NewLink Genetics' CEO Discusses Q4 2012 Results - Earnings Call Transcript

Feb.28.13 | About: NewLink Genetics (NLNK)

NewLink Genetics Corporation (NASDAQ:NLNK)

Q4 2012 Earnings Call

February 28, 2013 10:00 AM ET

Executives

Charles Link – Chairman, CEO and Chief Scientific Officer

Gordon Link – CFO

Nick Vahanian – President and Chief Medical Officer

Analysts

Mara Goldstein – Cantor Fitzgerald

Stephen Willey – Stifel

Laura Chico – Robert W. Baird

Megan Dow – MLV & Company

Operator

Good day ladies and gentlemen, and welcome to the NewLink Genetics Fourth Quarter and Full Year 2012 Earnings Conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder this conference call is being recorded.

I will now read the forward-looking statements. We’ll like to remind participants that the matters discussed on this call contain forward-looking statements of NewLink Genetics Corporation that involve substantial risk and uncertainties. All statements other than statements of historical facts discussed in this call are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements include among other statements about NewLink’s financial guidance for 2013 the timing for completion of enrollments of NewLink Phase-III clinical trials for HyperAcute Pancreas cancer immunotherapy product candidates. The timing of release of clinical data from ongoing clinical trials, the timing of commencement of any new clinical trials by NewLink or the indication in which such trials will be pursued, the efficiencies or effectiveness of NewLink’s product candidates or manufacturing process relating to them. NewLink’s future financial performance is result of operations or sufficiency of capital resources to fund its operating requirements and any other statements other than statements of historical fact.

Actual results or events could differ materially from the plans, intentions, and expectations to close in the forward-looking statements that NewLink makes due to a number of important factors including those we’ve discussed in Risk Factors and elsewhere in NewLink’s quarterly report on Form 10-Q for the period ended September 30, 2012.

Form S-3 registration statement filed December 28, 2012 and its other filings with the Securities and Exchange Commission. NewLink specifically disclaims any obligation to update or revise any forward-looking statements made on this call as a result of new information or future developments.

I would now like to hand the call over to your host, Mr. Dr. Charles Link, you may begin.

Charles Link

Thank you for joining us today to discuss our 2012 operations and our expectations for 2013. With me today our Gordon Link, our Chief Financial Officer; and Dr. Nicholas Vahanian, our President and Chief Medical Officer.

We’ve made significant progress during this past year. The enrollment rate in our pivotal Phase 3 IMPRESS trial with our active cellular immunotherapy product candidate, algenpantucel-L, has exceeded our original expectations. We initiated both the Phase 3 study in patients with locally advanced pancreatic cancer using algenpantucel-L, and a Phase 2B/3 adaptive design study to evaluate our active cellular immunotherapy tergenpumatucel-L in patients with progressive or relapsed Stage IIIB/IV non-small cell lung cancer.

In addition, we expect to move our HyperAcute melanoma immunotherapy into controlled Phase 2 studies in 2013. We’re also expanding our HyperAcute immunotherapy platform to include different tumor types. Furthermore, we expect to move the first of these into Phase 1 human studies in the second half of 2013.

First, let’s focus on our most advanced clinical effort, our pancreatic cancer programs. IMPRESS, our 722 patient Phase 3 clinical trial and the resected pancreatic cancer patients is the largest corporate sponsored study ever performed in its population to our knowledge. Thus, we have always expected a challenging enrollment tax, but I am pleased to say that based on our current enrollment rate, we expect to complete enrollment of all 722 patients this summer.

As you know, two integral analyses are our provision of our Special Protocol agreement with the FDA. Although the study is blinded and we have no way of knowing what the survival rate will be in either arm. We believe we will reach the first interval triggering event in this study in the next few months. The analysis will occur, when there have been 222 events in the trial. We expect an analysis of that data to occur around midyear.

For those of you don’t recall the infra-study has an overall survival at the primary endpoint. The data reported at ASCO in 2012 from our Phase 2 pancreatic cancer trial showed a 37%, 59%, and 121% improvement in the one, two and three years survival respectively as compared to standard-of-care.

The increasing effectiveness of immunotherapy over the standard-of-care, as time progresses has been absorbed in some other immunotherapies as well. At ASCO 2013, we’re planning to provide additional updates from our Phase 2 study with algenpantucel-L.

