Regulus Therapeutics Inc.
Q3 2015 Earnings Call Transcript

Published: 8 Nov 2015

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the Regulus Therapeutics Third Quarter 2015 Financial Results Conference Call. My name is Perea, 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 and good afternoon, everyone. This is Amy Conrad, Senior Director, Investor Relations and Corporate Communications and I'd like to welcome you to our financial results call for the quarter ended September 30, 2015. With me today from Regulus are Paul Grint, M.D., President and Chief Executive Officer; David Szekeres, Chief Business Officer and General Counsel; and Mike Huang, M.D. who recently joined us in late August as Vice President of Clinical Development. So, welcome to Mike. 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 provision 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. Now, I'll turn the call over to Paul.

[Paul Grint:]

Thank you, Amy. Welcome and thank you for joining us. Since becoming CEO of Regulus two quarters ago, I've spent time reflecting upon all factors of the company, where we've been, where we are today and where we're headed. Last month, we celebrated the third anniversary of Regulus being a publicly traded company. Since that important event, we have focused our efforts on continuing to build the leading microRNA therapeutics company and we've accomplished many goals along the way. We nominated three candidates to clinical development, demonstrated human proof-of-concept, grew our clinical pipeline and biomarkers platform independently and with our partners all while continuing our scientific leadership with publications in notable journals and presentations at key medical meetings. These achievements have led us to a favorable position today. We have a well balanced portfolio focused on validated microRNA target, an exciting wholly-owned lead asset in RG-101, which is our primary focus, an orphan disease opportunity with RG-012 to treat Alport syndrome, and the third candidate, RG-125 that is progressing well towards the clinic. All told, the life blood at Regulus has been and will continue to be the cutting-edge discovery and research efforts that enabled our lead candidates, which we hope will have meaningful impacts on patients' lives. In addition to advancing RG-101, RG-012, and RG-125, we expect to nominate at least one candidate for clinical development each year. We're currently working on multiple therapeutic targets where we believe we can engineer anti-miRs with a high therapeutic index that are matched with the right delivery approach. In the coming quarters, we look forward to sharing our progress on this important work. Now let's turn to our recent news on RG-101, our wholly-owned GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of HCV. Earlier this week, we announced the development expansion of RG-101 through a clinical collaboration with GlaxoSmithKline or GSK with the goal to evaluate the potential for a single visit therapy to treat HCV. To achieve this goal, we and GSK will be taking multiple steps. The first step will be to conduct a Phase II study evaluating the combination of RG-101, and an oral tablet formation of GSK175, an investigational non-nucleoside NS5B polymerase inhibitor for the treatment of HCV. In previous clinical studies, GSK175 has demonstrated substantial reductions in HCV RNA across all genotype as monotherapy and has displayed a PK profile consistent with a once-a-day dosing, with the potential for prolonged PK/PD activity. We believe these attributes make GSK175 well suited for combination with RG-101. The primary endpoints of the Phase II combination study is to evaluate the potential to achieve sustained viral responses post treatment with a single subcutaneous administration of 4 milligrams per kilogram of RG-101 in combination with daily oral administration of 20 milligrams of GSK175 for up to 12 weeks treatment in treatment naive patients chronically infected with HCV genotypes 1 or genotypes 3. Regulus is responsible for conducting the study, which is planned to begin in the first quarter of 2016. For the first time, this study designed offers Regulus the ability to investigate one subcutaneous administration of 4 milligrams per kilogram of RG-101 plus daily oral dosing the direct-acting