Q3 2019 Earnings Call

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Unknown Executive: Greetings, and welcome to TG Therapeutics' third quarter 2019 financial results and business update call.

Unknown Executive: At this time, all participants will be in listen-only mode, and a brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll turn the call over to Jenna Bosco. Jenna, you may now begin.

Jenna Bosco: Thank you. Good morning, and welcome to our conference call regarding TG Therapeutics' third 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, ubutuxima Before we begin, I would like to remind everyone that many 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 1995.

Greetings and welcome to TG Therapeutics third quarter, 2019 financial results and business up they call.

At this time, all participants will be in listen only mode and the brief question answer session will follow the formal presentation.

If anyone should <unk> operator assistance during the conference. Please press star zero from your telephone keypad.

Please note this conference is being recorded.

At this time I'll turn the call for two Jenna Bosco generally you may now begin.

Thank you good morning, and welcome to our conference call regarding TG Therapeutics third quarter 2019 financial results and business out there I'm Jenna Bosco TG Senior Vice President Corporate Communications and I Welcome you to our conference call today.

Following our safe Harbor statement, Sean powered PGS, 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 will provide an update on the ongoing development of our lead compounds were talking about an umbrella said as well as an overview.

Our overall company standing.

Before we begin I would like to remind everyone that many 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 1995.

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 filing. 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. Now, I would like to turn the call over to Sean Power, our Chief Financial Officer, to briefly discuss the financial results for the third quarter of 2019, as well as the company's overall financial condition.

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 SBC filings.

This conference call is being recorded for audio rebroadcast on teachers website, Www Dot TG therapeutics dotcom, where it will be available for the next 30 days.

All participants on this call on this call will be already listen only mode now I'd like to turn the call over to Sean power, Our Chief Financial Officer to briefly discuss the financial results for the third quarter of 2019 as well as the Companys overall financial condition.

Thank you Jenna and thanks, everyone for joining us as I'm sure you all now seen our financial results released this morning, it can be viewed on the investors and media section or website.

Sean A. Power: Thank you, Jenna, and thank you everyone for joining us. As I'm sure you've all now seen, 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 third quarter of 2019, excluding non-cash items, was approximately $59.9 million, with a gap net loss for this quarter of $61.9 million, or $0.69 per share, compared to a net loss of $34 million, or $0.43 per share, during the comparable quarter in 2018. Included in this quarter's net loss was an increase in manufacturing and CMC expenses of approximately $27 million. These costs relate primarily to manufacturing expenses associated with Phase III development and preparation for commercialization, and we've been able to secure favorable payment terms on the largest of these expenses, deferring payment of these costs for up to one year.

Our net loss for the third quarter of 2019, <unk>, excluding non cash items was approximately 59.9 million with the GAAP net loss for this quarter of 61.9 million were 69 cents per share compared to a net loss of 34 million were 43 cents per share during the comparable quarter in 2018.

Included in this quarter's net loss was an increase in manufacturing CMC expenses of approximately 27 million.

These costs relate primarily to manufacturing expenses associated with phase three development and in preparation for commercialization.

And we've been able to secure favorable payment terms on the bolus of these expenses deferred payment of these cost for up to one year.

Offsetting increases in manufacturing expenses has been the continued decrease in clinical trial expenses 3.8 million in the quarter, which we expect will continue into 2020.

Sean A. Power: Offsetting the increases in manufacturing expenses has been the continued decrease in clinical trial expenses, $3.8 million in the quarter, which we expect will continue into 2020. All in all, for the quarter, we saw a cash burn of approximately $33 million. With the bulk of our manufacturing costs now behind us, and with our clinical costs continuing to decrease, we expect our cash burn to be in the $25 to $30 million per quarter range. Accordingly, with a pro forma cash position as of September 30th of approximately $96 million, which includes approximately $24 million raised under our ATM facilities subsequent to the end of the quarter, and our future availability under the ATM, we believe our cash will be sufficient to fund our operations into the fourth quarter And importantly, through our near-term milestones of Phase 3 readouts for Unity CLL and MS, which we believe should be significant value-creating inflection points for the company. With that, I will now turn the call over to Mike Weiss, our Executive Chairman and CEO.

