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Vical, Inc. (NASDAQ:VICL)

Q1 2014 Results Earnings Conference Call

May 01, 2014 12:00 PM ET

Executives

Tony Ramos - Chief Accounting Officer

Vijay Samant - President and CEO

Dr. Larry Smith - VP Vaccine Research

Analysts

Christopher James - Brinson Patrick Securities

Reni Benjamin - H.C. Wainwright

Operator

Good day ladies and gentlemen and welcome to the First Quarter Financial Results Vical’s Incorporated 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 like to hand things over to Mr. Tony Ramos. Please go ahead, sir.

Tony Ramos

Hello, everyone. Welcome to our first quarter 2014 financial results conference call. Joining me on the call today is Vical's President and Chief Executive Officer, Mr. Vijay Samant and Vical's Vice President Vaccine Research Dr. Larry Smith. I will begin with a brief notice concerning projections and forecasts. This call includes forward-looking statements, including financial expectations and projections of progress in our independent and collaborative research and clinical 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 Report on 10-Q filed with the Securities and Exchange Commission, as well as the specific risks and uncertainties noted in Vical's news release on its first quarter 2014 financial results.

These forward-looking statements represent the Company's judgment and expectations as of today. The Company disclaims 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, Tony, and thank you to all participants for joining the call. Today, we will discuss the status of the clinical trials of partner program ASP0113, formally known as TransVax. As you know we are apart compared to Astellas, then we will give you an update on our independent programs of the herpes simplex II vaccine and to that effect have invited our VP of Research Dr. Larry Smith to joined us today to give a look at some of the intriguing factors of HSV-2 program. We will begin the call with a review of our financial results by our Chief Accounting Officer, Tony Ramos. Tony, you are on.

Tony Ramos

Thank you, Vijay. We recorded financial results this morning for the first quarter of 2014 which reflected advancement in our HSV-2 and CMV product development programs and our ongoing efforts to manage our operating expenses. Revenues were $2.4 million for the first quarter of 2014 compared with $1.6 million for the first quarter of 2013. The increase in revenues was primarily the result of an increase in development work performed under our contract with Astellas related to the ASP0113 vaccine program.

The net loss was $3.5 million for the first quarter of 2014 compared with $9.3 million for the first quarter of 2013. The reduction in our net loss was primarily the result of the savings realized as result of our August 2013 restructuring and other actions taken to improve, the efficiencies of our operation. I'm pleased to report that our net cash use for the first quarter of 2014 was $2.5 million compared to $8.5 million for the first quarter of 2013. The use of cash during the first quarter of 2014 is consistent with our prior guidance of $13 million to $16 million for the full year.

I will now turn the call back to Vijay.

Vijay Samant

Thank you, Tony. I'll begin with a clinical update of ASP0113, again this is our partner program with Astellas. As you may recall, we announced that in June our partner Astellas initiated a pivotal Phase 3 trial in hematopoietic cell transplant recipients to support the registration of this important product.

For the Phase 3 trial Astellas is enrolling patients who are CMV seropositive as they are at high risk for CMV reactivation during their post-transplant recovery period.

We worked with Astellas to design this Phase 3 trial with a primary endpoint that has the potential to support full approval in key markets with no post-approval study requirements. The Phase 3 trial incorporates an adaptive design that includes overall mortality as a standalone primary efficacy endpoint or as a part of a composite endpoint. Full approval requires a clinically meaningful endpoint based on this logic the Phase 3 trial was designed with the primary endpoint of overall mortality at one year after transplantation. Astellas has done a very good job in ramping up this global study, which will eventually include approximately 100 clinical sites in North America, Europe and Asia.

In parallel to this global Phase 3 HCT trial, Astellas is also conducting a Phase 2 HCT trial in Japan. This small trial was designed to assess the safety in Japanese halogenic HCT patients. Japan always likes to do studies in the major population. A positive safety outcome will allow Japanese patients to be included in the pivotal Phase 3 study Astellas completed enrolment in the Japanese Phase 2 study in Feb of 2014. And I’m pleased to announced that the interim safety data which should be reviewed by the safety review community supported the inclusion of Japanese major HCT patients in the global Phase 3 study.

