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TG Therapeutics Inc (TGTX -0.50%)
Q4Â 2019 Earnings Call
Mar 3, 2020, 8:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Greetings and welcome to the TG Therapeutics Fourth Quarter Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. Please go ahead.
Jenna Bosco -- Senior Vice President, Corporate Communications
Thank you. Good morning and welcome to our conference call regarding TG Therapeutics fourth quarter and year-end 2019 financial results and business update. I'm Jenna Bosco, TG's Senior Vice President of Corporate Communications, and I welcome you to our conference call today.
Following our Safe Harbor statement, Sean Power, our 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 lead compounds, ublituximab and umbralisib, as well as an overview of our overall Company standing.
Before we begin, I would like to remind everyone that various remarks 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's operations include various risk factors 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. 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 fourth quarter and year-end 2019 as well as the Company's overall financial conditions.
Sean A. Power -- Chief Financial Officer
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 & Media section of our website.
I'll begin with our fourth quarter financial results. As we've guided in the past few quarters, our net loss continues to decrease. Excluding non-cash items, our net loss for the fourth quarter of 2019 was approximately $34 million compared to $59.9 million in the third quarter of 2019 and $52.4 million in the fourth quarter ended December 31, 2018. The decrease we've seen in net loss as compared to the reference quarters is primarily related to decreased clinical trial and manufacturing expenses.
Our GAAP net loss for the fourth quarter of 2019, inclusive of non-cash items, was $39.6 million or $0.44 per share compared to a net loss of $53.9 million or $0.68 per share during the comparable quarter in 2018. Our net loss for the year ended December 31, 2019, excluding non-cash items, was approximately $161.4 million, which included approximately $56 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation for commercialization. The GAAP net loss for the year ended December 31, 2019, inclusive of non-cash items, was $172.9 million or $1.96 per share compared to a net loss of $173.5 million or $2.30 per share per share for the year ended December 31, 2018.
Turning now to our cash position. We ended the year with cash, cash equivalents, and investment securities of $140.4 million. With our major clinical programs, UNITY-CLL and the ULTIMATE MS program, continuing to near completion and the bulk of our manufacturing costs now behind us, we expect that our near-term R&D costs will continue to decrease. While we expect to modestly offset that decrease with some commercial launch and readiness costs, we believe our cash will be sufficient to fund our operations well into 2021, and importantly, through our Phase 3 readouts for UNITY-CLL and ULTIMATE in MS, as well as potentially our first approval in MZL and follicular.
With that, I will now turn the call over to Mike Weiss, our Executive Chairman and CEO.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Great. Thanks, Sean, and thanks, Jenna, and thanks everyone for joining us this morning. 2019 was an exciting year for us, and 2020 is off to a great start with multiple impactful catalysts on the way. But before I review all the great accomplishments of 2019 and what's in store for 2020, I want to start with an update on UNITY-CLL, which of course is on top of everyone's minds.
So let me remind everyone that the UNITY-CLL clinical trial is a randomized study of U2 versus the combination of the chemotherapy chlorambucil plus the CD20 obinutuzumab, which is marketed as Gazyva. This combination is referred to as GC. The primary endpoint is progression-free survival, and the trial is being conducted under a special protocol assessment with the FDA. This is an event-driven trial. I mean it can only end once a certain number of PFS events occur. A PFS event is when a patient dies or their disease progresses.
With that as a background, the quick update is that we have not yet hit the requisite number of events. To us, this is a very positive sign and further reinforces our confidence in a successful outcome, because the longer it takes for the events to occur, should point to a greater-than-expected benefit for the U2 arm. Based on our original projections, we would have expected a significant ramp in events over the past several months, which did not occur.
Accordingly, we believe we are either on the verge of a significant uptick in events, or that the U2 arm is providing greater benefit over GC than originally modeled. That, of course, assumes that the GC performance is relatively fixed within its historical range. However, since we are fully blinded to all the efficacy data, other factors, including GC performance -- outperformance could explain the slower-than-expected event rates. For a number of reasons, we believe that is less likely, but it certainly can't be ruled out.
