Regulus Therapeutics Inc.
Q2 2015 Earnings Call Transcript

Published: 5 Aug 2015

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the Regulus Therapeutics Second Quarter 2015 Financial Results Conference Call. My name is Eric, and I will be your coordinator for today. I would now like to turn the call over to the company. Please proceed.

[Amy Conrad:]

Thanks, Eric. Good afternoon, everyone. This is Amy Conrad, Senior Director Investor Relations and Corporate Communications. I’d like to welcome you to our financial results call for the quarter ended June 30, 2015. With me today from Regulus are Paul Grint, M.D., President and Chief Executive Officer; and David Szekeres, Chief Business Officer and General Counsel. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning Regulus’ future expectations, plans, prospects, corporate strategy and performance, which constitutes 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. I’ll now turn the call over to Paul.

[Paul Grint:]

Thank you, Amy. Welcome and thank you for joining us. The first-half of 2015 and the recent period have been an important period of progression for Regulus. During this time, we accomplished many goals, advanced our microRNA therapeutics portfolio, and continued to execute against the backdrop of change. Also, our Clinical Map initiative remains on track and we’re poised for a data-rich period in the second-half of this year. Today, we’re pleased to announce an important achievement from our leading microRNA therapeutic program RG-101, our wholly-owned GalNAc-conjugated anti-miR targeting microRNA-122 for the treatments of HCV. We have initiated our initial planned Phase II study, a randomized multicenter study to evaluate the efficacy of RG-101, when given in combination with three different marketed anti-HCV oral agents, Harvoni, Olysio, and Daklinza for 28 days or four weeks of total therapy. We are calling the combination approach our sandwich-design, meaning one subcutaneous administration of 2 milligrams per kilogram of RG-101 given on day one, 28 days or 4 weeks of oral agents, and then one more subcutaneous administration of 2 milligrams per kilogram of RG-101 given on day 29. Following completion of the dosing period, patients will be followed for 48 weeks to investigate sustained viral responses. Regulus expects to enroll approximately 70 naïve genotype 1 and genotype 4 HCV patients across the three arms. Patient screening has begun and dosing is expected to commence in the near term. The Phase II study is being conducted at multiple sites outside the United States, and the goals of the study are multifaceted. We want to investigate the potential to significantly shorten the course of therapy, improve patient compliance with our subcutaneous dosing regimen, and possibly improve upon the high viral cure rates. The primary endpoints of the Phase II study is to evaluate sustained viral load responses 12 weeks post treatment or SVR12, and the secondary objective is to evaluate the sustained viral load responses at 24 and 48 weeks post treatments or SVR24 and SVR48. In addition to the efficacy readouts, we will also monitor the safety and tolerability of RG-101 in combination with the oral agents. Before the end of the year, we expect to report interim data from the Phase II study, which we anticipate will be sustained viral response data four weeks following conclusion of dosing or SVR4. In the first quarter of 2016, we expect to report SVR12 results from the ongoing Phase II study. We believe that the Phase II study represents a reasonable opportunity for RG-101 in a frontline setting in the ever evolving HCV landscape. In addition to frontline, we believe there may be an opportunity for RG-101 in the second-line setting to treat certain patient populations with unmet medical needs. Based on the data reported earlier this year, we know that the real world failure rate of oral-agents is rising with some reports of more than 15%. This represents a significant increase from data reported in well-controlled clinical trials, and underlines the opportunity that we have for RG-101 to treat patients who failed that oral regimens from compliance or resistance that results in increasing failure rates. In addition to the emerging failure populations, we believe there may be an attractive opportunity to treat HCV patients with severe renal compromise. These patients have very limited treatment options today, and we estimated that there are approximately 100,000 to 120,000 of these patients in the United States. To address these needs in the current landscape, we’re