TG Therapeutics, Inc. (TGTX) Q3 2017 Earnings Report, Transcript and Summary

Greetings and welcome to the TG Therapeutics’ Third Quarter 2017 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host today, Ms. Jenna Bosco, TG's VP of Investor Relations. Please begin.

Thank you. Good morning and welcome to our conference call regarding TG Therapeutics' Third Quarter 2017 Financial Results and Business Update. I'm Jenna Bosco, TG's VP of Investor Relations and I welcome you to our conference call today. Following our Safe Harbor statements, Sean Power, TG's Chief Financial Officer, will provide a brief overview of our financial results and then turn the call over to Michael Weiss, the Company's Executive Chairman and Chief Executive Officer, who'll provide an update on the ongoing development of our novel glycoengineered anti-CD20 monoclonal antibody TG-1101, our novel once-daily PI3K delta inhibitor TGR-1202 for the review of our achievements and upcoming milestones. Before we begin, I would like to remind everyone that various remarks that we make about our future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks and uncertainties that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risks factors and uncertainties that can be found in our SEC filings. This conference call is being recorded for audio rebroadcast on TG's website at www.tgtherapeutics.com, where it will be available for the next 30 days. All participants on this call will be a listen-only mode. Now I would like to turn the call over to Shawn Power, our Chief Financial Officer, to briefly discuss the financial results for the third quarter of 2017 as well as the Company's overall financial condition.

Thank you, Jenna, and thanks, everyone for joining us. As you may be aware, our financial results were released this morning and can be viewed on the Investors and Media section of our website at tgtherapeutics.com. I'll begin with our cash position. At September 30, we have cash and cash equivalent of $91.8 million as compared to $86.5 million at June 30. During the third quarter, we were able to take advantage of favorable market conditions. Accordingly, our September 30 cash position includes approximately $28.2 million of net proceeds from utilization of our ATM facility raise during the quarter at an average price of $11.27. We have not been active under our ATM facility since the end of Q3. Our net loss for the third quarter of 2017, excluding non-cash items, was approximately $26.6 million, including $7.1 million of manufacturing and CMC expenses for Phase III clinical trials and in preparation for potential commercialization and $3.2 million in expenses related to the commencement of the Phase III program for TG-1101 in MS. The GAAP net loss for the second quarter of 2017 inclusive of non-cash items was $31.5 million or $0.48 per share compared to a net loss of $24.8 million or $0.50 per share during the comparable quarter in 2016. As we had expected, our net loss excluding non-cash items during Q3 was $26.6 million, which was very much in line with the $26.9 million we saw in Q2 of 2017. Our net loss for the nine months ended September 30, 2017, excluding non-cash items, was approximately $75.2 million, which included $20.4 million of manufacturing and CMC expenses for Phase III clinical trials and in preparation for commercialization. GAAP net loss for the nine months ended September 30, 2017, inclusive of non-cash items, was $87.6 million or $1.45 per share compared to a net loss of $54.6 million or $1.11 per share during the comparable period in 2016. As we had discussed on last quarter's call, we expected our cash burn to level off during Q3 and Q4 as enrollment into UNITY-CLL is completed and with the MS Phase III program just launching. Heading into next year, we expect our clinical expenses to remain relatively consistent; UNITY-CLL will wrap up as MS ramps, but do expect our CMC burn to be a bit more modest than what we saw in 2017. With these factors, we expect our overall cash burn to return to between $15 million to $20 million per quarter, which we believe will allow our current cash position to be sufficient to fund our operations in 2018. With that, I'll now turn the call over to Mike Weiss, our Executive Chairman and CEO.