All in all for the quarter, we saw a cash burn of approximately 33 million.

With the bulk of our manufacturing cost now behind us and with our clinical costs continuing to decrease we expect our cash burn to be in the 25 to 30 million per quarter range.

Accordingly, the pro forma cash position as of September Thirtyth of approximately 96 million, which includes approximately 24 million raised under our ATM facility subsequent to the ended the quarter and our future availability under the ATM, We believe our cash would be sufficient to fund our operations into the fourth.

Quarter of 2020, and importantly, there our near term milestones of phase three readout for usually CLL and M.S., which we believe should be significant value, creating inflection point for the company.

With that I'll now turn the call over to Mike right, our executive Chairman and CEO .

Michael S. Weiss: Great. Thanks, Sean, and thanks, Jenna, and thanks, everyone, for joining us this morning. Seeing as we were just on a call a few weeks ago, we're going to try to keep this one relatively short. I thought I'd start out by focusing on the ASH abstracts that were released last week, provide a little bit of color and context around those presentations, and then touch on some of this year's major accomplishments. We'll conclude after the Q&A with some upcoming goals and catalysts for the conference. So to start, let's talk about the two presentations and apps that we announced last week.

Great. Thanks, Sean and thank you gentlemen, thanks, everyone for joining us this morning.

Seen as we were just trying to call a few weeks ago, Oh, we're going to try to keep this one a relatively short I thought I'd start out by focusing on the Ash abstracts that we released last week I'll provide a little bit of color and contacts around those a presentation I touched on some of this year's major accomplishment accomplishments I concur.

After the queuing it with some upcoming Golden catalyst for the company.

So to start let's talk about the two presentations and actually we announced last week I first isn't oral presentation on the triple combination of 'em Burleson are highly selective theatrically delta and CK, one Epsilon inhibitor and people talk snob, our glycoengineered anti cdtwenty monoclonal antibody, which together.

Michael S. Weiss: The first is an oral presentation on the triple combination of Umbralicid, our highly selective PI3K Delta and CK1 Epsilon inhibitor, and Ublituximab, our glycoengineered anti-CD20 monoclonal antibody, which together we refer to as U2. U2 plus venatoclax, in patients with relapsed or refractory chronic lymphocytic leukemia, designed with For example, in this study, 12 months and then stop treatment if you achieve MRD- in the bone marrow. A few exciting and interesting tidbits in this abstract included that U2 alone was highly active with an overall response rate of 85% in 11 of 13 patients after three cycles of therapy. And this is, again, prior to the introduction of anatoclax; we start with U2 alone induction.

Other groups, we refer to as you too. So you two plus veneta clogs in patients with relapsed or refractory chronic lymphocytic leukemia also CLL.

This is a phase one two study design with the intent to assess whether you two plus fanatic clocks could potentially drive deep and durable responses any fixed timeframe of treatment.

For example in this study 12 months and then stop treatment if you achieve.

And Mark the negative.

In the bone marrow, a few exciting and interesting tidbits, it's abstract.

Clearly did that Oh, you to alone was highly active with an overall response rate of 85% 11 of 13 patients. After three through cycles of therapy. This is again prior to the introduction banana KLAX, we start with what are you to alone induction.

Michael S. Weiss: And these are patients who are heavily pre-treated, relapsed refractory CLL patients, including a number of whom that were refractory to abrutinib. Following Cycle 3, Phenatoclax was introduced to the study, and all nine patients that had at least seven cycles of follow-up at the time of the abstract submission had a complete or partial response to the three-drug combination. As importantly, of the five patients with 12 cycles of follow-up at the time of the ASH abstract submission, all of them had achieved undetectable minimal residual disease in the peripheral blood, and four or five of those patients had achieved undetectable MRD in the bone marrow and were able to stop treatment at the end of cycle 12.