designing additional clinical studies for RG-101 to investigate its potential in the second-line setting. In parallel, we’re also conducting additional preclinical studies to round out a virology package to support work in these patient populations. We believe this additional preclinical work, combined with our Phase I data will support the filing of an Investigational New Drug application or IND in the fourth quarter of this year. To wrap up on RG-101, let’s touch on the catalyst coming in the second-half of the year. We’re rounding out the virology package, completing the sequencing immunophenotyping and biomarker analysis from our Phase 1 study, and we expect to report SVR results from the Phase II study and follow our first IND with the US FDA before year-end. In addition, we expect to have a good presence of the American Association for the Study of Liver Diseases or AASLD Meeting in November. In addition to all this progress in RG-101, we have also made significant advancements in our RG-012 program during the second quarter and recent periods. RG-012 is an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. The disease is driven by genetic mutations in the type IV collagen family of proceeds. The impact of mutation in the collagen gene results in disruption to the structure of the glomerular basement membrane, increased expression in microRNA-21, increased fibrosis and progressive loss of renal function which leads to end-stage renal disease requiring dialysis or kidney transplantation. In early June, we achieved a Clinical Map Initiative goal, when we announce the dosing had begun in a, first in humans Phase I clinical study of RG-012. The Phase I clinical study is being conducted in the United States as a randomized double-blind placebo controlled single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous dosing of RG-012 in healthy volunteers. Initiation of this study represents an important achievement for the company. We declared as we cleared a significant hurdle by successfully filing our first IND for microRNA therapeutic with the US FDA. While the Phase I study is ongoing, we continuously enroll patients into our natural history of disease study called ATHENA. The goal of ATHENA is to learn more about the actual progression of Alport syndrome by documenting the change in certain renal biomarkers and glomerular filtration rates or GFR, in these patients. Currently, we have 13 clinical sites open across the globe that are actively recruiting patients, and we have over 60 patients currently enrolled. Data from the ATHENA study coupled with the results from the Phase I study in healthy volunteers, will provide the clinical basis for the design of the Phase II study to monitor the therapeutic effect of RG-012 on the decline in renal function and time to end-stage renal disease in Alport syndrome patients. We expect to initiate Phase II proof-of-concept study in the first-half of 2016. As a reminder, Sanofi has an exclusive option on this program, exercisable after proof-of-concept to assume worldwide developments and commercialization of RG-012, while we retain a co-promote right in the United States. We also have the opportunity to achieve significant milestones in royalties. We’re really excited about this program with our opportunity to potentially provide therapeutic benefits in an orphan disease. To close my introductory remarks, I want to briefly mention another success during the past quarter. In late April, AstraZeneca selected RG-125, a novel insulin sensitizer for the treatment of NASH in patients with type II diabetes, as a microRNA candidate for clinical developments. This represents our third clinical candidate for development – for clinical development to rise from our novel technologies in less than two years, which demonstrates the productivity of our platform and achieved a key goal under our Clinical Map Initiative for 2015. Currently, we and AstraZeneca are working on the program, and AstraZeneca expect to initiate a Phase I study by year-end. Once an IND is accepted, AstraZeneca will assume developments of the program, and we are then eligible for milestone payments in royalties based on achievement of certain goals. We are looking forward to seeing this program advance into the clinic. To summarize our recent progress has positioned us for an exciting period focused on growth of our clinical portfolio. Now, I’ll turn the call over to David to provide the numbers for the quarter. Following that, I’ll close the call with an updates on our microMarkers division and our pre-clinical portfolio. David?

