Engbring – Executive Director IR

Analysts

Stephen Willey – Stifel Nicolaus

Jason Kantor – RBC Capital Markets

Eric Schmidt – Cowen and Company

Ren Benjamin – Rodman & Renshaw

George Farmer – Canaccord Capital

Adam Cutler – Credit Suisse

Howard Liang – Leerink Swann

Operator

Please standby, we’re about to begin. Good day, and welcome ladies and gentlemen to the Vical Incorporated Financial Results Conference Call. At this time, I’d 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’ll 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 2011 Financial Results Conference Call. Participating on the call today, our Vice Sales 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 clinical development program that are subject to risks and uncertainties that could cause actual results to differ materially from those projections, including the risks set forth in Vical annual report on form 10K, and quarterly reports on form 10Q filed with the Securities and Exchange Commission, as well as the specific risks and uncertainties noted in Vical’s news release on 2011 financial results.

These forward-looking statements represent the companies judgments as of today. The company disclaims however, any intent or obligations 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, we had a productive fourth quarter, a productive full year in 2011, and we are poised for an exciting 2012. We have met steady progress in our key development programs. I’ll provide the dates in each of these programs on the call today, but before doing that, let me pass on to CFO, Jill Broadfoot to start the call with a review of our latest financial results. Jill?

Jill Broadfoot

Thank you, Vijay. Our revenues for 2011 were $30 million as compared to $8.7 million in 2010. 2011 revenues included $28 million from the upfront payment, an initial contract services under our transact license agreement with Astellas. We are eligible to receive another $10 million milestones payment from Astellas as we advance for initiation of the upcoming transact – and continuing reimbursements for contract services including development and regulatory support as well as manufacturing of clinical trial materials.

The increase in revenues decrease our net loss for 2011 to $7.3 million or $0.10 per share, compared with a net loss for 2010 of $30.4 million or $0.51 per share. As a result, our net cash burn for the year was $4 million, and we ended the year with cash and equivalent of $56 million which was at the high end of our guidance.

On January 6th we completed a $50 million follow-on offering [ph] that generated net proceeds of $46.6 million. Today, the underwriters exercise a portion of the over allotment for an additional $2 million in net proceeds, per total net proceeds of $49 million, combined with our year-end cash balance, we believe we have sufficient capital to support our on-going operations, and plan development and pre commercialization activities through at least the end of 2013.

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.

They’ll determine which subjects are clinical responses, which subjects has stable disease, which subjects progress through the course of trial, but not knowing whether each subject was in the treatment arm of in the control arm.

This process typically takes several months. It’s a very rigorous process. These results will remain completely blinded to Vical in a third party database until we reach the trigger for our secondary end-point survival.

Our goal is to announce both the endpoint of the top line data at the same time. For the survival endpoint, we are tracking the overall number of death events, but we are blinded to the number of events per study. Based on the trial enrolment history and the assumed survival times for both onto the study, we had expected to reach the target number of death events by mid 2012.

But the subjects in our trial continue to live longer than we had assumed on the basis of our Phase II results in historical chemotherapy trail results. Based upon the latest information received, we now believe that late 2012 is the most realistic projection of reaching the target number of death events.

Of course we are often asked if the delay in reaching the target number of death events is a good sign or a bad sign. What we can say – what we can say with certainty that we are blinded to the results until the trail is complete, but we can say that reaching the target number of death events sooner than expected would be not encouraging.

We're taking advantage of this additional time to advance self preparations for BLA filing and potential commercial launch and planning for Allovectin's success.

In the manufacturing and regulatory areas for example, we are completing our commercial [ph] process characterization proceeding to validation of our manufacturing process as well as analytical validation. This will include producing consecutive conformance laws and commercial skills to demonstrate consistency and comparability with clinical launch to finalize the expiration date.

We are also upgrading our data management systems in preparing for our electronic BLA submission. And our commercial preparations, we are securing our supply and distribution networks including validation of our selective contract, fill finish contract, manufacture operations, developing a comprehensive launch planned, detailed activity such as BLA submission, publication strategy, rising reimbursement, branding, distribution, identification of KOLs who’ll support Allovectin-7.

Some of these activities will extend beyond year-end, but we intend to make good progress by the time the data is released with the goal of filling the BLA at the earliest opportunity. I'll finish the Allovectin-7 update by confirming our timeline so there’s no confusion.