These are patients were heavily pretreated relapse refractory CLL patients, including number from that were refractory to Britain.

Following cycle, three and not have clocks was introduced to the study and all nine patients.

That had at least seven cycles, a follow up at the time of the ash abstract submission how to complete a partial response.

Oh it to the three drug combination as importantly, the five patients with 12 cycles, a follow up at the time at the Ash abstract submission all of them had achieved undetectable minimal residual disease in the peripheral blood and four or five of those patients had achieved undetectable at more D and the bone.

Merrell and were able to stop treatment at the end up cycle 12.

Well. These are small patient numbers. These results appear to represent a substantial improvement over existing therapy.

Michael S. Weiss: While these are small patient numbers, these results appear to represent a substantial improvement over existing therapies. We look forward to the presentation of additional data from this study at ASH, including additional patients to the longer and patients to the longer follow-up, to confirm these dramatic effects. This data will be presented at ASH by Dr. Paul Barr, Director of the Clinical Trial Center at Wilmette Cancer Institute at the University of Rochester. Additionally, we have already begun enrolling in what we hope will be a registration-directed Phase II single-arm study called the ULTRA-V study, which looks at the combination of U2 plus venatoclax in both relapsed refractory and treatment-naive CLL patients This study is being led by Dr. Richard Fuhrman, who is the director of the CLL Research Center at Weill Cornell Medicine here in New York City.

We look forward to the presentation of additional data from this study at ash, including additional patients.

Because of longer and patients are longer follow up.

To confirm these dramatic effects.

This data will be presented at ash by Dr., Paul Bar director of the clinical trial Center at Walnut Cancer Institute at the University at Rochester.

Additionally, we have already begun enrolling and what we hope will be a registration directed phase two single arm study called the Ultra V study, which looks at the combination of you two plus fanatic clocks in both relapse refractory and treatment naive.

CLL patients.

This study is being led by Dr. Richard Firming.

I used the director of the CLL Research Center at Weill Cornell Medicine here in New York City.

The second abstracts accepted for poster presentation is the phase one study of P.G. seventh you know one our novel BTK inhibitor as a single agent and in combination with you to for patients with a variety of relapsed refractory b cell malignancies.

Michael S. Weiss: The second abstract accepted for a poster presentation is the Phase I study of TG1701, our novel BTK inhibitor, as a single agent and in combination with U2 for patients with a variety of relapsed fractured B cell malignancies. As you may recall, we have previously studied the triple combination of U2 plus abrutinib, where we demonstrated 100% response rates in patients with CLL and marginal zone lymphoma, with a The promising results seen in the U2-Posibrutinib study, which was published in Lancet Hematology, motivated us to move our proprietary, once daily, BTK inhibitor into triple combination studies as rapidly as possible. The ASH abstract includes the first ever clinical data on our BTK inhibitor, TD1701, and includes data from the single agent cohort as well as the triple combination cohort with U2. Responses have been seen at all dose levels, and all patients treated in the triple combination at the lowest dose achieved a response at first assessment, including a complete response in a patient with follicular lymphoma and two partial responses, one in a patient with follicular lymphoma and one in a patient with marginal zone lymphoma.

As you May recall, we had previously studied the triple combination of you two plus a burden it where we demonstrated 100% response rate in patients with CLL and marginal zone lymphoma.

Well, they well tolerated safety profile.

The promising results seen in the you two plus a Britain and study, which was published in landscape hematology motivated us to move our proprietary once daily BTK inhibitor into Triple combination studies as rapidly as possible.

The ash abstract includes the first ever clinical data on our BTK inhibitor P.D. 17, a one and includes data from a single agent cohort as well the triple combination cohort with you too.

Sponsors hadn't seen at all dose levels and all patients treated in the triple combination the lowest dose have achieved a response.

