TG Therapeutics Inc

NASDAQ:TGTX

Earnings Call Transcript 2018-Q2

[Operator]

Greetings, and welcome to the TG Therapeutics Second Quarter 2018 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. I'll now turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. Thank you. You may begin.

[Jenna Bosco, VP, IR & SVP, Corporate Communications]

Thank you. Good afternoon, and welcome to our conference call regarding TG Therapeutics' second quarter 2018 financial results and business update. I'm Jenna Bosco, TG's Senior VP of Corporate Communications, 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'll provide an update on the ongoing development of our novel glycoengineered anti-CD20 monoclonal antibody, ublituximab; our novel once-daily PI3K delta inhibitor, umbralisib; as well as review of our clinical programs and overall company standing.

Before we begin, I would like to remind everyone that various remarks that we make about our future plans and expectations 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, www.tgtherapeutics.com, where it will be available for the next 30 days. [Operator Instructions].

Now I would like to turn the call over to Sean Power, our Chief Financial Officer, to briefly discuss the financial results for the second quarter of 2018 as well as the company's overall financial condition.

[Sean Power, CFO, Corporate Secretary & Treasurer]

Thank you, Jenna, and thanks, everyone, for joining us. As you may be aware, our financial results were released this afternoon and can be viewed on the Investors & Media section of our website at www.tgtherapeutics.com. I'll begin with our cash position. At June 30, we had cash, cash equivalents, investment securities and interest receivable of $126.3 million compared to $109.2 million at the end of the first quarter. The positive quarter-over-quarter improvement in our cash position was a result of approximately $52 million in equity financing during the quarter at an average price of $14.14 per share from our ATM sales facility.

We expect our cash burn to remain relatively consistent through the third quarter of '18, as the UNITY-CLL program continues to wind down and with the MS program reaching full enrollment. Into the fourth quarter of '18 and 2019, we expect the clinical burn to taper a bit as our key registration-directed clinical programs reach full enrollment. The only other significant variable will be our investment in CMC and precommercialization expenses that will be somewhat contingent on progress toward regulatory approvals and thus could increase into 2019.

Collectively, we believe our current cash position will be sufficient to fund our operations into the second half of 2019. Our net loss for the second quarter of 2018, excluding noncash items, was approximately $36.9 million, which included an increase in clinical trial expenses of approximately $10 million over the comparable period in 2017, which was primarily attributable to our registration-directed trials in both oncology and MS. The GAAP net loss for the second quarter of 2018, inclusive of noncash items, was $44.1 million, or $0.59 per share, compared to a net loss of $28.4 million, or $0.45 per share, during the comparable quarter in 2017.

Our net loss for the six months ended June 30, 2018, excluding noncash items, was approximately $70.1 million, which included an increase in clinical trial expenses of approximately $15.7 million over the comparable period in 2017, again, primarily attributable to our registration-directed trials in both oncology and MS. Also included in the six months ended June 30, 2018 are $11.4 million of manufacturing and CMC expenses for Phase III clinical trials and in preparation for commercialization. The GAAP net loss for the six months ended June 30, 2018, inclusive of noncash items, was $85.7 million, or $1.18 per share, compared to a net loss of $56.1 million, or $0.96 per share, for the six months ended June 30, 2017.

With that, I will now turn the call over to Mike Weiss, our Executive Chairman and CEO.

[Michael Weiss, Executive Chairman, CEO & President]

Thank you, Sean. Thank you, Jenna. And thanks, everyone, for joining us this morning. I want to kick off this call by thanking our long-term shareholders for their continued support and patience. [Indiscernible] all to know we've been working extremely hard to build shareholder value and to advance our pipeline vigorously toward approval. Please be confident that we are working tirelessly to develop our drugs with the best interest of the patients in mind, and we are confident that, that will eventually translate into significant shareholder value. We hear every day about patients who are benefiting from our drugs. Many have seen improvement, but for a variety of reasons, mostly tolerability, they need to seek new treatments. We also hear about patients who can't tolerate venetoclax. Fatigue can be crippling.