Later this month, final treatment will end for any subjects still on study. We can then proceed with the final data collection audits, lock the database for the primary end-point and conduct the independent end-point assessment and adjudication.

In late 2012, we expect to reach the target number of death events at which point will un-blind the data and release the top line results from both the primary and secondary end-points. We’ll continue to provide status reports in our quarterly conference calls.

Let me now move on to our CMV program, beginning with TransVax, our therapeutic vaccine designed to control CMV inspection or reactivation in transplant recipients. In Jan, we published detailed results from our completed Phase II proof-of-concept trial in the Lancet Infectious Disease journal.

We've discussed the results in conclusion in protocol. So I’m not going to go into that data today, but it’s worth noting however the encouragement expressed in the associated editorial comment provided by an Austrian CMV expert.

And I’ll quote, “In the transplantation setting, the efficacy of any CMV vaccine is probably even lower than it’s in pregnancy. Immunosuppressive and myeloglydotherapy [ph] has diminished the response of pre-existing immunity to antigens and immune maturation after primary infection and vaccination and it’s (inaudible). Despite these difficulties, use of TransVax reduced the occurrence, duration and the number of CMV volume [ph] episodes in the present study.”

He goes on to say, “The results of the study are exciting, particularly in view of frustrating failures of previews vaccine trials.”

We are of course quite pleased with these results which are instrumental in securing the TransVax license deal with Astellas last summer, we’re also pleased with our discussion to the FDA on the trial design.

We have recently participated in a public CMV workshops sponsored by the FDA and the other HHS agencies which is the Human Health Services agency. The workshop was designed as a forum for discussion on appropriate clinical trial design and end-points for the development and evaluation of CMV vaccines.

The primary focus of the workshop was the development and evaluation of prophylactic CMV vaccines designed to protect young women before they become pregnant, thereby protecting the fetus from transmission of CMV during pregnancy. Because a strong enrollment in the field, going back several years, we we’re the only biotech company participating in the round table discussion with four major pharmaceutical companies addressing the regulatory issue surrounding the general CMV vaccine development.

The challenge in this indication is the low incidence of congenital CMV disease then therefore the high cost of conducting very large long-term clinical trials. We believe the workshop brought all the right parties together provided they have the information needed for acceptance of appropriate bio-market as trail end-points.

Once that regulatory platform is clear, the I&D for our CyMVectin program, which is our prophylactic vaccine positions us to advance directly with both clinical development and bartering efforts to address this major medical needs. This target, the commercial size is just like what we have seen with (inaudible)

There was a small section of the workshop that ordered the therapeutic CMV vaccines for transplant or simply means, the exports who were participating echoed the inclusion of the EMA in response to Vical’s query last year, that CMV diseases is not a practical end-point for trials and stem cell transplant recipients.

The incidence of disease is simply to low because of the heavier lines on anti-viral drugs. We are actively engaged in discussion with DFD along with our partner Astella, about the primary end-point for our Phase III trial in stem cell transplant recipients and we are on track to start the trial as planned in the first half of 2012. A Phase II trial and organ transplant recipient should begin shortly thereafter.

Now let me move on to one of the most exciting developments of Vical, which is our Herpes Simplex 2 program. In our last call, we reviewed the latest data from our pre-clinical studies. Our Vaxfectin formulated vaccines against HSV-2 provides complete protection in guinea pigs against both primary and recurrent HSV-2 disease. The vaccines also significantly reduced gentle lesion recurrence and viral shedding as well as latent infection in the central nervous system.

These data were among the best that were seen in a pre-clinical HSV-2 vaccine model. We believe the ability of our vaccine platform technology to induce both antibody and T-cell response is key especially in a therapeutic setting.

Systemic antigen selection and formulation with the Vaxfectin antigen drive the right types of responses against the right targets to help control this chronic infection. These doctors give us confidence to proceed towards the initial human testing where the other vaccine approaches have failed in the past.

Since our last call, we made the decision to advance the therapeutic vaccine into the clinic and that’s why the (inaudible) money recently. We are currently preparing to conduct the safety talks and by distribution studies to support an I&D application. Our goal is to begin a Phase I slash II trial which is a proof of concept study as soon as possible.

