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Edited Transcript of TGTX earnings conference call or presentation 9-Aug-19 12:30pm GMT

Q2 2019 TG Therapeutics Inc Earnings Call

NEW YORK Aug 16, 2019 (Thomson StreetEvents) -- Edited Transcript of TG Therapeutics Inc earnings conference call or presentation Friday, August 9, 2019 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jenna Bosco

TG Therapeutics, Inc. - VP of IR & Senior VP of Corporate Communications

* Michael S. Weiss

TG Therapeutics, Inc. - Executive Chairman, CEO & President

* Sean A. Power

TG Therapeutics, Inc. - CFO, Corporate Secretary & Treasurer

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Conference Call Participants

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* Alethia Rene Young

Cantor Fitzgerald & Co., Research Division - Head of Healthcare Research

* Christopher Lawrence Howerton

Jefferies LLC, Research Division - Equity Analyst

* Edward Patrick White

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Matthew Lee Kaplan

Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research

* Peter Richard Lawson

SunTrust Robinson Humphrey, Inc., Research Division - Director

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Presentation

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Operator [1]

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Greetings, and welcome to TG Therapeutics Q2 2019 Earnings Conference 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, Corporate Communications. Please go ahead.

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Jenna Bosco, TG Therapeutics, Inc. - VP of IR & Senior VP of Corporate Communications [2]

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Thank you. Good morning, and welcome to our conference call regarding TG Therapeutics Second Quarter 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, 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 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 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 second quarter of 2019 as well as the company's overall financial condition.

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Sean A. Power, TG Therapeutics, Inc. - CFO, Corporate Secretary & Treasurer [3]

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Thank you, Jenna, and thanks, everyone for joining us. As you may be aware, our financial results were released this morning and can be viewed on the Investors and Media section of our website.

Our net loss for the second quarter of 2019 excluding noncash items was approximately $34.4 million. The GAAP net loss for the second quarter of 2019 was $36.2 million or $0.42 per share compared to a net loss of $44.1 million or $0.59 per share during the comparable quarter in 2018. As we had expected, our R&D spend continues to taper as the registration directed trials in both oncology and MS progressed into 2019, thus contributing to our decrease in net loss versus the comparable period in 2018. We expect this trend to continue through the remainder of 2019.

Our net loss for the 6 months ended June 30, 2019, excluding noncash items, was approximately $67.6 million. The GAAP net loss for the 6 months ended June 30, 2019, was $71.4 million or $0.85 per share compared to a net loss of $85.7 million or $1.18 per share for the 6 months ended June 30, 2018, which included a decrease in clinical trial expenses of approximately $10.4 million over the comparable period in 2018, primarily related to our clinical programs for ublituximab and umbralisib having completed enrollment during 2018. Partially offset by an increase in manufacturing and CMC expenses of approximately $4.7 million related to Phase III clinical trials and in preparation for commercialization.

Moving on to our cash position. At June 30, we had cash, cash equivalents and investment securities of $85 million. To ensure that we remain well positioned to execute on our goals, subsequent to the quarter end, we continued to opportunistically utilize our ATM sales facility to raise additional proceeds of $11.6 million for a proforma cash position as of June 30 of approximately $97 million. We have continued to streamline our spending and focus resources on our critical clinical programs. And for the remainder of 2019, we expect our quarterly cash burn to average roughly $25 million. With that said, we believe our current cash position, inclusive of those proceeds raised during the third quarter and future availability under the ATM will be sufficient to fund our operations through the third quarter of 2020.

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

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [4]

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Thank you, Sean, and thank you, Jenna. And thank you all for joining us this morning. It's exciting times here at TG as we prepare to initiate our first NDA filing around year-end and as we start to build our commercial team. We see many important value-creation milestones, all of which are now within approximately 12 months from today, including final marginal zone lymphoma data and marginal zone NDA filing, UNITY-CLL data and NDA and BLA filings associated with that study, and finally, our ultimate MS Phase III read out. It's nice to see the years of hard work by so many at TG heading towards fruition.