antiviral for a fixed total treatment period, which we're calling our open phase sandwich design. While the Phase II open phase sandwich study is ongoing, the next step is the GSK to advance their long-acting parenteral for injection or LAP formulation of GSK175 into humans. By way of background, LAPs are injectable formulations of a drug whose solubility limited release results in the ability to have a very long apparent half-life, potentially weeks to months. And LAPs have been successful for indications, such as HIV, where sustained release is critical. We believe that the concept is developing a long-acting HCV therapy that can be administered in a single visit is potentially disruptive to the current treatment landscape. We believe an LAP formulated therapy will improve patient compliance to reduce dosing intervals and potentially extend opportunities with therapeutic intervention. The LAP formulation of GSK175 once developed, maybe used in additional studies together with RG-101, following completion of the planned Phase II open phase sandwich study. This GSK clinical trial collaboration is just one of the many approaches we are actively pursuing with RG-101. On our last call, we announced the initiation of our four weeks Phase II sandwich study to evaluate one subcutaneous administration of 2 milligrams per kilogram of RG-101, given on day one, 28 or four weeks, and given on day 1, 28 and four weeks of either Harvoni, Olysio and Daklinza. 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. The goals of the study are to investigate the potential to significantly shorten across therapy, improve patient compliance with our subcutaneous dosing regimen, and possibly improve upon high viral cure rates. Previously, we had discussed the expectation to report interim data from the Phase II sandwich study before the end of this year, which we anticipated to be sustained viral response data four weeks following conclusion of dosing or SVR4. Today, we need to move our timelines out a bit due to longer than anticipated regulatory paperwork in some of the participating countries. We now expect to report interim data early in the first quarter 2016 and SVR12 results in the second quarter 2016. We believe the sandwich study and the potential single-digit regimen with GSK represent reasonable opportunities 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 a second line setting to treat certain patient populations with unmet medical needs, such as DAA failures and those with severe renal compromise. To address these needs, we are conducting additional clinical studies for RG-101 to investigate its potential in the second line setting. We're also conducting preclinical studies to round out our virology package to support work in these patient population. For example, we're conducting in vitro combinations of RG-101 with DAAs for multiple process and DAA-resistant HCV variants. To wrap up on RG-101, let's touch on the catalyst coming up through the end of this year and into 2016. In two weeks, we're pleased to present additional update for our Phase I study of RG-101 in the general plenary session talk at the American Association for the Study of Liver Diseases or AASLD meeting. In the published abstracts, we reported that the 28 weeks post a single administration of RG-101, 6 out of the 22 patients have undetectable levels of HCV RNA, which we believe is an encouraging result that reinforces the sustained and prolonged effect of RG-101. In early December, we will give another presentation on RG-101 at the Head Start meeting, primarily focused on our biomarker findings from the completed Phase I study. Then next year, we have a steady stream of data to report, interim SVR4 results from the Phase II sandwich study are expected early in the first quarter and SVR12 results from the same study are expected in the second quarter. In addition to these key data updates, we will advance the program with the start of key clinical studies. In the first quarter, we expect to initiate an IND opening clinical study in the U.S. and the Phase II open sandwich study with GSK to advance our understanding of the potential for a single visit ACV therapy. With that, I'll turn the call over to Mike, to discuss our recent progress on our second microRNA therapeutic, RG-012. Mike?