So where does that leave us in terms of timing from here? The short answer is relatively unaffected as a result of some additional good news we'd like to share with you. To protect against this scenario where U2 is outperforming and because of that the results are unnecessarily delayed, we reached an agreement with the FDA to conduct an interim efficacy analysis, which would allow us to stop the study early for greater-than-expected PFS benefit. So despite the slower-than-anticipated event rate, we are still positioned to deliver data reasonably close to the timelines we have been discussing with a target to reach the necessary events over the next 30 to 60 days and then ideally no more than 30 days thereafter to the analysis and announcement.
As importantly, assuming this timeline to data is maintained, our overall submission timeline remains intact, which is to complete an NDA/BLA submission by the end of this year. As you can tell, we're excited about the prospects for a successful PFS outcome for the UNITY-CLL trial. We also greatly appreciate the FDA's willingness to work closely with us on including a PFS interim efficacy analysis, and we look forward to bringing this study to conclusion, if the data supports that.
With that, let's do a quick recap of some of our major accomplishments over the past 12 months. Our UNITY-NHL trial stole the spotlight in 2019; first, with the positive data from the marginal zone lymphoma or MZL cohort and later with the follicular lymphoma cohort. As a reminder, both of these cohorts evaluated umbralisib, our dual inhibitor of PI3K delta and CK1-epsilon, used as a monotherapy in relapsed or refractory MZL or follicular patients.
For the MZL cohort, we announced we've received breakthrough therapy designation and presented preliminary data during oral presentations at AACR, ASCO, and ICML, demonstrating approximately 50% overall response rate and approximately 20% complete response rate with a generally well-tolerated safety profile. We also received orphan drug designation for umbralisib to treat MZL.
For the follicular lymphoma cohort, we announced toward the end of the year that it too met the primary endpoint of 40% to 50% overall response. And importantly, for both cohorts, we initiated rolling submission of a New Drug Application for umbralisib, initiating our first-ever NDA was a major milestone for us. And we're extremely pleased by the FDA's guidance to include both MZL and follicular in a single submission. I want to thank our NDA team and our clinical sites for the incredible effort and dedication they've committed to completing this submission as quickly as possible.
In addition to the tremendous progress we had with the UNITY-NHL program in 2019, we also had multiple data releases, presentations, and publications, including the publication of the Phase 1 triple therapy combination of ublituximab, umbralisib, U2, and ibrutinib published in Lancet Haematology and the Phase 1/Phase 1b combination trial evaluating U2, which was published in Blood. We also announced that after almost four years of follow-up, our GENUINE study demonstrated that ublituximab in combination with ibrutinib improved PFS over ibrutinib monotherapy in patients with high-risk relapsed refractory CLL. We plan to share the data with the FDA to determine if there is any regulatory use for such data and plan to present the data at a future medical conference.
And at the end of the year at the ASH Conference, we presented two sets of triple therapy combination data. The first was the triple combination of U2 plus venetoclax where we presented early data that showed an 87% overall response rate after just three months of U2 therapy. That was prior to the introduction of venetoclax. This is in heavily pretreated patients with relapsed-refractory CLL, some of whom were BTK refractory. And then after we added venetoclax for a treatment period of an additional nine months, we reported a 100% overall response rate with a 100% undetectable MRD in peripheral blood and a 78% undetectable MRD in bone marrow. While small patient numbers, these preliminary results suggest that this triple therapy combination has significant potential in these heavily pre-treated patients. We look forward to more data from this study, including additional patients through longer follow-up.
The second presentation at ASH was the first-ever clinical data from TG-1701, our BTK inhibitor, including the first-ever proprietary triple therapy data from U2 plus TG-1701. This study is particularly important to us as it represents a significant step forward in our mission to develop novel therapies that can be used in combination with each other. This is the first triple combination study conducted where all the pieces are proprietary TG drug candidates, something that we believe will be a vital component to making these combinations accessible to patients if approved.