The third clinical study enters a Phase 2 trial in solid organ transplant for this Phase 2 trial Astellas enrolling patients who are CMV, seronegative who will receive a kidney transplant from the CMV seropositive donor.

This is so called D+/R- patients are at high risk for CMV infection and disease after transplantation. So, we believe vaccination with ASP0113 may provide protection against CMV in this group. This trial will enroll 140 SOT recipients and dosing of the first patient was announced in December. The primary endpoint of the Phase 2 trial will be the incidence of CMV viremia after transplantation we’ll also be monitoring several secondary endpoints including CMV disease, CMV specific antiviral therapy, graft survival and overall mortality.

Astellas is currently anticipating this study to be complete in the first half of 2017. We continue to provide update for this ongoing trial as they become available. Astellas is also conducting a fourth clinical trial of Phase I pharmacokinetic immunogenicity trial in dialysis patients to characterize the immune response following vaccination.

And this study is being conducted (inaudible) in the United States. It’s important to point out all four trials, four trials as I repeat myself are being conducted and funded by Astellas. And that all our efforts to support these trials including manufacturing, regulatory and clinical support activities are also funded Astellas. I think as a result income the efficient cost cutting the Tony and (inaudible) have undertaken and the funding that we have receive from Astellas, we have been able to maintain a very good runrate for this quarter and we hope we continue in that fashion in the future.

In summary, we’re extremely pleased to be working with Astellas who is an excellent partner for the CMV vaccine program. We’re excited to have the Phase 3 trial underway as well as other Phase 2 trials and we look forward to completing the process as efficiently as possible.

Next, I’ll provide you an update of our HSV-2 clinical program. After I finish the update, I’ll have Larry Smith, our VP of Vaccine Research to provide you with the summary of the unique features of our vaccine design and the preclinical testing data.

As previously announced, we initiated a Phase 1/2 trial in December of 2013. This trial is a randomized double-blind placebo-controlled study to be conducted at 7 sites in the United States. We plan to enroll approximately 150 subjects for HSV-2 positive and we experience two benign recurrence per year of general herpes lesions who are otherwise normal and healthy. Because this is the first kind of these vaccines are being tested in humans, we are performing a dose escalation for the first two cohorts assuming favorable safety of full dose of vaccine for the third cohort. The first and the second quarter cohorts have been fully enrolled and the dosing is nearly complete. We are already screening our third and final cohort and the subjects will have initiated swab collection to monitor pre-vaccine shedding rate. Importantly this Phase 1/2 trial was designed with the primary efficacy endpoint for this third cohort. So the patients in the third dose escalation study will be included in the overall efficacy.

Let me take a few minutes to elaborate the efficacy component of our Phase 2 trial. We expect these symptomatic subjects with the history of recurrent general herpes to shed HSV-2 from mucosal tissues on an average of 20% of the time based upon the results than earlier independent study. We intend to measure viral shedding rates for 60 days before the first vaccination and then again for 60 days after the last vaccination.

This before and after shedding data effective lets each subject serve at their own control, because this is a randomized controlled trial, we have an opportunity to demonstrate proof-of-concept for efficacy against an important biologic endpoint which is surrogate clinical endpoint for mainly recurrence of general herpes lesions. In summary, our HSV-2 Phase I plus 2 clinical trial is proceeding according to plan. Additional details of this trial can be found at www.clinicaltrials.gov. Because there are few competing HSV-2 therapeutic vaccine candidates, I’ve invited our VP of Research, Dr. Larry Smith to discuss the unique nature of vital HSV-2 vaccine and its clinical trial design.

Larry will also provide you with the summary of the preclinical testing supporting our HSV-2 program. Larry, you're on.

Dr. Larry Smith

Thank you, Vijay. We developed our HSV-2 vaccine in collaboration with Dr. David Kohl and Dr. Larry Corey at the University of Washington and Seattle. The key HSV-2 to antigens were identified in their lab following extensive screening. We created DNA vaccines from these key HSV-2 antigens and tested them in several animal models. One of the key antigens tested was glycoprotein D. In a very stringent [milestones] model, we demonstrated that the full length version of this antigen provided significantly higher levels of protection than a truncated version of glycoprotein D.