Let me now briefly review some of the -- this year's major accomplishments. Most notably, we announced confirmation following our meeting with the FDA that we believe we have a registration path forward to submit umbralisib for accelerated approval and we are now anticipating the initiation of an NDA submission around year-end. We also have the opportunity to present positive interim results from the marginal zone lymphoma cohort in oral presentations at ASCO as well as at ICML, receiving positive feedback from many key opinion leaders in the U.S., and abroad. At ICML -- at the ICML meeting, we also presented data from our study of single-agent umbralisib in 51 CLL patients who are intolerant to, that is to say they discontinued due to toxicity from a prior BTK inhibitor or a prior PI3K delta inhibitor. We were very pleased to report that in those patients umbralisib was well tolerated with only 12% of the patients discontinuing due to an adverse event, which is significantly below what has been reported for other PI3K delta especially in patients who already demonstrated an inability to continue on a prior BTK or PI3K delta treatment. Additionally, for patients on the study, we reported an estimated median progression-free survival of 23.5 months. For those of you who have been following the UNITY-CLL trial, you may recall that we are targeting approximately 24 to 30 months of progression-free survival for the U2 combination of umbralisib plus ublituximab in patients with relapsed refractory CLL. So it's encouraging to see single-agent umbralisib perform at around that level.

At ICML, we also presented data from our U2 combination with the PD-1 inhibitor in patients with relapsed refractory CLL and in patients with Richter's transformation. In the relapsed refractory CLL patients, we saw an overall response rate of 91%, and notably, 4 of the 6 BTK refractory patients responded to U2 alone, prior to any introduction of the PD-1 inhibitor, and a 5th patient that was refractory to BTK responded upon triple therapy for an overall 83% response rate amongst BTK refractory CLL patients. Patients with BTK refractory disease with or without BTK mutations represent a challenging patient population. So it is encouraging to see U2 working in those patients. It also gives us further confidence in the activity of U2 in relapsed refractory CLL, again a patient population in our UNITY-CLL trial.

In the Richter's patients, another particularly challenging disease to treat, 3 of 8 patients responded to triple therapy, including CAR-T failures. Richter's is a very aggressive, transformed type of CLL, for which nothing is currently approved. On the MS side, we presented long-term follow-up data from the Phase II trial of ublituximab in patients with relapsing forms of MS, showing ublituximab continued to be well tolerated with a median duration of follow-up of 97.5 weeks, which is just a little bit longer than the 96 weeks in the ULTIMATE-MS Phase III trials, so nice to see the continued tolerability of the drug through that time point.

Now let me quickly provide some updates from our ongoing pivotal trials. Let's start with the marginal zone lymphoma cohort from our UNITY-NHL study, where 69 patients were treated with single-agent umbralisib and the primary endpoint for this single-arm study is overall response rate as confirmed by an independent review committee. We've previously announced that the study met its primary endpoint of a targeted 42% to 50% overall response rate for all 69 patients enrolled, and we presented interim data on the first 42 patients during oral presentations at 3 major medical meetings showing a 52% overall response rate. Additionally, we have received breakthrough therapy designation and orphan drug designation from the FDA for umbralisib in the treatment of marginal zone lymphoma. Most recently in June, as alluded to earlier, we met with the FDA and confirmed our path forward to submit umbralisib for accelerated approval in patients with relapsed or refractory marginal zone lymphoma. We anticipate the initiation of a rolling NDA submission around year-end. This is extremely exciting for us as we move closer and closer to bring umbralisib to patients with marginal zone lymphoma, the second largest form of indolent lymphomas with approximately 75 new cases each year in the U.S. alone and with an estimated approximately 3,000 patients relapsing each year in need of treatment. This represents a sizable patient population, and we are currently building our commercial and medical teams to ensure broadened awareness and adoption of umbralisib, if approved.

Next, let me provide a quick update on our UNITY-CLL trial, which is a randomized study of U2 in patients with both treatment naive and relapsed refractory chronic lymphocytic leukemia. The primary endpoint for this trial has and continues to be progression-free survival. As we've said previously, we hope to have results from this study around year-end or into early next year. But as this is an event-driven trial, it's challenging to accurately predict the timing. We remain extremely optimistic about this study and the prospects for a successful outcome. We think it is extremely important to note that the DSMB regularly meets to review safety from this study, and to date, no safety issues requiring modification of the trial have been noted. Since there are no currently approved PI3K deltas in first line CLL, in large part due to safety concerns, this is highly encouraging to us.