Finally, on the early clinical side we initiated Phase 1 first-in-human clinical trial of TG-1801, our anti-CD47, CD19 bispecific antibody and also presented first preclinical data for that compound. This mechanism of action seems to be generating some excitement recently, and we are excited to move this compound into combinations with U2 as soon as possible.
With that recap of 2019, let me conclude my prepared remarks with a brief recap of our ULTIMATE-MS program and some highlights of what to look for in 2020. As a quick reminder, our ULTIMATE I and II Phase 3 trials in relapsing forms of MS, our two independent, global, randomized, multi-center, double-blinded, double dummy, active controlled trials comparing ublituximab to oral teriflunomide. The primary endpoint for each study is annualized relapse rate following 96 weeks of treatment and designed to support submission for full approval of ublituximab in relapsing forms of MS. These trials are fully enrolled and being conducted under Special Protocol Assessment with the FDA. We are targeting top line data from these trials in the second half of this year.
The CD20 class plays an important role in the treatment of MS with the only CD20 approved for MS seeing its usage growing quickly and reaching approximately $4 billion in global sales in 2019. We believe CD20 usage will continue to grow as more physicians utilize the class earlier in the treatment paradigm. We also believe ublituximab's profile will be very competitive in this market providing significant value to patients with MS by offering a shorter one-hour infusion at a competitive price.
As you can see, 2019 was an exciting and impactful year for us, but we believe 2020 is the year for TG to really shine. Our hard work over the past years has brought us here, and we look forward to an exciting 2020 where we should see pivotal data for UNITY-CLL followed by completion of our MZL, FL, NDA submission, all of which we are targeting for the first half of this year, followed in the second half by pivotal data from our ULTIMATE-MS clinical trial, possibly our first NDA approval, and if all goes well with UNITY-CLL, an NDA/BLA submission for CLL before year-end. No doubt an action-packed and data-rich 2020 is on the way.
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 to make some concluding remarks.
Questions and Answers:
Operator
Thank you. At this time, we'll be conducting a question-and-answer session. [Operator Instructions] Your first question comes from the line of Alethia Young with Cantor Fitzgerald. Please proceed with your question.
Alethia Young -- Cantor Fitzgerald -- Analyst
Hey, guys. Thanks for taking my questions and congrats on a lot of the progress and it seems like it's going be an exciting 2020. Maybe three. One, I'm just a little curious about with GC like, is there anything related to maybe the baseline or that's being used in first-line that would lead to its outperformance. I just figured there must be some sort of hypothesis.
And then secondarily, a lot of times interims are kind of decided on earlier trials. So I guess I'm wondering, what points in broad strokes kind of got the FDA comfortable that you guys aren't -- that they were comfortable you taking an interim and spending the alpha, I assume to do that.
And then the third question is, is there any risk -- I think you sounded like there were some bolus events that should have occurred? I mean is there any risk of the bolus now occur faster than what you think and before an interim could occur in the next 90 days? Thanks.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Sure. So first question on GC outperformance. I mean, we certainly don't think GC is going to outperform. I think our personal belief is that GC is going to underperform certainly the CLL-11 study where it had about a 27-month PFS. In more recent trials, ILLUMINATE and ELEVATE, it had 19 months PFS in ILLUMINATE; 22 or 22.5 months of PFS in ELEVATE. Those are in frontline patients. And remember, you're going to almost cut that in half, give or take, just an approximate for the relapsed patients. So we think that it's more likely that the PFS for frontline patients using GC is going to be closer to the ILLUMINATE and ELEVATE than it would be to CLL-11.
One of the major reasons we believe that is that in CLL-11, they basically treated the six-month -- they did the six-month treatment period, they waited I think one month or two, they scanned the patients, and then all future scans were contingent upon the investigator basically recommending the patient for a scan. So they come in for an office visit. If they don't believe that they're progressing, they don't send them for a scan.