We also demonstrated a benefit for the use of our Vaxfectin adjuvant. These studies were followed up with very stringent therapeutic e guinea pig channel studies conducted by Dr. Nigel Bourne at the University of Texas Medical Branch. In these experiments, glycoprotein D was tested in conjunction with plasmas expressing HSV-2 tegument proteins.

Compared to the other published preclinical therapeutic vaccine studies conducted by competitors, our studies employed a two-fold higher HSV-2 challenge dose and a less frequent vaccination schedule. Now despite these stringent conditions our vaccine provided significant reductions in HSV-2 lesion recurrences. We believe our vaccine composition will be key to success specifically number one, the platform’s unique ability to simulate natural protein production pathways. Number two, a careful selection of the antigens included in the vaccine, full linked glycoprotein B and/or full linked tegument protein. And number three the use of our unique proprietary Vaxfectin adjuvant which has already been tested in several clinical trials, all of these attributes together provide a promising therapeutic vaccine.

Our current phase 1, 2 clinical trial design allows us to proceed rapidly without additional dosing studies this may allow us to embark on a pivotal phase 3 trials sooner in our competition.

With that I would like to turn back call to Vijay.

Vijay Samant

In summary, in 2014 we expect to see continued advancement in our ongoing clinical programs. I am frankly very pleased how rapidly the company has executed the HSV-2 program and we are working towards completion of enrollment on our phase 1, 2 trial. Our partner Astellas is making steady progress in enrolling patients in this phase 2 trial of TransVax in stem cell transplants recipients and a phase 2 trial of TransVax in solid organ transplants recipients.

We continue to report future progress as it occurs in quarterly update. That includes our prepared comments today. Operator, we are ready to open the call to questions from our 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 Christopher James of Brinson Patrick Securities.

Christopher James - Brinson Patrick Securities

Hi, good afternoon and thanks for taking my questions. And congratulations on a great quarter and your recent progress.

My first question, I guess pertains to the industry trial designs. It’s interesting collecting data two months before and have the treatment and each patient is serving in their own control. Could you talk a little bit about, sort of why you decided on this particular design is this sort of unique or dis-consistent with other HSV trials?

Vijay Samant

Well, I think it's a great question first of all, because some of the other trials are using less than 60 day of shedding measurement. I think Larry, if I'm correct it's our 28 day measurements most people are using, right?

Dr. Larry Smith

28 days with twice a day.

Vijay Samant

Twice a day. Talking to [KOLs] and the experts based on the experience that they had with other trials, they thought that using a 60 day once a day shedding measure would be more rigorous, would provide more meaningful data, would eliminate any other progression that you see in this collection.

And so the 60 day concept came from [KOLs] expert consultants but it really is based on the filings of the earlier trials that were completed.

Christopher James - Brinson Patrick Securities

Great, thanks for taking my question. Sort of along the same lines, I think you previously mentioned that you are looking for an ability to detect the 30% reduction between groups. Just help us understand (inaudible) concept and help us understand sort of what's the clinical relevance there and maybe sort of what reduction in outbreaks to just potentially correlate with?

Vijay Samant

Sure. So wireless shedding, occurs very frequently in systematic, herpes subjects and that shedding is really in a biologic surrogate to clinical and the clinical manifestations of herpes. So the more the people shed in the higher levels of a shed, it’s basically very highly associated with their clinical manifestation to genital herpes.

So we are really trying to reduce that shedding rate. We monitor it before vaccination and then again after, we are looking for a decreased number of days on which they shed and or decreased where load on which they shed, we think that’s our appropriate surrogates of the clinical manifestation to herpes.

Tony Ramos

Very little correlated with recurrence of lesion now, one in 30% reduction or 40% and how it impacts, recurrence of lesions is really something that we will find on, [I think the] study, I just want to remind you that that’s a second end point, right Larry?