Next, let's review our MS program. We have now presented final 48-week data from our Phase II MS trial as well as long-term follow-up data from this trial's open label extension. Highlights from the final Phase II data set include annualized relapsed rate of 0.7 as well as 100% reduction in gad-enhancing lesions as measured by MRI. Data from the open label extension continues to show that ublituximab is well tolerated, again, with a median follow-up of 97.5 weeks. We believe the Phase II results are highly supportive of our fully enrolled ULTIMATE Phase III program and our belief that ublituximab can deliver a best-in-class profile that includes comparable to better efficacy, comparable safety, convenience and price over anti-CD20 MS therapies.

Ocrelizumab is the only anti-CD20 approved for MS and is anticipated to generate approximately $4 billion in revenues in 2019, only in its second full year following launch. As we've mentioned before, this is a large market and one of which we believe we can provide significant value to patients with MS.

And finally, I wanted to briefly mention our early-development pipeline which continues to progress with three compounds now in Phase I and dose expansion cohorts. We have previously discussed early activity seen with our BTK inhibitor and hope to present more data from this study later this year. Dose escalation continues for our novel anti-CD47/CD19 bispecific antibody with the hope that we can identify a dose to begin expansion cohorts early next year.

With that, I'd like to turn the call over to conference operator to begin the Q&A session, following which I will return and provide some concluding remarks.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question today is from Alethia Young of Cantor Fitzgerald.

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Alethia Rene Young, Cantor Fitzgerald & Co., Research Division - Head of Healthcare Research [2]

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Congrats on all the progress. Just a couple. One, I just wanted you to kind of comment on how you're thinking about timelines with follicular. I know that it's kind of the third thing. And you have a lot going on. But just wanted to get an update on that thinking. And then the second question I had is, can you talk a little bit about how to think about kind of control arms comparisons for ublituximab and chlorambucil on your CLL study, whether it be frontline key comps or refractory key comps? And then my last question is just kind of how much data we expect to have for venetoclax in U2, ASH, and kind of how do we think about what might be a good response rate in that population.

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [3]

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Sure. So start at the top. So timelines with respect to follicular, given what we know now about the FDA's expectations for follow-up, the expected follow-up for the follicular as per what we expect FDA would be looking for would land us sometime probably in the late first quarter. And then so, again, I think data perhaps maybe sometime in the second quarter is about the early assessment again. And that will be a function of capacity and resource at that time to process that data. We will be hopefully very deep into CLL preparation for filing and would have completed the marginal zone filing for umbralisib single-agent. So -- but we know that they want enhanced follow-up. And so for sure, no earlier than 2Q is expected. In terms of the control arms for the CLL study or data on the control arm from the CLL study, so GC has been used in several frontline trials recently. The most -- I think the most near -- nearly -- recently completed comparable trial would be the ILLUMINATE trial that has readout where they used GC for 6 months, which is what they used in the label and what they used in CLL-11. In the ILLUMINATE trial, GC and frontline patients had a 19-month progression-free survival. In CLL-11, which is in the label for GC or for G, maybe C2, but G for sure, they have about a 27-month or a 28-month PFS in frontline. The difference between the two studies I believe is that for the CLL-11 trial, they did not require regular scans. So patients were only suspected of progression when they were brought in for scans and even in some cases they weren't even brought in for scans, they were just physician-determined progression. With ILLUMINATE, I believe they continue to have regular scheduled confirmation scans, and so more likely to pick up progression, and I think that's much more similar to how we've run our trial. But our current estimate is that somewhere between 19 to 27 months is the likely PFS for the GC arm in frontline patients. And remember, we have a blended -- we've included both frontline and relapsed/refractory, so the PFS for GC is going to be somewhat below what one might expect in frontline patients. There's not a whole lot of data on GC in relapsed patients. But we think a reasonable comp is looking at BR in that patient population and BR whether it was in the HELIOS trial or in MURANO, it's approximately 12- to 15-month progression-free survival for chemo-immunotherapy, which would be GC or BR in relapsed patients. So on a blended basis, you have about 40% of the patients who are relapsed-refractory in our trial, about 60% were frontline. So if you got a range of 12 to 15 months for the relapsed patients in the control arm, 19 to 27 or 28 months in the frontline, I think that leaves us we've done the blended and we think its neutral arm should be somewhere maybe between 20 and 22 months of PFS is how we are thinking about it. And as you saw in the -- or at least -- or you saw at ICML and heard in my prepared remarks, in our most recent Phase II where we treated 50 patients with CLL, pretty tough population as all these patients had previously seen BTK or PI3K delta. All of them were predisposed to having tolerability issues. Very few of them actually came off study for tolerability on our drug. But also we were able to show about a 24-month progression-free survival for single-agent umbralisib, which again we think is a good indication, we've always been saying we think 24 to 30 months for U2 in relapsed patients is about where we would hope to see it. Obviously, we think there'll be proportional improvement in frontline. But if you look at 24 to 30 months in relapsed patients versus 12 to 15 months for GC/BR in relapsed patients, we think we've got a pretty good cushion to be successful both in relapsed patients and in frontline patients, and most importantly, in the entire population, which is the primary endpoint for the trial.