[David Szekeres:]

Thanks, Paul. During the second quarter in recent period, we were pleased with the progress made on the business in financial front. In addition to our disciplined financial strategy and good cash management, we’re pleased to have received payments from our strategic partners and collaborators for our microRNA expertise. We ended the second quarter 2015 with $139.4 million in cash, cash equivalents, and short-term investments, which included $3.8 million of revenue, compared to $700,000 of revenue in the same period in 2014. The increase in revenue was due to the overall advancement and our work with our strategic alliance, partners, and collaborators. Specifically, we received a milestone payment for the candidate selection of RG-125 from AstraZeneca. We achieved our third research milestone under our biomarkers collaboration with Biogen, Paul will discuss this in more detail shortly, and we amortized the upfront payments received from our strategic alliances and collaborations, which we recognized over our estimated period of performance. During the second quarter 2015, our R&D expenses were $19.2 million compared to $10.8 million for the same period in 2014. This increase was primarily driven by clinical trial costs for RG-101, preclinical study costs for RG-125, an increase in personnel costs, including stock-based compensation and a one-time severance charge associated with the resignation of our former Chief Scientific Officer. Our G&A expenses were $5.8 million in the second quarter 2015, compared to $3 million for the same period in 2014. This change was primarily driven by an increase in personal costs, including stock-based compensation and a one-time severance charge associated with the resignation of our former Chief Executive Officer. Our net loss for the second quarter 2015 was $21 million, resulting in a basic and diluted net loss of $0.41 per share, compared to a second quarter 2014, net loss of $12 million, resulting in a basic and diluted net loss per share of $0.28 and $0.29, respectively. As we continue to execute on our goals, we expect to maintain our strong financial position and meet our previously stated cash guidance, ending 2015, with greater than $100 million in cash, cash equivalents, and short-term investments. With that, I’ll turn the call back over to Paul for closing remarks.

[Paul Grint:]

Thank you, David. As we’ve heard today, we’re pleased with the execution of our Clinical Map Initiative goals and the advancements of our science focused on microRNAs. Although, we’ve shown rapid progress across our clinical portfolio, we’re also focused on our microMarkers decision in identifying and discovering new attractive targets in areas of high unmet medical needs. On the microMarkers front, we are pleased to announce today under our research collaboration with Biogen that we have identified that microRNA biomarker signature to differentiate relapse remitting MS patients from healthy volunteers in several hundred blood samples. We believe that our partnership with Biogen is one example of how Regulus microMarkers is researching the role and the potential of microRNAs as biomarkers for numerous diseases. We’re excited that our platform has identified the promising microRNA biomarker, which we believe is a critical first step in understanding how microRNAs may indicate treatment response. As a next step in our research with Biogen, Regulus microMarkers is now analyzing microRNA profiles following treatments. In addition, we expect to utilize our biomarker technology to profile samples from both the RG-101 and the RG-012 clinical trials. We look forward to providing an update from the divisions work in the future. In addition to the advances made with biomarkers, we’re currently working on multiple therapeutic targets, where we believe we can engineer anti-miRs with a high therapeutic index so they’re matched with the right delivery approach. To complement our internal research, we also continue to advance our preclinical programs with our partners. miR-21 and miR-221 for Hepatocelluar Carcinoma with Sanofi. Through alliance with AstraZeneca, we announced today that both parties have agreed to terminate microRNA-19 program for oncology indications. Going forward AstraZeneca retains replacement rights to the target under the agreement. Looking ahead, we have a busy period with data readouts expected across multiple programs in the portfolio. In addition to presenting a corporate overview at multiple investor conferences, we are participating in several key clinical medical meetings. In September, we have presentations at the DIA/FDA Oligonucleotide meeting. And we and AstraZeneca will present preclinical data on RG-125 at the European Association for the Study of Diabetes meeting. In addition, we expect to have a presence at the American Society of Nephrology, AASLD, and HEPLOC [ph] meetings. With that, operator, we’re ready to take your questions.

[Operator:]

[Operator Instructions] Our first question comes from the line of Alan Carr. Sir, you may begin.

[Alan Carr:]

Hi, thanks for taking my questions. Wondering if you could comment on with the management changes that happened couple of months ago, whether or not there is any changes, contemplating changes, in corporate strategy. And then also with the miR-19 program, is that program terminated or just the collaboration terminated and you all might bring it forward? Thank you.