Dr. Larry Smith

Yes.

Tony Ramos

A measurement of recurrence of lesion.

Christopher James - Brinson Patrick Securities

Got it. Okay. Then maybe one more on this program and then one on the CMV. What can you sort of tell us about your partnership strategy around this program and would the data be sufficient to drive a meaningful collaboration?

Vijay Samant

This is a program that first of all is home grown, we put a lot of effort behind it working (inaudible) that particularly that’s a practical and (inaudible), we owned a lot of intellectual properties surrounding it. And this is a pretty reasonable program in terms of the size of the pivotal study, obviously that’s to be discussed with the agency, but based on guesstimates this is a reasonable program for us to pick forward, so unless there is a partnership that occurs which is going to be very lucrative, this is the program that we really want to leverage for white collar shareholders’ benefit.

Christopher James - Brinson Patrick Securities

Got it. Okay. And then on the CMV I think you mentioned Astellas is integrating I am just referring Phase 2 study in Japan, how do you plan to I guess integrate the Phase 2 with the global Phase 3 design which appear to have mortality end point and do you see great challenges along that?

Vijay Samant

No, no let me just and Larry correct me if I say this, the Phase 2 study really was to make sure that in the Japanese population the vaccine first of all tolerated there are no safety issues and it’s really the safety component that was done in those small number of patients. The minute the safety is okay by the Data Safety Review Committee now the patients will be automatically enrolled in the Phase 3, the patients for now on which will go directly into Phase 3 study. So those patients which were in the safety analysis are not in (inaudible) affects the analysis okay.

Christopher James - Brinson Patrick Securities

Got it, okay. Thank you for clarification. Congrats, thank you.

Vijay Samant

Okay. Thank you.

Operator

Our next question today comes from Joe (inaudible) Citi.

Unidentified Analyst

Hi there. This is Joe calling in for Jon Eckard. Thanks for taking my questions. My first question is about Vaxfectin adjuvant, recently there has been some (inaudible) or other novel agents seeking approval from regulators, like some of the work has done with Vaxfectin gives you comfort around the sales (inaudible) it may not carry some of the same concerns?

Vijay Samant

In any adjuvant since I have been in this vaccine business for very long time alum is probably the most widely adjuvant across the world today and when people call alum is not alum because every company that makes alum is a different it’s an aluminum hydroxide combination. The proof of any adjuvant is a lot of safety data in humans and I think I will tell you that we have gone through multiple clinical trials so far in a small patient database and we’re getting more experience in human. So I think that's the first step. If you haven't tested an adjuvant in human and we have survive testing in (inaudible) clinical trials we have gone through so far.

Dr. Larry Smith

Total, actually, yes. Total three.

Vijay Samant

Three and then HSV-2 is our next trial. So we got three trails and then the HSV-2 is our four trial. So we made a good progress and we've survived the adjuvant is well tolerated all the pre-clinical data and the human clinical data in human has shown that expected indeed value add to the antigen or the plasmid that it's formulated with. So far so good and that's why any adjuvant we're doing dose ranging study (inaudible) with a quarter dose than half dose and a full dose of the HSV-2 study.

We have a drug mass to file the adjuvant is well characterized is not a molecular adjuvant that people had (inaudible) pathway there are some auto immune issues this is a synthetic lipid that was developed at Vical through a wide screening of variety of lipid combination and it has been well characterized in our CMC program and we have a drug mass to file and as we have said this before and there is no (inaudible) we publish recently data where the adjuvant was used in preclinical studies with (inaudible) vaccine where we showed that it shows almost what Larry 10 fold, 15 fold dose paring. In their vaccine, in their testing, in their laboratory. So it's been currently tested on a variety of fronts and hopefully it will lead to some more partnerships beyond we’re testing so far.

Unidentified Analyst

Sure, thanks. And also one other question on the CMV, could you tell us about differences in the market size between the ASPs along (inaudible) vaccine partnered with Astellas and then with your other pre-clinical CMC vaccine. And also have you decided on a timeline to move that preclinical vaccine ahead and what would affect that decision?

To affect that decision?