At the first assessment.

Getting a complete response in a patient with the looked a little lymphoma.

And to partial responses one in a patient with slick lymphoma, and one in a patient marginal zone lymphoma.

Michael S. Weiss: This study is particularly important to us at TG as it represents a significant step forward in our mission to develop novel combination therapies for those patients in need. This is the first triple combination study conducted where all the agents are proprietary TG drug candidates. Needless to say, we are excited for the ASH meeting in Orlando next month.

This study is particularly important to us at GE GE as it represents a significant step forward in our mission to develop novel combination therapies those patients in need. This is the first triple combination study conducted where all the agents our proprietary P.G. drug candidates.

Needless to say we are excited for the Ash meeting in Orlando next month.

Michael S. Weiss: Both of these trials will come into better focus when we have the Unity CLL Pivotal data, but please understand that we're conducting studies today that will hopefully enable a strategy that puts U2 in a position to be used both as U2 alone and also on top of BTKs and Venaticlax to optimize those treatments. Neither BTKs nor Venatocreps alone are the solution.

Both of these trials will come into better focus when we have the unity CLL pivotal data, but please understand that we're conducting today. The studies that will hopefully enable strategy that puts you too in a position to use both as you to alone and also on top of be Teekays and banana clocks to optimize those two.

Treatments, neither be teekays northern out across alone are the solution.

Michael S. Weiss: Our belief is that you can make this treatment better and should enhance the number of patients to get long-term, durable remissions so patients can stop therapy. That is the goal of all this work. With that, it's probably a good time to transition to the Unity CLL study, as much of the excitement of these two abstracts hinges on a positive Unity CLL outcome. As a reminder, the UNITY CLL trial is a randomized phase 3 study of U2 compared to an active control arm of a combination of chemotherapy and an anti-CD20 monoclonal antibody in patients with both treatment nave as well as The primary endpoint for this trial is progression-free survival. As we have said previously, we hope to have results from this study around year-end or into the first quarter of next year. However, as this is an event-driven trial, it is challenging to precisely predict the timing of completion.

Our belief is that you to make this treatment better and should enhance the number of patients. They got long term durable remissions. So patients can stop therapy that is the goal of all this work.

With that it's probably a good time to transition to the unity CLL study as much of the excitement of these two abstracts hinges on a positive unity CLL outcome.

As a reminder, the unity CLL trial as a randomized phase three study of you to compared to an active control arm of the combination of chemotherapy and an anti cdtwenty monoclonal antibody in patients with both treatment naive as well as relapse refractory chronic lymphocytic leukemia.

The primary endpoint for this trial is progression free survival.

As we've said previously we hope to have results from this study around year end or into the first quarter of next year. However.

As this is an event driven trial, it's challenging to precisely predict the timing of completion.

Michael S. Weiss: We remain extremely optimistic about the study and the prospects for successful PFS outcomes. Before I transition to a quick highlight reel of what we've accomplished this year so far, let me also remind everyone that, in addition to the Unity CLL Phase 3 data, we have another large Phase 3 program reading out in 2020. That, of course, is our Ultimate 1 and 2 Phase 3 Trials in Relapsing Forms of Multiple Sclerosis. These are two independent phase 3 trials comparing ubutuximab to oral paraflunomide.

We remain extremely optimistic about the study and the prospects for successful PFS outcome.

[noise] odd before I transition to a quick highlight reel of what we've accomplished this year. So far let me also remind everyone that in addition to the unity CLL phase three data we have another large phase three program reading out in 2020 not of course is our ultimate one into phase three trials in relapsing form.

A multiple sclerosis. These are two independent phase three trials comparable to talk snap to oral tariffs minimize.