U2 has the potential to become the universal go-to regimen across first-line and second-line treatments alone and in combination with either a BTK inhibitor, like ibrutinib, or own proprietary BTK, or in combination with venetoclax, or potentially with both. The goal was to get CLL patients the deepest response in the shortest amount of time and get them off these drugs before tolerability or resistance occurs.

We have novel triple and quad combination trials planed with venetoclax as well as with our own preparatory BTK inhibitor, our anti-PD-L1 and our CD19/CD47 bispecific. These are very exciting times in the development of treatments for CLL as well as non-Hodgkin's lymphoma, and your support is extremely important to us and to the patients who are in need of novel treatment options. We believe cures are truly within our reach. Hopefully that gives just a little sense of why we're so excited about what's going on at TG and our future here. We believe as a company, we have never been better positioned for success. We have a number of exciting milestones and value-generating events occurring over the course of the coming months. And most significant, of course, will be the announcement of top line overall response results from the UNITY-CLL Phase III trial, for which we are targeting for announcement before the end of the summer.

Before providing an update on the current status of our ongoing development programs, I thought I highlight some of the notable achievements for 2018. First, we have presented a number of very important data sets this year, including the publication of the Phase I study for single-agent umbralisib in Lancet Oncology. We've also presented an analysis of long-term safety follow-up on umbralisib. In that presentation, we demonstrated the ability to safely dose umbralisib up to five years in certain patients with incidence of target toxicities remaining very well. And finally, we presented updated data from our Phase II MS trial, ublituximab, at the European Academy of Neurology meeting, showing with longer-term follow-up now up to 48 weeks in some patients that ublituximab continued to show complete elimination of T1 gad-enhancing lesions, reductions in T2 lesion volume and, importantly, very low annualized relapse rates.

In addition to important data sets, we have also expanded our portfolio of B-cell targeted drugs under development. Our vision is to develop functional cures across B-cell cancers. And to do so, we need agents targeting multiple key mechanisms. So far this year, we've added a novel BTK inhibitor, TG-1701, as well as a novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801. A few important points to note about this molecule. First, this is a true bispecific [indiscernible]. Accordingly, this agent should have the half-life of traditional antibodies, which could be approximately 3 to 4 weeks. Additionally, unlike other CD47-targeted agents, this agent is designed to specifically attack B-cells by including the CD19 arm. This avoids toxicity concerns of other agents in this class. And finally, this agent has retained CD19 activity. So this drug also should provide a dual mechanism for enhanced efficacy. We have a high level of confidence that this will be a best-in-class CD47-targeted agent.

And finally, we've broadened our senior management team this year with hiring of Adam Waldman as our Chief Commercial Officer. Adam was formerly head of U.S. hematology/oncology marketing at Celgene and will lead our effort to bring our products to market.

Let me give a high-level overview of the ongoing Phase III and pivotal programs. First and foremost, let's talk about UNITY-CLL Phase III program. For those of you are joining us for the first time, this is a Phase III trial comparing our U2 combination to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment naïve as well as relapse or refractory chronic lymphocytic leukemia. The trial is being conducted under Special Protocol Assessment with the FDA and is a large global trial, including over 600 patients. Enrollment into this trial exceeded our expectations and was completed ahead of schedule in October of 2017 and included approximately 60% frontline patients and 40% relapsed/refractory patients.

As previously guided, we are targeting top line overall response rate data from this trial by the end of the summer. To remind everyone, we are targeting a 15% absolute improvement in overall response rate. It is also worth reminding everyone that the primary endpoint to this study is progression-free survival, which is expected to support full approval of the U2 combination and ideally support a very broad label for the treatment of CLL.

Sticking with the CLL theme, let's chat a little bit about our GENUINE trial. As a reminder, GENUINE is a randomized Phase III trial of ublituximab plus ibrutinib compared to ibrutinib monotherapy in patients with high-risk relapsed/refractory CLL. We have previously discussed the hurdles for approval for this study and believe the key for successful filing will be demonstrating meaningful benefit over all currently available therapies, including venetoclax-based therapy. We continue to believe that this regimen does provide meaningful benefit of our all available therapies, and we are continuing to work on a risk-benefit analysis, which will highlight such benefits and would be included in the potential BLA filing.