We believe a relatively small study could be conducted in Herpes Simplex 2 positive symptomatic volunteers, given the large number of people infected by this lifestyle changing infection. In their high level of demand, we should be able to recruit the study very quickly and get the results rapidly.

The trial would enroll HSV-2 positive individuals with a pattern or recurring genital lesions. We will document the timing and severity of outbreaks and the amount of water shedding over a defined period of time before vaccination. But again in order to find the period of time, after a series of vaccinations was completed, subjects would thereby serve as their controls, we’d be able to compare results directly between vaccine and placebo growth.

This general trial design would be – it would provide initial human safety and proof-of-concept data, and if successful, it could lead directly with a high confidence to a large safety and efficacy study.

An effective therapeutic vaccine for Herpes Simplex 2 will serve a large and highly motivated market and could generate peak annual sales of more than a billion dollars. For the rest of the population a prophylactic HSV-2 vaccine would be a welcome protection against this dreaded sexually transmitted disease.

Let me summarize the call today. We are – our three exciting programs our Allovectin program, our CME program, Herpes Simplex 2 program, but I would like to take a minute and talk about what’s happening in then remainder of 2012. In our Phase III trial of Allovectin, we expect to complete enrollment in Feb 2012. All patients still on study and release the top line data for both the primary and secondary points at the end of 2012.

And our collaborative TrasVax CME vaccine program with Astellas, we expect to initiate a Phase III trail in stem cell transplant recipient and a Phase III trial in organ transplant recipient in the first half of 2012.

We expect to conduct a preclinical safety talk and a bio-distribution study of our Herpes Simplex 2 vaccine in 2012 to advance the program towards initial human testing. We expect our net cash bond rate excluding cash received from the sale of equity securities between $17 million and $22 million.

This concludes my prepared comments. Operator, we are now ready to open the call to questions from my invited participants. Thank you.

Question-and-Answer Session

Operator

Thank you, Mr. Samant.

The question and answer session will begin at this time. (Operator instructions)

Our first question comes from Greg Farmer with Canaccord Capital.

George Farmer – Canaccord Capital

Hi, it’s George Farmer. Thanks very much.

Vijay, can you kind of give us a little bit more guidance as to what’s going on? Why is this timing pushed out yet again until the end of 2012? And is it possible that this could extend into 2013 given the fact that the trial had completed enrolment some time ago? What’s going on here? What are you guys missing in order to give us a better handle on the timeframe?

Vijay Samant

Well, as I’ve told you in the last call that we will be updating the guidance in Feb of 2012. And we wanted to make sure we have experienced in the months of December and Jan.

And the way we look at it is the monthly event rates are misleading, we normally learn them by three or four months and see what kind of average we’re getting on a rolling three or four months basis because that’s a good indication of how we’re approaching our target. And we find that the leg is rolling three, four months average is below what we have seen previously.

And that’s why we updated the guidance because we know we’re not going to meet it by the middle of the year. And I think we feel sufficiently confident at this stage based on this rolling three, four month average that we’ve taken, that we should be achieving the goal by the year end.

We will keep you posted if anything changes. But I think we are on track right now.

George Farmer – Canaccord Capital

Okay. And is there any harm in un-blinding the response rate data with 40S?

Vijay Samant

There is none. But if you remember, right now, survival as you know, the response rate is the primary end-point and survival at the secondary end-point, both of them kind of go hand-to-hand. As you know, the response rate data is not in our hand.

I covered at my call, the last patient gets off the study in Feb. There’s a final follow-up with it that comes in March. After that, we lock the database and then we do all the ideological evaluations, which are done randomly by a bunch of radiologists, then the their oncologists and the radiologists to get to do the final adjudication.

I don’t think we’re going to have that data much sooner than the timing that we’re projecting the survival data. And if we’re going to get – moved it on at the same time, it’s right to announce them at the same time because if I announce one data, and one data is good as the other, there’ll be all kinds of reactions to the data by putting both data because survival is going to be a very important component of the data.

We want to make sure we put both our feet to the right side, okay…

George Farmer – Canaccord Capital

Okay.

Vijay Samant

…as we go forward, okay?

George Farmer – Canaccord Capital

And then a question on TransVax, you’re guiding here for a first half Phase III start, yet, it doesn’t sound like you know what the right end-point or trial design will be. What needs to happen? Are you going to get in front of the FDA and decide on that? And what do you think the right place or the end-point should be?