[Michael Huang:]

Thanks, Paul, and good afternoon, everyone. As Paul mentioned, we have made significant advances in our RG-012 program during the third quarter and recent period. RG-012 is an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life threatening genetic kidney disease with no approved therapies. The disease is driven by genetic mutations in the type IV collagen family of proteins. The impact of the mutation on the collagen gene results in disruption to the structure of the glomerular basement membrane, increased expression of microRNA-21, increased fibrosis and then a progressive loss of renal function, which ultimately leads to end-stage renal disease requiring dialysis or kidney transplantation, often by early adulthood. Today, we are pleased to announce an important milestone in the maturation of the RG-012 programs. We have recently completed our first in human Phase I clinical study of RG-012, which positions the program favorably to advance into Phase II. As a reminder, the Phase I clinical study was 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. A total of 40 healthy volunteer subjects were enrolled and RG-012 was found to be well tolerated. No serious adverse events were reported and all 40 subjects successfully completed the study. Clinically, we are off to a great start with this program and we look forward to advancing our plan to achieve human proof-of-concepts with RG-012. In addition to the Phase I update, I'd like to provide some commentary on our ongoing global Alport syndrome natural history study called ATHENA. Because so little is known about Alport syndrome, the goal of the ATHENA study is to learn more about the actual progression of Alport syndrome by documenting the change in certain renal biomarkers and glomerular filtration rate or GFR in these patients. Currently, we have 13 clinical sites opened across the globe that are currently actively recruiting our patients. Recruitment is going very well. We have approximately 80 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 a Phase II study to evaluate the therapeutic effect of RG-012 in patients with Alport syndrome. This is a very exciting and important time in our Alport syndrome program. To our knowledge, this Phase II study, which we expect to initiate in the first half of 2016 would be the first ever prospectively designed, randomized, double-blind placebo controlled study to be conducted in this indication. To complement our clinical work on this program, we have a well characterized preclinical package on RG-012, that we are discussing at the American Society for Nephrology Kidney Week taking place this week in San Diego. At the meeting, we are pleased to present three posters. First off, we will present preclinical results demonstrating the favorable pharmacokinetic and toxicokinetic results of RG-012, which supported the recently completed Phase I trial in healthy volunteers, and which will support future evaluation of RG-012 in Alport syndrome patients. Secondly, we will present results describing a novel methodology developed by Regulus scientists that allows for direct measurement of microRNA inhibition by determining the displacement of a microRNA from actively translating PolyZone complexes. And finally, we will present data from our Regulus microMarkers division that highlight the discovery of the urine micro biomarkers in a preclinical model of Alport nephropathy. In addition to the updates we are providing this week at Kidney Week, we have a few upcoming goals for our Alport syndrome program that I'd like to mention. Looking ahead, we are working towards initiating the Phase II proof of concept study in the first half of 2016. In addition, we plan to submit data from our ATHENA study in a future medical movie with the goal of sharing our increased knowledge of this little known disease. Overall, this program is maturing very nicely and we're excited about our opportunities to advance the science in this field, and potentially provides therapeutic benefit in an orphan disease such as Alport syndrome an indication with no currently approved therapies. So with that, I'll turn the call over to David to provide the numbers for the quarter. Following that, Paul will wrap-up the call. David?

[David Szekeres:]

Thank you, Mike, and good afternoon, everyone. In addition to our scientific progress, we also had an exciting quarter in the recent period on the business and financial front. We increased our investment in RG-101 to our clinical trial collaboration with GSK and realized a full economic value of our biomarkers collaboration with Biogen, which we announced last week. The level of interest in our microRNA expertise remains high, and we look forward to continuing to execute on our plans. Turning to our financial results for the most recent period, we ended the quarter with $131.7 million in cash, cash equivalents, and short-term investments. We recognized revenue of approximately $1.9 million in the third quarter 2015, compared to $1.1 million in the same period 2014. This includes revenue received from Biogen in regards to the achievement of the fourth and final milestone in our research collaboration to identify microRNAs as biomarkers for MS. We are pleased to have realized the full economic value of the collaboration, earning in aggregate of $3.7 million in payments. Additional revenue in the third quarter of 2015 included $900,000 for research services provided into our collaboration and license agreement with AstraZeneca, in addition to the continued amortization of upfront payments received from our strategic alliances and collaborations, which we recognize over our estimated period of performance. Our R&D expenses were $11 million in the third quarter of 2015, compared to $10.2 million for the same period in 2014. This increase was primarily driven by clinical trial cost for RG-101, pre-clinical study cost for RG-125 and an increase in salaries and related employee cost, including non-cash stock-based compensation. We expect our research and development expenses to continue to increase for the remainder of 2015 compared to 2014, as we advanced our ongoing clinical and pre-clinical forecasts. Our G&A expenses were $4.2 million in the third quarter of 2015 compared to $2.6 million for the same period in 2014. This change was primarily driven by an increase in salaries and related employee costs, including non-cash stock-based compensation. Our net loss for the third quarter of 2015 was $13 million, resulting in a basic and diluted net loss per share of $0.25, compared to a third quarter 2014 net loss of $9.8 million resulting in a basic and diluted net loss per share of $0.23 and $0.26 respectively. Looking toward the end of the year, we have the potential to realize an important goal. As AstraZeneca initiates the Phase I study of RG-125 in human, Regulus will be eligible for a $10 million milestone payment. In addition to this business goal, we expect to maintain our strong financial position and end the year with greater than $100 million in cash, cash equivalents and short-term investments. With that, I'll turn the call back over to Paul to closing remarks.