Moving along to our UNITY-NHL trial. As you may recall, this is a multifaceted program, evaluating single-agent umbralisib and building towards evaluating U2 double combination and, potentially, triplet combinations using U2 as the backbone across a variety of subtypes of non-Hodgkin's lymphoma. The UNITY-NHL trial currently has three distinct cohorts, evaluating different subtypes of NHL. The current phase of this trial includes a cohort evaluating patients with follicular lymphoma, which is enrolling relapsed/refractory follicular lymphoma patients into a single arm of umbralisib monotherapy, a cohort evaluating patients with marginal zone lymphoma, which is also enrolling relapse - patients with relapsed/refractory marginal zone lymphoma into a single arm of umbralisib monotherapy. And finally, the third cohort is evaluating patients with diffuse large B-cell lymphoma. In this cohort, we have completed target enrollment in the U2 combination arm and are now enrolling into the triple combination arm of U2 plus bendamustine.

We have made substantial progress with enrollment across all three major subtypes, follicular, marginal zone and diffuse large B-cell, and believe we are only one month or so away from completing enrollment in all three of these cohorts. Once complete, we plan to amend the protocol to open up the next phase of enrollment to study new combinations while we file the current cohort of patients for approximately 9 to 12 cycles.

Next, let's review our multiple sclerosis program. As mentioned at the start of this call, we've recently presented updated Phase II data. We believe this Phase II data is every bit as good, if not better, than the ocre Phase II data at the same point - at the same time point and thus, we believe, highly supportive of our ongoing Phase III program known as the ULTIMATE MS Phase III trials. As a reminder, we are running two identical Phase III trials under Special Protocol Assessment with the FDA, evaluating ublituximab in relapsing forms of MS. And as announced this morning, we completed target enrollment into the ULTIMATE I and II trials, and we are anticipating completion of full enrollment by mid-September. This is updated from our original guidance for both studies to complete by the first quarter of 2019. So right now we are well ahead of schedule.

Currently, ocrelizumab is the only anti-CD20 monoclonal antibody approved for multiple sclerosis and remarkably in its fifth quarter after launch at approximately $500 million in sales in the U.S. alone. That is a current run rate of over $2 billion per year and growing. I'm sure I don't need to state the obvious that this is a major opportunity for us, and we look forward to completing full enrollment into this program shortly and potentially having data available as early as mid-2020.

With that, I'd like to turn the call over to the conference operator to begin the Q&A session, following which I will return and provide some concluding remarks as well as a review of our remaining milestones for 2018.

[Operator]

[Operator Instructions]. Our first question is from Yatin Suneja from SunTrust.

[Yatin Suneja, SunTrust Robinson Humphrey]

Just a question on the time line. So UNITY-CLL data by the end of summer, could you, Mike, maybe tell us where will be in terms of the median or mean follow-up when you announced these data? What needs to happen between now and data release? And have you locked the database yet? And then I do have a follow-up after that.

[Michael Weiss, Executive Chairman, CEO & President]

Thanks for the question, Yatin, of course. So in terms of the median or mean follow-up when we open up, so I think I can give you the minimum follow-up. I don't think I can give you the median or mean follow-up. So I'm sure at this point, it's probably obvious to folks that we have decided to wait for the 12 cycles. So we'll have at least, basically, I guess, a minimum of 11 months because it's 48 weeks. It's 12 cycles of minimum of 48 weeks to follow up on all patients. The median is probably plus another 6 or 7 months, I don't know for sure, but approximately that probably get us to the median or the mean. What needs to happen now - between now and the release? I guess, in your next part of the question, have we locked the database yet? No, from, I think, when the database is locked to the actual data, it should only be a matter of a few days, I think, once that happens. So if the question was a trick question, you tricked me. Good work. So it's probably not in the next day or two. But then I think, yes, we're - the team - we have a big team, working hard, cleaning data, again, everything put together. Statisticians are making all their preparations to make sure we do this thing perfectly. And we know that the goal is to get some information out, but we also need to be mindful of the fact that there's a big PFS coming up behind this. I mean, we just need to be cautious. So again, the teams are working hard. The statisticians and our statistician consultants and our team of clinical ops folks are cleaning stuff. So I don't know what else you want to hear from me on next point. But everyone is working hard to get it done as quickly as they can.

