TG Therapeutics, Inc. (TGTX) Q1 2017 Earnings Report, Transcript and Summary

Greetings, and welcome to the TG Therapeutics 2017 Q1 Earnings Conference 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 like to turn the conference over to your host, Jenna Bosco.

Thank you. Good morning, and welcome to our conference call regarding TG Therapeutics first 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 statement, 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 will 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, as well as a corporate update. 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 risk 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 on a listen-only mode. Now, I would like to turn the call over to Sean Power, our Chief Financial Officer, to briefly discuss the financial results for the first quarter of 2017, as well as the company’s overall financial condition.

Thank you, Jenna, and thanks everyone for joining. As you may be aware, our financial results were released earlier this morning and can be viewed on the Investors and Media section of our website at www.tgtherapeutics.com. I’ll begin with our cash position. At March 31, we had cash, cash equivalents, investment securities and interest receivable of $109.5 million, as compared to $45 million at December 31, 2016. Our current cash position includes approximately $85 million of net proceeds raised through a public offering and our ATM program during the first quarter. We believe our current cash position will be sufficient to fund our operations through 2018. Our net loss for the first quarter of 2017, excluding non-cash items was approximately $21.7 million, including $5.3 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation for potential commercialization. The GAAP net loss for the first quarter of 2017, inclusive of non-cash items was $27.7 million or $0.52 per share, compared to a GAAP net loss of $13.8 million or $0.28 per share during the comparable quarter in 2016. The increase in consolidated net loss during the first quarter of 2017 was primarily related to the increase in research and development expenses, due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202. Worth noting is that our Q1 2017 other research and development expenses were consistent with the amounts seen in the fourth quarter of 2016. With that, I will now turn the call over to Mike Weiss, our Executive Chairman and CEO.