Vijay Samant

You’re presuming that we don’t know what the end-points are. We haven’t disclosed that yet because we are in active discussions. It’s just taking a little bit longer for two reasons, okay? First of all, as you know we patterned the program. In summer we had a new partner Astellas, which is now at the table.

And we wanted to make sure they’re fully involved in our prior discussions and got their inputs because they also have a lot of expertise in the transplant setting because they are the number one drug program selling in that market.

So it took us time to make sure because of their program right now, okay, along with ours, they own the programs to make sure what we submit to the agency has their concurrence. However, let me tell you that our discussions are going well, and Astellas has a lot of confidence in us because we still hold the I&D, we haven’t transferred the I&D.

So we are actually the people who are dealing at the agency, the discussions are going well. And I just mentioned to you in the workshop where most of the FDA people who are in discussion with us were there, heard what they experts had to say. So I think we are there. This is not - we have submitted a piece of paper and waiting. It has been an on-going dialogue.

So we have a fairly good confidence that this is all going to come together.

George Farmer – Canaccord Capital

Okay. Great. Thanks very much.

Operator

Our next question comes from Adam Cutler with Credit Suisse.

Adam Cutler – Credit Suisse

Hi. Thanks for taking the question. So, can you remind us what your assumptions were for survival in the control arm? And then, I guess, on a related note, can you share with us anything you know or thoughts about how the availability of Zelboraf and Yervoy could be impacting things?

Vijay Samant

Excellent question, Adam. Okay. First of all, to give you a reminder of what the – our assumptions were, our assumptions were that the control arm which gives the (inaudible) level about 11 months and the patient’s arm would leave 18 months, which is the lower bound of our number.

Okay. Remember, we have made number of changes in the phase of the study. And then based on, if you take a look at what we’re doing here, we expect that number to be around 22 months or north of 22 months. So, I think those assumptions are pretty conservative. Okay. So, those are the assumptions and that’s where the modeling was done.

Now, your question was what impacted these two drugs have in the study?

First of all, when our trial was going on – remember, our trial started – the January 7 guide, is it Feb? Yeah, it’s Feb now. Okay. I’m losing track of time. It’s five years since the study started. And the time the – study and the year where these studies were going in, their study would have treatment nine [ph] subjects. So, none of our patients who were on our studied could have gone into those studies, okay?

The earliest outpatients would have progressed and gone into the studies, assuming in the case of Zelboraf there might be entry criteria, such as the (inaudible) mutation, et cetera, was when the drug got approved in the United States in September of 2011. That’s almost four and a half years after our study started. And in May, when the year – got approved in the U.S. – the European approval was much later, okay.

The compassion used, there was not a lot of uptake [ph], so I don’t think any of our – so, if you assume that the chemo arm progress sooner and died sooner, and the Allovectin arm stayed longer, the problem really is some of the Allovectin of in-patients would have gone.

But I don’t know. We have no idea which patient post-approval are getting what, but that’s the reason the study is randomized. However the study is randomized two to one, so you can draw your own conclusions.

Adam Cutler – Credit Suisse

Okay. And then one other question, I appreciate the added color about the other activities, that you’re undertaking while you’re essentially waiting to be able disclose the results, assuming that these timelines that you’re describing today hold out and you continue to pursue those other activities, how quickly do you think you’ll be able to file after you announce the data?

Vijay Samant

I’m going to file BLA [ph]. Obviously, assuming everything goes well. Within about two-quarters after we get the data, okay.

Adam Cutler – Credit Suisse

Okay, thanks a lot.

Operator

Our next question comes from Stephen Willey with Stifel Nicolaus.

Stephen Willey – Stifel Nicolaus

Yeah. Hi. Good afternoon. Thanks for taking the question.

Vijay, I was just wondering if – I know you remain blinded to the data, obviously, but was there a cap on enrollment with respect to the percentage of Stage IIIs that were allowed into the trial? And was that a stratification factor as well?

Alan Engbring

Okay. This is Alan Engbring. It wasn’t stratification factor but there was no cap. We took them as they came. So, if the Phase II data or any indication, we would expect it to be a lot of 50-50 mix.

Stephen Willey – Stifel Nicolaus

Okay. That’s all I have. Thanks.