We’ve received encouragement from the investigators in our IMPRESS study to evaluate algenpantucel-L in other populations of pancreatic cancer patients and to combine it with other treatment modalities. Based on these comments and the results seen in other HyperAcute Immunotherapy trials. In October of last year, we launched an open-label, randomized, multi-institutional Phase 3 trials in patients of borderline resectable or locally advanced unresectable pancreatic cancer.

Let’s move on to our second most advanced active cellular immunotherapy product candidate, Tergenpumatucel-L. We reported Phase 2 data on this drug candidate at both ASCO and ACR this past year. Based on results from this study, we launched an open-label, randomized, multi-institutional adaptive design Phase 2 B/3 study, to evaluate its efficacy in patients with progressive or relapsed Stage IIIB/IV non-small cell lung cancer.

Correlative immunological data from our Phase 2 study showed 21.9 months versus seven months survival in certain patients capable of generating interferon-gamma responses versus patients who do not mount this response.

This suggests patients with the best immune responses may have significantly greater long-term overall survival. Based on this observation, we adopted several entry criteria in the new Phase 2B/3 study that we hope will enrich the population of patients with a healthy immune system.

Next is our HyperAcute Melanoma product candidate. As studied in an investigator-initiated Phase 2 clinical trial for the treatment of advanced melanoma in combination with an eight week course of pegylated interferon, which we previously reported at ASCO. Although this was a pilot study were patients only received active cellular immunotherapy for three months, at a lower dose than we currently employ it in the other immunotherapy protocols, we were encouraged that the results include several durable complete responses. Based on these results, we are evaluating the design of a larger controlled Phase 2 study, with this drug using higher dose of the active cellular immunotherapy given over an extended period.

In addition to our biologic and HyperAcute product candidates, we’re developing in indoximod, a small-molecule, orally bioavailable product candidate designed to inhibit the IDO pathway. Through our collaboration with the NCI, National Cancer Institute, we’re currently studying in indoximod in two Phase 1B/II safety and efficacy clinical trials in different chemotherapy and immunotherapy combinations.

One clinical trial combined indoximod with an adenovirus p53, autologous dendritic cell vaccine for solid malignancies with p53 mutations, such as lung, breast and colon cancers. The other clinical trial involved the combination use of indoximod and Taxotere for patients with advanced stage solid tumors, for which Taxotere is the standard-of-care treatment, such as metastatic breast, prostate, ovarian and lung cancers.

Preliminary data from these sides was presented in ASCO 2012 and additional data will be presented in ASCO this year. Based on the result of the study combining Taxotere with indoximod, we initiated a randomized Phase 2 study evaluating this combinations in the treatment of patients with metastatic breast cancer.

We are considering additional studies combining indoximod with other treatment modalities, at September 2012, we announced the University of Minnesota’s initiated investigator sponsored Phase 2 study evaluating sipuleucel-T PROVENGE plus indoximod in the treatment of patients with asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancer.

Chemosensitization is a term that is long been used in the context of using chemicals to increase a tumor sensitivity to radiation. Recently we and others have seen evidence suggesting that patients – with immunotherapy that later progress may become more sensitive to subsequent treatment with cytotoxic agents. We have observed this in the pancreatic cancer patients after treatment with algenpantucel-L, as well as the breast cancer patients treated with the combination of autologous P-53 Denritic Cell vaccine in indoximod. Pancreatic cancer is a particular aggressive form of cancer and it’s rare for patients to progress after chemotherapy to achieve complete remission to subsequent rounds of chemotherapy.

We identified three patients who progressed after treatment with algenpantucel-L who are subsequently treated with three different chemotherapy regimens and then went into durable complete remission. Separately, in patients with metastatic breast cancer has been treated with an Ad-p53 vaccine in combination with indoximod. We observed in an unusually high response rate with patients who had progressed on this treatment were later re-challenge with chemotherapy.

In particular, we observed that 75% which represented 6 out of 8 patients responded to a combination of carboplatin gemcitabine follow-on regime including one complete response in a patient in fifth line therapy.

In addition to our active clinical programs in the treatment of various forms of cancer, we have a small infectious diseases group that among other things is accounting to leverage both HyperAcute response and the over-expression of IDO uncertain to acute and chronic infectious diseases to improve therapies for their treatment and prevention. This work is being funded primarily by grants and government contracts.

With that, I’d like to turn the microphone over to Gordon Link, our Chief Financial Officer.