Vijay Samant

You asked couple of questions, and I think the first question is what the marked size is for the ASP0113, there are about 50,000 patients and the (inaudible) patients, U.S. and equal number of patients, but there is a jammer up which I will send you later on, which clearly lays out by region what the amount of body cell transplant that are recurring. So that can give you even much more better clarity then my top of line numbers, okay. It’s an important market, it’s an important unmet medical needs and the point that you need to understand that lot of people understand this is not an antiviral, this is a vaccine.

Our data was published in (inaudible) from the Phase 2 study which is a double blind efficacy study vaccines fundamentally or just the landscape, it teaches the immune system how to detect the pathogen and destroy the pathogen, it’s not viral side okay, it doesn’t have the level of toxicities that most of the antiviral do, take a look at ganciclovir okay, people does not getting ganciclovir comes to CMV disease. So antivirals is not a solution.

They are augmented therapy in vaccine that really the fundamentals scope or therapeutic vaccine will really make a lot of difference both in hematopoietic cell transplant and even more important solid organ transplant who are immune compromise throughout their lifetimes after getting their organ transplant, so they always have the CMV the activation.

So that’s the transplant market and that’s where we have partnered with Astellas our preclinical data where IND is the (inaudible) program which I understand we report to, which is the vaccine, which is not a therapeutic vaccine, but it’s a prophylactic vaccine for prevention or CMV infection of females to child bearing age, and the challenge there for us to embark on a program like that on our own is doing a small Phase 1/2 studies, okay but the real proof-of-concept study as you see in (inaudible) study which is in a similar patient population requires a lot of resources. And none of the big companies have embarked on it they are still debating whether they have the funding to embark on such a proof-of-concept study and a lot of discussions are going on from the big companies including us in terms of the target endpoint, which will allow us to reduce the size of the study and until that occurs. I don't think you would see any meaningful partnering activities in that program or us taking that program forward.

Unidentified Analyst

Sure. Thanks for those answers, that's all I have for now.

Vijay Samant

Thank you.

Operator

(Operator Instructions). The next is Reni Benjamin, H.C. Wainwright.

Reni Benjamin - H.C. Wainwright

Hi, good morning and thanks for taking the questions and congratulations on the progress. Vijay, I guess just a couple of questions, maybe starting with HSV-2 you had mentioned that you are measuring two months before and two months after. I could be wrong, but I think competitors in the fields are measuring six months and I guess the question is how confident are you or how do you know you'll be able to capture any sort of a difference within two months? Maybe if the patients should be followed for a year in order to get a sense as to the amount of the difference you might see in lesions or shedding. Can you help me understand that a little better?

Vijay Samant

Actually, if you Chris James’s early question was on the money. We are actually doing a much more rigorous measurement of studying data. Most of the people are doing the study are only doing a 28 day shedding study okay. We're doing a 60 day shedding study, so ours is much more rigorous. And I as I had explained previously that why did the 60 as post or 28 day, because with 28 days you can get data quickly. It came from discussing with our KORs, with their experience, with the previous trials in terms of making sure that [other] progression, the data has flattened out that 60-day will get us a rigorous baseline. So people have shown reductions, statistical reduction with the 28 shedding. With 60-day, we should be establishing in every patient solid baseline, so our calculations of the reductions will be very meaningful.

So nobody is doing six months of shedding, it is hard to do six month of shedding every day matters for patient. It’s a tough task to shed and these are very motivated patients, okay. That’s the amazing part of it. The HSV-2 patient, I mean we're doing shedding every day for 60-day and then putting those swabs and returning them to a central lap of PCR, okay. A lot of efforts.

Reni Benjamin - H.C. Wainwright

Can you give us a sense as to when, I mean in terms of timeline, when do you think either enrolment will be complete or when we might see, the first glimpse of the data?

Vijay Samant

Our target is right now, rather than giving you how many patients are enrolled or when the plan -- our target is to have the data sometimes the middle of next year. If that changes and we accelerate it, we’ll let you know, if it’s going to delay, we’ll let you know, but right now the goal is to get that data by the middle of next year.