[Yatin Suneja, SunTrust Robinson Humphrey]

Okay. This is helpful. Then you mentioned the big PFS. I mean, obviously, there is an important - that is the primary endpoint. So help us understand the timing or when could we expect that endpoint. I mean, obviously, you're going to use ORR as an accelerated approval endpoint. So maybe also talk about the importance of PFS and, obviously, help us regarding the timing?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So the PFS is, again, a little bit more vague in terms of when it will occur. We've said in the past that our best guess today is sort of [indiscernible] a normal distribution curve over 2019, put maybe a little talent to the end of '18 and a talent to '20. But that - as I said before, that's just a rough guess of what could happen. I think our goal is towards the end of the year or maybe as we get into the ASH time frame or even maybe at JPMorgan, we'll have enough information on event rates to create a better profile of when we think that will occur.

[Yatin Suneja, SunTrust Robinson Humphrey]

Okay. And then just maybe one final question. Moving on to the pipeline, you have some very interesting asset, particularly the newly acquired CD47/19 bispecific. Could you perhaps talk about how you are thinking on prioritizing these asset? When can we expect clinical updates on one or more of these programs? And then a quick one for Sean. If you can just tell us what is the current share outstanding.

[Michael Weiss, Executive Chairman, CEO & President]

Do you want me to go first to - okay, we'll get Sean on second - we'll get that one for you. So in terms of prioritizing assets, we are pushing forward as hard as possible on all the pipeline products. So we've got - in terms of just natural where we are, to give some of an update, we have not been too specific about where we are exactly. So I can give a little bit color if you'd like. But the PD-L1, our partners at Checkpoint have done a great job in getting us a dose. So they did all the work to get to a dose, and we're in the process of basically getting a protocol up and running so we can start expanding into heme malignancies with the PD-L1.

So that should happen, let's say, the October/November time frame. But we already have it there, so we'll be able to start at a fixed dose, which is nice. Our BTK, we are, hopefully, weeks away, maybe - it shouldn't be more than a month or two, but possibly we're weeks away from getting that study started as well. Our partners in China have already treated, I think, 1 or 2 cohorts of patients. So we're getting some good information from them to be able to start dosing our first patients. So that's exciting, and we're pretty excited about that program as well. And then the CD19/CD47 is just in, as you know, and so we're pushing as hard as we can. Again, if we can get into the clinic before the end of the year, that would be awesome. I think more realistically is first quarter, but obviously, super excited about that program and the profile of that compound versus some of the others that have become - are coming through the pipeline in the industry. And then as soon as we get combination dosing and we get heme dosing and we start to see some more signals around, we do have a pretty well laid out plan of clinical trials probably for the next several years, and we are pretty close to our designs of pivotal trials that we're looking for. So I think things will move pretty quickly into pivotal trials in some of these areas with some of these compounds. So stay posted for that. Again, I think we've got to get through the dosing, and then we'll be able to hit you guys with some exciting developments.

I'm sorry, I have forgotten. We have Sean Power, who will take the question on shares outstanding.

[Sean Power, CFO, Corporate Secretary & Treasurer]

So we have just under 82 million currently outstanding.

[Operator]

Our next question is from Matt Kaplan from Ladenburg Thalmann.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

Congrats on completing the enrollment in the MS study well ahead of schedule.

