Regulus Therapeutics Inc (RGLS) 2015 Q2 法說會逐字稿

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.

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, MD, 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's future expectations, plans, prospects, corporate strategy and performance which constitute 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.

I'll now turn the call over to Paul.

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 a 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 treatment of HCV. We have initiated our initial planned Phase II study, a randomized, multi-center 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 1; 28 days, or four 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 naive 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 endpoint of the Phase II study is to evaluate sustained viral load responses 12 weeks post-treatment, or SVR-12, and the secondary objective is to evaluate the sustained viral load responses at 24 and 48 weeks post-treatment, or SVR-24 and SVR-48. 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 SVR-4. In the first quarter of 2016, we expect to report SVR-12 results from the ongoing Phase II study.

We believe that the Phase II study represents a reasonable opportunity for RG-101 in a front-line setting in the ever-evolving HCV landscape. In addition to front line, we believe that there may be an opportunity for RG-101 in a 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 rates 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 fail their oral regimens from compliance or resistance that result 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 our 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 catalysts 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 I study, and we expect to report SVR results from the Phase II study and file our first IND with the US FDA before year end. In addition, we expect to have a good presence at the American Association for the Study of Liver Diseases, or AASLD, meeting in November.

In addition to all of this progress in RG-101, we have also made significant advancements in our RG-012 program during the second quarter and recent periods. RG-101 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 4 collagen family of proteins. The impact of the mutation in the collagen gene results in disruption to the structure of the glomerular basement membrane, increased expression of 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 announced that dosing had begun in a first-in-human 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-offending-dose study to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous dosing of RG-101 in health 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 a microRNA therapeutic with the US FDA.

While the Phase I study is ongoing, we continuously roll patients into our Natural History 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 a Phase II study to monitor the therapeutic effects of RG-012 on the declining renal function and time to end-stage renal disease in Alport Syndrome patients. We expect to initiate a Phase II proof-of-concept study in the first half in 2016.

As a reminder, Sanofi has an exclusive option on this program, exercisable after proof of concept, to assume worldwide development and commercialization of RG-012 while we retain the co-promote right in the United States. We also have the opportunity to achieve significant milestones and royalties. We're really excited about this program with our opportunity to present potentially provide therapeutic benefit 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 development. This represents our third clinical candidate for clinical development to arise 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 expects to initiate a Phase I study by year end. Once an IND is accepted, AstraZeneca will assume development of the program, and we are then eligible for milestone payments and 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 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 update on our microMarkers division and our preclinical portfolio. David?

Thanks, Paul. During the second quarter and recent period, we were pleased with the progress made on the business and financial front. In addition to our disciplined financial strategy and good cash management, we are 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 in our work with our strategic clients, 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, and 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 of 2015 compared to $3 million for the same period in 2014. This change was primarily driven by an increase in personnel costs, include 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.

Thank you, David. As you've heard today, we're pleased with the execution of our Clinical Map Initiative goals and the advancement of our science focused on microRNAs. Although we've shown rapid progress across our clinical portfolio, we're also focused on our microMarkers division 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 a microRNA biomarker signature that differentiates 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 on the division's 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 if 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 hepatocellular carcinoma with Sanofi. Through our alliance with AstraZeneca, we announced today that both parties have agreed to terminate the microRNA-19 program for oncology indications. Going forward, AstraZeneca retains replacement rights for 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're 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 of the Study of Diabetes meeting. In addition, we expect to have a presence at the American Society of Nephrology, ASLD, and HEP DART meetings.

With that, operator, we're ready to take your questions.

(Operator Instructions.) Alan Carr.

Wonder if you could comment on, with the management changes that happened a couple of months ago, whether or not there's any changes or contemplated 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.

So Alan, good afternoon. This is Paul. So with regard to your first question about management changes and potential strategic direction changes for 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. And 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. The original AstraZeneca agreement 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.

Correct. And maybe, Alan, I could just add onto 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.

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

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

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

It's a good question, Alan. They have four years from the date that they signed the agreement. So the agreement terminates in August of next year, so they have up to that time period to make a replacement target.

Oh, okay. Thanks very much.

Liana Moussatos, Wedbush Securities.

The first one has to do with enrolling in the Alport's program. After you finish 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 identified a signature for relapsing-remitting MS. Is this to diagnose it, or used with Biogen's Tecfidera, and can you comment a little bit more on that? And you mentioned looking for signatures for RG-101 and 012. What are you looking for there?

Right. Liana, this 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 a Phase II therapeutic study, that won't be the case.

As I indicated, what we're going to do is, obviously, the goal of the Natural History Study was to enroll these patients, follow them longitudinally with detailed measures of also some biomarkers, microRNA signatures, because we are looking for microRNA signatures also in these patients, both in blood and 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, the patients we're enrolling in the ATHENA and Natural History Study basically are our patients who are around Stage 3 kidney disease. GFR's a little bit higher, but we believe, based off 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 our 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 roll over 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 the Natural History Study. But I really believe there are many, many benefits that are going to come out from the ATHENA study for this program.

