Q2 2019 Earnings Call

Greetings and welcome to TJ Therapeutics, Q2, 2019 earnings conference call.

Operator: Greetings and welcome to TG Therapeutics' Q2 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone.

At this time all participants are in a listen only mode.

A question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

Operator: 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.

I would now like to turn the conference over to your host Jenna Bosco Senior Vice President Corporate Communications. Please go ahead.

Thank you Kim good morning, and welcome to our conference call regarding TG Therapeutics second quarter, 2019 financial results and business update.

Jenna Bosco: Thank you. Good morning, and welcome to our conference call regarding TG Therapeutics' second quarter 2019 financial results and business updates. 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 Guglutuximab 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.

I am Jenna Bosco TG senior Vice President of corporate Communications and I Welcome you to our conference call today.

Following our safe Harbor statement, Sean Power TG, Chief Financial Officer will provide a brief overview of our financial results and then turn the call over to microwave the company's executive Chairman and Chief Executive Officer.

Who'll provide an update on the ongoing development of our lead compound we're talking about an umbrella hub 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 provision under the private Securities Litigation Reform Act of 90 95.

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.

Jenna Bosco: 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 files. 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 in a listen-only mode.

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 T. She's website www Dot TG therapeutics Dot com, where we'll 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 Finance Chief Financial Officer to briefly discuss the financial results for the second quarter of 2019 as well as the Companys overall financial condition.

Sean A. Power: 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... 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 in the Investors and Media section of our website. Our net loss for the second quarter of 2019, excluding non-cash items, was approximately $34.4 million. The gap 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 our 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.

Thank you Jenna and thanks, everyone for joining us as you may be aware our financial results 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 non cash items was approximately 34.4 million.

The GAAP net loss for the second quarter of 2019 was 36.2 million or 42 cents per share compared to a net loss of 44.1 million or 59 cents per share during the comparable quarter in 2018.

As we had expected our R&D spend continues to taper as a registration directed trials in both oncology and mass progressed <unk> 2019, thus contributing to our decrease in net loss versus the comparable period in 2018.

Sean A. Power: We expect this trend to continue through the remainder of 2019. Our net loss for the six months ended June 30, 2019, excluding non-cash items, was approximately $67.6 million. The gap net loss for the six months ended June 30, 2019, was $71.4 million, or 85 cents per share, compared to a net loss of $85.7 million, or $1.18 per share, for the six 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 ubatuximab and umbilicib, 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.

We expect this trend to continue through the remainder of 2019.

Our net loss for the six months ended June Thirtyth 2019, excluding noncash items was approximately 67.6 million.

The GAAP net loss for the six months ended June Thirtyth, 2019 was 71.4 million or 85 cents per share compared to a net loss of $85.7 million or $1.18 per share for the six months ended June Thirtyth 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 little bit talk some hub and burleson, having completed enrollment during 2018, partially offset by an increase in manufacturing and CMC expenses of approximately $4.7 million related to phase three clinical trials and in preparation for commercialization.

Moving on to our cash position at June Thirtyth, we had cash cash equivalents and investments securities of 85 million.

Sean A. Power: Moving on to our cash position, at June 30th, 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 continue to opportunistically utilize our ATM sales facility to raise additional proceeds of $11.6 million for a pro forma cash position as of June 30th 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 said, I will now turn the call over to Mike Weiss, our Executive Chairman and CEO.

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 pro forma cash position as of June thirtyth 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 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.

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 margin zone lymphoma data and marginal zone Anda filing unity CLL data.

Michael S. Weiss: 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 three readout. It's nice to see the years of hard work by so many at TG heading toward fruition.

And India and BLE filings associated with that study and finally, our ultimate mess phase three readout.

It's nice to see the years of hard work by so many at TG heading toward fruition.

Let me now briefly review some of the this years major accomplishments.

Most notably we announced confirmation following our meeting with the FDA that we believe we have a registration path forward to submit under listen for accelerated approval and we are now anticipating the initiation of an anda submission around year end.

We also had the opportunity to present positive interim results from the marginal zone lymphoma cohort in oral presentations at ash ASCO as well as at ice CML receiving positive feedback from many key opinion leaders in the U.S and abroad.

And I see a mill at the female meeting we also presented data from our study of single agent on Burleson in 51, CLL patients who are intolerant to that is to say they discontinued due to toxicity from a prior BTK inhibitor or prior rig Kate fee three k.

Michael S. Weiss: Let me now briefly review some of 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 had 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 the ICML meeting, we also presented data from our study of single-agent umbralicid in 51 CLL patients who were intolerant to, that is to say, they discontinued due to toxicity from a prior BTK inhibitor or a prior PI3K delta inhibitor.

Delta inhibitor.

We were very pleased to report that in those patients on Burleson 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 pithree K Delta is especially in patients who already demonstrated an inability to continue on a prior BTK or pithree K Delta treatment.

Additionally for patients on the study we reported an estimated median progression free survival of 23 and a half months.

Michael S. Weiss: 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 deltas, 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.

For those of you have been following the unity CLL trial, you may recall that we are targeting approximately 24 to 30 30 months of progression free survival for the U. two combination of Umbro listen plus we will touch on that in patients with relapsed refractory CLL. So it's encouraging to see single agent on burleson perform at around that level.

At ice CML, we also presented data from our you two combination with the PD one inhibitor in patients with relapsed refractory CLL and in patients with Richters transformation.

In the relapsed refractory CLL patients, we serve an overall response rate of 91% and notably.

Four of the six BTK refractory patients responded to you two alone prior to any introduction of the PD one inhibitor.