Thanks Sean and thanks everyone for joining us this morning. 2017 is off to a great start for TG. We believe the announcement of the positive results from our GENUINE Phase 3 study in early March was just the beginning of a data rich next 6 to 18 months for the company, where we expect results from our UNITY-CLL Phase 3 trial, our UNITY Diffuse Large B-Cell Phase 2b registration direct to trial, as well as multiple presentations on additional doublets and triplets combinations for 1011 and 1202 in chronic lymphocytic leukemia and non-Hodgkin's lymphoma. Additionally during that same period, we expect additional data from our Phase 2 MS study, including the longer-term B-cell depletion repletion data, as well as effects of TG-1101 on established MS efficacy endpoints for example reduction in gad enhancing lesion. In the near term, we are very much looking forward to presenting a more detailed analysis of the GENUINE Phase 3 study and an oral presentation at the upcoming 53rd annual meeting of the American Society of Clinical Oncology also referred to as ASCO, which is being held in early June. As most of you will recall, we released topline results for the GENUINE study in early March. As a reminder the GENUINE Phase 3 trial compared to combination of TG-1101 plus ibrutinib to ibrutinib alone in patients with relaxed refractory high-risk CLL. The study made its primary endpoint with TG-1101 plus ibrutinib increasing overall response rate by greater than 70% over ibrutinib monotherapy. Following the ASCO presentation in June, we plan to request a meeting with the FDA to discuss the data and the potential for filing for accelerated approval. We expect the meeting could occur in the fourth quarter and if positive will keep us on track for a BLA filing in the first half of 2018. In addition to announcing positive results from the GENUINE trial, we have achieved a number of other key objectives thus far this year, including in January, we announced a receipt of orphan drug designation for the combination of 1101 and 1202, which as many of you know we refer to affectionately as 1303 for the treatment of both chronic lymphocytic leukemia and Diffuse Large B-Cell lymphoma. We also announced the publication of clinical data from a Phase 1/2 trial of TG-1101 monotherapy in NHL and CLL patients and the British Journal of Haematology. The data described in the publication supports our belief that TG-1101 is a best-in-class anti- CD20 monoclonal antibody, which demonstrates an overall response rate of 45% as a single agent in patients that were the last or refractory to rituximab. Also in March, on the heels of the positive topline Genuine data release, we were able to raise approximately 89 million in gross proceeds through the combination of a public offering and use of our at the market sales facility, solidifying our cash reserves, and providing us with sufficient capital to advance our key programs. Next, we announced the first presentation of preclinical data of our anti-PDL1 monoclonal antibody at the American Association for Cancer Research annual meeting. We are very encouraged by these early signings and plan to commence a first in human Phase 1 study or anti-PD-L1 later this year. And just last week, we presented the first data from our MS Phase 2 at the American Academy of Neurology annual meeting, demonstrating that TG-1101 resulted in median B-cell depletion at week four of 99%. Additionally, 1101 was well tolerated with no grade 3, 4 adverse events observed and was safely administered in a convenient in one-hour infusion. This data compares favorably with other anti-CD20 monoclonal antibodies and we look forward to reporting on established MS clinical efficacy endpoints later this year, or possibly early next. And finally, we announced our schedule of data presentation at the upcoming ASCO meeting, which will include the oral presentation of the results of the GENUINE Phase 3 trial on Saturday, June 3 and a poster presentation and poster discussion reviewing the tolerability and activity of the chemo free triplet of 1101, 1202 and ibrutinib in CLL and NHL patients. With that, let me switch gears and provide an update on our ongoing Phase 3 registration direct to trials. Let me begin with a brief update on our unity CLL Phase 3 study, as many of you are aware UNITY-CLL is being conducted under special protocol assessment with the FDA and as a randomized controlled forearm clinical trial that is designed to support full approval for both 1101 and 1202 with a potentially broad label for the treatment of both frontline and relapsed/refractory CLL. The study is initially randomizing patients into the forearms of the 1303 combination, which again is 1101 plus 1202, 1101 alone 1202 alone and the active control arm of obinutuzumab plus chlorambucil. A planned interim analysis expected by mid-year will assess contribution is of each single agent to the combination and if successful, will allow early termination of both single agent arms. A second interim analysis of overall response will be conducted following full enrolment into the study, again which if positive, we plan to use for accelerated approval, while we wait for the PSS to readout for a possible full approval. This study was launched in February of last year and currently has approximately 140 sites opened globally. As of our last update, we announced strong enrolment of 30 plus patients per month and we had approximately 200 patients on study before the end of February. That enrolment figure is important as, as the number of patients we need to run the interim analysis to drop the single agent arms, again which we expect would occur by midyear. We also updated our guidance for the completion of enrolment in this study to Q1 2018. Previously we had guided to the first half of 2018. We are pleased to report that enrolment continues to be robust, including across the US, which we believe speaks to the clear need for additional treatment options for patients with CLL. Next, let me review our UNITY Diffuse Large B-Cell study, which is our Phase 2b registration directed program evaluating both TGR-1202 alone and in our 1303 combination with 1101 in patients with relapsed/refractory Diffuse Large B-Cell that are not eligible for high-dose chemotherapy or transplant. The primary goal of this study is to assess the efficacy as measured by overall response rate. The study is randomized and each arm is subject to early stopping based on achievement of pre-specified hurdle rates of overall response. Our expectation is that after approximately 20 to 40 patients, we will be able to drop the single agent arm, while the double arm will continue. We expect to have our first interim analysis for this study also in 2017. And lastly before I turn the call over to the conference operator to start the Q&A session, I’d like to review the status of our MS program. As noted earlier, we are extremely pleased with the recent announcement of our preliminary Phase 2 data of 1101 in MS, which showed a median B-cell depletion of 99% at week four. 1101 was well tolerated and notably we were able to safely administer 1101 in a convenient one-hour infusion, which we believe represents a significant advantage over the approximately four hour infusions required for other anti-CD20 monoclonal antibodies in MS. Our plan is to continue to treat and follow these patients and present data on established MS clinical efficacy endpoints later this year or early next. Additionally, we continue to collaborate with the FDA to design our Phase 3 program in MS, which we hope to launch in the coming months. The recent approval of Ocrelizumab for the treatment of MS has validated that B-cell depletion therapy is a highly efficacious treatment option for patients with MS. We believe 1101 can be a competitive product to Ocrelizumab with some potential convenient advantages and we hope to be able to offer to MS patients at a very attractive price. As you can see, we have been hard at work advancing our pipeline towards approval. We are extremely pleased with the progress we have made thus far this year and look forward to an exciting remainder of the year. 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, and reiterate some of the goals for the remainder of the year.

