Regulus Therapeutics Inc.
Q1 2016 Earnings Call Transcript

Published: 3 May 2016

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the Regulus Therapeutics First Quarter 2016 financial results conference call. My name is Brian, and I will be your coordinator for today. I would now like to turn the call over to the company; please proceed.

[Amy Conrad:]

Thank you, Brian, and good afternoon, everyone. I'd like to welcome you to Regulus's financial results call for the quarter ended March 31, 2016. Joining me on today's call are Paul Grint MD, Chief Executive Officer; Jay Hagan, Chief Operating Officer; and Mike Huang MD, Vice President Clinical Development. During our call today, Paul will provide introductory remarks, Mike will provide an overview on our microRNA therapeutics pipeline and Jay will review our financials and business highlights for the year, and then Paul will wrap up the call. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning Regulus's future expectations, plans, prospects, corporate strategy and performance, which constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as of the date of this webcast, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. With that, I'll turn the call over to Paul. Paul?

[Paul Grint:]

Thank you, Amy. Welcome, and thank you for joining us this afternoon. We're off to a great start in 2016 and the year is shaping up to be one of pivotal growth for the company. We've demonstrated our ability to advance multiple clinical programs and execute well on our goals. In particular, we were pleased with the rapid progression of RG-101; our potent antagonist of microRNA-122 for the treatment of chronic hepatitis C virus infection, currently being developed in a broad Phase 2 program, designed to investigate stability to eradicate HCV in four weeks or less, a significant advantage over currently available HCV therapies, which generally require 8 to 12 weeks of therapy. A few ago, we presented additional interim data from an ongoing Phase 2 combination study during a plenary session at the International Liver Congress, or EASL, meeting in Barcelona Spain. These data followed our prior interim analysis conducted in early February. We reported follow-up data on HCV viral load reductions for all invaluable patients some of whom had completed 24 weeks of follow-up. Overall RG-101 used in combination with four weeks of either Harvoni, Olysio, or Daklinza continues to demonstrate significant viral response. Based on the consistency of the response rates and the favorable safety profile to date, we have accelerated developments of the clinical program and CMC readiness and the actively designing additional combination studies to help us further understand the potential for the product and define the optimal path for regulatory approval. From a global perspective, it is estimated that there are approximately a 185 million people chronically infected with Hepatitis C. While we've seen significant advancements in the standard of care, the currently approved agents have been difficult for patients to access. Investments by the pharmaceutical industry to date have been aimed at developing more potent, pangenotypic, shortened treatment regimens. While these goals for incremental improvements to standard of care have clear market merits RG-101 stands alone as the only agents to date to demonstrate significant viral load reductions in the majority of patients treated with just a four week treatment course in combination with available DAAs. Based on the results we’ve seen thus far, we believe that RG-101 is uniquely positioned to help address this global healthcare problem. In addition to all the progress with RG-101, our second program RG-012 targeting microRNA 21 in developments to treat an orphan kidney disease called Alport syndrome is progressing well towards the next phase of development, which we aim to initiate around midyear. Our third program RG-125 targeting microRNA 103, 107 to treat Type II diabetes in NASH currently in Phase I development is being led by alliance partner AstraZeneca. In February we received a $10 million milestone triggered by the initiation of this Phase I study from AstraZeneca, which has contributed to our strong cash position ending the first quarter with $106 million. So to close by introductory remarks, I’d like to summarize our goals for the current year. RG-101 remains our main focus. We’ve accelerated development with the initiation of key clinical trials in both Europe and the United States. We expect to report additional combination data from multiple trials and we expect to obtain clarity on a potential path for approval. With RG-012 we will be presenting pre clinical data and longitudinal data from our ATHENA natural history study at ERA, EDTA later this month and around midyear start a key Phase 2 study in Alport syndrome patients. We're also working hard on the preclinical portfolio and we expect to nominate an additional candidate for clinical development before the end of the year, which will be our fourth micoRNA drug candidate. With that I will turn over to Mike.