Gordon Link

Thank you, Chuck, and thanks to all of you for joining us on our conference call this morning.

We ended 2012 with approximately $21.7 million in cash, cash equivalents and marketable securities. Our financial guidance this time last year was to end 2012 with about $20 million in cash and cash equivalents and marketable securities. As we announced on February 4, 2013, NewLink closed an underwritten public offering of 4.6 million shares of common stock including 600,000 shares of common stock pursuant – sold pursuant to the underwriters’ exercise of their over-allotment option, at a price of $11.40 per share, which was the closing price of NewLink’s common stock on the prior day. We expect to end 2013 with approximately $40 million in cash, cash equivalents and marketable securities.

Grant revenues in 2012 were $1.7 million compared with $1.9 million for 2011. Grants fund the majority of the research efforts in our Infectious Disease division. Research and development, R&D expense increased $3.5 million to $17.8 million in 2012 over 2011, due primarily to higher personnel-related expenses and increased clinical trial cost. We expect R&D expense to increase as we expand our clinical trials. Recall that Chuck told you we will be completing enrolment in our 722 patient in Phase 3 pivotal trial this year and we have recently launched new later stage trials in both locally advanced pancreatic cancer and in lung cancer.

General and administrative expense increased $1.4 million to $7.1 million in 2012 over 2011, primarily due to higher personal related expenses and public company costs. We have an increase in general and administrative expenses as we began to perform the activities required to prepare to launch allogene pancreatic cancer cell should it be approved by the FDA.

We currently expect our cash resources to allow us to fund operations into 2015. The loss for 2012 was $23.3 million, compared with $18.1 million in 2011. Comparison of our per share losses is not meaningful as our share count changed dramatically with a conversion of preferred shares in our IPO in late 2011. With that I would like to turn the mike back over to Dr. Link.

Charles Link

To summarize, in 2012 and early 2013, we’ve advanced all of our major development programs. We are nearing the completion of enrollment in our IMPRESS pivotal clinical trial and we have secured adequate capital to continue to significantly advance all of the described programs. In addition, we expect to meet the following goals in 2013.

Complete enrollment into the Phase 3 IMPRESS trial of algenpantucel-L in resected pancreatic cancer patients in the summer of 2013. Data safety and monitoring the first interim data for IMPRESS and our Phase 3 trial are on mid-year 2013. Execute our enrollment plan in our Phase 3 clinical study of algenpantucel-L for locally advanced pancreatic cancer, execute our enrollment plan in the Phase 2B/3 clinical study at tergenpumatucel for non-small cell lung cancer, initiate enrollment into a Phase 2 trial and melanoma patients with HyperAcute immunotherapy in the second half of 2013, initiate enrollment in a Phase 1 trial HyperAcute immunotherapy in renal cell cancer, patients were in the second half of 2013 continue to make progress on our small molecular program targeting the ideal pathway, and to end 2013 with a total of $40 million in cash, cash equivalents and marketable securities.

With that we’ll open up for questions.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Mara Goldstein of Cantor Fitzgerald. Your line is over.

Mara Goldstein – Cantor Fitzgerald

Thanks very much for taking the question. My question is on the non-small cell lung cancer trial and you did mention around patients you had and it showing gamma responses will be, I am guessing preferentially enroll to some sort and I am wondering, if you can give us some details about how you will be measuring that and what that involved in terms of screening for the trial?

Charles Link

Nick, why don’t you sort of review a little bit design in the trial what changes we’ve made?

Nick Vahanian

Sure, the Phase 2B portion of the study will evaluate two dosing schedules for tergenpumatucel-L versus docetaxel and the Phase 3 portion of the study will further asses will further asses efficacy of the selected dose against docetaxel. The primary endpoint of the study to evaluate survival in second-line therapy for patients with advanced non-small cell lung cancer. Secondary objection will include progression-free survival, and evaluation of tumor responses, as well as neurological response. In the Phase II portion of the study, 240 patients will be randomized between Arm 1 Docetaxel versus Arm 2 Tergenpumatucel weekly versus by weekly schedule.

To further specifically answer your question Mara is as Chuck mentioned patients with interferon-gamma responses showed dramatically better response rate in the Phase III trial. To capitalize on that idea that we focused on selecting patient based on total lymphocyte counts in the Phase II study was 500 was the limit we increased that to 1,000, performance status of the patients one or better, as well as number of prior chemotherapies, two or less as opposed to be in Phase 2 patients were in line to receive higher number of chemotherapies. So those are our selection criteria that we’ve implemented – we’re implementing in the Phase 2B/3 trial.