Thank you. [Operator Instructions] Our first question is from Matt Kaplan with Ladenburg Thalmann. Please state your question.

Hi good morning.

Good morning Matt.

Congrats on the progress during the quarter. Just wanted to focus a little bit more on the MS we saw some very positive data last week, with respect to when we could see I guess additional information about the durability of the T-cell depletion, could you give us some detail on that and then I have some other questions as well.

Sure. We are obviously following on these patients. So we will continue to follow the B-cell depletion over time. Our goal almost as we have done with cancer is to kind of update this data every six months or so, 6 to 9 months whatever the conference schedule looks to us that there is sort of this April-ish timeframe where there is a series of conferences and then there is also the October, November timeframe. So our goal again subject to acceptance by the different conferences is that each time we will be able to update the patients as we're going through, so it will be - I think at the end we will have about 40 patients on this Phase 2 study and we will just continue to follow those patients. I think we follow from at least a year. I’m not sure if we are following beyond a year, I can double-check that, but I think we are following at least a year. We should have all 40 patients done in the next two or three months. And then again assume we will be following for a year, after that at least, so we have at least two or three more good presentation, a follow-up data and each one will just become more robust and more robust.

Okay that’s helpful. And then in terms of, you mentioned in your prepared remarks you plan to launch the Phase 3 in the coming months, how should we think about that design, is it something that you look at Ocrelizumab and follow that recipe so to speak or what are your thoughts here?

Yes, for sure. We have been pretty clear that we are going to try to copy as closely as possible the okra recipe, so I think we have taken as much as possible from their experience rolled it into our clinical program, I think we’ve added some improved aspects, which we will share hopefully sooner or rather than later, we are still working closely with the FDA and again I think we certainly, we have said before that we are not trying to do, I think each one of those studies had somewhere a little below 800 patients on each study. We are trying to do something a little bit more practical and so that's required a little more effort and time and thought from both us and the agency. So, I think they’ve given us a great deal of advice and help in trying to figure out the best way to this, without having to run a full 1,600 or even patients. So, we are, as soon as we get to the process we will be able to share, but I think the general starting point is let’s work off the okra experience and then we’ve been talking to KOLs and they have given us ideas for improvement. We have worked with some really great statisticians. So, I think we are generally following the recipe as you describe it, but I think with some improvements.

Okay. And then just going back to the data that you presented AM last week, it seems to have a very clean safety profile of the sides, I guess some infusion-related reaction, can you describe some of the, any other side-effects that were observed during the study or besides IRR.

Yes, there was nothing else reported.

That's helpful.

No other status has been noticed. I mean we have a lot of experience with the drug, the only thing you will see is, I mean there is other rarely, but first dose is sometimes challenging. And these patients have really wasn’t, you have really modest levels of infusion-related reactions and none of them were really severe in any way, which was the design, I mean we wanted to make sure these patients didn't feel anything, to the extent possible, there is I think one or two or three of them who felt a little bit, but you just got the infusion for a little bit and restart 99% of the time the patients are fine and again this is semi to most typical for CD20’s we, and once we get past the early dose, you don’t even really know you are taking them. They are really, Rituxan has shown us and I think most of them for the most part turn to drug, once you get past the first one it is really hard to tell you, you are taking a drug.

Okay that's helpful. And then just one more question, I will jump back in the queue, shifting gears a little bit. In terms of can you give us a little bit of an update in terms of your pipeline, the programs that you have earlier stage PD-L1 delta inhibitors give us a quick update on where they stand?