[Mike Huang:]

Thank you, Paul and good afternoon, everyone. As Paul mentioned we’re extremely pleased with our progress so far this year, most notably with the demonstration of favorable interim combination results with RG-101 and the overall progression of our clinical portfolio. Our broad Phase II clinical development plan for RG-101 is advancing well. This plan includes evaluating RG-101 in combination with multiple different oral agents to achieve shorter treatment regimens, but also in combination to enable a single visit therapy through our clinical trial collaboration with GSK and in certain underserved patient population such HCV patients with chronic kidney diseases where treatment options are limited. We're very encouraged with the results of RG-101 thus far. Our clinical experience to date has demonstrated potent anti-viral activity both as monotherapy as well as in combination with oral DAAs and a shortened four week regimen across different oral mechanisms. To date RG-101 has been well tolerated with nearly all adverse events considered mild or moderate and with no adverse events leading to discontinuation in any study. Additionally the pharmacodynamic markers have consistently shown that we have achieved effective target engagement with RG-101. Later this quarter, we expect to have another read-out from this combination study, which will be the primary endpoint analysis or 12 weeks to follow-up for all 79 patients enrolled in this study. Now let's turn to the second facet of our broad Phase 2 program, our clinical trial collaboration with GSK. The goal of this collaboration is to evaluate the potential for a single visit therapy to HCV, which if successful could dramatically change the HCV treatment landscape. During the first quarter, we initiated the Phase 2 combination study evaluating RG-101 in an oral tablet formulation of GSK 175, an investigational non-nucleoside NS5B polymerase inhibitor for the treatment of HCV. In previous clinical studies, GSK 175 has demonstrated substantial reduction in HCV RNA across all genotypes as monotherapy, and has displayed a PK profile consistent with once-a-day dosing. The primary endpoint of this Phase 2 combination study that will evaluate the potential to achieve virologic responses post treatment with a single dose of RG-101, in combination with daily oral dosing of GSK 175 for up to 12 weeks in treatment-naive patients chronically infected with HCV genotypes 1 or 3. We anticipate reporting interim safety and efficacy data from this study by the end of the year. We believe GSK 175 has the right physical chemical properties amenable to formulation into a long-acting parenteral or LAP injection. GSK is working to advance this LAP formulation of GSK 175 as a single injection that would deliver the equivalent of up to 12 weeks of oral drug. GSK's LAP technology enables injectable formulation of a drug solubility of limited release results in the ability to have very long apparent half-lives, potentially weeks to months. LAPs have been developed in other settings such as the treatment of HIV and schizophrenia, where a sustained release in unofficial. Developing a long-acting HCV therapy that can be administered in a single visit could potentially transform the current treatment landscape by improving patient compliance and extending opportunities for therapeutic intervention. We also continue to make significant progress in our development of RG-101 in patients with chronic kidney disease. We're on track to report safety and efficacy data from this study towards the end of the year. And as we talk about on our last call, we're actively designing additional clinical studies to optimize RG-101 containing treatment regimens. We expect to initiate additional studies in the second half of this year. Now let's turn to our second clinical program, RG-012, targeting microRNA 21 for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapies. We have made significant progress with the RG-012 program. In March, we had a productive meeting with the FDA to discuss a potential path for regulatory approval of RG-012. We're on track to initiate the next phase of development midyear. As well, we will be presenting longitudinal data from the ATHENA natural history study together with some preclinical data at the ERA-EDTA meeting later this month. As you can see, we had a very busy quarter on a clinical front and we look forward to updating you on our continued progress throughout the year. With that, I'll turn the call over to Jay.

[Jay Hagan:]

Thanks Mike. The first quarter of the year has been very productive executing on our key goals. Our financial footing remains solid. We ended the first quarter of 2016 with $106 million in cash, cash equivalents and short-term investments, which included a $10 million milestone payment from AstraZeneca received in February of 2016. We recognize revenue of approximately $500,000 in the first quarter of 2016, compared to $4.2 million for the same period in 2015. Revenue in the first quarter of 2016 was attributable to the amortization of upfront payments received from our strategic alliances and collaborations established earlier. Our R&D expenses were $16.8 million in the first quarter of 2016 compared to $13.4 million for the same period in 2015. This increase was primarily driven by Phase 2 clinical trial cost for RG-101; cost associated with our global ATHENA Natural History study and manufacturing cost for RG-012. Our general and administrative expenses were $5.1 million in the first quarter of 2016, compared to $3.6 million for the same period in 2015. This change was primarily driven by an increase in non-cash stock-based compensation. Our net loss for Q1 2016 was $21.2 million or $0.40 per share versus a net loss for Q1 2015 of $14.5 million or $0.29 per share. Overall, our results of operations and related cash burn for the first quarter were in line with our operating plan. We’re pleased with our progress during the quarter and look forward to providing further updates throughout the year. We will be presenting at the BOA Healthcare Conference in Las Vegas next week and the UBS and Jefferies Healthcare Conferences in May and June in New York. With that, I'll turn the call back over to Paul for closing remarks.