Operator

And our next question comes from Jason Kantor with RBC Capital Markets.

Jason Kantor – RBC Capital Markets

Thanks for taking the question and thanks for the update. I’m just wondering, can you give us some kind of qualitative sense of – is it just that the event rate is continuing to slow overtime because now you’re pushing it out a couple of times, so is it just – would you describe this as a flattening of the curve? Is there some possibility that you could go very, very, very far out without hitting the number of events at the rate you’re going?

Vijay Samant

Your question is, are we on the flat nature, I don’t think so. I don’t think so we’re in the flat nature of the curve. I think the slope has slowed down, but I don’t think we’re in the flat nature of the curve.

So, your question was have we reached the asymptotic level, the answer is no.

Jason Kantor – RBC Capital Markets

Okay. And when you kind of think through this, obviously, the fullest view would be that if – because the drug working, is there any other reasonable explanation, somebody thought about other drugs that people might be getting and you kind of debunked that, but is there any other external aspect that could be influencing the death rate in the study?

Vijay Samant

Well, the only thing is – the only reason the survival documents [ph] have been postponed as a certain – there are three reasons right without knowing the data, one is that the control arm is living longer, B, the treatment arm is living longer or both are living longer, okay.

I don’t think there are – as far as interventions from Zelboraf during the conduct of the study or you’re wondering the conduct of the study, we believe there were no interventions, okay.

Jason Kantor – RBC Capital Markets

Okay. Thank you.

Operator

Our next question comes from Eric Schmidt with Cowen and Company.

Eric Schmidt – Cowen and Company

Good morning. I just had a question on the Allovectin Phase III study, Vijay. I understand, maybe from an investor relation standpoint you’re intention to group together the primary and secondary endpoints as far as timelines. But given the unpredictability here and overall survival and from a corporate planning standpoint, I would assume you would rather know and not waste your time and money on, say, preparing for the BLA filing or for pre-commercial activities in the event that that primary end-point was not achieved?

Vijay Samant

I think the agency will – has a – has not told us directly and directly everybody knows that survival is going to be very important element of the study, okay. Because given the fact that the landscape has changed since the original SBA was approved, two drugs have been approved survival.

So, we’re going to have to come up with survival data besides meeting the primary end-point. Okay. So – in order for us to get a good label. So, both those end-points are very important to us, okay. And how the agency is going to look at both the end-points collectively, it remains to be seen. And as I've said earlier, where we are right now, I don’t think the timing between those end-points is hugely apart because of the adjudication, that activity that needs to go on that there is any much to get to announcing one single end-point end out of the other.

Eric Schmidt – Cowen and Company

Well, maybe you’re highly confident in meeting the primary end-point, or response to the end-point. But on the off chance that that misses, then aren’t you kind of wasting time and effort?

Vijay Samant

Absolutely not. I think we did – we do miss the end-point, the question is how far we missed the end-point? Whether we hit the homerun on survival and had a P value of 0.00, whatever the number is, and show a significant change between control (inaudible) widely separated. I mean that’s really the ultimate proof of the success of the study, okay?

Eric Schmidt - Cowen and Company

Okay. Is there a – is there a potential, possible outcome here where you cure such – so many of these patients that have cutaneous disease and never develop internal metastasis, never die from their underlying the static melanoma that you never hit a number of endpoints that drives power here to the study?

Vijay Samant

Well, you know, Eric, I think we will have – because patients do die as we have seen in our stage – in our prior Phase II study. We are tracking deaths. It’s not like there are no deaths occurring in the study, Okay.

Eric Schmidt - Cowen and Company

Okay.

Vijay Samant

They're slow. So, we should be able to hit the target. Okay.

Eric Schmidt - Cowen and Company

Okay. Switching topics on the TransVax?

Vijay Samant

Yeah.

Eric Schmidt - Cowen and Company

Can you just talk about your latest discussions with your partners, Astellas, and the FDA on CMD (inaudible) based end-point and how close you are to kind of nailing down that protocol?

Vijay Samant

I think we are very close. That’s all I can tell you. The discussion will actually be – the discussions over the agency not with our partner because the partner and I, we already had our discussion on the basis of which we are having the discussion with the agencies. So, close – we said today that our intent is to start the trial in the first half of this year. And if we indeed want to do that, we need to be close.