And then to the third question, the data on U2 plus venetoclax, we have an ongoing Phase I trial of U2 post venetoclax. We do think that in the future that is a regimen that has some importance because we do think at some point in the future that the market is going to move toward fixed duration treatments. We think U2 plus venetoclax is a great alternative to any BTK-based treatment plus venetoclax or any CD20-based treatment plus venetoclax. And in terms of the amount of data, I think we'll see probably around 10 patients with at least a year of follow-up, which again is the mark that you're looking for. These are heavily pretreated patients. I think anywhere in and around 50% CRs/and/or/MRD negative rate would be quite impressive. Again, these are relapsed patients. Of course, once we get a chance do frontline patients, we'd expect that to be higher. But I think if we have 50 CR/and/or/MRD negative that would be pretty impressive.

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Alethia Rene Young, Cantor Fitzgerald & Co., Research Division - Head of Healthcare Research [4]

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Can I ask one follow-up on the first comment you made. When you say on follicular enhanced follow-up, is that a year that the FDA is looking for or is that longer?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [5]

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We haven't disclosed exactly what that is. But suffice to say it's more than a year.

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Operator [6]

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The next question is from Matt Kaplan of Ladenburg Thalmann.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [7]

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I wanted to just dig into the rate winning steps for the marginal zone NDA filing and then if you could talk about really kind of the marginal zone opportunity in the competitive landscape for umbralisib as well?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [8]

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Sure. So in terms of...

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [9]

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Other questions as well.

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [10]

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Should I answer these now and wait for the next question? You want to keep hitting me with questions?

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [11]

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No, why don't you do these first.

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [12]

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Sure. So the rate-limiting step for marginal zone lymphoma filing, essentially, again, as I sort of alluded to earlier, the FDA is definitely looking for enhanced follow-up, which puts our clinical data towards the end of the year, which gives us a short time window to get the final data cleaned and prepped and put into a filing. So I think most of the other sections should be done and the clinical section will probably be the last section that goes in to the package. In terms of the marginal zone market and competitors out there, there is 2 approved agents, one -- or two approved regimens. One is ibrutinib, which was approved based on accelerated approval. They had about a 45%, 46% overall response rate, and I think a 2% complete response rate. So it's a good treatment option for patients with marginal zone lymphoma. It is obviously not a cure for the disease nor is it as robust as it is in CLL. Duration of response I think is in the 12 to 15 months range. But it's a good drug. It's far from a cure. And then you have R-squared which was recently approved and received full approval. There I think the data is somewhat mixed in terms of what happened in that trial. I think the response rates were in excess of the Rituxan control arm, but the PFS and overall survival, PFS I think was equivalent and overall survival I think was inverted in some way. So there were some interesting effects. R-squared -- having said that, R-squared has been available to patients with marginal zone lymphoma and follicular lymphoma for many years. Obviously, Celgene wasn't able to promote it during that time. But I think from an awareness standpoint, folks who had an interest in using R-square for marginal zone have been well aware that that's an option for them. So I think that R-squared approval, my guess is that the teams that are going to be promoting that will be focused heavily on follicular lymphoma and marginal zone because of I think the interesting parts of that data set are less likely to be heavily promoting into marginal zone. So having said all that, we think that marginal zone is a relatively open field for us. Obviously, there's other agents but we don't think that they're the focal points for promotion of those drugs. And we think we have the best option for those patients. We think in comparison to ibrutinib-based therapy, we have the ability to induce responses more quickly in terms of median time to response, ours so far in the interim is about 2.5 months versus 4.5 months for ibrutinib. RCR rate is nearing 20% versus a 2% CR rate for ibrutinib. And we have a keen interest in building a marginal zone franchise. I don't think that any other company in the world has as much interest in building that franchise. We think that not only are we going to be focused on marginal zone with umbralisib but our next step is marginal zone with umbralisib plus ublituximab in the U2 regimen, which we think is a really -- should be a very strong option for those patients. And then we plan to build even further with U2 plus our BTK inhibitor. So I think we plan on really focusing in building out a presence in the marginal zone community. We think with that promotion and with the best treatment option available for patients that that's a market that we can really see a major impact in.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [13]