You really move me around the fields here. So, yes on the pipeline PD-L1 clearly our lead [indiscernible] at this point, we are very excited about getting that proprietary combination going, with 1303. I think the current timelines will hopefully be in the clinic over the next 3 to 4 months. We just saying later this year to give us a little bit of a room as we complete some of the final talks work and get the IND going. So that’s moving forward, very excited I think. You know, if fingers crossed if all goes well towards the end of the year will be able to show some preliminary data on 1303 plus PD-L1 or proxy stated as we have been working on the Dr. Mato. We’ve been going pretty slow there and cautiously because of the potential interactions, but I think everything is going along well and I think we're pretty excited to get like I our proprietary ones are. The other step in the pipeline a little bit further beyond that, I think it would be sometime next year. The BET inhibitors, we think later this year possibly early next year, but I don't have as much clarity. I have to admit, we have been super focused on the clinical programs and we have been just letting those things run their course in the pipeline as they get there, they will get there, but PD-L1 is the one we have been really focused on and moving aggressively forward as quickly as we can.

Great. Thanks a lot for taking the questions.

Yes thanks, Matt.

Our next question is from Yatin Suneja - SunTrust.

Good morning guys, thank you for taking my question. Couple of question on the MS, I mean, could you maybe talk a little bit more about the differentiation especially in terms of the infusion time for the first dose, I think you were trying to get 60 to 90 minute, is it still the goal, we haven't seen that data yet, have you achieved that in part two of the ongoing trial?

Yes. So just everyone is on the same page with the question, so with CD20s typically the first dose you want to really take your time, again this is back to Matt’s question about the infusion related to reactions to everyone, everyone who gets a CD20, go super slow on the first infusion. We did that as a matter of course with our CD20 the first part of this program. So our goal was rarely get one hour fusion for the day 15 and six months and 12-months and every infusion after that, but everyone typical uses a bit of caution in the first infusion. Since we didn't see any issues and in our NMO study, we actually treated patients with 450 mg on day one, without any issues also, without using sort of lower dose, again in typically and we copy this from okra. They did a 150 dose on day one, sort of a alluding dose or an introductory dose, and then a 450 day, day 15. So we are able to safely give the 450 milligrams at day 15 and beyond, in one hour we designed the part two to basically say, hey could we actually shorten the front one as well. And so we are in the process of doing that, we haven't given any updates yet, but I think again that will be part of the next presentation that we do later this year.

Got it. And would you wait to see that data before you go ahead and start the Phase 3 program?

No, I don't think so.

Okay. And then in terms of the patient population, I mean are you going to initially go after the RMS or would you do the PPMS as well? And then are you also trying to get a spa on the study design with the FDA?

Yes, the patient population is the last thing remitting patients. That’s the one, the okra study was widely successful with P-Values with I think three or four zeros before you get to a number. So that’s the one that we feel most comfortable following the game plan or the recipe using, trying to use max terms, but the progressive patients, you know the win was amazing for okra. We obviously believe that CD20, it is the only class and that is the only drug that’s ever been approved, rather proven to help those patients, but the P-Value was like 0.49, not less than our 0.049 rather. And so when you think about powering the study that has an outcome of the 0.049, we probably need to use 50% more patients then they use in that study to be safely powered for that kind of a trial, whereas with the okra experience and the relapsing patients with all those zeros and the P-Value we can use less patients, and that is obviously, for us a much more manageable and proxy for program for a small company. Having said that, we do believe that we would have the same effect in progressive patients and we do have some ideas on how we can approach at least showing in the marketplace that they should feel comfortable using CD20s across RMS and progressive disease.

Maybe just one more question and I will get back into the queue. On GENUINE, do you anticipate to collect may be another cut of the data when you file with the FDA next year? Thank you.

So, as I said today, we were not anticipating doing that. They can certainly ask for and we will certainly do it for them, but as it stands most of blinds broken, that is the official data as of the days of the blind is broken, but like I said, we will do whatever the FDA asks us to do, but typically you wouldn't do that unless asked for.

Got it. Thank you and congrats on all the progress.

Thank you.