[Paul Grint:]

Thanks, Jay. As you heard today, we're off to a great start this year. We focused on advancing RG-101 and RG-012, advancing our research pipeline and nominating our fourth clinical candidate for development. With that operator, we’re ready to take questions. Thank you.

[Operator:]

Yes, sir. [Operator Instructions] Our first question comes from the line of Jim Birchenough with Wells Fargo. Your line is now open. Please go ahead.

[Jim Birchenough:]

Hi guys, congrats on all the progress. Just wondering if you have any updates in terms of Phase II data for RG-101 from the day that was recently presented, particularly on any baseline characteristics that might have included different mutations resistant mutations, different genotypes trial, again a sense for the patients that didn’t have a durable response and obviously that were few of them. Were there any base line characteristics you’ve identified so far that might help predict the future development.

[Paul Grint:]

So, Jim good afternoon. This is Paul. So right now currently we're still sequencing samples from the study. So we don’t have a clear cut answer, but we'll do in the relatively in future from a sequencing standpoint. Otherwise if you look at overall, I think I’m correct in saying, if you look at overall baseline characteristics there is nothing obvious that would -- you could relate to those two patients who substantially relapsed. Obviously bear in mind, we’re talking about two patients out of 79 here. So the numbers are very small from a relapse standpoint.

[Jim Birchenough:]

And then is there any further detail you can provide on the studies you're going to initiate in the second half or are you considering a two week regimen? Are you considering an open phase stand with the DAA? Just wondering if you could give any more detail or what you're thinking about in the second half of these new studies?

[Jay Hagan:]

Yeah, hi, this is Jay here. We are actively considering adding a four week course without that second injection. As we talked about in the past Jim as you know that’s an open question that we want to understand from a commercial perspective on whether that’s required and clearly seeing the results we've seen thus far with a 100% response rates in Harvoni are beg the question, do we need that full treatment course? So, whether we do that on our own or in clinical trial collaboration and analogous to what we have with GSK remains an open point of discussion. We're working through those and we’ll have more color on the specifics of these additional studies as we iron them out.

[Jim Birchenough:]

Great. Thanks for taking the questions.

[Paul Grint:]

Thanks Jim.

[Operator:]

Thank you. Our next question comes from the line of Bill Tanner with Guggenheim Securities. Your line is now open. Please go ahead.

[Bill Tanner:]

Thanks for taking the question. And I can't remember Paul if it was you or Mike did mention on the 12-week 101 data this quarter that’s -- so this -- is the second quarter then in calendar quarter, you released the data, is that correct?

[Paul Grint:]

That’s correct Bill. Our plan is as we settle along is late second quarter to release what we call in the primary endpoint data. This was the data point that was laid out in the stat analysis plan once we had everybody through 12 weeks of follow-up. So yes, you are right.

[Bill Tanner:]

Okay. And then is it contemplated that’s going to be PR or how do you anticipate disclosing that?

[Jay Hagan:]

Yeah, I think we would plan to PR and host the call. There are a number as Paul alluded to a number of secondary analysis based on the fiscal analysis plan that will have more data than just viral load reductions.

[Paul Grint:]

That’s correct. Yeah.

[Bill Tanner:]

And then may be just a last question, what other tranches of data might we anticipate over the balance of the year beyond that for this study?

[Paul Grint:]

For the four week study, we'll obviously have more patients through longer periods of follow up and so we would expect to report those out at appropriate times and using medical conferences where appropriate to submit that information. So you can imagine given the studies 48 weeks in duration, that we'll have data in the second half of the year, reading out more from that study. We also though as we mentioned will have data from both GSK collaboration towards the end of the year, interim analysis from that study as well from the study in patients with chronic kidney disease and Hepatitis C virus.