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And then just with the UNITY-CLL, I know you're talking about the timeline there with respect to readout you got later this year, early next year. Can you -- I guess, do you have visibility to the event rate there, so that it allows you to fine-tune and predict readout?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [14]

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Yes. I mean, periodically we do get updates on the total events in the trial. And I think it's -- it is a bit like enrollment curves. You think you know what's happening and you hope you have a good visibility, but things can change. And again, when its events, it's kind of the inverse of an enrollment curve right where you see this hockey stick and towards the end of those trials they keep rolling in an event-based trial, you've got a big bolus and then you don't know exactly when you're going to start to see that curve flatten out. So that creates more of the mystery here, which is, when that curve flattens out and you start to trickle in events, so again I think we have good visibility that we feel like we can get to the events towards the end of the year and into early next year. But we could hit a point where we get a flat curve and then things start to trickle in and it takes a little bit longer. So at this point we feel pretty good about where we are, based on what we're looking at in terms of the events, but we still want to be cautious.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [15]

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Okay. That's very helpful. And then with respect to your pipeline, can you talk a little bit about the competitive landscape in the BTK space? I guess, some companies are getting attention for their non-covalent BTK data in a few handful of patients. I guess, what's your perspective here on the -- given your internal BTK program?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [16]

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Yes. So I think the -- two parts of that. One is our own BTK program and where we see it fitting in and then where we see non-covalent inhibitors fitting in. I'll start with the non-covalent and then I'll talk about how we are viewing our BTK program, which I think is somewhat unique and again just goes to the whole culture and philosophy of TG and our combination approach. But with respect to the non-covalent inhibitors, obviously, we've watched closely what's happening there, and the interest by investors in that area. To us it is a interesting academic exercise to try to identify patients with the mutation and then treat them with a drug specifically for that mutation, it certainly is something that you can see the marketing and intuitive neatness of that. However, U2, as we described in that pembro or PD-1 poster, out of the 6 BTK refractory patients, 4 of them responded to U2 alone in the first three months before they even saw pembro. So I think when we think about the market and how these patients are actually going to be treated versus this academic exercise of thinking about these mutations, they're going to be treated with whatever is in front of them, which will be U2 before people start testing, recall we again -- CLL is a market that is driven by community practices, 80% -- 85% of these patients are treated locally because this is a chronic condition. And you may recall from all our genuine wows in the old days when they just weren't even testing for mutations or for genetic risk factors, the community is very unlikely to be focused on this mutational stuff there. They're much more focused on, I have U2, it works in patients that I've already seen BTK, whether they have a mutation or no mutation, no one really cares all that much. They're going to treat them with the easy, effective treatment that's sitting in front of them. And again, I think in academic centers, you will see more people working off of the genetic information and making them feel like that's a interesting tie-in to the treatment, but that's going to be just literally a handful of patients in our view. So I think it's interesting, but commercially I don't see that as a major competitor to what we're doing.

And then that will circle back to our pipeline and our BTK and why we chose covalent binder versus a non-covalent. We do think that covalently bound drugs inherently have better activity. So they're stronger, tighter bonds and seem to overall across different diseases where you've had covalent versus non-covalent, covalent just appeared to be more active agents. So that's why we chose that because we view U2 as a first line and second line treatment option, and ultimately, we're reviewing U2 plus BTK as a great first line or second line treatment option and whether we end up treating patients who have seen BTK before, where we think U2 will be a great option and U2 plus venetoclax will be a great option in patients who have already seen BTK inhibitors. We think that's the -- will someday be the -- certainly in the academic centers the first line of defense after you come off your BTK. And I think there's been what 50,000-ish patients in the U.S. that are treated with the BTK inhibitor. That patient pool is growing. So we expect that when we hit the market there will be a lot of patients coming off BTK inhibitors, they're going to go on to, we would expect they would go on to U2. And in academic centers, we would think they would consider U2 plus venetoclax. So for us our BTK is part of a program to build on to U2. Like I mentioned earlier, U2 plus our BTK marginal zone we think will be a very active treatment option. I think we would be somewhat disappointed if we didn't use that triple regimen and see 85%, 90% overall response rates with 30%, 40%, 50% complete response rates in marginal zone lymphoma. We think we'll see extremely high. We did do 17, 18, 19 patients with U2 plus BTK in CLL patients. That, of course, was a 100% response rate with also close to I think a 30% CR rate. So we know that putting these three drugs or three mechanisms together will have a great outcome for patients and the goal is to get there early, give them a deep response and get them off therapy if you can.