And a fifth patient that was refractory to BG K responded upon triple therapy for an overall, 83% response rate amongst BTK refractory CLL patients.

Patients with BTK refractory disease with or without became mutations represent a challenging patient population.

Michael S. Weiss: 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, Four of the six BTK refractory patients responded to U2 alone prior to any introduction of the PD-1 inhibitor. And a fifth 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 you, too, 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 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.

So it is encouraging to see you too.

Working in those patients.

It also gives us further confidence in the activity of you to in relapsed refractory CLL again, a patient population in our unity CLL trial.

In the Richters patients, another particularly challenging disease to treat three of eight patients responded to triple therapy, including car T failures.

Richters is a very aggressive transformed type of CLL, which nothing is currently approved.

On the EMS side, we presented long term follow up data from the phase two trial of open toxic in patients with the relapsing forms.

Of MMS, showing all the tux MEP continued to be well tolerated with a median duration of follow up of 97 and half weeks.

Which is just a little bit longer than the 96 weeks.

In the ultimate MMS phase three trials, so nice to see.

The continued tolerant 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 margins on lymphoma cohort from our unity NHL study were 69 patients.

Were treated with single agent on Burleson and the primary endpoint for this single arm study is overall response rate as confirmed by an independent review Committee.

Michael S. Weiss: On the MS side, we presented long-term follow-up data from the phase two trial of ilvetoximab in patients with relapsing forms of MS, showing ilvetoximab continued to be well-tolerated with a median duration of follow-up of 97 12 weeks, which is just a little bit longer than the 96 weeks in the ultimate MS phase three trials. So it was nice to 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 previously announced that the study met its primary endpoint of a targeted 40 to 50 percent overall response rate for all 69 patients enrolled, and we presented interim data on the first 42 patients during oral presentations at three major medical meetings, showing a 52 percent overall response rate.

We previously announced that the study met its primary endpoint of a targeted 40% to 50% overall response rate for all 69 patients enrolled and we presented interim data on the first 42 patients during oral presentations.

At three major medical meetings, showing a 50%, 52% overall response rate.

Additionally, we have received breakthrough therapy designation and orphan drug designation from the FDA for Umbro listed 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 on the listed for accelerated approval in patients with relapsed or refractory marginal zone lymphoma.

We anticipate the initiation of a rolling Anda submission around year end.

This is extremely exciting for us as we move closer and closer to bring him or listen to patients with marginal zone lymphoma. The second largest form of indolent lymphomas with approximately 75, new cases, each year in the us alone.

And with an estimated approximately 3000 patients relapsing each year in need of treatment.

Michael S. Weiss: Additionally, we have received breakthrough therapy designation and orphan drug designation from the FDA for umbralicib in the treatment of marginal zone lymphoma. Most recently, as alluded to earlier, we met with the FDA and confirmed our path forward to submit ombilicib 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 represents a sizable patient population and we are currently building, our commercial and medical teams to ensure broaden awareness and adoption of lumber illicit if approved.

Next let me provide a quick update on our unity CLL trial, which is a randomized study of you two in patients with both treatment naive and relapsed or 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.

Michael S. Weiss: This is extremely exciting for us as we move closer and closer to bringing umbralicib to patients with marginal zone lymphoma, the second largest form of inulin lymphomas with approximately 75 new cases each year in the U.S. alone and with an estimated 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 broad awareness and adoption of Umbralicib 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 or refractory chronic lymphocytic leukemia. The primary endpoint for this trial has been, and continues to be, progression-free survival. As we've said previously, we hope to have results from this study around year-end or early next year. But as this is an event-driven trial, it's challenging to accurately predict the timing.

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 successful outcome.

We think it is extremely important to note that the DSMB be 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.

Approve pithree K deltas in first line CLL in large part due to safety concerns. This is highly encouraging to us.

Next let's review our Mds program.

We we have now presented final 48 week data from our phase two MSK trial as well as long term follow up data from this trial is open label extension.

Highlights from the final phase two dataset include annualized relapse rate of 0.07, as well as a 100% reduction in garden enhancing lesions as measured by MRI.

Data from the open label extension continues to show that will the tux amount was well tolerated again with a median follow up of 97 and a half weeks.

Michael S. Weiss: We remain extremely optimistic about this study and the prospects for successful outcomes. We think it is extremely important to note that the DSMB regularly meets to review safety from the study, and to date, no safety issues requiring modification of the trial have been noted. Since there are currently no approved PI3K Deltas in first-line CLL, in large part due to safety concerns, this is highly encouraging to us.

We believe the phase two results are highly supportive.

Of our fully enrolled ultimate phase three program and our belief.

That will tux AMAP can deliver a best in class profile that includes comparable to better efficacy comparable safety convenience and price.

Over.

Anti Cdtwenty Emmis therapies.

Okay realism man is the only anti Cdtwenty approved for MMS.

And is anticipated to generate approximately 4 billion in revenues in 2019 only in its second full year following launch.

Michael S. Weiss: Next, let's review our MS program. We have now presented final 48-week data from our Phase 2 MS trial, as well as long-term follow-up data from this trial's open-label extension. Highlights from the final Phase II dataset include an annualized relapse rate of 0.07, as well as a 100% reduction in GAD-enhancing lesions as measured by MRI. Data from the Open Label Extension continues to show that Oobutuximab is well-tolerated, again with a medium follow-up of 97.5 weeks. We believe the Phase 2 results are highly supportive of our fully enrolled, ultimate Phase 3 program and our belief that Ubuntuxamab can deliver a best-in-class profile that includes comparable to better efficacy, comparable safety, convenience, and price.