[Paul Grint:]

Thank you, David. As you've heard today, we're pleased with our recent accomplishments. We've expanded developments of RG-101, advanced RG-012 through Phase I and realized the full economic value of our biomarkers collaboration with Biogen. We also continued to advance RG-125 with AstraZeneca, which is planned to enter the clinic before the end of the year, and we continue our preclinical work across multiple targets and disease areas of interest. These accomplishments reflect our steady progress in building a leading microRNA therapeutic company and we are encouraged about where Regulus is headed. With that operator, we're ready to take your questions. [Operator Instructions]

[Operator:]

Our first question comes from the line of Alan Carr of Needham. Your line is now open.

[Alan Carr:]

Hi, thanks for taking my questions. Wonder if you could talk a bit more about the outcome from the RG-012 Phase I trial and anymore details around the safety profile? Are there any differences from what you saw with RG-101? And then also in the deal with GSK, are there any financial on those? Is each responsible for or each company responsible for its own costs? Thanks.

[Paul Grint:]

Yeah. So, Alan, this is Paul. So let me just answer the second one quickly. So the answer to your question is yes. Basically, this is a clinical collaboration. Each company has – obviously has that work they're going to do. Our part of it is to conduct the Phase II study and advance that clinically and GSK's part is to continue to advance the LAP formulation to formulation work and the relevant toxicology work and the Phase I work to evaluate that formulation. So it really is a collaboration. That's correct.

[David Szekeres:]

And, Alan, this is David, I'll take the second question. As you know, we don't typically breakout spend by program, but what I can tell you is that we will be spending a reasonable amount and we won't break the bank on the study. I do think it's important to mention that the GSK study cost will be incurred in 2016. So, it won't damage our year end guidance.

[Paul Grint:]

Yeah. And then, Alan, maybe I'll ask Mike to talk a little bit more about the RG-012 Phase I.

[Michael Huang:]

Sure. Hi, Alan. So with regard to your question about the RG-012 study, so overall the safety profile was very much as expected. We're still analyzing the data, the data is not quite final at this point. The majority of the events were very mild, very much in line with what we would expect for the class of drug, which is oligonucleotide. The PK profile was also very consistent with what we would expect for this class of drug. So, the data overall are still being annualized. However, the initial impression is that the drug was very safe, very well tolerated. As I mentioned earlier, all 40 subjects were successfully dosed and they all completed the trial as scheduled. So, we're very pleased with the safety profile thus far.

[Alan Carr:]

Great. And then, one last one. Your R&D spend dropped off quite a bit in 3Q. Should we expect that to remain at that level in the fourth quarter or is it going to pick up again? What's your expectation there?

[Paul Grint:]

Well, I think it's going to vary quarter-by-quarter, Alan. They could, I mean if you think about it. So, we had, obviously, if you go back to our first RG-101 study, obviously we spent quite a bit of money to start with that and then the spend drops off as we're on the longer tail follow-up now of patients. Obviously we've reported it's less patients now. And again, I think as you're all well aware, as you initiate clinical studies, you generally tend to have a lot more spend upfront as you get a slice of the ground of all the different contract organizations that you're working with as you enroll the patients. And then, as you follow them out, that spend tends to drop-off because those visit frequencies also decrease. So, long answer, there isn't an easy answer to your question, it's going to vary. But, generally we'll spend a bit more as we'd start off activities in studies and then it will tend to reduce over time.

[Alan Carr:]

All right. Thanks very much.

[Operator:]

Thank you. Our next question comes from Bill Tanner of Guggenheim Securities. Your line is now open.

[Bill Tanner:]

Thanks for taking the question. Mike, just follow up on the RG-012 on the Phase 1. I'm wondering if you could comment on the dose that was, I guess, I don't know [indiscernible] what kind of a dose patients were dosed up to as to whether or not that was a level that might be predicted to have some kind of a therapeutic effect, if you would have an idea of that at this point?

[Michael Huang:]

Yeah. Sure. So we look at a wide array of dosage strength starting from 0.5 mgs per kg all the way up to 8 mgs per kg. We anticipate that in the Alport syndrome population that 8 milligrams per kilograms is much higher than what we would need. We expect that the therapeutic dose will be at the lower end of that range, and this is based on what we know about the drug characteristics itself as well as a pretty extensive preclinical package that we've put together thus far. But we think, overall, we looked at a very wide array of dosage strengths, and as we mentioned, it was safe and well tolerated in the study and we think that the Alport syndrome patients should be dosed at the lower range of that procedure regimens.