And then your second question with respect to the microMarkers, given this is a collaboration with Biogen, we're not going to speak to more detail, really, about the findings with regard to the MS patients. Suffice it to say, obviously, we, as I already indicated in my previous remarks, we're very excited by the outcome of that, and we continue to work with Biogen to further explore the utility of these micromarkers.

From the standpoint of support of our own programs, we are 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's 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 output 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 are looking at micromarker signatures there. So we're now moving on to look at the clinical situation.

So as we move forward, the plan for the microMarkers, and we'll talk about more of this at some point in a future call, it's obviously to support our own programs, together with important collaborations with other companies.

Thank you very much.

Robyn Karnauskas, Deutsche Bank.

Hi, guys, this is Ali on for Robyn. My first question is what are your thoughts around initial trial designs for RG-125 and when we could maybe get initial signs of efficacy for this?

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 that Phase I study is going to be conducted in the US. But that's pretty much it. They haven't -- it's really up to them to disclose the nature of the design of the studies, and they probably will be doing that moving forward.

Okay, great, thanks. And then in terms of Hepatitis C, can you talk about why you decided to do the study outside of the US?

Yes, well, just to remind you, we conducted our Phase I study in the Netherlands in Europe, and the regulatory filing, the clinical trial application, the CTA to support that, was already in place. And so for us to move on to the Phase II meant that we could take an existing regulatory document and update that. So it's probably a matter of speed.

But also, outside the US, there are a number of countries, or we're selecting countries where we have investigators who are very interested in the conduct of the protocol, plus where we can access patients.

From the US standpoint, we've filed a pre-IND, and we've had discussions with the FDA. And really, as I indicated, again, in my comments, our interest in the US 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 we're going where we should go in different parts of the world to achieve the goals we need to achieve.

Okay, that's helpful. Thanks.

Bill Tanner, Guggenheim Securities.

Paul, congratulations on your first quarterly call as the CEO of the Company. Just a couple of questions. Number one, can you just walk us through the rationale on the sandwich design?

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 designs, 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 believed, at least initially, that that oral 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 component 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 and to assure half-life. So we put all that together, and that really constituted the design of the study.

And can you just remind us, like the PK profile, how that would actually, on 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 talk about?

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 administer this drug subcutaneously, by 24 hours 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 to the hepatocytes. We know from preclinical studies, particularly in non-human primates, that we've got a liver tissue half-life, probably in the region of two weeks or so; so a four-week period, you've gone through two half-lives. And so we thought that was a good period, then, a good time window, then, to give a second administration.

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

Profiled in which way?

For the miR-21?

So, well, we're taking multiple samples from these patients, both blood and urine. And we will profile for multiple microRNAs, not just miR-21. We actually run a panel of a significant number of microRNAs. And what we're interested in looking for is 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 declining 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.

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

Well, again, that's really -- AstraZeneca will take the 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, rodent models of 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's interested in this in not just with patients with diabetes, but perhaps those patients that have metabolic disregulation with, obviously, abnormal lipids in diabetes. But there will be a lot more data and information on this in next month, September, at the European meeting, the European diabetes meeting.

Okay, great. All right, thanks very much.

Christopher James, FBR and Company.

Congrats on the progress made this quarter. First, starting with 101, Paul, can you remind us why you're choosing only the 2-milligram dose in Phase II versus the 4-milligram dose? And then when could you start some of the other HCV studies?

So, Chris, great question. So I think, as I mentioned just a bit earlier, we, coming out from the Phase I, there are a 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 was 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 formula gram-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 II enrolled. We have a set of sites that's set up, that will be set up in a number of countries. And once we've got the first protocol enrolled, we can then start initiating additional Phase II protocols.

Okay, great. That's helpful. And then on 12, RG-012, 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 and going?

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, 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 are their own controls, so to speak? 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, and it could be variable. I think the key question here, Chris, is could we come up with a reasonable size study, a duration period that probably is of minimum for a year, which if we could find some good biomarkers, could potentially constitute a way of getting some type of accelerated approval for this orphan population. And that's clearly something we want to explore with the regulatory agencies.

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

I think it's both. So we know that it clearly has an insulin-sensitizing effect. But also, as I mentioned, it -- blockage or an inhibition of these microRNAs has a beneficial effect on lipids as well. So I would look at it as both.

I think part of the difficulty nowadays is the very large size and very long duration of a diabetes development program, given the current regulatory requirements. So I think it's being looked at in more of a broader light, as you've indicated.

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

Thank you. Jeff Chen, Cowen and Company.

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 incorporated into later trials?

Well, the way the study's designed, as I said, 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 and some additional secondary endpoints, and I've highlighted those, with the primary being SVR-12 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 that 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 at the data.

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

I mean, currently, our focus is to move through the Phase II development program with both studies in Europe and the US 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 of the molecule here. 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 at a future time, we'll clearly enter into those.

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

That's a good question. So it depends. 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 deadline's so far in advance of the meeting. But we'll look for the right place to talk about this in a medical meeting as soon as we can, probably in the early part of next year.

Thanks very much.

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

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.

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