ILLUMINATE, ELEVATE, and UNITY-CLL were all regularly scheduled scans. So it was every three months, I think I believe in the first 24 months on study and then every six months thereafter. So our feeling is that when you're looking for it, you'll see more the investigators. When they're doing on their own, you just end up missing. And I think that's the difference between ILLUMINATE, ELEVATE, UNITY-CLL, and CLL-11 on the other hand. So again, we don't believe that there is any real good chance that GC is outperforming. It really wouldn't make much sense. We have a lot of recent information with the drug combination. So that's that point.
In terms of the interim analysis, we work closely with the FDA. I think, again, part of what we provided to them was information that we didn't have available when we started the study, which was ILLUMINATE and ELEVATE and studies like that, and also the U2 data that we didn't have. We didn't -- when we started the study, we didn't have any real information on U2 what we'd expect for progression-free survival, both for umbralisib and for U2. In recent studies that have been presented, the U2 -- while the U alone has about a 24-month PFS in the studies, U2 coming out of the Phase 1 was closer to 28 months.
So, again, I think post starting the study, a lot of information that is publicly available, both on GC and on U2, I think helped us to discuss with them adding the interim. And again, I think their -- they want to see the study and drugs get to market when appropriate. So I don't think there is any concern about the interim.
And then the last question was I just wrote any risks. What was the last part of that question, part three?
Alethia Young -- Cantor Fitzgerald -- Analyst
It was just a question like, I think you said there was a bolus of events that you guys expected to come. So I just wondered I guess is there any risk that now the interim you know that your bolus of events comes before you get to an interim, meaning the trial completes the final before you get to the proposed interim 90 days from now.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
I don't think so, but either way, it will be fine. If it ends up being a final analysis, because we do get a large bolus in over the next few months, I mean there is a lag in us getting event information, the scans come in, and then they're batched, and then we get them. So, yes, I mean, is it possible that there is a large bolus sitting there and then over the next several -- next several times we get scan reports, there will be a big bolus in there and we go to a final analysis, it's possible. I don't think it's likely. This thing has flattened out pretty good for us and -- But if it does, that's fine, too. If it doesn't, won't really impact us in any way. That would be fine. But when -- at the point in which we are in this trial, where our -- I think we're 28 months approximately, give or take, from the last patient in. Meeting and follow-up is probably in the 32-ish month range at this point, give or take. So we are out there.
We are well beyond -- even in the most rosy scenario, we are well beyond the GC median. If you look at the studies with GC, at this -- even looking at CLL-11 and obviously ILLUMINATE and ELEVATE, GC in the frontline will have provided about as many events as it's going to provide at this point. So the missing and one would, of course, expect that the GC relapsed patients have already given up all of those events, and one at this point of maturity the U2 relapse arm will have given up quite a bit of their events. So the only missing link is the U2 frontline patients and that's why we feel confident that what we're seeing is a substantial difference in what we expected and benefit. But I don't think it's a risk. If those events do come in, that's great. So we'll go to a final analysis. But we're already well beyond when we thought we would've had all those events based on the original powering.
And that's -- and just to go back, and we've talked about this for quite some time, where we were saying, look, our expectation is if the powering is correct, we should have these events in a certain timeframe and that's why we were expecting the events in the timeframe which we had just passed through. We didn't say it -- again, I think the short answer to your question is there's no risk. If it happens that's great. If not, we've got the interim. So we have a hedge basically. We're going to -- study is going to be completed essentially in the timeframe that we've discussed. It's either going to be via an interim or via the final; more likely via the interim at this point.