Reni Benjamin - H.C. Wainwright

Okay. And so the same question for the CMV Phase III program, can you give us a sense as to how enrolment is going and the timing of completion for either enrolment or data?

Vijay Samant

Tony, correct me if I’m wrong. This is -- we have to be careful. Astellas is running the program, it’s their program, so we don’t want to say anything [of firm] but the enrollment is expected based on their Q&As and their communication to media by fourth quarter of 2013. That’s the milestone that they put out.

Reni Benjamin - H.C. Wainwright

Okay. And then…

Vijay Samant

This is -- they are recruiting, so just, as you look at though competitor studies, people are recruiting CMV, we're recruiting worldwide in 100 centers; these are hard patients to get, these are really sick patients to get. So we’re telling you 4Q ‘15, Astellas has done a lot of in terms of projecting their timeline, okay, this is not a (inaudible) projection.

Reni Benjamin - H.C. Wainwright

Right. And then just extrapolating from that the primary endpoint is one year mortality, so I am assuming by the end of 2016 is when we’ll see the data.

Vijay Samant

‘16, yes. You got it. You’re right.

Reni Benjamin - H.C. Wainwright

Okay. And then is there any interim -- is there any sort of an interim analyses or anything built into the study?

Vijay Samant

Yes, there is, because remember, there is at the -- it’s an adaptive trial design, 500 patients; we’re going to look, see at the data, at the first 100 patients to make sure that the mortality endpoint is following the appropriate track, if it’s following the project track. And the efficacy portion of the trial 400 will stick to the mortality endpoint. If you believe that we need to augment it with some other measures in clinical positive endpoints, we will indeed do that. We need to make sure whatever the final endpoint is, is agreed with the FDA if we’re going to change for mortality to something else before we recruit the last patient. Whatever that endpoint is, that has to be completed no later than the end of 4Q ‘15 and that’s what our target of enrollment of the patient is. So yes there is an interim analysis at 100 patients which you’ll look at how the mortality for end point is trending, are we going to stick to that endpoint, are we going give a composite endpoint.

Reni Benjamin - H.C. Wainwright

And would it be unfair for me to saying just given that as started in June 2013 that the interim analysis would likely happen in 2014, is it?

Vijay Samant

We have not publicly disclosed, but I mean if we’re going to recruit the trial by fourth quarter 2015, you have to make that judgment yourself.

Reni Benjamin - H.C. Wainwright

Got it. Okay. One final question, can you give us any sort of expected milestones for 2014, data presentations at upcoming scientific conferences or anything that you feel we should be focused on?

Vijay Samant

I think more importantly, I think we will be talking more about our HSV-2 program at appropriate forums including some of the preclinical data that we need to really position correctly, so people understand how Larry kind of mentioned how the uniqueness for preclinical data we use 2X challenge compared to the competitor 1X challenge. Dosing regimen was different from what competitors have used. So, I think we need to communicate that and we'll take the appropriate opportunity to make sure that data is properly presented.

I think since I said our timeline for -- giving you some idea of what the data on the HSV-2 program, which is middle of 2015, at some point in time, we'll have to give you some update in terms of where the trial is in terms of its progression or completion of enrollment. I think that would be a meaningful endpoint. We should also hopefully present some data on Vaxfectin just like we did with that Baxter data few months ago where we showed the dose capabilities of Vaxfectin in influenza. We are working with some other people. Hopefully some of that data will mature and we will be able to share with how Vaxfectin is worth -- is behaving, so on the other studies that we're conducting; and some periodic updates on CMV as we make some progress okay, including hopefully some partnering activities and some programs. But those are all unpredictable. When they happen, they’ll happen.

Reni Benjamin - H.C. Wainwright

Got it. Thank you very much and good luck.

Vijay Samant

Thank you, Ben.

Operator

At this time, there are no further questions. So, I'll hand things back to our speakers for any additional or closing remarks.

Vijay Samant

Well, thank you all for participating. We look forward to continued progress in our development programs and to meeting with some of you at our upcoming conferences. Thank you very much.

Operator

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

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