[Paul Grint:]

So, Allen, good afternoon. This is Paul. So with regard to your first question, with regard – about management changes and potential strategic direction changes of the company, the simple answer is, no. We went through a really good detailed goal-setting exercise both at high-level for the company and down to individuals at the end of last year. We continue to move forward aggressively against those goals. And obviously as I’ve indicated in the previous narrative, we’ve been successful to this point and there is no plan to change those goals. So, I’m very pleased with the progress so far. With regard to your second comment, obviously, you go back to the original AstraZeneca agreement, it had several potential targets that they could select; miR-19 was one of those. We’ve worked with them on a series of studies, but come to a point where AstraZeneca obviously has decided to actually terminate that. So, David, correct me if I’m wrong, but basically the rights of that now revert to us.

[David Szekeres:]

Correct. And maybe, Allen, I could just add on to Paul’s comments, to the latter part of your question. In that, the collaboration has not terminated. They do have a replacement target for miR-19.

[Alan Carr:]

Oh, I wasn’t referring – I was wondering whether or not you all would pursue developing miR-19 or if it’s just that that particular program is terminated overall. And then, I guess, to follow up on that, when we’re going to learn about – or at what time do they have to decide on a replacement for it?

[David Szekeres:]

So I think it’s undecided yet what we are going to do with miR-19. This is relatively new development, but we’ll keep you updated in the future as we progress with our thoughts there.

[Alan Carr:]

And then time to – for them to make a decision on another program and then to replace 19?

[David Szekeres:]

It’s a good question. And they have four years from the date that the sign the agreement, so the agreement terminates in August of next year, so they have up to that time period to make replacement target.

[Alan Carr:]

Okay. Thanks very much.

[David Szekeres:]

You’re welcome.

[Operator:]

Thank you. Our next question comes from Liana Moussatos from Wedbush Securities.

[Liana Moussatos:]

Thank you for taking my questions. The first one has to do with enrolling in the Alport’s program. After you finished the healthy volunteer Phase I and you’re enrolling Phase II, at the same time you’re enrolling in the ATHENA natural history. Have you thought about how you’re going to select patients from both pools? And then my second question has to do with the microMarkers division. You said you had – you identified a signature for relapse remitting MS. Is this to diagnose it or use with Biogen’s Tecfidera, and can you comment a little bit more on that? And you mentioned, looking for signatures for RG-101 and RG-012, what are you looking for there?

[Paul Grint:]

Right. Liana, it is Paul. Let me take the first question first. So our goal is to have the ATHENA natural history study fully recruited before the end of this year. So if your question was, was there any concern about competing enrollment with patients in the natural history study versus Phase II therapeutic study; that won’t be the case. As I indicated, what we’re going to do is, obviously, the goal of natural history study was to enroll these patients farther than longitudinally, with detailed measures of all sorts of biomarkers, microRNA signatures, because we are looking for microRNA signatures also in these patients, both in blood and the urine; together with formalized measures of GFR. So our goal is to take data from this study together with the safety tolerance and PK study from our Phase I program. And as we had agreed with the FDA at our pre-IND meeting that we had last year, then work with the agency to design the Phase II therapeutic intervention study which we plan to start in the first-half of next year. So just to remind you, that the patients we’re enrolling in the ATHENA natural history study basically are patients who are around the stage 3 kidney disease. GFR is a little bit higher, but we believe based of what limited data exists that once patients get to this stage of loss of renal function, that there is a more reproducible and measurable decline over a reasonable period of time. And that’s why we’re monitoring them. So it is conceivable that we will want to enroll a similar patient population into Phase II therapeutic intervention study next year. And in fact, what we’ve achieved by enrolling patients into the ATHENA natural history study, in essence, is having a pool of patients there who potentially might have the ability to rollover from the natural history study into a therapeutic intervention Phase II study. So that’s the way we look at it. So definitely it’s been a lot of work and a lot of learning for us to set up natural history study, but I really believe there are many benefits that are going to come out from the ATHENA study for this program. And that your second question with respect to the microMarkers, given this is a collaboration with Biogen we’re not going to speak to more detail about – really about the findings with regard to the MS patients. Suffice it to say, obviously, we as I pretty indicated in my previous remarks, we’re very excited by the outcome of that. We continue to work with Biogen to further explore the utility of these microMarkers. From a standpoint of support of our own programs, we’re obviously interested in looking at microMarkers in those patients that we treat with our anti-miRs. We’re just in the process of wrapping up testing samples from our RG-101 program; wait to see with interest what the data is going to show with that. We’re just about to start testing samples from our RG-012 program. There we’re looking at both blood and urine. But, in fact, to remind you we have this, so called, Alport mouse model. We have a mouse model that really emulates the human disease. And we’ve been very intrigued by data that we’ve seen there from the mouse model when you look in urine and looking at microMarkers signatures there. So we’re now moving onto look at the clinical situation. So as we move forward, the plan for the microMarkers, we’ll talk about more of this at some point in the future call. It’s obviously to support our own programs together with important collaborations with other companies.