[Michael Weiss, Executive Chairman, CEO & President]

Thank you. Really appreciate it, and we're pretty excited about that, obviously.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

Just staying on MS a little bit. Can you talk a little bit about the opportunity there from a commercial point of view, I guess, seeing what ocrelizumab has done in the first half of the year and the second quarter as well? Help us [indiscernible] on that what you are thinking.

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So first thing I'm going to say is, wow, the ocre data is and the ramp is impressive, to say the least. I think it just shows you that there's a demand for better treatment options in MS. I think CD20s represent some of the best data that's ever been produced, and I think that's demonstrated in the launch. So obviously, we think it's a huge opportunity. They're at a $2 billion run rate and growing. So by the time we hit the market, who knows, $3 billion, $4 billion market opportunity for us to jump into. We have a really nice product profile that, we think, is developing here. We have a one-hour infusion, which, I think, is great for patient, it's great for the infusion suite. And in terms of the activity level, I said in my prepared remarks, our Phase II data - as we compare it to the Phase II data of ocre, the similar tie point is certainly as good, if not better. Obviously, we can't compete across trial, but certainly, optically, we're doing quite well.

So I think we should have a very nice, highly efficacious compound, with a convenient dosing schedule. And then we're going to do what we can to gain market share using price to our advantage. We know that there is certainly a changing tone here in the U.S. And I think ex U.S., there has long been a changing tone, and I think there is room. No one has really been that aggressive. And we think we can be pretty aggressive in pricing, and we are - for us, we will certainly trade price for market share. So I think with a great profile, which we are hoping for and expecting and a very nice price point, we think we can do quite well in this market. And again, if we're working off of a $4 billion Asian base, even 10% to 20% is amazing. But who knows, I mean, if we really push hard and we put together a very nice package, who knows, it's hard to say exactly where it will be. But I think we're going to do really well.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

That's helpful. And then, I guess, with the near term turning over the cards for the objective response rate for UNITY-CLL and progress you're making on the rest of the pipeline as well, can you give us an update on your preparation for commercialization and what you're doing there as things move forward?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So we took the big step forward and we brought in a chief commercial officer. So that's a good step - first step. Adam is working hard, putting together his commercial plan. So I think the idea is, let's give him a little space right now. I've told other folks in one-on-one meetings who ask me about this that they're not allowed to talk to him yet, and I'll say it to you and whomever is listening on the call. But hopefully, in short order, we'll - Adam will get his plans in place, and he'll have enough to talk about, and we'll bring him out on the road, and we'll introduce him to folks. But for now, I can't really say too much more than that, I think. I've got to give him a chance to build out his plan.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

Sounds good. And then last question. Just digging a little bit more - in more detail into the UNITY-NHL programs and follicular lymphoma, marginal zone and DLBCL. Can you give us a sense in terms of the timing there for a potential data readouts?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So our expectation is that we'll follow patients for somewhere between nine and 12 cycles, so from completion of enrollment to data. So again, we think first half of next year into middle-ish, but it really depends. I mean, if it's - certainly, nine cycles will be handling within the first half. If we go for 12 cycles, it'll be sort of middle of the year. But it's where - we're tracking, I think, exactly where we've been all the time, which is pretty much first half of next year we should update on these programs.

[Matthew Kaplan, Ladenburg Thalmann & Co.]

And do they roll out sequentially or is it kind of all at once?

[Michael Weiss, Executive Chairman, CEO & President]

They'll probably end up reading out together. I guess, I'm not 100% sure. Certainly, the follicular and marginal zone have a chance of being closer together. So - and these things will happen at a proper - we'll do it through the DSMB. And so I think they'll be formally analyzed together. Diffuse large B-cell, I guess, is slightly different, and we need to think about the timing of that because the expectation is you're going to have potentially shorter durations of response and possibly needing shorter follow-up time. So I guess, that one we need to think a little bit more about, but I think we've got a fairly little bit of time to think that one through.

[Operator]

Our next question is from Ren Benjamin from Raymond James.