Thank you, Sean, and thank you, Jenna, and thank you all for joining us this morning. We had another exciting quarter of positive progress along with positive data and like to start by reviewing some of the highlights for the third quarter of 2017. First, we announced the successful outcome from the first preplanned interim analysis for the diffuse large C-cell cohort in the UNITY-NHL trial, where based on preset hurdles of overall response, the DSMB recommended continued enrollment in the TG-1101 plus TGR-1202 combination arm, referred to as U2, and replacement of the single-agent TGR-1202 arm with U2 plus bendamustine. We also received a special protocol assessment from the FDA for the TG-1101 Phase III program in patients with multiple sclerosis and announced that the trials were open for enrollment. We commenced clinical development of our anti-PD-L1 monoclonal antibody. We completed full enrollment into the UNITY-CLL Phase III clinical trial, which puts us on track for topline overall response data in the second quarter of 2018. We presented three posters at ECTRIMS, showing complete elimination of GD-enhancing lesions and robust B-cell depletion through six months. Last week, we announced that six abstracts were accepted for presentation at ASH next month and those abstracts are now available on the ASH website. And last but not least, we met with the FDA regarding the use of the GENUINE study for filing for accelerated approval and confirmed that approval would be a review issue, consistent with all of our previous guidance. On this last topic, we encourage investors to carefully review the FDA guidance for industry on expedited programs for serious conditions, drugs and biologics dated May 2014. I believe once you have read the document, you will understand better how the rules that accelerate approval work and how they apply to our situation. Let me simply restate that using overall response for accelerated approval in CLL is not an issue. However, as we stated in the PR, the FDA-provided guidance that if another agent obtained full approval before we could obtain accelerated approval, we would need to show meaningful benefit over that agent as well. As noted in the PR, we will continue to evaluate new available therapies as they become approved. And related to that, the guidance referenced earlier describes many ways in which one may prove meaningful advantage over available therapy without conducting a head-to-head trial which would not be required here. And we believe TG-1101 plus ibrutinib has some strong attributes on its side. Finally, whether we provide a meaningful advantage over available therapy would be a review issue based on the written submission as part of our BLA filing. Lastly, in the press release, we announced that the FDA was open to a discussion on the potential use of PFS from the GENUINE study to support full approval of TG-1101. The nice part of the potential use of PFS and full approval is it would take us out of the more rigid rules of accelerated approval and not require us to compare to all available therapies. We'd also avoid the need for post approval trial and will provide much more robust label claim. We plan to have an initial meeting with the FDA by the end of this year to begin discussing the viability of this approach. It is possible these discussions may require multiple back-and-forth before a decision will be made regarding the potential use of PFS. As stated in the PR, our goal would be to reach an agreement that permits the use of the GENUINE PFS data for full approval in a similar timeframe to potential filing for accelerated approval, based on overall response. With that, let's move on to our flagship UNITY-CLL and UNITY-NHL programs. Starting with our UNITY-CLL trial, which we continue to believe, is the main value driver for TG, its shareholders and for patients. We were very excited to announce that full enrollment has now been reached nearly nine months ahead of our initial projections. This update puts us on track for topline overall response data in the second quarter of 2018 and a potential filing in the second half of 2018. Again, as a brief reminder, the UNITY-CLL Phase III trial is a randomized study of TG-1101 in combination with TGR-1202, again, our U2 combination compared to an active control arm of alemtuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia. This trial is being conducted under special protocol assessment with the FDA. It is a large global randomized study of over 600 patients, and if successful, we would anticipate a very broad label for the treatment of CLL setting up the U2 regimen as a flexible treatment option to be used by doctors in any CLL setting. The strong demand for the study reinforces our belief in the need for novel treatment options for CLL. We believe U2 will become one of the leading treatments for first and second-line CLL, representing a significant market opportunity. In addition to the significant opportunity in CLL, there's a great need for novel treatments in the NHL, non-Hodgkin's lymphoma. And PI3K delta inhibitors appear to be some of the most active novel agents in this area. We believe our UNITY-NHL trial is designed to showcase the unique profile of TG-1101 and TGR-1202. As everyone hopefully remembers, this study now has three independent