As we've mentioned before this is a large market and one in which we believe we can provide significant value to patients with Mds.

And finally I wanted to briefly mention our early development pipeline, which continues to progress with three compounds now in phase, one 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 CD 47, Cdnineteen by specific 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 the conference operator to begin the Q and a session.

Following which I will return and provide some concluding remarks.

Thank you.

At this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

A confirmation tone will indicate your line is in the question queue.

Operator: Anti-CD20 MS Therapy. Ocrelizumab is the only anti-CD20 antibody approved for MS, and it 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 in 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 one 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 the conference operator to begin the Q&A session, following which I will return and provide some concluding remarks.

You May press Star two if you would like to remove your question from the Q.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Our first question today is from Elisa Young of Cantor Fitzgerald. Please go ahead.

Hey, guys. Thanks for taking my questions and 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, it's kind of a 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 optimism and Colorado facility or CLL studying whether it be front line TKI comps or refractory Kay comps.

And then my last question is just kind of how much data we expect to have for Veneta Clackson, you to ash and kind of how do we think about what might be a good response rate in that population. Thanks.

Sure so.

Start at the top so timelines with respect to Follicular.

Given what we know now about the fdas expectations for follow up.

Operator: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the list. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.

The expected follow up for the Follicular.

As per.

And what we expect to FDA, we'd 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.

It is about the early assessment again and that will be a function of.

Capacity and resource that time to to process that data.

We will be hopefully very deep into.

Alethea Young: Our first question today is from Alethea Young of Cantor Fitzgerald. Please go ahead. Hey guys, thanks for taking my questions, and 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 arm comparisons for opituzumab and chlorambucil in your CLL study, you know, whether it be frontline key comps or refractory key comps. And then my last question is just kind of how much data do we expect to have for venetoclax and U2 ash and, you know, kind of how do we think about what might be a good response rate in that population thing.

CLL preparation for filing and will have been completed the.

The margins on filing for.

From a list of single agent, so, but we know that they won enhance follow up and so for sure no earlier than two Q is.

Is expected.

In terms of the control arms for the CLL study.

Our data on the control arm from the CLL study. So GC has being used in several frontline trials recently.

The most.

I think the most near.

Nearly complete and recently completed comparable trial would be the ILLUMENATE trial that has read out.

Where they use GC for six months.

Which is what they used in the label.

And what they use in CLL 11.

In the eliminate trial GC in frontline patients.

I had a 19 month progression free survival.

In CLL 11, which is in the label for GC or for gene MAPC too, but for GE for sure.

They have about a 27 month or 28 month PFS in front line the difference between the two studies.

Michael S. Weiss: 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 follicular, as per, you know, what we expect the FDA would be looking for, would land us sometime, you know, 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, you know, capacity and resources and time to process that data. We'll be, hopefully, you know, very deep into CLL preparation for filing, and we'll have completed the marginal zone filing for embolistic single agent. So, but we know that they want enhanced follow-up, and so for sure, no earlier than 2Q is expected.

I I believe is that for the CLL 11 trial.

That they did not require.

Regular scans.

So patients were.

Only have suspected a progression where they brought in for scans and even in some cases, they weren't even garden for scans. They were just.

Physician determined.

Progression.

With ILLUMENATE I believe they continue to have regular scheduled.

Confirmation scans or.

And so.

More likely to pick up progression.

And I think thats much more similar to how we run our trial.

But.

Our our current estimate is that somewhere between 19 to 27 months is the likely.

Fs for.

The GC arm in frontline patients and remember we have a blended.

We've included both frontline and relapse refractory.

So the PFS for the for GCA is going to be somewhat below.

Michael S. Weiss: In terms of the control arms for the CLL study, or data on the control arm from the CLL study, GC has been used in several front-line trials recently. The most recently completed comparable trial would be the Illuminate trial that has read out, where they used GC for six months, which is what they used in the label and what they used in CLL11. In the Illuminate trial, GC and frontline patients had a 19-month progression-free survival. In CLL11, which is in the label for GC or for G, maybe C2, but for G for sure, they have about a 27-month or 28-month PFS in frontline. The difference between the two studies, I believe, is that in the CLL11 trial, they did not require regular scans.

One might expect in frontline patients.

Theres not a whole lot of data.

On GC in relapse patients.

But.

We think a reasonable comp is looking at VR.

In that patient population.

And be our weather was in.

The Healios trial.

Or a 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 of the patients were relapsed refractory in our trial by 60% were frontline.

So we've got a range of 12 to 15 months for the relapse patients in the control arm 19 to 27 to 28 months in the in the front line I think that leaves us we've done the blended we think it's a control arm should be somewhere maybe between 2022 months of PFS.

Michael S. Weiss: So patients were only brought in for scans if they were suspected of progression, and even in some cases, they weren't even brought in for scans. They were just physician-determined progression. With Illuminate, I believe they continued to have regular scheduled confirmation scans, and so were more likely to pick up progression. And I think that's much more similar to how we've run our trial.

Is how we're thinking about it.

And as you as you saw in the or at least.

These solid ice email and heard in my prepared remarks.

In our most recent phase two where we treated 50 patients with with CLL pretty tough population. These are all these patients had had previously seen BG care Pithree K Delta all of them were are predisposed to having tolerability issues.

Michael S. Weiss: 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 analysis, 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.

Very few of them actually came off study for Tolerability on on our drug but also we were able to show about a 24 month.

Progression free survival for single agent on Burleson.

Which again, we think is a good a good indication we've always been saying, we think 24 to 30 months for you too in relapsed patients.