[Reni Benjamin, Raymond James & Associates]

Mike, can you just help me understand - I know in the press release, you mentioned potential to file the company's first BLA. I think in the prepared remarks, you mentioned that GENUINE would be part of or included as part of any filing, which makes me think that UNITY is likely to be the first BLA or NDA to be submitted. Does that mean like GENUINE is kind of out of the running right now in terms of it being filed by itself. Has that - or is that still in the work? How do you see this unfolding?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So I don't think we're at any different point than we were in the past. I think we're - nothing has changed in that GENUINE is still out there as one of our options. Until we see the UNITY-CLL data, I don't think we can make any decisions on which one will be first or second or whether they go together or one doesn't go and one [indiscernible]. I think we need to - we need more information, which is what we've been saying for quite some time. So no change to that.

[Reni Benjamin, Raymond James & Associates]

Okay. And then when you mentioned that you've decided to wait for 12 cycles' worth for data for UNITY, can you just give us a sense - I would have thought that most of the responses for the control arm would have been recorded within six months. I'm assuming that you're waiting for 12 cycles because, in the U2 arm, you're expecting some late responders. Can you give us a sense from prior studies just how many late responders you might see? I wouldn't expect that much, but maybe I'm remembering the data wrong?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So the purpose of leading additional cycles is, honestly, not about enhancing the overall response. I think that's a potential secondary benefit. And I think your recollection of the data is correct that no one would expect a monumental shift in overall response as a result of waiting from 6 to 12 cycles. I think what 12 cycles gets us is more information on duration of response, it gets us more information on safety, longer term follow-up for safety. So those are more of a reason to do it. Like I said, I think probably not even a secondary benefit, maybe more of a tertiary benefit would be that, yes, we would expect to have a handful of the late onset responders. So I don't think it's going to get worse going longer. So like I said, I think probably tertiary benefit, they will pick up a few extra percentage points.

[Reni Benjamin, Raymond James & Associates]

Got it. Okay. And then just one final one for me. I don't think we've talked about this in the past, but do you have kind of an ex U.S. strategy that you might be thinking about? And what sort of business development thoughts do you have, not just for the CLL franchise, but also for the MS franchise?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So Adam Waldman was the global head of marketing for Celgene. So he's got some thoughts on global as well or he's part of the global team, I know that. So he's got some thoughts. He's looking into that strategy as well. So I think we need to let him do his work. And once he gets a sense of how he feels about that ex U.S. marketplace, we'll make a decision on how we want to approach it. And I think that probably goes for MS as well. He's exploring both sides of this at the same time.

[Operator]

Our next question is from Madhu Kumar from B. Riley.

[Madhu Kumar, B. Riley FBR, Inc.]

Thinking about multiple sclerosis, considering how quickly the relapsing trials recruited, I mean, is there a plan in mind for a trial in primary progressive disease?

[Michael Weiss, Executive Chairman, CEO & President]

So there is a plan. Let's say, it's a fully vetted plan, so [Technical Difficulty] plan to look at primary progressive. I don't think at the moment we'll be looking at a large Phase III. I think we'd like to start with some sort of Phase II study, probably - or perhaps possibly in comparison to ocre. So I don't - we're not running out to do a large Phase III trial in primary progressive. I think if you look at the ocre data, it was marginally statistically significant at the size of the trial. And I don't remember exactly what size it was, but it wasn't a small trial. And with the marginal - and I think it was a p value of 0.04 or something. We would - to power for that, we would need an even larger study. So I don't think we have the appetite this minute, but I do think that a more moderately sized Phase II comparison of the two drugs to each other in a head-to-head fashion in primary progressive patients could be interesting. So let's say that it's on our preliminary plans to do, but it's not going to start tomorrow and that's for sure. I think we're going to wait a little bit before we get that going.

[Madhu Kumar, B. Riley FBR, Inc.]

Sure. And then can you remind us that under SPA for UNITY-CLL, has the FDA given an explicit guidance that success on objective response rate would support a BLA and NDA filing for accelerated approval?

[Michael Weiss, Executive Chairman, CEO & President]

You broke up him a little bit. Can you just restate that question?