Our next question is from Ren Benjamin from Raymond James. Please state your question.

Hi good morning guys, thanks for taking the questions and congrats on the progress as well. Maybe just starting off with the ASCO data, can you just remind us should we be expecting to see any sort of PFS data and at least going into ASCO have the 14-patients or so been confirmed for response?

So, answering the second one, to my knowledge all the patients have come back for their visits. I think the last patient was due back in the last few days, I believe that the patient came in. I guess I don't have a full combination on the last patient, but up to that last patient I heard that every patient actually did come back for at least the confirmation scan. So that’s all very positive from where I sit. In terms of the data presentation, yes we will certainly present PFS curves, again the study was not powered, no longer powered for PFS, but as we said in the press release, we did observe positive trends or, I can’t remember the exact terminology we use, but we are definitely seeing some positive effects in PFS, we will certainly preset that data with all the cautionary around that, you know it is, the study was no longer powered for PFS.

Got it. And just of sticking with the CLL theme, when we think about UNITY CLL, and the first interim analysis that’ll be taking place, just remind me, is that interim analysis, primarily driven by response rate and non-PFS and when you make the announcements should we just be expecting an announcement that forearms have become two or would actually get an actual new miracle response rate for each of the arms?

Yes. What we should be able to report is that, either the two arms dropped or did not drop and that I think at the same time, I will take a safety look as well and that there is no safety issue or there is a safety issue. I think that is about all we will be able to talk about until the study is complete. And some time will discuss with the FDA what we can do with that interim data once enrolment is complete. I don't think we can do anything where the mutual enrollment is complete there for sure.

And I'm pretty sure about this answer, but there is not resizing option at that point is that correct?

Now there is no resizing option and to my knowledge, I don't believe they're looking at PFS. So, I don't - they are not even looking at the resize even.

And then just switching gears to the UNITY-DLBCL, so an interim analysis there as well comparing both the arms, I thought there was the potential that once the monotherapy arm is dropped that another arm of 1303 plus bendamustine would be headed? Did I write that down wrong somewhere else or is that still part of the game plan?

No, that is part of the game plan, probably should have them in the prepared, but it is actually in my closing comments, but you are right that was - yes, the plan for the UNITY Diffuse Large B-Cell is that, again our expectation has always been that 1202 has activity in Diffuse Large B-Cell, but on its own it is probably not a sufficient agent, it is not toxic enough and fast acting enough to deal with such an aggressive disease, but we do believe it has really nice activity in the disease. So the whole point was, we want to get as quickly as we can to a doublet or triplet combination. So the study, as you know is designed when we start off with two arms, we set a hurdle rate, our expectation is that 1202 will not meet the hurdle rate to move forward. So we will be moving forward with the doublet and then yes, exactly what you said, as soon as we can knock out the 1202 arm, we're going to replace that with a 1303 or 1101, 1202 arm plus bendamustine, which we are quite excited about. And it is kind of what we describe it as always as it is kind of stepwise contribution, so we start by knocking out 1202 and we get to show the doublet versus the triplet and our expectation is that again that doublet is going to be good, but the triplet is going to be better. And it’s a disease that’s very fast being, sounds a little chemo in is probably very important. The chemo responses are typically not durable, but what we do see is that the 1202, 1101 responses are durable. So again we need that extra arms to get the induction of response once you get the response induced, basically we have the double arm board to really try to push it an extend the durability and that’s kind of the enthusiasm that we have and not any investigators have without building that triplet combinations that we.

Alright. And then just regarding the hurdle that must be cleared, how do you guys determine that hurdle, is that mould in conjunction with the key opinion leaders as to what is a clinically relevant hurdle or how should we be thinking about it?