Michael S. Weiss: Unknown Speaker...on GC in relapsed patients, but we think a reasonable comparison is looking at BR in that patient population, and BR, whether it was in... The Helios trial or Murano, it's approximately a 12 to 15-month progression-free survival for chemoimmunotherapy, which would be GC or BR, in relapsed patients. So on a blended basis, about 40% of the patients were relapsed refractory in our trial, and about 60% were frontline.

Is about where we would hope to see it.

Obviously, we think there'll be proportional.

Improvement in front line.

But if you look at 24 to 30 months in relapsed patients versus 12 to 15 months for Ford GC size BR in not in relapse 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 you to plus of an asset class.

Michael S. Weiss: So you've 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 blending, and we think the control arm should be somewhere maybe between 20 and 22 months of PFS. That's how we're thinking about it. And as you saw in the work, at least, well, you... sorted ICML and heard in my prepared remarks, in our most recent phase two where we treated 50 patients with CLL, a pretty tough population. All these patients had previously seen BTK or PI3K Delta, and all of them were predisposed to having tolerability issues. Very few of them actually came off the study for tolerability on our drug, but we were also able to show about a 24-month progression-free survival for single-agent umbralisib, which again we think is a good indication.

We have an ongoing phase one trial of utilization and in fact, we do think that in the future.

That is a regiment that has some importance and because it.

We do think at some point in the future that the market is going to move toward.

Fixed duration treatments.

We think you too close banana clocks is a great alternative to any BTK based treatment plus banana clocks or any cdtwenty based treatment plus banana clocks.

And in terms of the amount of data.

I think we'll see probably around 10 patients with at least a year a follow up.

Which again is the is the mark that you're looking for.

These are heavily pretreated patients.

I think.

Anywhere.

In and around 50%.

See our slash and door MRG negative rate would be quite impressive.

Again these are relapsed patients.

Of course, once we get a chance to do frontline patients, we'd expect that to be higher but I think if we have 50% CR and or MRG negative.

Michael S. Weiss: We've always been saying that 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 patients, but if you look at 24 to 30 months in relapsed patients versus 12 to 15 months for GC slash 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 one trial of U2 plus venetoclax. We do think that in the future, that is, a regimen that has some importance, and because we do think at some point in the future, 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.

That would be pretty impressive.

And then can I ask one follow up on the first comment you made when you say on Follicular enhanced follow up is that a year, but the update look as far as the longer.

We haven't disclosed exactly what that is.

But suffice to say, it's more than a year.

Okay, great. Thanks for all the color.

Yes, you got it.

The next question is from Matt Kaplan of Ladenburg Thalmann. Please go ahead.

Hey, guys. Thanks for taking the questions and.

And on the progress.

Wanted to just digging into the.

The rate lending staff square the margins zone NDA filing and then if you could talk about really kind of in marginal zone, the marginal zone opportunity and the competitive landscape for both us as well.

Sure.

So in terms of my other questions as well.

Sure to answer these now and wait for the next question you want to keep hitting me with questions.

Now once you do these first.

Sure.

So the rate limiting step for marginal zone lymphoma filing.

Michael S. Weiss: And in terms of the amount of data, you know, I think we'll probably see probably around ten 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, you know, anywhere, you know, in and around a 50% CR slash and or MRD negative rate would be quite impressive. Again, these are relapsed patients. Of course, once we get a chance to do frontline patients, we'd expect that to be higher, but I think if we had 50% CR and or MRD negative, that would be pretty impressive.

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.

A short time window to get the final data cleaned and prepped and put into a filing.

So I think most of the other section this should be done in the clinical section will probably be the last section that goes in.

To the package.

In terms of the modules on market and.

Competitors out there.

You know the.

There's there's two approved agents one or two prove regimens one is a burden of which was approved.

Based on accelerated approval.

They had about a 40, 546% overall response rate and I think a 2%.

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

Complete response rate. So it's a 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 in CLL.

Michael S. Weiss: We haven't disclosed exactly what that is, but suffice to say it's been more than a year.

Duration of response.

Alethea Young: Okay, great. Thanks for all the color.

Thing is in the 12 to 15 months range, but it's.

Michael S. Weiss: Yep, you got it.

It's a good drug it's far from mature and then you have R squared, which was recently approved in received full approval.

Matthew Lee Kaplan: The next question is from Matt Kaplan of Ladenburg-Fowlman; please go ahead. Hey guys, thanks for taking the questions and for updating us on the progress. I wanted to just dig into the rate lending steps for the Marginal Zone NDA filing, and then if you could talk about really kind of the Marginal Zone opportunity and the competitive landscape for Umba-Bustad as well.

There I think the data is somewhat mixed.

In terms of of what happened in that trial I think the response rates, where we are in excess of.

The reduction control arm.

But the PFS and overall survival PFS I think was was equivalent and overall survival I think was inverted in some way so.

Operator: Sure. So in terms of other questions, should I answer these now and wait for the next question, or do you want to keep hitting me with questions?

There was some interesting effects are square and having said that our squared.

Has been available to patients with marginal zone lymphoma inflicted lymphoma for many years, obviously celgene wasn't able to promote it.

Michael S. Weiss: Now, why don't you do these things first?

During that time, but I think from an awareness standpoint.

Operator: Sure.

Operator: Bye. Bye.

Folks who had an interesting using our square for marginal zone, which have been well aware that thats an option for them. So I think.

Michael S. Weiss: 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 toward the end of the year, which, you know, gives us, you know, 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 into the package.

I think that our squared approval my guess is that the.