Alethia Young -- Cantor Fitzgerald -- Analyst
Okay, great. Thanks. That's helpful color.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Your next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.Hi, good morning, guys. Thanks for the color. Just wanted to -- since it's new for us, just dig into a little bit more into the mechanics of the interim. You kind of walked through kind of quickly how it's going to work in your prepared remarks, but can you kind of set the stage again on how it will work?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes, I mean it will be hopefully relatively straightforward. Again, there is a set number of events for that interim. Once those events are in, which like we said, we expect those will be in, in the next 30 to 60 days. Soon as that's in, you can basically lock the database for that interim and then hopefully it will take no more than 30 days to get that data put together. There is a delay in which they are basically reading all the scans and making sure what is there is there. And so once that occurs, we should have the data out soon thereafter.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
So I guess on that interim analysis, it's potential that you could see that you could see that GC hit its median PFS while the UNITY U2 arm did not. And so in that case, it still hasn't hit its median PFS. Is that a data set you could file on?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes. So it's all based on hazard ratio. So the medians are useful in creating the differences, but the hazard ratio takes into account the entire curve. And so just by way of example, in ILLUMINATE, in ELEVATE, in MURANO, in CLL-14, none of the active arms reached a median when the studies were stopped. So it's not -- it's actually more rare to see the active arms reach a median in these recent studies than it is to see them reach a median. And those all studies obviously were fine. And, of course, this interim is under the Special Protocol Assessment. But no, it's based on a hazard ratio, and it does not necessarily need to have hit a median for the active arm.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Thank you. Perfect. And just switching gears a little bit to your pipeline, I guess the ULTIMATE program. Can you give us a sense in terms of, if that reads out positive in terms of I know relapse rate, what the position of ublituximab could be in the MS market?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes. So we would expect, at this point, that that will be the third CD20 to market. You've got ocrelizumab, which is on the market and is selling, as we mentioned earlier, almost $4 billion in 2019. Ofatumumab, formerly ARZERRA on the cancer side, will be rebranded -- I'm not sure what the new brand name is -- will be rebranded and brought forward. That application is in to the FDA, and so the expectation is in the next six to nine months or so, there'll be on the market. And then we will come in after that. To my knowledge, there is no other CD20s in development or late-stage development for MS.
So I think that the CD20 portion of this market, at least for some foreseeable timeframe, will be locked as the three competitors. In terms of positioning, there'll be two drugs, assuming, of course, that we get approved and assuming, of course, that ofatumumab gets approved there'll be three drugs on the market. Two of them, ocre and ubli will be IV infusions, and ofatumumab will be a -- after three weeks in a row of subcu injections in the office. It will be a take-home one month or every month subcu injection. So it's going to come down to personal preference is what we've been hearing. It will be -- actually personal preference in access.
So depending on -- if the patient has access to all three compounds, the physician will have a discussion with them on what their preference is, do they want to self-inject themselves, do they want a IV infusion. If they want an IV infusion, we think we have a very competitive profile where we'd hopefully be able to offer a very competitive price, but ours will be a one-hour infusion versus currently a three- to four-hour infusion for ocre.
So I think we'll do quite well with the convenience factor. And again, hopefully, if we're -- if we can get it done, we can try to bring a product that could even be less of a financial impact to the patients themselves. So I think we've got a nice position in this marketplace. It's a pretty tight market. Projections are that this market could be -- just the CD20 portion of MS treatment could be upwards of $10 billion to be shared by three companies. I think that's a pretty good place to be, and obviously we're super excited about it.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Great. Thank you. And then last question, I guess since November, there has been building excitement around the anti-CD47 class of products, culminating yesterday with the Forty Seven [Phonetic] buyout for almost $5 billion. Can you give us some more detail on your anti-CD47 bispecific program and how that fits into that landscape?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes. So our CD47 has and I say this in a positive way as some limitations. So it's been basically attached to a CD19. So there's two arms to this antibody. There's a CD47 arm and a CD19 arm. And this drug is designed specifically to attach to CD19 positive cells. So the good news is that it should ideally avoid some of the hematological toxicities associated with targeting CD47 on a naked basis, and the further good news is that for a company like ours where we're focused exclusively on B-cell malignancies that landing on CD19 is a perfect complement to our mission, which is to find the best treatments available for patients with B-cell malignancies. So it's a highly targeted agent that's focused on CD19 positive cells and once it's there, engages and blocks CD47.