Michael S. Weiss: The primary endpoint for each study is annualized relapse rate following 96 weeks of treatment and is designed to support submission for full approval of lubotoxinab in relapsing forms of MX. These trials are being conducted under special protocol assessment with the FDA and have been fully enrolled for over a year now. We are targeting top-line data from these trials in the middle to second half of next year. For sure, exciting times ahead for TG, but let's not forget all the progress we've made already this year.

The primary endpoint for each study is I realize annualize relapse rate. Following 96 weeks of treatment <unk> designed to support submission for full approval Ublituximab relapsing forms cabana.

These trials being conducted under special protocol assessment with the FDA and have been fully enrolled for over a year now we are targeting topline data from these trials in the middle to second half of next year.

For sure exciting times ahead.

For TG, but let's not forget all the progress we've made already this year.

Unknown Executive: Let me finish my prepared remarks with a little recap of the major achievements for the first three quarters of 2019. Early in the year, we announced that our registration-directed Unity NHL Studies Marginal Zone Lymphoma cohort met its primary endpoint, and we received a breakthrough designation from the FDA for this indication. Soon thereafter, we presented preliminary positive data at a few important medical conferences demonstrating an approximately 50% overall response rate and approximately a 20% complete response rate for umbilicib as a monotherapy, with what appeared to be a well-tolerated safety profile. Later, we announced that we met with the FDA to discuss a modular zone of filing, and after that meeting, we announced our intention to target the commencement of a rolling NDA submission around year end

Let me finish my prepared remarks with a little recap of the me with the major achievements for the first three quarters of 29 pm.

[noise] early in the year, we announced that our registration directed unity NHL studies marginal zone lymphoma cohort met its primary endpoint and we received breakthrough designation from the FDA for this indication.

Soon thereafter, we current presented preliminary positive data at a few important medical conferences demonstrated an approximately 50% overall response rate and approximately a 20%.

Response rate for under listed as a monotherapy.

With what appear to be well tolerated safety profile.

Later, we announced that we met with the FDA to discuss our margins on the phone filing and after such a meeting we announced our intention to target the commencement of a rolling NDA submission around year end.

Then we announced that almost with almost four years a follow up are genuine study demonstrated that we would talk some out in combination with the bruton to improve progression free survival overburden, a monotherapy in patients with high risk relapse refractory CLL.

Unknown Executive: Then, we announced that with almost four years of follow-up, our genuine study demonstrated that Ulutuximab, in combination with Ibrutinib, improved progression-free survival over Ibrutinib monotherapy in patients with high-risk relapsed refractory CLL. Despite recent approvals, this patient population remains a high unmet medical need; we plan to share the data with the FDA and present this data And finally, just two short weeks ago, we announced that the follicular lymphoma cohort from our Unity NHL study also met its primary endpoint of overall response rates. The follicular lymphoma cohort was designed to replicate the successful accelerator approval pathways taken by other PI3K deltas. Overall response for the approved PI3K deltas ranged from 42% to 59%, and our target range for success was 40 to 50%.

Despite recent recent approvals this patient population remains a high unmet medical need.

Thank you share the data with the FDA and present.

The stayed at a future medical conference.

And finally, just two short weeks ago, we announced that the for looked a little inform a cohort from our unity NHL study [laughter] also met its primary endpoint of overall response rate.

The for looked a little lymphoma cohort was designed to replicate the successful accelerated approval.

Pathways taken by other theatrical deltas.

Overall response for the approved theatrically deltas has ranged from 42% to 59% and our target range for success was 40% to 50% we.

Unknown Executive: We plan to discuss these results with the FDA with the goal of initiating an accelerated approval filing for follicular lymphoma in 2020. 2019 has been an exciting year for us, and we plan to keep the momentum going into 2020, which we believe will be a transformational year for our company, with two substantial pivotal data readouts for our Unity CLL and Ultimate MS Phase II trials and our transition into a commercial organization with the potential approval of Umbralisib for Marginal Zone Lymphoma before year end. With that, I'd like to turn the call over to the conference operator to begin the Q&A session, following which I'll return to make some concluding remarks.