The teams that are going to be promoting that we'll be focused heavily on follicular lymphoma.

And in marginal zone because of I think the.

The interesting parts of that data set.

Are less likely to be heavily promoting and tomorrow's alone.

So.

Having said all that we think that marginal zone is a relatively open field for us.

Michael S. Weiss: In terms of the marginal zone market and competitors out there, you know, there are two approved agents, or two approved regimens. One is Abrutinib, 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. The 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.

Obviously theres other agents, but.

We don't think that they are the focal points for promotion of those drugs and we think we have.

The best option for those patients.

We think in comparison to a brutally based therapy.

We have the ability to induce.

Responses more quickly in terms of median time to response ours was so far in the interim is about two and half months versus four and half months for Bruton Nib RCR rate is.

Nearing 20%.

Versus a 2% CR rate for Britain.

And.

Michael S. Weiss: 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 ways. So there were some interesting effects.

We have a keen interest in building.

A marginal zone franchise I don't think than 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 on Burleson.

But our next step is marginal zone with on Burleson, plus we'll talk some Av in the U two regiment.

Which we think is a really should be very strong option for those patients.

Michael S. Weiss: 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-squared for marginal zone lymphoma were well aware that that's an option for them.

And then we plan to build even further with you two plus our beach cane heavier. So I think we plan on really focusing in building our presence in the margins on community.

We think that promotion and with the best treatment option available for patients.

That thats a market that we can.

Really see a major impact in.

That's very helpful. Frank will detail and then just with unity CLL and now you're talking about.

The timeline there with respect to readout data late this year early next year can you I guess do you have visibility to it to the event rate there so that.

Michael S. Weiss: 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. Having said all that, we think that Marginal Zone is a relatively open field for us. Obviously, there are 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 a brutinib-based therapy, we have the ability to induce responses more quickly in terms of median time to response. Ours, so far, in the interim, has been about two and a half months versus four and a half months for brutinib.

It allows you to.

Fine tune and predict.

On a readout.

Yes, I mean periodically we do get updates on.

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 good visibility.

But things can change and again when to Vince.

It's.

Kind of the.

Inverse of a.

Of enrollment curve right, where you see this.

This hockey stick in towards the end of those trials they keep rolling.

In a.

In an event based trial, you've got a big Bolus and then you you don't know exactly when you're going to start to see that curve flattened out.

Michael S. Weiss: Our CR rate is nearing 20% versus a 2% CR rate for brutinib. We have a keen interest in building a marzalzone 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 marzalzone with umbralisib, but our next step is marzalzone with umbralisib plus uvetuximab in the U2 regimen, which we think should be a very strong option for those patients. Then we plan to build even further with U2 plus our BTK inhibitor. I think we plan on really focusing on and building a presence in the Marsalzone community. We think with that promotion and with the best treatment options available for patients, that that's a market that we can penetrate.

So that 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 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.

Okay. That's very helpful. And then and then with respect to your pipeline.

Can you talk a little bit about the competitive landscape in the UK, Spain cigarettes.

Some companies are getting attention for their non covalent BTK data and a few handfuls of patients I guess, what's your perspective here on that given your internal BTK program.

Michael S. Weiss: really see a major impact on.

Michael S. Weiss: That's very helpful. Thanks for the detail. And then just with Unity CLL, I know you're talking about the timeline there with respect to readout data late this year, early next year. Do you, I guess, have visibility into the event right there so that...

Yes, so I think the.

Two two parts to that one is our own BTK program and we were we see a fitting in and then where we see non covalent inhibitors fitting in.

I'll start with the non covalent and then talk about how we're 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.

Michael S. Weiss: It allows you to, you know, fine-tune and predict readout. Yeah, I mean, periodically, we do get updates on the total events in the trial, and you know, I think it's a bit like enrollment curves. You think you know what's happening, and you know you hope you have good visibility, but things can change, and again, when it's events, it's, It's kind of the... Inverse of an enrollment curve, right, where you see this hockey stick and, you know, 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 mystery here, which is when that curve flattens out, and you start to trickle in events.

But with respect to the non covalent inhibitors, obviously, we've watched.

Closely what's what's happening there and.

The interest by investors in that area.

You know to us it is a interesting.

Academic exercise to try to identify patients with the mutation and then treat them of the drugs specifically for that mutation.

It certainly is something that you can see the the the marketing and intuitive neatness of that.

However.

You too as Weve described in.

In that Pembro or PD one poster.

And of the six BTK refractory patients four of them responded to you two alone in the first three months before they even saw pembro. So.

Michael S. Weiss: So, again, I think we have good visibility that we feel like we can get to the event toward the end of the year and 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, you know, we still want to be cautious.

I think when we think about the market in 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 in front of them, which will be you too.

Before people start testing recall we.

Glenn close is a is a market that is driven by community practices.

80, 85% of these patients are treated locally because this is a chronic condition.

Michael S. Weiss: 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 handfuls of patients. What's your perspective?

And you may recall from all our genuine.

Well it was in the old days when they just weren't even testing for.

For mutations or for genetic risk factors.

The community is is very unlikely to be focused on on this mutational stuff. There. They are much more focused on I have you too.

Michael S. Weiss: Transcripts provided by Transcription Outsourcing, LLC. Yeah, so I think the two parts. 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 inhibitors, and then I'll talk about how we view 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, you know, obviously, we've watched closely what's happening there and, you know, the interest by investors in that area. To us, it is an 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.

It works in patients that I have already seen BTK, where they have a mutation in new mutation on really cares all that much.

They're going to treat them with the the easy effective treatment that sitting in front of them.

And again I think in academic centers.