Mara Goldstein – Cantor Fitzgerald

Okay. And do you have any idea in terms of this population, how – or the percentage of patients who will fulfill that criteria, is it a very large percentage or moderate?

Charles Link

There is no specific number that I would give you right now, but it’s moderate amount of patients, may be 20.

Mara Goldstein – Cantor Fitzgerald

Okay.

Charles Link

Around 20% or so, 20%, 25%.

Mara Goldstein – Cantor Fitzgerald

Okay. Thank you.

Charles Link

Sure.

Operator

Our next question comes from Stephen Willey of Stifel. Your line is open.

Stephen Willey – Stifel

Yeah. Hi, guys. Thanks for taking the question and congrats on a good year.

Charles Link

Hi, Steve. Good morning.

Stephen Willey – Stifel

Just a couple of locally advanced questions. I’m wondering just if you guys would be willing to kind of communicate some of those powering assumptions at this point. And then I guess another question, just related to the use of insulin. we hear that a lot of use of that regimen that occurs in the U.S. kind of occurs with a bit of – a bit of a modification in terms of the regimen, just to try to ameliorate some of the tox. So I’m wondering if that something that you’ve kind of built into the protocol? And I guess how do you kind of control for the fact that – this regimen tends to yield a bit of a high discontinuation rate amongst patients?

Charles Link

Yeah. The main toxicity was related to that. And we have actually adopted the regimen of that proxy of insulin which has been the pure dominant regimen in the academy centers in the U.S. under the recommended regimen, and some of the earlier assessment of the response which are similar to the European data. What we’ve seen in the Phase 2 patients were three patients one had Taxotere, one had Gemzar C and one of those patients had problems and having dramatic response rates at 3CRs has led us to trial design with actually lot of inflows from the PI’s conducting the Phase 2 study.

So, with that in mind the study design came about Toxicity is real for patients but with the adjusted regimen, it’s more manageable partly similar to vaccine regimen toxicity levels. And, also with some of the recent data there is some confusion in the field but nevertheless and in the current outlook we have been setting having better survival rates and the higher response rates. In our opinion, we will continue to be the dominant regimen in the locally advanced part of little different in metastatic study with Gentamicin.

Stephen Willey – Stifel

Okay. Just in terms of I guess, what we should maybe we expecting out of a – out of a control arm or full Fernox only arm within the locally advanced setting?

Charles Link

Yes, we look towards your question regarding that, it’s correct; the control arm is full Fernox only.

Stephen Willey – Stifel

No but I guess just with respect to kind what we should be expecting in terms of what a median OS might look like with respect to that patient population, because at this point I don’t think there is a ton of at least publicly available data and I know it’s a lot of physicians that are kind of using it inherently at this point, but I just don’t think there has been much, that’s been published on it.

Charles Link

Yeah, at this point, we’ll also wait for additional data to come, but we made our assumptions conservative as we always do.

Stephen Willey – Stifel

And then presumably you guys will be able to kind of look at some of the down stage resected tumors on the following treatment?

Charles Link

That’s a good question, Steve. This trial is interesting in several fronts. One is, we can – we have the opportunity, we will have the opportunity directly compare – directly compare survival rates between the two groups – in the study group where patients received algenpantucel as a priming dose for three consecutive weeks and compared to survival rates. In addition to that, we elude opportunity compare response rates between the two groups as a secondary end point. So there might be differences there as well. You made one more point, could you repeat your question again.

Stephen Willey – Stifel

With respect to I guess your ability to look at the biology or the histology of tumors that have been treating new adjuvantly and then down staging and then subsequently effective.

Charles Link

Right, right.

Stephen Willey – Stifel

And kind of – what kind of information you think you might be able to get out of that?

Charles Link

Absolutely so that was exactly my point of having response rates based on giving algenpantucel and follow with (inaudible) or hypothesis, part of the hypothesis will lead to high response rates, and that might lead to downstaging in more surgical eligible patients, but we shied away from making that the primary end-point of the study because of the complications and compounding factors between different surgical groups maybe in some patients resectable in one side versus on other side, but nevertheless we will closely follow that data.