[Mike Huang:]

That’s right, So where appropriate we'll use a mix of medical meetings or press release to release that information. Clearly where if fits from a timing standpoint, we obviously do like to release the medical meetings if we can.

[Bill Tanner:]

Sure. And so I guess without just putting words in your month where it seems like it would be in a decent position to have pretty good set of presentations at ASLD I guess in the fall?

[Paul Grint:]

Yes absolutely, our goal is to get as much data as we can at ASLD, you're correct. Yes.

[Bill Tanner:]

Okay. All right. Thanks very much.

[Paul Grint:]

Thank you.

[Operator:]

Thank you. Our next question comes from the line of Alan Carr with Needham. Your line is now open. Please go ahead.

[Esther Pang:]

Hi, this is Esther in for Alan. Thanks for taking my questions. So what can we expect to learn from the ATHENA study and what will Phase II program with RG-012 look like? Will you be enrolling patients straight from the ATHENA trial or will you be expanding that and what kind of endpoints will you be using?

[Mike Huang:]

Yes so this is Mike. So with the ATHENA natural history study, we've learned a lot from the study in terms of the how patients progress over time with this condition with Alport syndrome. Keep in mind that there has really never been a prospectively designed natural history study in this indication that characterize appropriate biomarkers, endpoints and rate of decline with this disease. And I think all of those items are now being answered and we have now good set of longitudinal data to help inform the next study. And it is really our intent that the ATHENA study would be able to help feed patients into the next trial as well. So not only is the ATHENA study giving us important longitudinal data, but is also helping us to identify those patients that are most appropriate for inclusion in the next trial.

[Paul Grint:]

And this is Paul. Just to add, so thanks Mike. As we said, we needed data from the ATHENA study to help us define the endpoints. To this point we haven’t talked about -- publicly about data from the ATHENA study. As we said in our script, we will be releasing data for the first time later this month at the European Renal Association and then I think once that's out there, then we'll talk more about how we use that data to design our Phase II program and we will in the future talk more about the endpoints and the nature of the types of patients that we'll be enrolling into that study.

[Esther Pang:]

Okay. And earlier you mentioned a few other preclinical candidates, can you -- what can you talk about them? Anything about timing or indication?

[Paul Grint:]

Yes we continue obviously, we have a very powerful research engine here. So we continue to look for great target opportunities. We have a focus really on liver and kidney diseases which you know because we can -- so far we've demonstrated we can effectively deliver all the oligonucleotides to those organs. We will talk later in the year about -- more about the science and what are the types of targets we are looking at. But the goal that we set ourselves for this year is for our fourth clinical candidates in 2016 and we're on track for that. So stay tuned. You'll hear more later in the year about our clinical candidate and the progress on the research pipeline.

[Esther Pang:]

Okay. Thank you.

[Operator:]

Thank you. Our next question comes from the line of Matthew Luchini with BMO Capital Markets. Your line is now open. Please go ahead.

[Nate Smith:]

Hi this is Nate Smith on the line of Matthew. Thanks for taking our questions. So first could you comment on the development plans that you mentioned for RG-101 after the Phase 2 trial? Are you planning to expand in traditional patient population and these trials other genotypes or treatment experienced patients?

[Jay Hagan:]

Yes this is Jay here. So we have designed a Phase 2 program and as we said, we're contemplating and actively designing additional studies now to really round out the Phase 2 program to inform what the right optimal strategy is and to take forward for a pivotal study for approval. And we haven’t really said much more than. A number of these things we're designing on our own, a number of things are in discussions with others where we stated we have an interest in doing additional clinical trial collaborations along the lines of what we’ve done with GSK. The totality of that will help inform then what the past forward is from a approval standpoint and which would expect to initiate next year.

[Nate Smith:]

Great and could you also speak to any plans to accelerate the long acting GSK 175 formulation?

[Paul Grint:]

That’s being done in parallel right now. So while we're enrolling patients in the study what we call Open Phase Sandwich Study combining one injection of RG-101 was either six, nine or 12 weeks of oral DAAs, they are in parallel developing the long acting print role formulation of either six, nine or 12 weeks of therapy. So, that will be in a position then to test in a true proof-of-concept, two injection single visit cure and the potential for that.