We plan to discuss these results with the FDA with the goal of initiating an accelerated approval falling from Follicular lymphoma in 2020.

2019 has been exciting year for us and we plan to keep the momentum going to 2020, which we believe will be a transformational year for our company with two substantial pivotal data read outs for our unity CLL and ultimate and this phase two trials and our transition into a commercial organization with a potential approval of 'em Burleson.

For marginal zone lymphoma before yearend.

With that I'd like to turn the call over to the conference operator to begin the Kunaev session, following which our churn to make some concluding remarks.

Thank you.

Unknown Executive: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Well that'd be conducting a question answer session. If you like to ask a question. Please press star one on your telephone keypad and a confirmation tone indicate your line is in the question Q.

The press Star too if you like to move your question from the Q.

Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star Keith.

Matthew Lee Kaplan: One moment, please, while we poll for questions. Thank you. The first question comes from the line of Matt Kaplan with Leidenberg-Fallon. Please proceed with your questions.

One moment, please so we pull for questions.

Thank you. That's the first question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Yeah. Thanks for taking my questions and congrats on the on the progress during the quarter and Mike Uh Huh.

Michael S. Weiss: Hi, thanks for taking my questions and congratulations on the progress during the quarter. Hey Mike, can you just give us some added detail with respect to next steps for the Unity NHL cohorts for Marginal Zone and Follicle Lymphoma with respect to preparing and filing potential NDAs for those two indications for ombilicis?

Just a guess and added detail with respect to next steps for the unity NHL cohorts for marginal zone and slick lymphoma with respect to.

Pairing and and filing to pencil and da's for for those two indications thrombolysis.

Michael S. Weiss: So, as we've discussed previously, with respect to marginal zone lymphoma, we've already met with the FDA. We feel like we have a good plan for filing the NDA. And the plan, our current plan, is to get a rolling submission started for marginal zone lymphoma around year end. It should take about three months or so to get that filing complete.

Sure Yeah sure. So so as we've discussed previously with respect to margins on the pharma, we be birdie I've met with the F.D.A., we feel like we have a good plan.

For filing the NDA ER and the plan. Our current plan is to get a rolling submission starter for margins on lymphoma around year end.

It should take a about three months or so to get that filing complete.

Michael S. Weiss: And then with respect to follicular lymphoma, as you know, we just received that data. Our current thinking is that perhaps we can squeeze that one into the marginal zone filing. It will depend on timing and FDA's interest in that kind of combined filing. So, some things to think about. And then if it does not go into the marginal zone filing, which again we think is the less likely scenario, it will be a standalone filing in 2020, or it will be combined with the filing for CLL based on the Unity CLL data, assuming that's positive. So we've got a few options for how we would get the follicular on file, but they're all good options. We just have to figure out which one makes the most sense.

And then with respect to Follicular lymphoma, or as you know we just received that data. Our current thinking is perhaps we can squeeze out one a into the margins on finally, it will depend on timing will depend on a hefty is interested in that kind of a filing so some some things to think about.

A and then if it does not go into the marginal zone lymphoma, together, because less likely scenario it'll all it'll be a standalone filing in 2020 or.

It would be combined with the filing for CLL based on do you feel all day, so you're not positive. So we've got a few options for how we get the follicular on file a but there are all good options. We've just got to figure out a which when it makes no sense.

Okay very good and then in terms of with with the the near term I guess, a regulatory filings and and kind of I guess turning over the card for unity CLL can you give us a sense in terms of your commercial preparations.

Michael S. Weiss: Okay, very good. And then, in terms of the near-term regulatory filings and kind of, I guess, turning over the card for Unity CLL, can you give us a sense in terms of your commercial preparations for, I guess, Numberless and U2 as well?

For I guess number listen you too as well.

Ah, yes, so as I think.

Michael S. Weiss: Yeah, so, as I think most everyone knows by now who's been following the company, we hired Adam Waldman to be the Chief Commercial Officer. He has been busy building his team. He's got a great team he put together.