You will see more people.

In working off of the genetic information and making them feel like Thats a interesting.

Tie into the treatment, but thats 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 to what we're doing.

And then that will circle back to our pipeline and our BTK and why we chose.

Equivalent.

Binder versus a non covalent we do think that covalently bound drugs inherently have better activity.

Michael S. Weiss: However, U2, as we described in that PEMBRO or PD1 poster, you know, out of the six BTK refractory patients, four of them responded to U2 alone in the first three months before they even saw PEMBRO. So, I think, you know, 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... What's ever in front of them, which will be U2. Before people start testing, I mean, you know, recall we, you know, 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 woes 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. They're much more focused on, I have you two.

So they are stronger tighter bonds.

And seem to overall across different diseases, where youve have covalent versus non covalent give alan just appear to be more active agents.

So thats why we chose that because we view you too.

As a first line and second line treatment option and ultimately we are reviewing due to plus BG Kay.

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 Q2 will be a great option and you two plus the nanoflex will be a great option in patients who have already seen BTK inhibitors.

We think thats a will someday be the certainly in the academic centers. The first line of defense. After you've come off your became I think theres been what fiftyish thousand patients in the us.

That have treated with a BTK inhibitor.

That patient pool is growing so we expect.

That when we hit the market will be a lot of patients coming off beach K inhibitors.

Michael S. Weiss: It works in patients that I have 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'll see more people working off of genetic information and making patients feel like that's an interesting tie-in to the treatment. So that's going to be just a handful of patients, in our view. So I think it's interesting, but commercially, I don't see it as a major competitor to what we're doing.

They are going to go onto we would expect that would go on to you too.

And in academic centers, we would think they would consider you to placement out of clocks.

So for us.

Our BTK is part of a program to build on to you to like I mentioned earlier, you to pause our BTK modules zone. We think we'll be very active treatment option I think we would be somewhat disappointed if we didnt use that triple regimen and see.

85, 90%.

Overall response rates with 30 40, 50% complete response rates in marginal zone lymphoma.

Michael S. Weiss: And then that will circle back to our pipeline and our BTK and why we chose a 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, you know, overall across different diseases where you've had covalent versus non-covalent therapy, they just appear to be more active agents.

We think we'll see extremely high we we did we did do.

17, 18, 19 patients with you two plus.

BTK CLL patients out of course was a 100% response rate.

We've also close to I think a 30%.

CR rate. So we know that putting these three drugs these three drugs or three mechanisms together.

We'll have a great outcome for patients and the goal is to get there early gives them a deep responds get them off therapy. If you can.

Michael S. Weiss: So that's why we chose U2 because we view U2 as a first-line and second-line treatment option. And ultimately, we view U2 plus BTK as a great first-line or second-line treatment option. And, you know, whether we end up treating patients who have seen BTK before, where we think U2 will be a great option, and U2 plus venaticlax will be a great option, and patients who have already seen BTK inhibitors, we think that's a, will someday be the, certainly in the academic centers, the first line of defense after you've come off your BTK. And I think there have been, what That patient pool is growing, so we expect that when we hit the market, there'll 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.

Thank goodness that you got it.

The next question is from Ed White of H.C. Wainwright. Please go ahead.

Hi, guys. Thanks for taking my edge you there.

Mike, Yes, I am here can you hear me.

As being a little light.

Can you hear me now.

Yes, we get area.

Okay.

So just the first question for you Mike.

You gave us an update on 81 and seven snow on average as far as it will give us an update on 15 or one year PDL one inhibitor.

Yes, So 15, one we've got a.

A phase one.

Study that's now open in the us in heme malignancies. So we inherited a dose from from our good friends from checkpoint, who did it in solid tumors and we're basically using that now that same dose.

Michael S. Weiss: And in academic centers, we would think they would consider U2 plus venaticlax. So for us, RBTK is part of a program to build on to U2, like I mentioned earlier, U2 plus RBTK in the marginal zone. We think it 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 rates. We did do 17, 18, 19 patients with U2 plus BTK and 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. That good? Yep, you've got it.

In heme patients and we're building a database of patients just to make sure that thats a good safe dose.

For those patients simultaneously, we have 15 or one.

Plus you too that is.

Soon to be open.

And now we'll open apparently in the last five one second is open.

At Memorial Sloan Kettering.

For patients, who are BTK refractory and for patients with Richters transformation.

So that is the current.

Status of 15 alone.

Okay, Thanks, and Dino when we'll see data from either of those two the phase one or the combo study.

The earliest would be in next year, probably late next year. My guess is more like an ash.

At this point for that.

Okay. Thanks, Mike.

And then maybe just a question of course on.

Just on the ATM how much left do you have in the HCM. After a wasn't good so far in the third quarter.

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

Okay.

Thanks for taking my questions guys.

Yes. Thanks.

The next question is from Peter Lawson of Suntrust Robinson Humphrey. Please go ahead.

Edward Patrick White: The next question is from Ed White of H.C. Wainwright. Please go ahead. Hi guys, thanks for taking my question.

Thanks for taking the questions just on the final MZ Hill data is that little over 69 patients and what's a good both for the discontinuation rate.

Operator: Ed's being a little bike guy.

Operator: Can you hear me now? Yep, we can hear you.

Michael S. Weiss: Okay. So, just the first question, maybe for you, Mike. You gave us an update on 18.01 and 17.01. I was just wondering if you could give us an update on 15.01, your PD-L1 inhibitor.

Yes, so it will be on the full 69 patients and we think discontinuations due to toxicity is I think the bars and in the 10% to 15% range.