parts targeting different subtypes of NHL, including diffuse large B-cell, follicular and marginal zone. Starting with the diffuse large B-cell. As a reminder, our goal here is to develop the combination of U2 plus bendamustine for the treatment of patients with relapsed refractory diffuse large B-cell. We believe this combination is highly active, well-tolerated, off-the-shelf treatment option for these very advanced patients. As noted earlier, we announced the successful completion of the first preplanned interim analysis, and we are now enrolling in the triple combination arm of U2 plus bendamustine in addition to continuing enrollment in the U2 doublet arm. Next, let’s discuss the follicular cohort. We are currently enrolling into a single arm of TGR-1202 monotherapy in the same population that supported the recent approval of copanlisib. We view their approval as being positive for us in a number of ways. First, we believe they have pioneered a regulatory approach that we are rapidly imitating, and second, they also demonstrated that PI3K delta targeted inhibitors can be both active and not have idelalisib-like toxicity. This fact was largely overlooked at the time of their approval. It's important to note that we don't view copanlisib as a major competitive threat as it is an IV drug that needs to be given weekly until progression. We've heard from a number of clinicians that, that will significantly impact its utilization. Lastly, we have the marginal zone reformer cohort. As mentioned during our last call, we are using the ibrutinib approval study as a point of reference, and this arm is also open to enrollment. With that, let's switch gears and briefly review the exciting developments happening on the MS front. For this special protocol assessment for our Phase III program in hand, we're excited to announce during the third quarter that enrollment has begun into the Phase III ULTIMATE II and ULTIMATE II trials. Currently, many of our U.S. sites are open, and we're actively working to get our ex U.S. sites onboard and hope to have the majority of sites open by early next year. Complementing the launch of the Phase III trials, we've recently presented three posters at the ECTRIMS-ACTRIMS meeting last month and subsequently hosted a conference call with Dr. Edward Fox, the Director of the MS Clinic of Central Texas and the principal investigator for our Phase II trial. Hopefully, you will had a chance to listen, but he highlighted some of the key data presented at the conference, including 100% or complete elimination of all T1 GD-enhancing lesions at week 24 in the first 20 patients, 99% median B-cell depletion was observed at week four and maintained at week 24 for the first 24 patients. And 96% of subjects, 23 of 24, were relapse-free at week 24. The only reported relapse occurred in the patient initially randomized to the placebo arm, and the relapse occurred just 12 days after the patient's first infusion of 150 milligrams of TG-1101, but before the patient received their first 450-milligram dose of TG-1101, which was to be given on day 15. The patient remains on study and has now received the second and third infusions of TG-1101 and, to-date, has remained relapse free. And lastly, TG-1101 was well tolerated across all patients, including those receiving rapid infusions as well as one hour for the 450-milligram Phase III dose and produced similar levels of B-cell depletion with no identified change in infusion-related reactions or overall safety profile. Finally, I want to briefly review the recently published ASH abstracts. We'll have six presentations at the ASH conference this year. Some of the clinical abstract highlights included updated data from the integrated analysis of TGR-1202 in 336 patients with relapsed refractory lymphoid malignancies exposed to a TGR-1202-based regimen for upwards of four-plus years, which demonstrated a favorable safety profile. Importantly, the most common Grade 3/4 adverse events typically seen with first-generation PI3K delta inhibitors were rare with transaminitis less than 3%, colitis less than 1%, and pneumonitis less than 0.5%. In another abstract, results from the study looked at patients with chronic lymphocytic leukemia who were intolerant to prior BTK or PI3K delta inhibitor therapy and subsequently initiated TGR-1202 monotherapy, which showed that TGR-1202 was well tolerated, but none of the 22 patients discontinuing due to TGR-1202 intolerance with a median follow-up of six months. In the final clinical abstract, TG-1101 plus TGR-1202 plus a PD-1 inhibitor was discussed. While still small numbers, 60%, three of five, BTK refractory CLL patients responded to the triple combination. Ibrutinib refractory patients are becoming an emerging challenge with very short overall survival and very limited treatment options. This will clearly be an area of interest for development of our proprietary PL-1 inhibitor. In addition to the formal ASH presentations, we'll be hosting an investor reception with a panel of leading experts on Sunday, December 10, at 8 PM at the Ritz-Carlton Atlanta Downtown. And we welcome and encourage all of you to join us. With that, let me turn the call over to the conference operator to begin the Q&A session. Following which, I will return to make some concluding remarks.