[Liana Moussatos:]

Thank you very much.

[Operator:]

And our next question comes from the line of Robyn Karnauskas from Deutsche Bank. Please proceed with your question.

[Ellie Merle:]

Hi, guys. This is Ellie on for Robyn. Thanks for taking our questions. My first question is, what are your thoughts around initial trial designs for RG-125, and when we could may be get initial signs of efficacy for this?

[Paul Grint:]

So just to remind you, the way the collaboration is set up, Robyn, that AstraZeneca takes over operational responsibility for the Phase I study. At this point, what we can talk about is the fact that Phase I studies can be conducted in the U.S., but that’s pretty much it. They haven’t – it’s really up to them to disclose the nature of the design in the studies and then probably we’ll be doing that moving forward.

[Ellie Merle:]

Okay, great. Thanks. And then in terms of hepatitis C, can you talk about why you decided to do the study outside of the U.S.?

[Paul Grint:]

Yes. We – just to remind you that we conducted our Phase I study in the Netherlands and Europe, and that the regulatory filing, the Clinical Trial Application, the CTA to support that was already in place. And so for us to move onto the Phase II meant that we could take an existing regulatory document and update that, so that it’s sort of a probably a matter of speed. But also outside the U.S., there are number of countries or with selected countries, where we have investigators who are very interested in the conduct of the protocol plus where we can access patients. From the U.S. standpoint, we filed the pre-IND and we’ve had discussions with the FDA. And really as I indicated, again, in my comments, our interest in the U.S. is to move forward and treat medical need populations; and so, we’re focusing our discussions, and as I remarked, some extra preclinical work that we need to do to support an IND for that type of patient population. So where it’s going, where we should go in different parts of the world to achieve the goals we need to achieve.

[Ellie Merle:]

Okay. That’s helpful. Thanks.

[Operator:]

And our next question comes from the line of Bill Tanner from Guggenheim Securities. Please proceed with your question.

[William Tanner:]

Thanks for taking the question, guys. Paul, congratulations on your first quarterly call as the CEO of the company.

[Paul Grint:]

Thank you, Bill.

[William Tanner:]

Just a couple of questions. Number one, can you just walk us through the rationale on the sandwich design?

[Paul Grint:]

Yes. I mean, so to remind you to this point, we only have single administration data that we generated in the Phase I. As you think about Phase II study design, there are multiple variables that we could potentially have looked at. So our conclusion was that in combination with oral therapy to make a treatment regimen really meaningful that we needed to have that oral duration of just four weeks. And based on data that we generated, we believe, at least, initially, that whole regimen was best flanked in the sandwich design with injection before and at the end. Just to remind you, we – through our preclinical program, we did the top study, where we did administer four doses of RG-101 each four weeks apart. And we also did a multiple dose components of our Phase I in healthy volunteers, again, where we gave four doses of 2 milligrams per kilogram, each injection being four weeks apart. And so, the duration was partly predicated on what we know about pharmacodynamic activity in tissue half-life. So we put all that together and that that really constitutes the design of the study.