[Paul Grint:]

So, Bill, this is Paul. It's interesting. So our philosophies on Phase I and you saw this with RG-101 that we don't – we obviously – we start fairly low and the starting dose is driven of safety margins from the tox studies. What we do is, we very adequately to the bracket, the range that we think is going to be needed therapeutically and we're actually pretty efficient on calculating and predicting that off in many of our preclinical studies. And so, for example, with RG-101, we did single-dose escalated up to 8 mgs per kg. We could have gone to 16 mgs per kg, we're ready to do it, but we made the decision to stop back over there and then move on to multiple dose and get into patients as soon as possible. It was similar here with RG-012. We've bracketed what we believe is the therapeutic dose range. We do look at the PK on an ongoing basis as we dose escalate. So it's not just safety, we know what's happening in terms of drug exposure to the patients. And so I think, generally for all the dose, it's not one of these situations where we just keep cranking up doses to get to an MPV, because we could end up with weeks and weeks of months worth of work, getting up to cravvy high doses, which is not going to be informative in any way I think for the program. And really our goal in particular for RG-012 in Alport patients of an Alport disease is to get to those patients as fast as we can.

[Bill Tanner:]

Yeah. So you guys are just trying to see if you can go, or would be above the period of therapeutic dose, and then hopefully see nothing there and then – most likely you need to back off I guess?

[Paul Grint:]

Yeah. That's exactly correct. Yeah.

[Bill Tanner:]

Okay. And then just on RG-101, Paul, just the rationale on the open phase sandwich just – I mean you're obviously twice the dose?

[Paul Grint:]

Yeah. So again, just to remind you with RG-101, as we looked at the pharmacodynamic markets, we basically saw that the – at 2 milligrams per kilogram, we pretty much maxed down effect. We then moved into the patients with both 2 milligrams per kilogram and 4 milligrams per kilogram. Both those doses were very well tolerated, and obviously we've talked about we'll continue to present the results with regard to ACV responses. The cohort side is small. And as we look to the data, there wasn't an obvious dose response, if you like, and we discussed this at some length at the end of last year and earlier this year, but maybe some people going to sense that perhaps 4 mgs per kg was a little bit better than 2 mgs per kg. And so, frankly, this is the way to examine that. So, we're obviously generating data with 2 mgs per kg right now. And this study, since it's only going to be a single dose, we came to the decision that probably it will be a good idea to go with 4 mgs per kg. So that's sort of part of the rationale.

[Bill Tanner:]

Yeah. I mean, sorry, I guess, my question was the rationale to go with the single dose rather than to do the initial dose in the DAA and then subsequent dose?

[Paul Grint:]

Well, the goal of this is to get to a single visit therapy as we say, so...

[Bill Tanner:]

Okay.

[Paul Grint:]

We're looking at – we know – obviously, we're reporting six months data coming up. We know that in the proportion of patients with a single agent, we have a very long term effect of RG-101. The LAP formulation, what the GSK has done is really credibly elegant. I mean they can basically, and this is what they've shown with their HIV-integrated inhibitor clinically and now we have shown preclinically with GSK175 in essence is, you could give – it's an intramuscular injection of whatever concentration of drug has to be determined. And basically, you emulate the equivalent of oral dosing for a period of many, many weeks, just with that one injection. And so, this technology and in fact the chemistry of the GSK175 molecule lends itself to this formulation. So, it's a pretty unique opportunity, which in discussion with GSK we felt was a very important one to collaborate on and evaluate. I mean if the concept is, you come to your doctor, you've got hepatitis C, this regimen should be pan-genotypic [indiscernible] get into doing genotype testing. You have a subcu injection, an intramuscular injection and then it's basically, come back in four months or six months and we'll test you to make sure that you're HCV negative.

[Bill Tanner:]

Right. Right. And maybe just the last question. You mentioned one clinical candidate per year. I mean, could you just give us an idea as to the characteristics of that as the company matures insofar as opportunities that Regulus might be able to undertake on their own, just help us understand a little bit what's the screen on that?