And what we've seen with the other CD47 compound is that in combination with CD20 -- actually on its own, the CD47 and B-cell malignancies, the naked version on its own is relatively inactive as a single agent. It had dramatic activity once you mixed it with CD20. So I guess two things of note; one, this drug already has its own CD20-like activity. Since it as a CD19 arm, it will have a similar activity to CD20. And then, of course, we have ublituximab to combine with this compound. So we are very excited to commence the combinations of our CD47 with U2, particularly in things like follicular marginal zone in CLL where U2 looks to be quite active. And again, in diffuse large B-cell, we're still waiting to hear more, but the CD47 and CD20 combination looks quite interesting. So we're looking forward to trying ours in that setting as well.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Thanks, Mike. And congrats on the progress.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Thanks, Matt.
Operator
Your next question comes from the line of Ed White with H.C. Wainwright & Company. Please proceed with your question.
Ed White -- H.C. Wainwright & Company -- Analyst
Hi, guys. Good morning.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Hey, Ed.
Ed White -- H.C. Wainwright & Company -- Analyst
Hi. So just a follow-up on the 1801. When will we see the next data from this study?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
So you're being generous by saying next. You really meant the first.
Ed White -- H.C. Wainwright & Company -- Analyst
First -- saying first.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Very generous. So the first data, I would expect that for sure -- I shouldn't say that for sure. I would expect certainly by ASH we'd be able to present a reasonable portion, if not all of the Phase 1 trial -- well, not all because there'll be longer follow up, but I think certainly we'll be through the dose escalation phase. It's plausible that we could do some early data at EHA, but I think it's -- sometime EHA to ASH is the most likely scenario. We're in the dose escalation. We think we're getting close to finding a dose. And then once we get there, we'll be able to do some expansion and start the combinations. So we're on the precipice, but we're still trying to figure out the right dose.
Ed White -- H.C. Wainwright & Company -- Analyst
Okay, great. Thanks, Mike. And just maybe if you can give us an update on the Phase 2 ULTRA-V trial. This data was very exciting at ASH and just talk about your expectations for the trial in ultimately where it's going to fit in the treatment paradigm if the data holds up.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes. So ULTRA-V is taking off. So enrollment has really started to kick in as we got into the early part of this year, which we're still in, but things are starting to roll along. I'd say we're, give or take, about a third of the way through enrollment. But it's really all been in the last two months or so. So it's moving quite well. Our goal is to have that fully enrolled before the end of the year. I would also just mention that ULTRA-V is that larger multi-center Phase 2, but the Phase 1 which we do have open at I think at least two, maybe three sites has also continued to enroll, and I think we're at 30-plus patients in there. So collectively we may have 60-plus patients, maybe even more, on the U2 plus venetoclax combination at this time. So we're looking forward to a -- hopefully be a nice update at ASH this year with a significant number of patients. Again, the only drawback of this trial design, but there's no way to control it, is that the 12 month is where we basically look at the bone marrows to assess undetectable MRD.
So we'll see how many patients we actually have through 12 months at this coming ASH. But we'll have patients through interim periods and we'll be able to show obviously the safety profile of putting these things together and the ability to take venetoclax high- and medium-risk patients and drop them down to low-risk. There'll be plenty of information. Where do we see this regimen today in the U2 plus venetoclax? Right now venetoclax is primarily used in academic centers. It's used in some community centers, but it's not as popular. Certainly it's not as popular as it is today in the academic centers. And I think all the reasons for that are pretty well known to folks.
But we do believe that over the next five years, it will be accessible across not just the academics but into the community. And when it is, we want to make sure that this combination is something that folks consider. We think that it's -- anytime you want to use venetoclax, we want physicians to have a choice, whether they want to use venetoclax with Rituxan, they want to use venetoclax with obinutuzumab, or they want to use venetoclax with U2. Obviously, we would like them to use venetoclax with U2. We think at least from the early data that we presented, obviously there will be a lot more data, and we'll see if it holds up.
But as we've seen it thus far, it's the best data we've seen in combination with venetoclax. And again small patient numbers and we need more maturity, but if that all holds up, we'll make the case that if you want to -- you want the best chance of getting your patient to undetectable MRD using U2 plus venetoclax versus simply using a CD20 with venetoclax is a better approach. So that would be our positioning assuming the data supports that. And we think that again academically that would be the first place. But over the next five years, as venetoclax permeates the community, we want to make sure that folks are able to use U2 with venetoclax as well.