[Jay Hagan:]

Yeah, this program is already moving very quickly. So we’re very pleased with the right to progress.

[Nate Smith:]

Great, thanks for taking the questions.

[Operator:]

Thank you. Our next question comes from the line of Joe [Toe] with Cowen and Company. Your line is now open. Please go ahead.

[Joe:]

Hi, thank you and congratulation on a productive quarter. I’m on the line for Eric. I know that we’re going to expect that additional post oblige data coming up over the next quarter, but I was curious if you're going to continue to put out a 16, 20 and 24 week data along with that and may be what you think -- what you view as the importance of that extended data going forward in future trials now?

[Paul Grint:]

Yeah, absolutely. So the primary endpoint goal with to have all patients through 12 weeks. So, yeah clearly we’ll have quite a lot of patients through 16 and 24 weeks. And as we reported at the usual meeting, we will show whatever dataset we have. Clearly it’s important that we continue to watch these patients over time and monitor their response. So, yeah basically we'll be doing a data cut but have everyone through 12 weeks a number of patients with additional longer term time points and we will have all that data, yeah.

[Joe:]

Great. Thank you.

[Operator:]

Thank you. Our next question comes from the line of Madhu Kumar with Chardan Capital Markets. Your line is open. Please go ahead.

[Madhu Kumar:]

Hey guys. My questions is about the patient who had a serious adverse event related to elevated bilirubin, will there be -- do you have any additional color on that now or will additional color on that come out with the next data release?

[Paul Grint:]

Yeah, we’ll talk -- that was nicely summarized during the usual presentation, what the information we had and if you basically what was reported was the patient was recovering the total bilirubin was decreasing over time, but yes obviously we continue to get follow-up information from this patient and we will report further information on this individual when we have data overall 12 week primary endpoint data.

[Madhu Kumar:]

Great. So will you be -- just to guided, how much have you thought about pricing and payer structure and that selling in when would you release any work you might have done on that front?

[Paul Grint:]

Good answer, I’ll ask Jay to answer that.

[Jay Hagan:]

Yeah, so we’ve completed a first round of physician payer work, very promising feedback. As you know this is our constant process that you get feedback. It begs additional questions and you continue to do market research. We’ll have color on that physician impair research as we make progress with further articulating the additional Phase II work that we're undertaking as well and so at an appropriate even we'll find time to share that with you all.

[Madhu Kumar:]

Great and then on the RG-012 front in the ATHENA natural history studies, are those patients taking the angiotensin blockers now?

[Jay Hagan:]

Yeah, so we do have number of patients that are on angiotensin blockers as well as ARB and other standard of care medications that are used and attempt to treat the condition. So what we’re finding is that in this disease there aren’t any approved therapies that treating physicians are going to use what they think is perhaps is possibly effective. And so a good proportion of those patients are on those ACE inhibitors and we expect to enroll patients both with and without ACE inhibitors in the next trial.

[Madhu Kumar:]

Thank you very much guys.

[Jay Hagan:]

Sure.

[Operator:]

Thank you. Our next question comes from the line of Jim Birchenough with Wells Fargo. Your line is now open. Please go ahead.

[Jim Birchenough:]

Hi guys, thanks for taking the follow up. Just a question on the CKD patient population and whether you think that might provide a path more acceleration approval and just maybe you could quantify the percentage of patients that have compromised renal function and HCV and what are the patient populations might you consider difficult to treat that you could also pursue, thanks?

[Jay Hagan:]

Yes Jim, that's a great question. So this is a patient population up until recently really with the approval of the tier which has this specific patient group in any indication claim, has been difficult to treat historically. There are a number of DA that you can't effectively use in these patients because they're primarily renally excreted and therefore obviously their metabolism is affected by renal function. And so many of these patients, their treatment paradigm is being long term interferon on a low dose ribavirin. They're just being difficult to manage. So generally many of them have not been treated and so I think we in talking to some of the big renal dialysis groups, we're hearing estimates of approaching 40% of dialysis patients being Hepatitis C positive. And so I think if you start doing approximate back of the envelope calculations, you may be talking about a patient population size that could be around 100,000 patients in the U.S. and we think that the definite opportunity here, if we can get a treatment course, that's well tolerated and relatively short in duration then I think definitely an opportunity here to treat a lot more of these patients that have been treated historically. The other patient population that we've talked about that we believe offers a real opportunity are those folks who are currently failing the approved oral agents. If you felt, what do you do for these patients, there isn’t a formal so second line indication yet in Hepatitis CapEx, but obviously given RG-101 novel mechanism it offers a potential to be part of a combination regimen yet to be defined that could be used in the second line setting. So that's definitely something else that we're very interested in and we've had some dialog with the FDA on that.