Eric Schmidt - Cowen and Company

Would we see that milestone paid even before the start of the trial?

Vijay Samant

I think so. Once we get the protocol approved, we should get the milestone payment. That’s not an issue there, okay.

Eric Schmidt - Cowen and Company

Thanks a lot.

Vijay Samant

Thanks, Eric.

Operator

Our next question comes from Ren Benjamin with Rodman.

Ren Benjamin – Rodman

Hi. Good afternoon and thanks for taking the questions and congratulations on the progress. Just regarding Allovectin, can you – have you disclosed or can you tell us what the target death events are?

Vijay Samant

No, we have not.

Ren Benjamin – Rodman

And then can you tell us why the DSMB might not be able to – even if there's no utility aspect built-in for any of the other looks that may or may not be happening, can they still not stop the trial for either a safety issue or an overwhelmingly good survival benefit?

Vijay Samant

Well, remember it’s not – they don’t look at any efficacy data. It’s primarily is safety committee, okay? So, they only look at safety. So, obviously they can stop the study because of a safety issues. But since they don’t have access to the efficacy date and that’s on their – they can’t make any recommendation that relates to efficacy. They don’t see any efficacy data.

Ren Benjamin – Rodman

Okay. And I guess just going off of a question that Eric asked. At one point, let’s just say even at the end of this year, let’s take a wild assumption that the curve reached at asymptotic level. Do you have a point in where you just have to un-blind according to protocol? Or do you have to let the required number of events take place?

Vijay Samant

No, we don’t. We’re not forced to do that. But that’s a decision that we have to look at. If indeed that occurs, we are speculating at this stage. We need to look at it. And we always have all kinds of contingency plans. But that should be – if the growth really flattens out, that should be good for the program.

Ren Benjamin – Rodman

Right. Okay. And then just switching gears to TransVax side, I understand you had a discussion with the FDA, especially regarding end-points. But aside from the end points, can we talk a little bit about what sort of a trial this will be, how big, how long do you think it would last? And without giving away let’s say what the end-point is, how long do you think this trail could progress?

Vijay Samant

Well, we have not discussed the end-points. So, trying to speculate without the end-point of the trial design, I will be undermining our discussions with the agency right now because the definition of end-point leads to the definition of trial design.

But as I said previously, the trial design would be around 500 or less than 500 patients. It’ll take us about a year plus to recruit and there will be a follow up on another nine months or 12 months. So it’s a two-and-a-half-year program, okay?

Ren Benjamin – Rodman

Okay. And just switching gears, we didn’t really talk much about the Collategene program that AnGes has. Can you give us any sort of an update as to what might be happening there?

Vijay Samant

Well, the only thing we can tell you from our friends in AnGes is they are actively working with two sources of money because they want to make sure they – I don’t know what their current cash balance is, but they want to raise money so they have sufficient cash that allows them to complete the trial. They’ll be raising money both from – some public sector moneys and private sector moneys. And that funding activities they’re very active right now. And we should be getting something then by the end of this quarter. Okay.

That’s all I can tell you at this stage.

Ren Benjamin – Rodman

Okay. And then just ending with the HSV-2 program, you had mentioned that the Phase I and II would begin in 2012. Just to get some additional clarity probably second half of 2012, are you looking for something earlier?

Vijay Samant

No. I did not say that in the call that it will start in 2012. What I said is we will probably give you some – granularly, the timing towards in 2012. Right now we are designing a bio-distribution talk studies. We need to have a pre-I&D meeting to make sure the agency is on board.

And once we have that behind us, we should be in a better position to tell you the timing.

But one thing that’s important that you understand, which I said in the (inaudible), that this trial is like an influenza trial. It can be recruited in a matter of days, okay, because given the number of patients who want to be in the trial. And then the trial conduct can be completed in about nine months, okay. Three months of pre-measurement of our load sharing, three months of vaccination, I’m just – three months of efficacy data.

So, it’s a short trial which will give you a proof of concept that allows you to do a larger study. So, we will give you some guidance in the second half of this year in terms of timing. But our goal is to move forward. My team is working round the clock making the stuff, getting all the pre-clinical studies lined up.

Ren Benjamin – Rodman

Okay. Thanks for the clarification. And I guess just – you brought up influenza, anything happening with the influenza program and the...?