[Paul Grint:]

Yeah.

[Bill Tanner:]

If there's a commercial screen or if it's really about the biology and the medicine.

[Paul Grint:]

So, that's a great question. So, we're taking several things into account right now and I've talked to this before. From the GalNAc delivery and liver target standpoint, we obviously learnt a lot with RG-101 and it's clear to us that GalNAc is an unbelievably effective way of delivering [indiscernible]. And so, we are very actively looking for other microRNA targets in the liver, because we know we can deliver and there are at least, if you look to this, there may be targets associated with important liver disease. It's a still unmet medical need. So that's one potential focus. I've also talked about, as we've got the Alport study up and running, it's been a lot of work for us, but we've got – we've built this clinical trial infrastructure now where we've really standardized very effectively, measured both formerly, for example, with measured GFR either through the biomarkers in patients with chronic kidney disease across multiple countries. And it's become and in fact, it's – right now at the American Society of Nephrology, there is a section that focuses on microRNA targets in chronic kidney disease. And there are a number of my Regulus colleagues actually attending that session. So we think that there are additional kidney diseases that also may lend itself. And so, we're actively looking at those from a research standpoint. So I think the answer to your question is, as we move forward, we're going to follow the science, delivery is important. So we're going to focus on holdings where we know we can deliver. And then depending on the disease state and the number of other factors in the company, we'll make decisions about whether we'll keep these molecules or potentially partner them. But we're very well placed to move molecules into the clinic and get the clinical proof of concept.

[Bill Tanner:]

Yeah. Great. Makes sense. Okay. Thanks very much.

[Operator:]

Thank you. Our next question comes from the line of Liana Moussatos of Wedbush Securities. Your line is now open.

[Liana Moussatos:]

Thank you for taking my questions. You mentioned having 80 patients enrolled in ATHENA and going to start the Phase II in the first half of next year. What do you need to get from ATHENA before you can start the Phase II? And what medical meetings are you considering to present the ATHENA data?

[Michael Huang:]

Yeah. Hi, Liana, this is Mike. So from now until the anticipated start of the Phase II study, we're going to be looking very closely at the longitudinal data that's been collective in these patients. I think really the key with Alport syndrome is that it is a chronic kidney disease and often times you do need a fair bit of data on each individual patient. And so what we're doing is, we're following each of these patients very closely. They have visits approximately every three months. We're collecting a large number of biomarkers. We're calculating as well as measuring the glomerular filtration rates. And so, what we're trying to collect here is as much longitudinal data on the natural course of the disease and we want to be able to use this data and get a sense of how rapidly patients with Alport syndrome deteriorate over time and which biomarkers maybe predictive of this type of decline. And so I think that's going to be really important at this juncture as we move ahead to design and initiate the next trial. Now, I think your second question was regarding the medical meetings, that's – those in discussion at this point. We're looking at some possible meetings in the first half of next year. Once we have, I think a decision here internally, we'll certainly announce that and provide you all with the data.

[Liana Moussatos:]

And how many patients from ATHENA do you need before you can start the Phase II?

[Michael Huang:]

Yeah. That's a good question. I think, we have a fair number of patients in the trial already, 80 patients. I think with 80 patients, we have a good amount of data and I think it really again comes down to the length of time for which each patient is in the trial. I think we're pretty close. We have patients at this point that have been involved in the study for over a year. And so, I think as we analyze the data, we're going to be doing additional data cuts later this year and next year and continuously looking at that. So, we think over the next couple of months or so, we should have enough data to really make a fairly good solid decision on the design of the next trial.

[Liana Moussatos:]

Thank you very much.

[Operator:]

Thank you. Our next question comes from Christopher James of FBR & Company. Your line is now open.

[Christopher James:]

Hi, guys. Thanks for taking the questions. My first question is on RG-101. Could you maybe elaborate on the timelines for the LAP formulation and then the start of the single injection study? And then I have a follow-up to that.