Yes, I mean we use of basic sign in two-stage design concept to basically set a target basic rate of a response and that when you pick your target, it basically gives you the numbers you need to have, X number of responders in the first 18 patients and you go out from 18 to 36 or 40 patients or approximately - so I can't remember what we targeted, but I think we are targeting close to 30% as the - what we plugged into the model, maybe 35%, I can't remember, but - and that gives you just the numbers of responses you need to see and it provides some confidence interval piece around so you don't assume that something is negative when it could already be positive, but again, I think the way we have designed our expectation is that the 1202 two arm should not make it pass. The first checkpoint if it does it is not likely to make a pass the second. We know that it’s - as a single agent it’s not a good answer for patients, it is a good drug, but for patients they need something more, right our goal is to get to something better for the patient.

Got it. And then just one final question from me and I hate to ask this, but I will anyway because we get it all the time, which is, in the MS space, why do we need another anti-CD20 and I know we talk about the one-hour infusion, the better side effect, but maybe you can talk just a little bit more broadly, how meaningful clinically is the one hour infusion, are there issues with - in these clinics regarding these infusion sites, and how should be thinking about it when compared to subcu formulations?

Yes, so we have talked to physicians, there’s not one that says though it was like a 4 hour infusion of rely on infusions, so all else being equal, it is a nice thing for both doctors and patients. I mean it is clearly in advance for the field to be able to give a one hour infusion. So yes, I think that alone is humanly worthwhile to add to the mix, and certainly price is going to matter and we think we can do much better for the patient. So, we're talking about a third CD20 in MS and we have, I don't think you can name too many classes of drugs, VEGF, VEGFR lipid statins, [indiscernible], mean how many don’t have more than three. Find me a class that doesn’t have more and find me all the different, the most important differentiators being some of those agents. The fact is that, not everyone tolerates everything the same, drugs are all different, and they are all having, they all have slightly different profile, whether it’s surely convenient and priced, maybe it is tolerability, maybe it’s infusion reactions, you know, but had we given up on PI3K delta when everyone told us we shouldn't be the third PI3K delta, now we are the only actual PI3K delta, we found out the rest are actually are not even Deltas alone. We would, there would be a lot of patients without treatment options who can't tolerate ibrutinib, who are of ibrutinib and I am going to show you, we’ve heard even more and more that the second generation B2Ks [ph] are not much of an advance over the first generation, so I think it’s - I know you processed it by saying you had to ask, because people ask you. I think it is a silly question for them to ask, but as you said I think the one hour infusion and the cost benefit is that was all we brought to the table, would be quite beneficial to both patients and to the healthcare system. And, but you had another question I feel like…

No, that was it. Thank you very much and good luck.

Thank you.

[Operator Instructions] Our next question is from Matthew Andrews from Jefferies. Please state your question.

Hi good morning. So a couple for me. Mike, first of all what remains to be completed as it relates to finalizing your Phase 3 plan for ubli and MS? Two, when will the next DSMB safety review for UNITY DLBCL take place? And then three, any thoughts on potential next steps for 1303 and indolent NHL, I know you have a lot going on, as it stands, but when may we hear about next steps in INHL? Thanks.

Thanks Mike you really, you too moving me around the field with one, Sean can’t even write them down fast enough. So to get the MS I have been running with the FDA?

Absolutely, yes.

We are down to I think some very short strokes on working with the FDA on this, I think we're working just a bunch of statistical modeling and how we are just going to do the final pieces of it. So, I think we are close to the finish line. It’s hard to know, I think our last submission addressed all the last returns and I think most of it was, it is just two considerations that we are finalizing with them. So, fingers crossed, so hopefully we would be there for not, we will continue to work closely with them. They have been great and helpful, and I think they have given us good suggestions to make it a better overall program. So we're not complaining. We’re good shape and as should, if it doesn’t happen and just go around, I really think we are blacklisted to finalizing it, but most it - most it and not all of it is just based on finalizing the statistical plan. The second question Sean didn’t get?

Sorry the next DSMB analysis for UNITY-CLL you had mentioned in the past, it may be conducted every, roughly 6 to 9 months, I was just wondering when may that occur it seems like we would be made but this year, but I don't know?

So that is exactly right now. So we're going to do it in conjunction with the interim contribution analysis. So what will happen is one DSMB meeting. So the interim for contributions is designed at the DSMB meeting anyways so now that act is basically maturing to a conclusion, so that they can have a meeting. It will be hosted as a full DSMB, so they will look at the safety and look at the contribution at the same time, so that will also be sometime this summer.