Vijay Samant

No, I’ve said these both publicly and privately, there’s no money in the influenza business because the ex-factory price of influenza – is $6. The government is not committed to putting money or procuring vaccine form smaller companies that are relying on the existing technology.

I think we use the influenza money to validate our technology, get proof of concept, got back – in two studies that give us to show that it’s a safe vaccine which allows us to get an effective I&D.

So, we’re not spending any money in influenza unless there’s a major crisis like SARS, or something like that, that we have an active I&D and we could make the SARS vaccine, which we tested in humans and children to be efficacious, but those are our focus right now on these real commercial targets where there is money, okay?

Ren Benjamin – Rodman

Okay. And I think that’s it. Thank you very much and good luck.

Vijay Samant

Thanks, Ren.

Operator

(Operator instructions). Our next question comes from Howard Liang with Leerink Swann.

Howard Liang – Leerink Swann

Great, thanks very much. Vijay, the readout of overall survival, sounds like will be about 30 months after the end of the enrollment. Typically, that means that the plan that median survival is at least that – or is about 30 months.

Is that the right interpretation or can you help us understand how shall we interpret the length of the time to train an agreement – an enrollment and the time of our overall survival readout?

Vijay Samant

Well, it’s hard to draw a conclusion. And actually, we’ll be working close to this call in terms of analyzing that information ourselves, okay. But remember, half of our patients were recruited in the first two years and the half were recruited in the later part of the year. And that makes it a little complicated in terms of prediction.

So, either way, it tells you that patients across the trial are living longer, okay? And as I said, not clear to us at this stage whether it’s the treatment arm or the Allovectin. So we would like to believe it’s the Allovectin seminar [ph].

I can tell you one thing though that as we are completing – we couldn’t close the study earlier than Feb 2012 because patients was still on study, which is a good sign, meaning they were getting drugs. Again, we are blinded which arm they were in. So that’s where I would stop.

I would speculate in terms of what the number is until we’re getting different statistical interpretations. But we will hold off on it at this stage, okay?

Howard Liang – Leerink Swann

And is the – I guess I call it – the rate of loss to follow-up, is that consistent with other trials, consistent with your assumptions?

Vijay Samant

Yes, the answer to that question is, yes. We are watching that like a hawk. We meet on it very frequently. Every patient is being followed so that we don’t have loss to – the minimum amount of censured data consistent with what the prior trials are. Otherwise, we recognize that we have small trial and we need to be on top of the game, okay?

Howard Liang – Leerink Swann

Okay. And do you have visibility into what kind of patient that have been enrolled and what’s the breakdown between U.S. and ex-U.S.?

Vijay Samant

Well, about 40% of the patients are in the U.S. and about 60% overseas. Alain, is that a fair number?

Alan Engbring

Yes. I haven’t seen the exact figure, but it’s going to be in that ballpark.

Vijay Samant

In that ballpark, okay. As Alan said that the patients we recruited are normal LDH, Stage III for M1b patients. And the question before, somebody had said is, what’s the split between Stage III and Stage IV? We don’t know that you should assume that it’s what we got in our Phase II study, which is about 50-50. Okay.

Howard Liang – Leerink Swann

Lastly, if the overall survival end-point is the most important, should the primary end-point be changed to overall survival? Just in the case in the event that response rate is not hit, then you would technically have a negative study even if the survival...?

Vijay Samant

The challenge here is we are so late in the study trying to change anything. We don’t want the agency to feel that we know something about the study, okay? So we are blinded from the study.

Unfortunately, all these new drugs that are approved very recently in the last six, nine months and trying to change an SPA, it’s not a one-month deal, it takes six to nine months.

And I think at this stage trying to change anything and change the primary and secondary end-point will – first of all, raise a lot of questions. I think the agency knows. We have told them the data is blinded. They know the conduct of the trial. The data is going to stand on its own legs, okay.

Howard Liang – Leerink Swann

Great, that’s fair. Thanks very much.

Vijay Samant

Well, if there are no other questions. Thank you very much. And we look forward to seeing you again at the next quarterly call.

Operator

Ladies and gentlemen, this concludes our conference for today. You may now disconnect.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

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

Check out Seeking Alpha’s new Earnings Center »

This Transcript
All Transcripts