[Paul Grint:]

Yeah. Chris, good afternoon, this is Paul. Yeah. So, I'd like to add in [indiscernible]. It's our intention to start the Phase II study that we're going to run in the first quarter of next year. So that's basically the single injection of RG-101. And using the oral molecule, the GSK175, it's going to take us obviously most of next year to run that study and obviously get the results out. At the same time in parallel, GSK is moving forward with all the relevant work that needs to be done with the long-acting formulation to get it to a point where the next study we do is a combination of the two. I can't speak in detail to that timeline because obviously that's sort of proprietary to them as a company, but that's the plan. So there'll be a lot of activity next year both with us conducting the clinical study and GSK moving their activities forward.

[Christopher James:]

Okay. Great. That's helpful. And then why specifically did you chose GSK175 and non-nuc NS5B versus another mechanism for the open sandwich approach in combination with RG-101?

[Paul Grint:]

So, in talking with GSK, they have a lot of expertise in this space with the long-acting formulations. There are certain characteristics, chemistry or structural characteristics in different molecules that really lend themselves to this long-acting formulation. And so this wasn't the case of how we're choosing this mechanism, type of drug, it was a question of, okay, this molecule really lends – based on GSK's experience, really lends itself to be put in to an LAP formulation. So, for example, my understanding is that that you probably can't do this for any of the commercially approved drug that exists now. They don't have the right chemical characteristics. So, it's really based on those characteristics not on the mechanism of the drug. Now having said that, this is a pan-genotypic molecule with good antiviral activity, GSK has reported the virology at ESO last year and then reported clinical data with two data dosing at AASLD last year. And there was a good viral load drop and activity across different genotypes. So, it's a good molecule for a pan-genotypic approach.

[Christopher James:]

Great. That's helpful, Paul. Really appreciate it. Thanks.

[Operator:]

Thank you. Our next question comes from the line of Jeff Chen of Cowen & Company. Your line is now open.

[Jeff Chen:]

Hi, good afternoon. Thank you for taking my questions. A couple, if I may. So, in terms of the RG-101 Phase II combination data, will the SVR4, the interim data and the SVR12 primary endpoint be announced via press release or is this going to be at a medical conference?

[Paul Grint:]

So, great question. So obviously this is important data and it's our intention to announce this via press release. Part of the difficulty with medical conference is the abstract deadline – the deadlines are so far in advance of the meetings that it's not always easy to coordinate things. So it's our intention to do it by press release. Now, once we press release, obviously, as we have done with RG-101 so far, we'll continue to put in abstracts at the major medical meetings and absolutely it's our intention to provide appropriate updates at these meetings as it's important to do that. And that's where I think we obviously get the ability to educate a lot of the visions and obviously understand their views with respect to where this therapy may fit.

[Jeff Chen:]

All right. Understood and thanks. And in terms of the data itself, could you just describe what you would categorize as good data then once we get to see the SVR4 and SVR12?

[Paul Grint:]

That's a difficult question. We'll know it when we see it.

[Jeff Chen:]

Okay.

[Paul Grint:]

I mean, realistically, we've got to have high SVR rates. I mean, so if you're asking me, if we soar up 50% SVR rate, no I don't call that good data, I mean, we are really looking at around a 90% SVR level, that's where we need to be to be competitive on that.

[Jeff Chen:]

Understood, understood. Okay. And maybe just one last one. So in terms of maybe other partnerships for RG-101, are you contemplating other compounds, maybe one with the polymerase inhibitor or any other type of molecules that you might be looking at?

[Paul Grint:]

Yeah. So the answer is we're opened to a number of things. So what we've done with the current Phase II was to use the commercially available drugs, and the reason we've designed the arms that we have is that we're using these so that it represents just a mechanistic classes if you like. So, clearly once we see this data that will help us, I think understand if potentially there are some drug classes that might be better combining with than others. So it's going to be data driven, so we'll wait for the data.

[Jeff Chen:]

Got it. Thank you very much.

[Operator:]

Thank you. And at this time, I'm showing no further participants in the queue. I'd like to turn the call over to management for any closing remarks.

[Paul Grint:]

I just like to thank everyone for their time and their questions today and look forward to talking with you early next year with full year results. Thank you.

[Operator:]

Ladies and gentlemen, thank you for your participation on today's conference. This concludes your program. You may now disconnect. Everyone have a great day.