Stephen Willey – Stifel

Okay and maybe just a similar kind of control arm question around the ongoing Phase III. We kind of get just a lot of questions with respect to, some of the new chemo regimens that are seemingly gaining wider adoption here within the U.S. specifically kind of Folfirinox in those patients what I guess look at performance status and then general vaccine and just kind of wondering kind of what your thoughts are with respect to kind of a control arm in the ongoing Phase 3?

Charles Link

Well, as we have previously stated, the strict regimen was the most relevant study to compare, because it was a U.S.-based study, and as you recall, the survival rate in the old population was 18.5 months in that study. With that in mind and also potential follow-up, there might be as you stated in your recent reports patients might be lost to follow-up in longer term.

Our expectation is in the control arm somewhere between 16 months to 17 months in the control arm. When given that that our study is control arm powered for 21 months, we feel very comfortable how the study is powered regarding to Phase 3. In addition to that any potential benefit that might come from salvage treatment in the setting either a Taxotere or (inaudible).

As we hypothesize that patients who may be getting chemosensitized tergenpumatucel-L and had this 3CRs in the phase 2. We in fact believe that we made benefit better from the salvage treatment under control arm. So their delta will be fully separated in our opinion if that was true. So we feel comfortable with the control arm powering and expectations and the potential benefit of salvage treatment will bring to this semi.

Stephen Willey – Stifel

That’s helpful.

Charles Link

I just wanted to mention that we made the assumptions about the performance of the control arm. We base that in part on the second type of analysis we did on our phase 2 data. If you recall people are repeatedly say that we’re only comparing – on the trials that simply is not true. We actually perform the initial announces in the primary end-point of our Phase 2 study was to lookout recurrence free survival comparing the two arms of the high dose and low dose together net-net its primary statistical end-point with a P value of 0.2 and show that on recurrence free survival of one year the high dose was superior.

Subsequently the analysis of overall survival between the two arms showed difference as well, wasn’t powered to look at overall survival but the P value came in at like 0.051 or 0.052 very close to significant even on a small study.

And so was it actually internally controlled study, I know that’s unusual for oncologic studies done much more in pharmacologic studies, blood pressure medicines or depression drugs and the reason that was done initially is we had intended to go from there into an extended Phase 2B, but after discussion with the Food and Drug Administration and their willingness to do a Special Protocol Assessment, we went directly to the pivotal Phase 3 IMPRESS trial.

The second analysis we did, in fact we consider in case control analysis not just reporting out a comparison to a historical data, which has – we specifically use – that was developed that allows you to match single individual patients to patients in their database and do a case control analysis of each individual patient and then create a curve and a median for all of those patients combined.

And that actually, that case control analysis after taking it one-step further than the internal comparison of the two arms in the controlled study showed even more favorable meaning worse, expected, survival at median than the RTOG comparative study, it’s also been a little bit of confusion around the RTOG study, which is the paper – believe reports the 20 month median survival but the sectors reporting without the detail of Pancreas tumors. If you look in the paper that all comers in that study publishing the publishers that manual script the median survival they actually 18.6 months. So we believe that is important, the final point I wanted to emphasize was that no positivity in U.S. patients because all the U.S. tend to have many nodes involved or different than European population.

And we’ve compare no positivity to the RTOG-97-04 study in the NewLink phase two study, they were around 20% fewer node positive patients. They were also some comparison between resection margin R0 versus R1 patient, but if you look at the large corporate group study what you find, is that noticed as by far and away as the greatest hazard ratio in a many of the larger multi-institutional studies, resection margin in fact has a hazard ratio of one and has no impact and survival.

And the reason for that is unless that analysis is done very carefully and consistently both by the way the surgeon does the surgical resection and by the way the pathologist does the analysis, it’s too inconsistent of a measure to actually predict, outcomes are very difficult to compare between studies.

Charles Link

In fact Steve if when you look at diseases at their own comparison of their hazard ratio was one...

Stephen Willey – Stifel

It’s helpful, thank you. And then just I don’t if it’s too early, but any chance of getting any idea of around what we’ve might be seeing at ASCO in June or should we just kind of way close the abstraction?

Charles Link

I think this kind of way through the abstract obviously those go through over a review process, so we can’t guarantee at this point which abstracts are accepted or not, but we think that we expect those updates to be accepted and therefore we’ll be able to present them.

Stephen Willey – Stifel

Fair enough, thanks guys.