Most everyone knows if I now can be found the company rehired Adam all men.

To get Chief commercial officer. He has been a busy building his team he's got a great teams put together.

Michael S. Weiss: a number of additional Celgene employees and others from other

A number of additional celgene, along and others from other a large companies. So the teams coming together there they're building the plan I think where we're getting to position I think probably in the early part of next year.

Michael S. Weiss: So.

Unknown Executive: So the team's coming together, they're building the plan, and I think we're getting to a position where, probably, in the early part of next year, we'll finally roll Adam out and let him personally tell everyone about his great plan for commercialization. But he is working actively on building the team. Like I said, he's put together a great team, and they're all building together a great launch plan.

I will finally rollout a nod and let him personally tell everyone about is great plan for commercialization, but.

He is working actively I'm bill do the team.

He said he's put together great team and they're all building together a great launch plan.

Alicia Young: Thanks for adding detail and taking the questions. Thanks, everyone. Thanks, everyone.

Thanks for that to detail on taking questions.

Thanks.

The next question is from the line of elite the young with Cantor Fitzgerald. Please proceed with your question.

Michael S. Weiss: The next question is from the line of Alicia Young with Cantor Fitzgerald. Please proceed with your question.

Michael S. Weiss: Hey, good morning. This is Lee Ahn for Alethea, and we have a couple questions here. So, first, for the rolling submission for single-agent BRA-LISP in MCL around year-end, how much follow-up did the FDA ask for in order to file, and how much follow-up do you guys have now? And then, for the Unity CLL trial, obviously, the PFS data is reading out around year-end or early 2020. Could you just remind us why you decided not to conduct an ORR analysis as originally planned but instead to look at PFS readout?

Hi, good morning, definitely arm falling yeah, and we have a couple questions here on the first whatever rolling submission for single agent Umbra, unless the A.M.C.L. around year end, how much follow up did that if they ask for in order to file and how much follow up to <unk> now.

And then for the young unity sat out trial, obviously, the key I've asked theaters tweeting out around year end or early 2020 could you just from mine as to why you decided not to conduct an L.R. analysis and originally planned in his dad.

Okay Yep, that's been out.

Sure so.

Michael S. Weiss: Sure, so on the rolling submission for Marginal Zone and the follow-up, we haven't disclosed the precise amount of follow-up required, but I could say that greater than 12 months of follow-up would be required to make a filing in this area, and it's longer than that. So we are in the process of following patients, and probably the last piece that will go into that rolling submission will be the clinical data with the required follow-up. But again, we haven't disclosed it, but I think we should. You know, we've made it pretty clear that the rolling submission will be in some reasonable time frame after we get the rolling started, the completion should be done, and the follow-up that was requested by the FDA will be all in there.

On the rolling submission for margin zone, and I'm, a follow up a leap we haven't disclosed the precise amount a follow up required but I could say that is greater than 12 months a follow up a would be required to make filing a in this area. So.

And then it's longer than that so we are we are in the process of falling patients.

Indeed, I, probably the last piece that will go into that rolling submission will be the clinical data with the required follow up.

But again, we haven't we haven't disclosed but but.

I think we should you know we've we've made a pretty clear that the rolling submission will be in some reasonable time from after you get the rolling started the.

Completion should be done and the follow up that was requested by the after they will be all in there.

Okay and for the usual trial, yeah, yeah. So for unity CLL. So you may recall, a the D.S.N.B. I'm back in September of.

Michael S. Weiss: Okay, thanks. And for unity, I would follow. Yeah.

Michael S. Weiss: So for Unity CLL, so you may recall the DSMB back in September of 18, I guess it was, decided that the data were not mature enough at that time to conduct the overall response analysis. That was based on their assessment that they could not, I guess, reliably consider it complete. And so if they couldn't feel it was complete, the data was not mature.