[Madhu Kumar, B. Riley FBR, Inc.]

Right. So under the FDA - the SPA for UNITY-CLL, has the FDA said explicitly that success on objective response is sufficient to support a BLA and NDA filing for ublituximab and umbralisib?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So the FDA can never say that in any circumstance to anyone. Accelerated approval is always a function of the available care at the time of the application, and you can really never SPA around that. Full approval, you can. So if full approval, you can lock in the control arm, you can lock in all the pieces of the stat plan with the FDA and that holds. But because accelerated approval lives under a separate regulatory regime, you don't get an SPA to lock in these kinds of pieces. Certainly, overall response was discussed as part of the SPA process and the possibility of filing it. But of course, as we've discussed too much I think in the context of the GENUINE trial, anything that goes for accelerated approval under any circumstance needs to prove that they are - provide a meaningful benefit over available therapy and so that standard would always apply to anyone and to us.

[Operator]

Our next question is from Matthew Andrews from Jefferies.

[Matthew Andrews, Jefferies]

Mike, could you just repeat the enrollment update on NHL? I wanted to be clear what you said on that.

[Michael Weiss, Executive Chairman, CEO & President]

Yes. So in terms of where we are, we're just about completing the enrollment in the current - what I call the current cohorts. It's just I believe that once we finish one set, we move on to the next step. We've tried to keep the break in between, but - so right now we've been enrolling into follicular lymphoma in a single arm of single-agent umbralisib. In marginal zone, we've been enrolling into a single arm of single-agent umbralisib. And in diffuse large B cell, we've been enrolling into a single arm of U2 plus bendamustine. And what we said is, we should be completing enrollment in the target number of patients for each of those categories, hopefully, in the coming weeks.

[Matthew Andrews, Jefferies]

And then for the diffuse B-cell, the doublet closed the enrollment a while ago, right?

[Michael Weiss, Executive Chairman, CEO & President]

Yes, U2 alone.

[Matthew Andrews, Jefferies]

Got it. The other question I have is early July, there was a paper published on the Phase IIIb GREEN study - the real-world study of obinutuzumab versus - I'm sorry, plus a number of chemo agents as well as the drug on its own. And within it, appreciating this is a real-world study, not a true Phase III, the combo in frontline showed 82% ORR and relapsed/refractory was 54, which suggests a 71% response rate blended. So my question is, if this is true and translates into UNITY-CLL and the control arm shows 71% based on the way study is powered, et cetera, in trying to show a 12% to 13% to 15% difference, how comfortable are you that you'd able to show a stat sig benefit for the U2 arm?

[Michael Weiss, Executive Chairman, CEO & President]

Yes. I mean, if it comes in, I think 70%, 71%, blended is pretty much in line with what we've been saying what we have here. I mean, I have in mind 67% to 71% in my corporate deck. So certainly, well within our predictions of what could happen. And yes, I certainly think we can win on that. I have reason we wouldn't win on that if that were to be the true result.

[Operator]

[Operator Instructions]. And if there are no further questions, I'd like to turn the floor back over to Mr. Weiss for any closing comments.

[Michael Weiss, Executive Chairman, CEO & President]

Sure. Thank you very much. And thanks also - again, I'm going to wrap up this call by just reviewing briefly the key goals and objectives for the remainder of the year. As we've discussed, we plan to present the overall response rate data for the UNITY Phase III CLL trial. We are continuing to prepare for a potential filing of the company's first BLA and/or NDA. We're expecting to complete enrollment in the current arms of the UNITY-NHL trial, including for follicular and marginal zone and diffuse larger B-cell cohorts. And we're looking forward to presenting updated clinical data from our ongoing oncology trials later this year and plan for results from our Phase II trial of ublituximab in MS at a major medical meeting for the end of the year. So on behalf of all of us here at TG, certainly want to thank all of our investigators and their patients for their participation in our trials as well as thanking our shareholders for their continued support. Thanks, again, everyone for joining us. Have a great evening.

[Operator]

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.