Thank you. At this time, we will conduct a question-and-answer session. [Operator Instructions] Our first question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Hi, good morning.

Good morning, Matt.

Congrats on all the progress during the quarter. Impressive. Can you give us a sense in terms of what the MS Phase III program with the strong results you announced in Phase II, what's the time potential time line of the Phase III?

Sure. So I think what we're saying is probably a 15 to 18-month enrollment period, which started in mid-September, I think. So I think that's where we are today in terms of enrollment time line. After that, of course, we have to wait basically two years, 96 weeks for the last patient out. And then obviously soon thereafter we could analyze the data and, of course, hopefully we're already by then – I'd be surprised, but by then hopefully we'll have TG-1101 already on the market so it'll be an sBLA filing at that point.

Okay. That's helpful. And then in terms of UNITY-CLL now that enrollment is complete and topline results are expected in the second quarter. Can you walk us through some of the powering assumptions in terms of the ORR that you used in the design of the study?

Yes. So the study is designed to basically show a 15% delta between the two arms. So with the number of patients we have, I think, probably the minimum detectable difference is down to about 13%. But I think that's where we are. Does that help?

Yes. That's helpful. Thank you. And then thank you for the added detail on the GENUINE. And I have had a chance to read through the guidance. Can you just walk us through some of the regulatory pathways?

That was quick. You just read that now? That was very quick.

I had a chance to read it before. Just the regulatory pathway with GENUINE given the recent feedback that you received from the FDA with specific attention to the potential to use the PFS endpoint there?

Yes. So right now, we are preparing our BLA submission. We think we could be done with that before the end of the second quarter of 2018. So that's running in parallel as we absorb and wait for and see if there's any intervening drugs that get approved. If they do, we'll have to take a look at their profile, both safety and efficacy and have to basically see how we compare to those. We and everyone else will get that information at the same time. I think for the most part, we're all on an equal playing field in terms of evaluating how we view the competitive landscape when it occurs. And again, our feeling is that we're driving toward a filing, but we certainly will be cognizant of what is going on and be respectful of where we are in the process, which leads us to the second part, which is the progression-free survival possibility. Again, we're trying not to make too much of a big deal about that. Again, I think with full disclosure, we felt we had to mention it. But we have not had a formal discussion with the FDA yet. Like I said, the goal is to do that before the end of the year. We've done our own statistical analysis. We think it’s feasible to complete the trial for progression free survival outcome within a reasonable time frame of what we could have with the filing of overall response, which would be basically before the end of 2Q. PFS wouldn't be the same time frame. It would be – we think similar is probably anywhere within six months would be a pretty darn good outcome for us. But again, I think we've dealt with the FDA statisticians. They're very good. And they're tough. And so I think we're waiting for our meeting to see where they are, what they're thinking about in terms of progression free survival. But again, it does have obviously some very important attributes that we've described in the prepared remarks. It would get us outside of the more rigid rules of accelerated approval. It would give us a better and a broader better label in terms of using progression free survival, and it would avoid the need to have a confirmation trial. So collectively, those are all very positive. And I think we're in a – we'll-see-what-happens phase. And I think in a lot of ways, with things that we're focused on getting everything ready for filing, we want to see what happens with these negotiations on PFS. We want to see what comes out if it is something that gets approved between now and then. We want to fully evaluate what that option looks like, what the safety profile, what the efficacy profile is.

Great. That’s very helpful. Thanks for taking the questions.

Thanks, Matt.

Our next question comes from Yatin Suneja with SunTrust. Please proceed with your question.

Hey, guys. This is David Fang on for Yatin. Thanks for taking my question and congrats on all the progress. We saw in the UNITY-CLL that enrollment was up to 600, up from 450. I was just wondering what was the main driver for the increase in enrollment. Did you see a lot of increased patient and physician demand? And I have a couple more...

Yes. Sure. So let me answer that one and you can go with the next set of questions. So basically, if everyone remembers, that study started out as a four-arm trial and the target enrollment for the four arms was 50 patients to do the interim analysis. Enrollment, but to do the interim analysis on 50 patients, you don't to the analysis the day the 50th patient is enrolled. You do the analysis three months after the 50th patient is enrolled. And we couldn't stop enrollment before we knew the outcome of the analysis, which meant that we had to continue to enroll into all four arms until we did the analysis. Recruitment was quite robust throughout the trial, and at that point in time, it was running quite strongly. So we ended up actually with almost 90 patients in each of the single-agent arms by the time we got to that three-month mark, where we could actually do the analysis and turn off those arms. So that accounts for some portion of the increase over 450. The remainder of the increase was, you may recall, we met the target enrollment on September 1st-ish. But for logistical reasons and sites had been working very hard and contacting patients, we left it open till about the second week of October. So in that, again, 40-day period-ish that would account for the remainder of the over enrollment. So again, I think all of it is all about just the demand and enthusiasm we saw for the trial and the high rate of enrollment.

Great. Thanks for all the clarity. And also given that you have the UNITY-CLL reading out in 2Q in 2018 and then potentially the maturing PFS data from GENUINE, how should we think about the priorities for the filings for these two different indications?