Charles Link

Thank you.

Operator

Our next question comes from Chris Raymond of Robert W. Baird, your line is open.

Charles Link

Hi, Chris. Good morning, how are you?

Laura Chico – Robert W. Baird

Good morning. This is actually Laura Chico in for Chris Raymond today.

Charles Link

Oh, Laura.

Laura Chico – Robert W. Baird

Thanks for taking the questions and congratulations on the progress in the quarter and the year. Just really briefly, could you kind of walk through perhaps, I think, we’ve been getting a lot of questions around what the interim announcement is going to look like in terms of how you’re going to convey the information and what the data release will include. So just wondering if you can review for every one potential scenarios there and outcomes in each instance?

Charles Link

Sure, it’s actually quite straight forward, but I’ll share your view that there is some confusion out there. The interim analysis, two interim analysis, the recent interim analysis is based on 222 events, and second interim analysis will be based on 333 events, and the final is 444 events. The first interim analysis, the Data Safety Monitoring Committee, when those events are reached, we’ll look into data, and if there is no opportunity analysis, there is some confusion around that.

There won’t be any future laboratory analysis and when Data Safety Monitoring Committee reviews the data, if – we will get two responses either we have reached a statistical significant to stop this on early stoppage or we continue. Same holds for second interim analysis. All these final analysis will be done hopefully.

Laura Chico – Robert W. Baird

Okay. And then I guess in terms of the timing to the trigger event. Could you just clarify that that trigger event you said that was probably going to be by midyear, did I hear that correctly?

Charles Link

So we don’t know exactly when the trigger event is going to occur. We had originally projected that it would occur in the first quarter 2013, now we believe it’s going to happen in the second quarter of 2013, but those are estimates. We’re going to sort of let the events to speak for themselves and that’s the best guidance we can give at the moment.

Laura Chico – Robert W. Baird

Okay. Thank you very much.

Charles Link

Sure, thank you.

Operator

Thank you. (Operator Instructions) Our next question from Megan Dow, MLV & Company. Your line is open.

Charles Link

Good morning, Megan.

Megan Dow – MLV & Company

Hello, everyone. Hello. Thanks for taken my call and congratulation on the fantastic 2012, we’re looking forward to 2013. I think you’ve given some really nice detail, I know that’s to the pancreatic and one trial. Thank you for those. I was wondering if you could tell us little bit more about the trial in bringing the plant.

Gordon Link

So the trial, we will announce when it gets launched, the trial is basically in the final design stages right now. But it will, it intends to be a randomized Phase 2 trial standard of care versus standard of care plus vaccine, the standard of care arm is probably going – single agent and so we think that our preclinical data across range of different vaccines and things suggest that there could be a strong synergies between Checkpoint inhibitors that include both (inaudible) the PD-1 antibodies, the PDL1 antibodies and IDO inhibitors.

So for all three classes of drugs that are Checkpoint inhibitors that break immune tolerance and we think that that is an next logical step in the evolution of the technologies obviously combined. What’s wrong in their therapy response with a drug that’s removing the tumor tolerance and since it’s going back and reduce responses in patient as a single agent, and that drug is already approved in that setting of metastatic melanoma, we think that’s a good combo and trial to execute.

Megan Dow – MLV & Company

Fantastic. Could you say they would be alone or do you offer – envision a combination on?

Gordon Link

So we think that the basic trial now is going to be strong plus the HyperAcute melanoma

Megan Dow – MLV & Company

Okay.

Gordon Link

But we’ll put out more details we’re close to launch, which is coming up anytime now.

Megan Dow – MLV & Company

Excellent. Great. Thanks, Chuck, and good luck with the rest of the year.

Gordon Link

Thank you very much.

Charles Link

Thank you.

Operator

Thank you. I’m showing no further questions in the queue at this time. I’ll hand the call back for closing remarks.

Charles Link

Well, we appreciate everybody calling in today and listening to us. We’re obviously very excited about 2013, is a lot of work to do. We are doing a lot of internal planning and work preparing for aspects at commercialization. Our current goal again is to commercialize within the United States ourselves. Although we are in a lot of active discussions with a lot of groups about potential collaborations and I hope everyone has a great day.

Gordon Link

Thank you.

Operator

Thank you. Ladies and gentlemen this concludes the conference for today. You may all disconnect and have a wonderful day.

Charles Link

Thank you.

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