What we have done.

12% in the.

In the CLL and tolerance, we had what 14% in the in the original.

Michael S. Weiss: Yeah, 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're building a database of patients just to make sure that that's a good, safe dose for those Simultaneously, we have 1501 plus U2 that is soon to be open and now open, apparently, in the last five, 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.

So and that was on all 69 patients I mean, the safety is always been report on all 69 patients.

So yeah, we think in the 10 to 15, well can be can be 10, now because it's already 14, so 14% to 15% around their own 15% would be would be good.

Again, we're following the patients for pretty extended amount of time.

So.

Okay. Thank you and then the loss.

DCB meeting what was.

What was the ceiling.

The the last TSMC meeting was not that long ago.

I don't have the exact date, but it was in the last 30 days.

And as you know as noted in the in the prepared remarks.

They still have found no.

Safety concerns that require modification of the trial.

Thank you and then any details you can share.

June FDA meeting and deal.

I don't think we can really say much more than what we have said I mean, it was a very productive meeting we left the meeting extremely excited.

Edward Patrick White: Thanks, and do you know when we'll see data from either of those two, the phase one or the combined study?

Michael S. Weiss: The earliest would be next year, probably late next year; my guess is more like in Ash. Page PAGE of NUMPAGES www.verbalink.com Page 2 of 9

About the prospects of of getting the margins on filing in.

As quickly as we can and like I said that the goal is to to get it started around year end.

Operator: Okay, thanks Mike. 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? That's a good question. I think it's in the neighborhood of 80 million or so. Okay. Thanks for taking my questions.

And probably finished the rolling submission about three months after that so.

Yes, we left very excited.

The team is.

Is focused.

Aggressively on getting everything put together for that filing.

Thank you Linda.

Thanks for the color around R&D for the year.

Sean A. Power: Thanks for the questions, guys.

Where is that going to shake out for next year do you think the R&D spend.

Edward Patrick White: Yep. Thanks, Chad.

Operator: Thanks guys.

And then kind of a follow up just a little.

Peter Lawson: The next question is from Peter Lawson of SunTrust Robinson Humphrey. Please go ahead. Thanks for taking the questions. Just on the final MZL data, is that on all 69 patients, and what's a good bar for the discontinuation rate there?

Although I know its just the rail Lynch with ads and be able to help you.

Plus the color the follow and indications how should we be thinking about it.

I didn't quite get the second half of the question, but in terms of the.

The R&D spend into into next year.

Michael S. Weiss: Yeah, so it will be on the full 69 patients, and we think, you know, discontinuations due to toxicities. I think the bar is, you know, again in the 10 to 15 percent range. What do we have?

Same same basically applies.

As we get into the first quarter for sure.

We're really.

Now winding down on the CLL and the and the ultimate trials.

Michael S. Weiss: 12% in the CLL intolerance test. We had, what, 14% in the original. And that was on all 69 patients. I mean, safety's always been reported on all 69 patients. So yeah, we think in the 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're following the patients for a pretty extended amount of time, so.

Obviously, no new enrollment has been for a while and we've paid a lot of the the bigger expenses certainly on the EMS side, So thats starting to wind and again continues to wind down into.

Into one Q.

As we head into Twoq too.

Again, I think again, the clinical side is still continuing to decline.

And that's where we'll start to to to think about given some nice resources to our good friends on commercial team to start their ramp and again I think thats going to be based on.

The application for Marshall Zone, and the timing again, assuming our timelines are locked in as they are today.

Peter Lawson: Okay, thank you. And then the last DCMB meeting, when was that for CLL?

Yeah, we think.

The the commercial spend.

Leading up to that second quarter is reasonably modest.

Michael S. Weiss: 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 haven't found any... Safety concerns that would require modification of the drive.

The plan is to to bring on.

People, but not so many people don't like a higher sales force.

And obviously, we're going to start some.

Some promotion, but not promotion that's not the right word some.

Peter Lawson: Any details you can share about the June FDA meeting on MZL?

Commercial activities.

But it's all pretty modest I think as we get closer to the second quarter. That's when we start to really think about when we when we pull the trigger so I think.

Michael S. Weiss: 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 three months after that. So, yeah, we left very excited. The team is focused. [inaudible]

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.

Got you then.

How should we think about any management adds over the next 12 to 18 months.

I think the the major hires are underneath Adam.

Peter Lawson: And then, thanks for the color around R&D for the year. Where's that going to shake out for next year, do you think, the R&D spend? And then, kind of a follow-up on the other line item, just around management ads and build-out for MZL, plus the kind of follow-on indications. How should we be thinking about that?

In terms of.

Key commercial players and he has been working on putting his.

His line up together.

I've got a I've got a picture of of what what's to come have met a bunch of great people through him and.

I think thats, where were most of the focus I think.

Yes, I think thats, where the most the focus is right now.

Great. Thanks, so much.

Yep.

The next question is from Chris Howerton of Jefferies. Please go ahead.

Michael S. Weiss: 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've paid a lot of the the bigger expenses certainly on the MS side so that's starting to wind and again continues to wind down into into 1Q. As we head into 2Q, again I think again the clinical side is still continuing to decline and that's where we'll start to 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 be based on you know The application for Marginal Zone and the timing, again, assuming our timelines are locked in as they are today, you know, we think, you know, the commercial spend leading up to that second quarter is reasonably modest.

Hey, good morning, Thanks for taking the questions Im pretty sure the majority of them minute asked at this point.

[laughter].

But in terms of the.

Post approval confirmatory study for marginal zone.

What what have you thought about that or maybe what can you tell us about what you think that might look like.