Yes. I don't know that we have a priority in terms of filing. I think we just need to see where we are. Again, the PFS for GENUINE is more of a wildcard at this moment. So again, I think our focus is on the – obviously, the big focus for the company has been and continues to be UNITY-CLL. So we're looking forward to that overall response data. That's certainly a major priority for us. But again, we're not walking away from GENUINE in any way, shape or form. I just think we need more information before we make our final decision. Again, we'll be prepared to go. I think we just have a lot of good options at the end of 2Q, and we'll know and you'll know before that, of course, as well that we'll have the UNITY-CLL data. And I would assume by then, we would have completion of discussions on progression free survival. We'll also see if anything gets approved between now and then. And there'll be data out before that, I'm sure. So we're all going to be in the same boat together. We're all going to get the information, and we'll all get to process it. We don't have any more information than you have or you will have. But we do know we have a lot of great options, and we'll be prepared to act on whatever the most – the best option we have available for us at the time, we'll be able to move on quickly, that we know for sure.

So congrats on your clinical asset maybe. Could you talk a little bit about the opportunity here? It looks like the Phase I is enrolling. You guys have the opportunity in hematologic space. Phase I trial is enrolling the Hodgkin lymphoma patients. You mentioned maybe your triplet combination therapy in CLL. Would you potentially – what are some of the other hematologic indications that you might pursue with your PD-1 asset?

Yes. So we do have our PD-L1 now in clinical development. We think that we'll get to a Phase II dose pretty rapidly. I think we're anticipating within six months-ish we should be at the Phase II dose. It's not that complicated of an area. We've got lots of precedent in PD-L1 development and PD-1, but we're PD-L1, so we'll look at that more closely. So again, I think we feel like we can rapidly get to a Phase II dose. We are, from the hematological side, obviously, we're interested in looking into Hodgkin's lymphoma. We'll see what that looks like for the PD-L1s, but we're also very enthusiastic about the potential for triple combinations with U2 plus our PD-L1. We have a taste of a possibility that we discussed in the prepared remarks. We'll have a poster presentation at ASH looking at U2 plus the PD-1 inhibitor pembrolizumab. So obviously, that's more of a proxy study. We'll get to use our PD-L1 hopefully soon enough. But one of the greatest areas of unmet medical need right now is the treatment of ibrutinib refractory patients. So that's certainly something we're going to want to follow up on. We're going to continue to enroll more patients into the current triple therapy with the PD-1 inhibitor, pembro, and try to get more ibrutinib refractory patients on that trial just to see if we're really seeing a good pattern of response. And hopefully we'll get some data on the duration of those responders. Because again, the ibrutinib refractory patients, to my knowledge, have a very short overall survival even – and there's really nothing or very little to treat these patients with. So that's one area. We know that PD-1, PDL-1 seems to have some activity in Richter's Transformation. That's an area that we'll want to follow-up on from the published literature. And just generally, looking at U2 plus PDL-1 in areas like diffuse large B-cell, perhaps using a U2 plus benda plus PDL-1 combination could be something that might be interesting. And same we'll have to explore on Follicular Lymphoma. So we're going to have an open and ideally robust Phase II program exploring the different ways in which we can use that triple combination.

Great, thank you for taking my questions and congrats in all the progress.

No problem. Thank you.

Our next question comes from Ren Benjamin with Raymond James. Please proceed with your question.

Hey good morning guys. Thanks for taking the questions. I guess maybe just starting off with GENUINE. Mike, can you talk to us a little bit more about the competitive landscape that could influence your decision? I guess, I was just thinking about the Gazyva-ibrutinib combination that could prevent going to things, but I thought that was mainly in frontline. But maybe you can just kind of guide us as to what things you're looking for?

Yes. So Gazyva-ibrutinib is not one that we're too worried about. I think in relapse refractory CLL, the only thing that is really on our radar screen is venetoclax plus Rituxan, which is we're studying some [indiscernible] study. In a few weeks before we went down to the FDA, they reported positive outcomes for that trial. They haven't actually presented any data. We expect that data to be presented at ASH this year. So I guess, we all get to see that data. And then I think from a regulatory standpoint, I think one can encourage people to read the guidance – a laundry list of ways in which one could be provide meaningful advantage over available therapy assuming that becomes available therapy and just backtracking, so the MURANO study is the confirmation trial for venetoclax accelerated approval in 17p patients, which are the high-risk patients. So until venetoclax has full approval, it's not deemed available therapy. Once they are approved, then it becomes available therapy and something of which we would need to compare ourselves to. So again, that's the one that's in front of us, we think, in terms of the competitive landscape. Ibrutinib-Gazyva. There's also acalabrutinib-Gazya, there's also I think its venetoclax-Gazyva, all in front line treatment. Those are all progression free survival studies and won't have any effect on our relapsed refractory application.