Great, okay.

And then I do have your last question, Sean was able to get than one down for me. He is a great CFO but a horrible technician, stenographer. So indolent lymphoma, so indolent is interesting because it is the area where, again if you think across the continuum clearly the PI3K delta’s work probably best in terms of inducing response in CLL, and the medal which is also great, which is about 50% response rate is in the indolent and then as you move closer to, if you - so the aggressive, it is going to be whatever, or 10% to 20%, whatever it is. So there is activity across the continuum, but we are working right now in the bookends, right. The CLO has the highest signal. The Diffuse Large B-Cell has the highest unmet medical need and right smack in the middle is the follicular group which is the drugs work great, our drug we think works great, but the registration approach in follicular is challenging. Because of the treatment options that are available on the long PSS and overall survival. So that is a very long way of saying we are working on it. We have some very good idea that I think we are going to announce soon a Phase IIb approach that will help us to a place where we can run a proper phase with randomized trial in follicular. But we haven't announced it yet, but we are working on it. I would say maybe next 60 days to 90 days we will be able to talk about that follicular, it will probably be like a registration directed Phase 2b kind of approach, somewhat similar or quite similar to what we are doing in Diffuse Large B-Cell and I think that will give us a lot of good information for how we can move forward with a proper registration program. I think there is, we have some good ideas, we have some great people working with us on the follicular side. Our net and server has been super helpful at MD Anderson and so I think we're going to get something really nice put together, it is just, I think we need probably a little more information on the single agent, then double it, and possibly given a triplet in follicular because there is a lot of beyond there is a lot of chop used, and so if you think about first line and second line follicular it is usually PR to chop or chop to PR. So, we are trying to work our way around the best way to improve the outcomes for patients in follicular. We don't think - we haven't done it and we don't think it is a great place for us to spend our time in running the same double refractory single arm follicular study that was run by both and idelalisib and duvelisib. It is a registration strategy. I think we could just do better for patients with a better label. The label has not been very helpful for duvelisib sales have been not as good as they should be and again I think in part the latest challenge I think we could do better, create a better label for ourselves.

Okay great, thanks for the information. See you.

Ladies and gentlemen, we have reached the end of the question-and-answer session. I would like to turn the call over to Mike for closing remarks.

Right. Thanks everyone again for joining us. We really appreciate all the strong support we’ve had. What I thought I would do is just wrap up today's call by reviewing some of the exciting milestones. We still expect to achieve during the remainder of the year. First in the near-term, we plan to present updated clinical data at ASCO, EHA, and Lugano for our CLL and NHL program and most of course is the detailed analysis of the GENUINE trial results at ASCO. Sometime this summer as we have been challenging out, we plan to complete the interim assessment of contribution for the UNITY-CLL trial and that with the DSMB we will need to do that, so we will be covering both the contribution and the updated safety and we hope at that point we will be able to terminate the two single agent arm. Around mid-year, we plan to complete the first interim analysis, and the UNITY-Diffuse Large B-Cell trial so again hopefully we will be able to drop that single agent 1202 arm and replace it with the triplet 1303 plus bendamustine. Also this summer we plan to initiate all those well with the FDA on our next call around to initiate our MS Phase 3 clinical program. We do look forward to be able to share the final design with everyone, as soon as we can. Then in the second half of the year, we're looking forward and hoping to have a meeting with the FDA to review the GENUINE data and discuss the filing of the data for accelerated approval. Towards the end of the year and into early next year we plan to report additional clinical data from our Phase 2 MS study, showing the impact of 1101 on established MS endpoint, as well as longer-term follow-up on B-cell depletion and repletion. And finally, as is typical for us, we would expect to present new and updated data from the ongoing studies at ASH in December. So again, on behalf of all of us at TG we would like to thank our investigators and their patients, all our shareholders for their continued support, thanks again for joining this morning and have a great day.