Ed White -- H.C. Wainwright & Company -- Analyst
Great. Thanks, Mike. And maybe just a last question for Sean. The G&A non-cash comp was significantly higher in the fourth quarter of '19 versus pretty much all prior quarters. I'm just wondering if this is a one-time impact, what's going on here, or if this is the new base going forward? Thanks.
Sean A. Power -- Chief Financial Officer
Thanks, Ed. That stuff tends to be a little bit lumpy from quarter to quarter. I would say it's more likely a one-time bump in that than a new base.
Ed White -- H.C. Wainwright & Company -- Analyst
Okay, great. Thanks, Sean.
Operator
Your next question comes from the line of Chris Howerton with Jefferies. Please proceed with your question.
Chris Howerton -- Jefferies -- Analyst
Great. Yes. So I think most of the important questions were asked. And maybe just a couple clarifying ones with respect to the interim analysis. So what are the actual outcomes that can happen here? Is this a success/failure question only, or is there a possibility that the study would continue as a result of the interim analysis perhaps with an increased sample size or something of that nature?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes. So thanks for the question, Chris. So the sample size is set. The total events for a final analysis, as I was kind of discussing earlier, maybe not so clearly, but there is a set number of events for the final analysis that's been -- that was predetermined when we started the trial. There is another smaller number of events that is set for the interim. So, yes, there is two outcomes it can -- the study could stop for efficacy or would continue on to the final analysis.
If the final -- again, which goes back to our point of -- if we're going to a final analysis, there should be a spike in events pretty soon. I mean it's inconsistent with statistics and with life for the study to not stop and also not to see the events, something has to give. Again, unless GC is so much better than it's ever been in any trial, it's not inconsistent that one of the two things had to happen. Either the study stops because it's working so well, or we're going to wake up in the next few weeks and there's going to be a lot of new events. It just can't be that magically there is no events and also there's not a differential.
Chris Howerton -- Jefferies -- Analyst
Sure, it totally makes sense. And then I guess maybe could you give us a frame of reference in terms of the percentage of patients that would be required for a PFS event for the full relative to the interim? Like how big of a difference are we talking about here? And how might this relate to other trials that are PFS driven in terms of percentage of patients?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
I don't know that I can speak to how this would impact other studies that are being reported as PFS.
Chris Howerton -- Jefferies -- Analyst
Not impact, but just with other PFS-driven trials, they have a certain percentage of their patients that would need to experience an event. How would you relate your percentage of patients that require event, both in the final and the interim analysis just in terms of other oncology trials that are event driven and this nature?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes, I mean I think this -- I still don't fully understand the question, Chris, but I'm just going to answer your question that I think I'm going to -- I think you're asking which is...
Chris Howerton -- Jefferies -- Analyst
Okay.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Sorry about that.
Chris Howerton -- Jefferies -- Analyst
No problem.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
I think this interim analysis is relatively consistent with other studies that have been conducted in the B-cell space where there have been early stoppage for activity.
Chris Howerton -- Jefferies -- Analyst
Okay, all right. Well, I think that's all my questions. Thank you so much. And really look forward to updates in the future.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Great. Thanks, Chris. Appreciate it.
Operator
[Operator Instructions] Your next question comes from the line of Mayank Mamtani with B. Riley FBR. Please proceed with your question.
Mayank Mamtani -- B. Riley FBR -- Analyst
Thanks for taking my question and congrats team on the progress. Just on UNITY-CLL, if -- I mean there were a couple of monotherapy arms that were also part of the study originally. I was just curious if that added any value to some of the recent dialog around the interim or the full analysis. And then I have a follow-up question on the rolling submission
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Sure. So the short answer is no. The single agent arms were not part of the conversation. It is purely based on just the timing of events and the new information from other studies outside of our trial that impacted that discussion.
Mayank Mamtani -- B. Riley FBR -- Analyst
Okay. Is there a median -- maybe clarify on that? Is there a median on that has been raised?