Got it. And just sticking with GENUINE for one more second, when we talk about PFS, I mean, the study was kind of halted early for a lack of a better word and PFS is – we're no longer powered to detect the PFS difference, correct me if I'm wrong. But who sort of – who initiated these PFS discussions and the potential for full approval, because I thought from a company perspective, it was all about accelerated approval?

Yes. So again, I think when you're having discussions and the discussion turns to what are the barriers for accelerated approval, and again, we could not have been more clear about what we see as – if there's any barrier to approval, we've kind of made it clear that we think it's some intervening available therapy, which kind of naturally brings you to a conversation about, well, what are ways in which you don't have to worry about available therapy, and certainly, a full approval based on progression free survival will get you there. So I don't recall exactly how the conversation got to the discussion of progression free survival, but it was an evolution of an open discussion as we were discussing the accelerated approval application and what again were potential issues that could get in the way of that application or not really application but the approval. So yes, that was the genesis.

Got it. And then just switching gears to UNITY real quick, just two questions there. Is the ORR part of the SPA and – or is it something sort of outside of the SPA, because I thought the primary endpoint for maybe full approval is PFS, if you can just remind us of the assumptions there? And then related to that, since enrollment is complete and you're talking about an ORR expected in the second quarter of 2018, are we looking for six-month ORR or three-month ORR and then a significant amount of time collate all the data? How should be thinking about that?

Yes. So it's a best overall response with a minimum of six months follow-up on all patients.

Okay and then just regarding the ORR as part of the SPA?

Yes. The ORR was part of the SPA.

Okay. And then just digging in a little bit deeper onto the unity assumptions, I think you guys had already stated that 60% were enrolled in the front line, 40% in the second line. And I think to an earlier question, you mentioned that a 13% to 15% delta between the treatment arm and the control arm, and I'm assuming that's a delta and overall response, right, but correct me if I'm wrong. Can you just walk us through the assumptions for how you expect the control arm – Gazyva arm plus chlorambucil to behave in the second line, because I think we have fairly good data for how this should behave in the frontline. I think the response rates we've seen is 80% or so. But just would love to hear kind of how you're thinking about it and then as far as what you think your combination would do?

Yes. So I mean, there's a few pieces of information out there. So one I think it's about a 78% response rate for Gazyva-chlorambucil frontline patients. We don't have any direct data available for Gazyva-chlorambucil and relapsed refractory patients. The only proxy that we have is – well, that we believe is the most appropriate or the closest we can get is the bendamustine-Rituxan arm from the HELIOS trial. That's a recently run large randomized trial. And that came in at about 68% overall response in relapsed refractory patients. They excluded in the trial 17p patients, which would be expected to pretty much have no response or very limited response to chemotherapy, which is why it was limited there. In our particular trial, it was an all-comer study, so we didn't restrict the number of 17p patients. So I mean, I think we're – and also we didn't restrict all those types of high-risk patients as well, which also would be more resistant to chemotherapy-based treatments. So our assumption is that response rates for the Gazyva-chlorambucil arm in this trial should somewhere – should fall in somewhere between 50% and 60%, and that's our expectation. We don't have any hard data to support that. But I think that's where we're leaning. In terms of what we think the U2 arm will do, our belief is that U2 is as good as ublituximab plus ibrutinib in relapsed refractory CLL patients. Our expectation is somewhere between 75% to 80% overall response rate, similar to what we saw in the GENUINE study with ublit plus ibrutinib and in front line patients, we think we're going to be north of 90%. I think if you do the blinded averages on all that stuff, we would come in a pretty safe place.

Excellent. Thank you very much and good luck going forward.

Yes, thank you.

[Operator Instructions] Our next question comes from Matthew Andrews with Jefferies. Please proceed with your question.

Hey, good morning. My question for you on unity diffuses large B-cell just in terms of data timing. Do you think there's the possibility we see some interim data at the ASCO meeting next year? Or since it's a potential registration study, FDA may ask you to hold off and wait for final data, perhaps present it later next year at the ASH meeting?