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Operator [17]

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The next question is from Edward White of H.C. Wainwright.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [18]

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Mike, I am here, can you hear me?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [19]

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Ed being a little shy. Yes, we can hear you.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [20]

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So just the first question maybe for you Mike. You gave us some update on 1801 and 1701. I was just wondering if you can give us some update on 1501, your PD-L1 inhibitor?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [21]

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Yes. So 1501, we've got a Phase I study that's now open in the U.S. in heme malignancies. So we inherited a dose from our good friends from Checkpoint who did it in solid tumors. And we're basically using that now that same dose in heme patients and we are building a database of patients just to make sure that's a good safe dose for those patients. Simultaneously, we have 1501 plus U2 that is soon to be opened and now opened apparently in the last 5 -- one second, is open at Memorial Sloan Kettering for patients who are BTK refractory and for patients with Richter's transformation. So that is the current status of 1501.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [22]

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Okay. And when will we see data from either of those two, the Phase I or the combo study?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [23]

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The earliest would be next year, probably late next year. My guess is more like in ASH at this point for that.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [24]

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Okay. And then maybe just a question for Sean. Just on the ATM, how much left do you have in the ATM after what you did so far in the third quarter?

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Sean A. Power, TG Therapeutics, Inc. - CFO, Corporate Secretary & Treasurer [25]

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That's a good question. I think it's in the neighborhood of $80 million or so.

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Operator [26]

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The next question is from Peter Lawson of SunTrust Robinson Humphrey.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [27]

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Just on the final MZL data, is that on all 69 patients? And what's a good bar for the discontinuation rate there?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [28]

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Yes. So it will be on the full 69 patients. And we think discontinuations due to toxicity is I think the bar is again in the 10% to 50% range. What do we have? 12% in the CLL intolerance, we had what 14% in the original. So -- and that was on all 69 patients. I mean, the safety has always been reported on all 69 patients. So yes, we think in a 10 to 15 -- well, can't be 10 now because it's already 14. So 14% to 15% around there, around 15% would be good. Again, we are following the patients for a pretty extended amount of time. So...

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [29]

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Okay. And then the last DSMB meeting, what was -- when was that for the CLL?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [30]

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The last DSMB meeting was not that long ago. I don't have the exact date, but it was in the last 30 days. And as noted in the prepared remarks, they still have found no safety concerns that would require modification of the trial.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [31]

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And then any details you can share about the June FDA meeting on MZL?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [32]

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I don't think we can really say much more than what we've said. I mean, it was a very productive meeting. We left the meeting extremely excited about the prospects of getting the marginal zone filing in as quickly as we can. And like I said, the goal is to get it started around year-end and probably finish the rolling submission about 3 months after that. So yes, we left very excited. The team is focused aggressively on getting everything put together for that filing.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [33]

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Okay. And then thanks for the color around R&D for the year. Where is that going to shake out for next year do you think, the R&D spend? And then kind of a follow-up just on the underlying item, just around management adds build out for MZL plus the kind of the follow-on indications, how should we be thinking about that?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [34]

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I didn't quite get the second half of the question. But in terms of the R&D spend into next year, same basically applies as we get into the first quarter for sure. We're really winding down on the CLL and the ULTIMATE trials. Obviously, no new enrollment has been for a while, and we paid a lot of the bigger expenses certainly on the MS side. So that's starting to wind and again, continues to wind down into 1Q. As you head into Q2, again, I think again the clinical side is still continuing to decline and that's where we'll start to think about giving some nice resources to our good friends on our commercial team to start their ramp. And again, I think that's going to based on the application from marginal zone and the timing, again, assuming our timelines are locked in as they are today, we think the commercial spend leading up to that second quarter is reasonably modest. The plan is to bring on people but not so many people. We are not going to hire sales force and obviously, we're going to start some promotion, but not promotion, that's not the right word, some commercial activities, but it's all pretty modest, I think, as we get to closer to the second quarter that's when we start to really think about when we pull the trigger. So I think the next three quarters should be pretty modest on commercial and clinical trial costs will continue to drop, which, again, is why I think Sean is comfortable with his projections.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [35]