Yes, so we're we're trying to be.

Creative about that trial design. So we're thinking about of a number of studies that can be run.

But I think.

The base case is the base case trial is essentially a melissa.

Plus.

Chemotherapy.

Versus chemotherapy.

Immuno chemotherapy, so I'm, Melissa plus immuno chemotherapy versus.

Chemotherapy in.

Basically relapsed refractory CLL, which is first relapse and beyond.

Michael S. Weiss: The plan is to bring in people, but not so many people. We're not going to hire a sales force, and obviously, we're going to start some promotion, not promotion, that's not the right word, some commercial activities, but it's all pretty modest, I think, as we get closer to the second quarter. That's when we start to really think about when we pull the trigger. So, I think, you know, the next three quarters should be pretty modest in terms of commercial, and clinical trial costs will continue to drop. Which again is why I think Sean is comfortable with his projection.

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 a mixed population.

In.

And Thats the design those two arms.

We haven't given too much detail, but we'd like to do but obviously, if we could we'd like to do something more with you too.

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 some of those details both internally and obviously were going off to work that out with the with the FDA.

Peter Lawson: Gotcha, thank you. And then, how should we think about any management ads over the next 12 to 18 months?

Got it okay.

And then maybe just a question on and what are your expectations for an air raid and what do you think would be important to be.

Michael S. Weiss: You know, I think the major hires are underneath Adam in terms of, you know, 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, I think. Yeah, I think that's where most of the focus is right now.

On competitive in that space Curtis.

Yes, so so oak realism in their phase three trial had about a <unk> 0.155.

EMR.

We think anything around that would be competitive we don't again, we don't our.

Operator: Great. Thanks so much. The next question is from Chris Howerton of Jeffreys. Please go ahead. Hey, good morning. Thanks for taking the questions. I'm pretty sure the majority of them that asked at this point.

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 will be bringing to patients.

Chris Howerton: ..

Chris Howerton: But in terms of the post-approval confirmatory study for a marginal zone, what have you thought about that, or maybe, what can you tell us about what you think that might look like?

But the base case has always been our comparable.

Activity comparable safety.

More convenient infusion schedule. So one hour every six months.

Michael S. Weiss: Yeah, so, you know, we're trying to be creative about that trial design. So we're thinking about a number of studies that can be run. But I think the base case trial is essentially umbrellisim plus... chemotherapy. Unverlissive versus immunochemotherapy, so it's unverlissive plus immunochemotherapy versus immunochemotherapy in... basically relapse or fractricilla, 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.

And.

And we feel that we can strategically price.

Well the toxin ma'am.

To avoid as many step through is as possible, creating access better access to the patients. So despite the fact.

That oak realism, Mab 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.

Cdtwenty two patient.

Michael S. Weiss: They include a mixed population, and that's the design, those two arms. We haven't given too much detail about what we'd 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 gonna work through some of those details, both internally and, obviously, we're gonna have to work that out with the FDA.

As early as possible in our opinion can't be stressed enough. So we think that the key to providing value to patients is to is to impart strategically price. It in a way that they can get it as early as possible and then also give them the convenience that one hour infusion.

Got it okay.

Great well I think Thats, all I had and I look forward to the next exciting 12 months for your company.

Thank you very much I appreciate it.

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

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

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 index I think we actually covered them in pretty good detail in the prepared remarks, and mcewen, a but just to hammer home the point.

Michael S. Weiss: Yeah, so Ocrelizumab in their phase 3 trial had about a 0.155 ARR. We think anything around that would be competitive. But we don't, again, we don't... Our value to patients doesn't hinge upon whether we have an efficacy advantage.

Case anyone wasn't listening carefully.

We are we are in the next so for the remainder of 2019 and into early 2020, what we're looking for obviously driving toward the.

Michael S. Weiss: If we have an efficacy advantage, that obviously increases the value that we will be bringing to patients, but the base case has always been comparable activity, comparable safety, a more convenient infusion schedule, so one hour every six months, and we feel that we need to avoid as many step-throughs as possible, creating access, and better access to the patient. So, despite the fact that Ocrelizumab has achieved 4 billion in sale run rate in its second year, patients still have to step through multiple therapies in many cases, which again does restrict access to patients. The importance of getting a 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 to, 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 one-hour infusion.

Initiation of that rolling NDA submission for patients with previously treated marginal zone lymphoma, and presenting the final data from this cohort we are 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 you to play has been adequate stayed out around year end I think we have.

Some upcoming SMS data at ACTRIMS so.

We have some 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 Weve always of course, we'd like to thank investigators and patients who who participate in our trials without their support would not be possible and of course.

For the great employees at TG, and the great shareholders, who have been supporting us.

Chris Howerton: Got it. Okay. Great. Well, I think that's all I have, and I look forward to the next exciting 12 months for your company. Thank you.

Thanks, everyone and have a great day.

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

Operator: Thank you very much.

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

Michael S. Weiss: Great. Thank you very much.

Michael S. Weiss: So again, thank you 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 preparatory remarks and the Q&A, but just to hammer home the points, in case anyone wasn't listening carefully.

[noise].

Operator: We are in the next, so for the remainder of 2019 and into early 2020, what we're looking for, obviously driving toward 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, and some U2 plus venadoclax data out around year-end. I think we have some upcoming MS data at ECTRMS. So we have some, I think, additional information that will come, but we've got a lot of big things coming as well.

[noise].

Why.

Why.

Operator: With that, let me just say, on behalf of all of us at TG, we would always, of course, like to thank the investigators and patients who participate 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.

Oh no.

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