So it's a good question, and I don't have a good answer other than I think we have – we should have a good amount of information available for ASCO next year. But there is a question whether we'll be able to present it. But I think I would lean toward saying that we should have some available data at ASCO.

Okay. And then following up on Ren's question on UNITY-CLL, can you remind us of your thoughts on potential PFS timing and when we may see that? Is that a 2019 or 2020 type event which would support potential full approval?

Yes. So I hope it doesn't take that long. The nice part of having the combined cohorts of both front line and relapsed refractory is that we should pull that medium progression free survival back. So I think median progression free survival for [obinutuzumab] chlorambucil is I think 27-ish months, give or take a month. I can't remember, but 27-ish months. I think when you look at the, again, HELIO's bendamustine-Rituxan, interesting, even though they had a 68% overall response rate, the responses were not very durable. And so the median PFS in relapsed patients for bendamustine-Rituxan was 12 months. So we don't – and again, that did not include 17p or other high-risk patients. So we think it'll be hard to see benda chlorambucil better than a 10 to 12-month PFS in relapsed refractory patients. So when you blend those two pieces together, I think the control arm, median PFS should be somewhere in the call it, 19 to 20, 21 months tops. Again this is all purely speculative and that's kind of our assumptions based on the weighted average of what we believe. We do have data from our trials where we looked at U2 in relapsed refractory CLL. And I think we're 24 to 30 months PFS and I don't even think that's a complete number. I think it's still growing. So we feel highly confident that our front line is going to be dramatically better than that even. And so we should have a very, very robust difference in progression free survival. I don't think that's going to be even close. And so in times of time frame, it depends on when the events come again, because we have the relapsed refractory patients in there, we'll have an acceleration of those events, certainly more so than the studies that are looking at solely frontline patients. I think it's possible that we can see a PFS outcome before the end of 2018. And if not, I'd be shocked if it made it out of – certainly if it made it out of 2019 without a PFS outcome would be shocking.

And then just lastly on the triplet with pembro, appreciating it's obviously not your in-house PD-1. Do you have a general sense what the profile is in terms of a minimum ORR you'd like to see or CR and ORR you'd like to see in the BTK refractory CLL market? What's the early delta or hurdle you think there to want to advance into a Phase II, Phase III program in that market? Thanks.

Sure. So I think anything above zero is a good outcome for an ibrutinib refractory patient. But I would think we would want to see between 30% and 50% in a larger patient population. I think that would be a great outcome. Again, there's really nothing for these patients, so that would be phenomenal, really.

Okay, great. Thank you.

Thanks Matt. End of Q&A

There are no further questions in queue at this time. I would like to turn the call back over to Mr. Weiss for concluding remarks.

Great, thank you. So I'd like to wrap up today's call by reviewing our goals and objectives for the remainder of 2017 and into 2018. We plan to aggressively onboard and enroll patients into the ULTIMATE I and II global Phase III trial for multiple sclerosis. We plan to meet with the FDA as we've been discussing to talk about the potential use of progression free survival for full approval. We plan to aggressively enroll into all the cohorts of our UNITY-NHL clinical trial. That's a high priority for our enrollment. We look forward to presenting exciting updates at ASH. We think further solidifying the safety profile of TGR-1202. I know that was a hot topic for folks over the last few years. Perhaps now people are fully convinced that TGR-1202 has a nice safety profile, but hopefully that kid of data will help to further solidify that belief. Through the end of the year and into next year, we will continue to pare, as we discussed, our BLA for TG-1101 and also prepare our NDA for TGR-1202. Again, the corporate goal internally is to make sure that we're prepared for a filing at the end of 2Q of next year. And probably the biggest event of the first half next year, we expect to have our topline overall response data from our UNITY-CLL in the second quarter. We certainly believe we have a lot of value-creating milestones set for the next 6, 12 months as we drive closer to potential approvals for both of our key product candidates. Beyond that, we continue to build towards better combinations, and our pipeline of clinical-stage product candidates should grow in 2018. With that, I'd like to thank all of our investigators and their patients as well as all of our shareholders for their continued support. Thanks, again for joining us on this call and have a great day.

Thank you. This does conclude today’s teleconference. You may disconnect your lines at this time and thank you for your participation.