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
I don't have that information.
Mayank Mamtani -- B. Riley FBR -- Analyst
Okay, great. And then on the rolling submission, is there a follow-up -- and I understand there's a lot of non-clinical elements of the filing also going in. I'm just curious, is there a particular follow-up you need to go for MZL or even FL that informs when you could kind of got the data and submit the package.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
So there is, but it has passed, yeah. So there was definitely a requested minimum follow-up by the FDA. We haven't actually disclosed exactly what it was, but that has now passed. So our databases are locked, and they're cleaning everything and getting the CSRs in place. And so, yeah, it's all happening, but there was a requested minimum follow-up from the FDA.
Mayank Mamtani -- B. Riley FBR -- Analyst
Okay, great. And the next one is maybe for Sean and Mike both. As you think about the R&D next 12 months to 24 months, like, which is the -- which is like a bigger study that you might be thinking about? I understand a lot of earlier-stage studies are dose escalation. But if you think about advancing any of the triple therapy to maybe get to a finite duration cure like regimen for CLL like what should we expect that could be a larger study in the next 12 months.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes. So I think in the next 12 months, things that we are considering -- well, one thing we will have to do is a randomized trial in follicular and marginal zone lymphoma. As part of assuming all goes well and we get approved, we will have a post-approval commitment to run a randomized trial. So that study will, again, based on the timelines of when we would hope to be approved that study would certainly have to start within the next 12 months. So that would be one study. And then, yes, turning back to the triple therapy. We are positioning U2 plus our BTK inhibitor 1701 for Phase 3 trial that ideally we would like to get up and running within the next 12 months.
Some of it is contingent on making sure we've identified the right dose for the combination together. But that is something we would like to be able to do if possible. And then the other part of it is, yeah, the other one would be U2 plus venetoclax to assess whether a randomized trial would be required. So that's I think on the docket for exploration. We're certainly going to look at the ULTRA-V data plus our Phase 1 data and assess the usability of that data for perhaps an accelerated approval, which would certainly -- if that were the case, it would lead to a requirement for a randomized. And if that's not usable, we'd also consider starting a randomized in that triple combination as well.
Mayank Mamtani -- B. Riley FBR -- Analyst
Great. Thanks for the helpful color.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Yes. Anytime.
Operator
Ladies and gentlemen, we have reached the end of the question-and-answer session, and I would like to turn the call back to Mr. Mike Weiss for closing remarks.
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Great. Thank you very much, and thanks all for joining us. Let me just wrap up today's call once again by reviewing the upcoming key goals and objectives. So, first and foremost, we expect to have the top line PFS data from the Phase 3 UNITY-CLL trial over the next 60 to 90 days. Soon thereafter, we are targeting completion of our first rolling NDA submission for patients with previously treated marginal zone lymphoma and follicular lymphoma, again, also first half of this year. Heading into the second half, we are targeting top line data from the ULTIMATE Phase 3 trials in relapsing MS. And if all goes well, toward the end of the year, we could possibly have the first approval for MZL and/or follicular, and also by the end of the year, we'd like to, again, assuming all goes well for UNITY-CLL, we'd like to have that submission in before the end of the year.
And then, finally, of course, we will continue to advance our early development pipeline 1501, 1701, 1801, all as single agent, but also in combination with U2 and our other pipeline products. So on behalf of all of us at TG, I'd like to thank, of course, our investigators and their patients. Without them, we wouldn't be anywhere, and of course our employees also without them we wouldn't be anywhere, and our shareholders for their continued support. So thanks again everyone for joining us and have a great day.
Operator
[Operator Closing Remarks]
Duration: 49 minutes
Call participants:
Jenna Bosco -- Senior Vice President, Corporate Communications
Sean A. Power -- Chief Financial Officer
Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer
Alethia Young -- Cantor Fitzgerald -- Analyst
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Ed White -- H.C. Wainwright & Company -- Analyst
Chris Howerton -- Jefferies -- Analyst
Mayank Mamtani -- B. Riley FBR -- Analyst