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Got you. And then how should we think about any management adds over the next, I guess, 12 to 18 months?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [36]

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I think the major hires are underneath Adam in terms of key commercial players and he's been working on putting his line up together. I've got a picture of what's to come. I've met a bunch of great people through him. And I think that's where most of the focus is right now.

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Operator [37]

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The next question is from Chris Howerton of Jefferies.

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [38]

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I'm pretty sure the majority of them are asked at this point. But in terms of the post-approval confirmatory study for marginal zone, what have you thought about that or maybe what can you tell us about what you think that might look like?

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [39]

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Yes. So we're trying to be creative about that trial design. So we are thinking about a number of studies that could be run. But I think the base cases -- base case trial is essentially umbralisib plus chemotherapy versus chemotherapy -- immunochemotherapy. So it's umbralisib plus immunochemotherapy versus immunochemotherapy in basic relapsed/refractory CLL, which is first relapse and beyond is the basic design of those -- of the trials that are currently running for confirmation of either marginal zone or follicular the studies are the same. They include a mixed population and that's the design of those two arms. We haven't given too much detail about what we would like to do. But obviously, if we could, we'd like to do something more with U2 in that setting. We think that would be more interesting to us and provide additional benefit to patients. So we're just going to work through some of those details both internally and obviously we're going to have to work that out with the FDA.

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [40]

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Got it. Okay. And then maybe just a question on MS. What are your expectations for an ARR rate? And what do you think would be important to be competitive in that space with OCREVUS.

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [41]

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Yes. So ocrelizumab in their Phase III trial had about 0.155 ARR. We think anything around that would be competitive. We don't -- again, we don't -- our value to the patients doesn't hinge upon whether we have an efficacy advantage. If we have an efficacy advantage that obviously increases the value that we'll be bringing to patients. But the base case has always been comparable activity, comparable safety, a more convenient infusion schedule, so 1 hour every 6 months. And we feel that we can strategically price ublituximab to avoid as many steps there is as possible creating access -- better access to the patients. So despite the fact that ocrelizumab has achieved $4 billion in sales run rate in its second year, they still have to step through multiple therapies in many cases, which, again, does restrict access to patients, the importance of getting CD20 to a patient as early as possible, in our opinion, can't be stressed enough. So we think that the key to providing value to patients is due in part strategically price it in a way that they can get it as early as possible and then also give them the convenience of that 1-hour infusion.

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Operator [42]

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There are no additional questions at this time. I would like to turn the call back over to Michael Weiss for closing remarks.

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Michael S. Weiss, TG Therapeutics, Inc. - Executive Chairman, CEO & President [43]

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Great. Thank you very much. So again, thanks, everyone, for joining us on today's call. Let me just finish by reviewing some of the remaining goals and objectives. I think we actually covered them in pretty good detail in the prepared remarks and in the Q&A, but just to hammer home the point in case anyone wasn't listening carefully. We are -- in the next -- for the remainder of 2019 and into early 2020 what we're looking for obviously driving towards the initiation of that rolling NDA submission for patients with previously treated marginal zone lymphoma and presenting the final data from this cohort. We're targeting top line PFS results, as we've discussed, hopefully by year-end, into early next year, for the UNITY-CLL Phase III trial. And we do expect to present updated data from our pipeline products and combination studies. So again, hopefully, we'll get some BTK information out around year-end, some U2 plus venetoclax data out around year-end. I think we have some upcoming MS data at ECTRIMS. So we have some I think additional information that will come but we got a lot of big things coming as well. So with that, let me just say, on behalf of all of us at TG, we always, of course, we'd like to thank the investigators and patients who've participated in our trials, without their support it would not be possible. And of course, for the great employees at TG and the great shareholders who have been supporting us. Thanks, everyone, and have a great day.

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Operator [44]

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This concludes today's conference. You may now disconnect your lines. Thank you for your participation.