[Jim Birchenough:]

Great, thanks again for the follow up.

[Operator:]

Thank you. Our next question comes from the line of Katherine Xu with William Blair. Your line is now open. Please go ahead.

[Katherine Xu:]

Good afternoon. Thank you for taking my questions. I was just wondering about the Phase II study we have the two relapses, you might have talked about it, but I apologize if I missed it, what were the characterization of those two relapses?

[Paul Grint:]

What actually do you mean by characterization?

[Katherine Xu:]

Just what kind of mutations have you seen from those?

[Paul Grint:]

We haven’t yet completed the sequencing data to look at the mutation but we have that ongoing. So obviously very interested in seeing that information as well.

[Katherine Xu:]

Right and then for on the GSK 175 it's new, you said it's pan genotypic. Can you just comment on the pan genotypic activity against various ideas how it's been also on the barriers resisting.

[Paul Grint:]

So yes, so there is you are back I think it was, can't remember which meeting. So there is quite a lot of information in the public domain both about the virology and with regard to the antiviral activity with the two day dosing course on the molecule. So we can actually point you in that direction.

[Katherine Xu:]

So sorry, and lastly I am just wondering about your view on the market suppose that you launched 101 and with the common regimen let’s say in 2020-2021 timeframe, what would you envision how this product fits into the market at that time in U.S., Europe, Japan, the high value market as long as in the global market outside also of those territories?

[Jay Hagan:]

Yes we think that -- this is Jay here. We think that the two distinct profiles that we're actively disclosing right now, we have alluded to some variations in between but just for simplicity either a four week course or a single visit course represent real attractive product profiles for physicians, patients and payors to choose from in making their determination of what to use. And that's been borne out in the market research that we've done today and so as we think then about how those product profiles would work in a marketplace, I think they would achieve their natural preference share based on those constituents desire for a shortened course. It's the same reason why other competitors in the space have tried four week treatment courses and have failed in the past because short is better.

[Katherine Xu:]

Do you think the induction nature of the therapy would be unfavorable in the global market outside of the high value market?

[Paul Grint:]

So I think it actually would be more favorable because of insurance compliance and control over the administration of regimen.

[Katherine Xu:]

All right. Thank you.

[Operator:]

Thank you. Our next question comes from the line of Christopher James from FBR Company. Your line is now open. Please go ahead.

[Chris James:]

Hi. Good afternoon. Thanks for taking the question. Sorry, I jumped on a little bit late. Maybe regarding your discussions with FDA in March, maybe can you give a little bit more clarity around your discussions around specific with Alport syndrome potent urea and is that an approvable end point? Thanks.

[Paul Grint:]

Chris, this is Paul. Good afternoon. So as you're well aware, in the ATHENA study, we're measuring multiple, multiple different parameters aside from just GFR in terms of biomarkers and other clinical chemistry markers. So clearly that's the dataset we've discussed with the FDA. So as I remarked earlier, once we made the ATHENA at least say the analysis, current interim analysis we have in ATHENA publicly available at European Renal Association, I think following that, we'll be able to talk more about the nature of the endpoints. So we will be including in the Phase 2 design to talk about it now without people having seen that dataset and understanding why we're selecting the things that we've agreed with the FDA. So it makes it little difficult for people to understand, but obviously was something in there that we were measuring frequently in these patients.

[Chris James:]

Great. Thanks Paul. Appreciate the color. Thank you. Congrats.

[Operator:]

Thank you. Ladies and gentlemen, this concludes our question-and-answer session for today. I am now handing the call back to Paul Grint, Chief Executive Officer for closing comments.

[Paul Grint:]

Thank you again for joining us on the call this afternoon. We're very excited about the future and look forward to reporting more progress to you soon. Thank you.

[Operator:]

Ladies and gentlemen, this does conclude today's program and you may all disconnect. Everybody have a wonderful day.