[William Tanner:]

And can you just remind us, like on the PK profile, how that would actually run 101, how that would actually match up over the course of, I guess, the month, where it’s being used in combination with the DAs or is that even a relevant thing to...?

[Paul Grint:]

Yes. Well, the PK profile of RG-101, if one looks at just what pharmacokinetics that you can get from the blood is very short. When we administered this drug subcutaneously within – by 24 hour, you can no longer detect any RG-101 in the plasma, because basically as we had expected, the GalNAc targeting is very effective at delivering the oligonucleotide the-parasite [ph]. We know from preclinical studies, particularly in nonhuman primates that we’ve got a liver tissue half-life probably in the region of two weeks or so. So four week period, you’ve gone through two half-lives. And so, we thought that was a good period then to a good time window then to give a second administration.

[William Tanner:]

Okay. Fair enough. And then, just as it relates to the Alport – the ATHENA study, can you remind me, are these patients being profiled?

[Paul Grint:]

Profiled in which way?

[William Tanner:]

For the miR-21?

[Paul Grint:]

So well, we’re taking multiple samples from these patients, both blood and urine. And we will profile for multiple microRNAs. It’s not just miR-21. We actually ran a panel of significant number of microRNAs. And what we’re interested in looking for is that – what we call the signature, which is a small number whether it’s 8, 10, 12 whatever microRNAs that might correlate, let’s say, with decline in renal function or something like that. So, the answer to your question is, yes. We’re looking at microRNA-21 together with a lot of other microRNAs.

[William Tanner:]

Okay. And then, maybe just one last question on 125, but – it’s obviously very early, but how would just conceptually would you contemplate using this as a – if it’s an insulin sensitizer then, it’s an add-on to insulin or with other agents, how do you think about that?

[Paul Grint:]

Well, again that’s really AstraZeneca would take lead in designing that. From the preclinical study, the biology is quite fascinating because it is an insulin sensitizer. And we demonstrate that in multiple models of – rodent models with diabetes. But also importantly, we see a significant beneficial effect on lipids, in particular, quite a significant lowering of triglycerides. And so, my understanding is AstraZeneca is interested this in, not just with patients with diabetes, but perhaps those patients that have sort of metabolic dysregulation with obviously abnormal lipids in diabetes. But there will be a lot more data and information on this in the next – what next month, September, at the European meeting, the European Diabetes Meeting.

[William Tanner:]

Okay. Great. All right, thanks very much.

[Operator:]

And our next question comes from the line of Christopher James from FBR & Company. You may proceed.

[Christopher James:]

Hi, good afternoon. Thanks for taking my questions and congrats on the progress made this quarter. First, starting with 101, Paul, can you remind us why you’re choosing only the 2mg dose in Phase II versus the 4mg dose? And then, when could you start some of the other HCV studies?

[Paul Grint:]

So, Chris, great question. So, I think as I mentioned just a bit earlier, coming out from the Phase I there are lot of variables that we could have studied. One of them is dose genotype prior treatment history, just to give some examples. So what we’ve elected to do is to look at those, but we’re not going to do them all in one study. Our goal is to design a study and efficiently, operationally drive to get important results by the end of this year. So, it is our intention in additional studies to examine other doses, including the 4 milligram per kilogram dose groups, maybe less than two injections of RG-101 in combination with oral agents and other genotypes. So, the answer to your question is, we have those study designs pretty much designed now. Our goal is to get the first phase to be enrolled. We have a set of sites that set up, will be set up in a number of countries. And once we got the first protocol enrolled, we can then start initiating additional Phase II protocols.

[Christopher James:]

Okay, great. That’s helpful. And then on 12, RG-12, maybe discuss a little bit more about the Phase II design? Do you know the trial size and length and will this be an adaptive design considering ATHENA will be up going?

[Paul Grint:]

That’s a good question. So, we haven’t got much in the way of detail of that. I think as you just pointed out that, again, there are a lot of variables in this. Could it be an adaptive design? Could we use patients from the ATHENA study, who perhaps have their own control, so to speak, that there are a number of different aspects to it. With regard to size, we’ve had some discussion on this with Sanofi-Genzyme our partner, I think it could be variable. I think the key question here, Chris, is, could we come up with a reasonable size study, duration period, probably, it’s minimum for a year, which if we could find some good biomarkers, could potentially constitute the way of getting some type of accelerated approval for this orphan population, and that’s clearly is something we want to explore with the regulatory agencies.

[Christopher James:]

Great. That’s helpful. And then, finally, on 125, do you view this more as a diabetes product that control hyperglycemia, or is it to address the liver inflammation fibrosis, or is it both?

[Paul Grint:]

I think it’s both. So we know that clearly has an insulin sensitizing effect. But also as I mentioned blockage or any infection of these microRNAs has a beneficial effect on lipids as well. So I would look at this as both. I think positive difficulty nowadays is the – is a very large size and very long duration of diabetes development program, given the current regulatory requirements. So I think it’s being looked at in more of a broader life as you’ve indicated.

[Christopher James:]

Got it. Thanks, again, and congrats on your progress and good job.

[Paul Grint:]

Thank you.

[Operator:]

Thank you. And our next question comes from Jeff Chen of Cowen and Company. Sir, you may proceed with your question.

[Jeff Chen:]

Hi, thanks for taking my questions. First on RG-101, I think previously you discussed maybe taking data points from week 8, 12, 48, and I noticed that week 8 was not one of the time points for this trial. Should we expect that to be sort of incorporate into later trials?

[Paul Grint:]

Well, we – the way the study is designed is the study, it’s obviously we’re dosing the patients. And we then obviously look at data points with respect to viral load at fairly frequent intervals over the 48-week period. From a protocol design standpoint, what we need to highlight or what we consider the primary endpoints in some additional secondary endpoints, and I highlighted those with the primary being SVR12 and the secondary basically being six months and 48 weeks. But we can look at additional time points as well. But you don’t generally put in secondary endpoints to list every time point. But we’ll be continuing to follow the patients up so we have the ability in the future to take additional looks of the data.

[Jeff Chen:]

Okay, thanks. And in terms of partnership talks for RG-101, do you have any – provide any color on that?

[Paul Grint:]

I mean, currently, our focus is to move through the Phase II development program with both studies in Europe and U.S. that we’ve discussed. And I think it’s important for us to do that to really understand the potential of what is a novel mechanism obviously molecule here, having we’ve all been very, very pleased with the results of a single administration. But I think the key question is through these studies, our goal is to say where could RG-101 or where could the therapeutic regimen that contains RG-101 fit both from a medical need and commercial fit standpoint. And so, at the moment, our goal is to drive through those studies generate that data and then obviously if that warrants potential partnering discussions in the future time, we’ll clearly enter into those.

[Jeff Chen:]

Okay. And maybe last one on RG-012. When might we be able to see this first data in healthy volunteers?

[Paul Grint:]

That’s a good question. So it depends. We haven’t – we’re moving through the Phase I study as planned. We will not have data from this at the American Society of Nephrology Meeting this year, because unfortunately, obviously, the abstract deadlines are so far in advance to the meeting. But we’ll look for the right place to talk about this in the medical meeting, as soon as we can probably in the early part of next year.

[Jeff Chen:]

Thanks very much.

[Paul Grint:]

Yes. Thank you.

[Operator:]

And I’m showing no further questions at this time. I would like to turn the call back to Paul for any closing remarks.

[Paul Grint:]

Thank you, again, for joining us on this call this afternoon. We’re very excited about our recent progress and look forward to providing further updates to you in the second-half of the year.

[Operator:]

Ladies and gentlemen, that concludes today’s conference call. Thank you for your participation. You may now disconnect. Good bye.