18, I guess of loans I decided that the data were not mature enough at that time to conduct the overall response analysis.

That was based on their assessment that they could not I guess reliably consider it complete and so if they couldn't feel was complete the data was not sure. So the net result was the SMB looked at the maturity of the data not the data itself and decided that.

Michael S. Weiss: So the net result was the DSMB looked at the maturity of the data, not the data itself, and decided that they preferred to wait to do that analysis. At that point, we as a company decided that there was probably no further use for overall response as the delay, if it was three, six, or et cetera, would be putting the overall response information too close to the progression-free survival information. And so we decided at that point to reserve the overall response assessment for the same time as the PFS. Having said that, at this point, then, the overall response has no value to us. The overall response was built into the trial as a potential way to get an early filing for accelerated approval. However, once we decided to wait for progression-free survival, which is and was the primary endpoint for the trial, the relevance of overall response as a regulatory indicator went away.

They prefer to wait to do that analysis at that point, Oh, we as a company.

Decided that do is probably no no further use for overall response has the delay if it was three fix or or et cetera would be putting the overall response information to close to the progression free survival information a and so.

We decided that point to reserve the overall response assessment.

For the same times, the PFS, having said that.

This point than the overall response has no value to us.

The overall response.

It was built into the trial or as a potential way to get a an early filing in for accelerated approval. Once we decided to wait for progression free survival, which which is in was the primary endpoint for the trial.

The relevance of overall response as a regulatory important went away.

Michael S. Weiss: Okay, thank you for the additional caller. Sure, no problem.

Okay. Thank you for any additional color.

Edward Patrick White: Share it; no problem.

Sure no problem.

Next question this renewal and if and white with H.C. Wainwright. Please proceed with your question.

Michael S. Weiss: The next question is from the line of Ed White with HC Wainwright. Hi guys, thanks for taking my questions. So first, you know, congratulations on the 1701 data. Maybe you can give us the next steps and your thoughts on development for 1701.

Hi, guys. Thanks for taking my questions.

So first congratulations on a 17, no one data or maybe give us the the next steps and your thoughts for development.

For seven kilowatts.

Sure. So you know, we're where we are super excited about 71, we're excited to present the data or.

Michael S. Weiss: Sure, so, we're, we are super excited about 1701; we're excited to present the data. But, what I think is, you know, probably the most interesting initially about 1701 are the potential applications outside of CLL.

What I think is you know probably most interesting initially about 17, along other potential applications outside of CLL. So as you saw it and you would see initial cohort of patients.

Michael S. Weiss: So as you saw in the initial cohort of patients, in the Phase I that were treated at the lowest dose of all patients responding. All three patients were indolent, so these are patients that are either follicular or marginal zone, again, two core areas for us, as everyone is now aware, based on our underlisted data as monotherapy immunity NHL. So just to give you a sense, this has been and continues to be an iterative process.

In the phase one that were treated the lowest dose.

With all patients responding.

All three patients where England patients. So these are patients that or either follicular or margin zone, you got to core areas for us.

Everyone is now where based on <unk> number lifted.

Data as a monotherapy a unique NHL. So just to give a sense. This is this <unk>. This has and continues to be an iterative process. So in step one in indolent lymphoma. So for the killer margins on a step one has been let's look at a Melissa monotherapy.

Michael S. Weiss: So in step one in indolent lymphomas, so follicular marginal zone, step one has been, let's look at ombilicid monotherapy. Step two is what we're looking at, [inaudible] would be to layer in U2 plus BTK. So again, there's a stepwise process to build toward doubles and triple combinations, and we think U2 plus 1701 could be a really exciting... opportunity for patients with Indolent Lymphomas where again, you know, a Brutonib monotherapy in the marginal zone is pretty good. It's about a mid-40s response rate.

Step two is we're looking at.

You too in those same indication.

And so we are willing to enrollment into our hopefully what could be registration directed you two studies on New Jersey NHL in marginal zone inflict <unk> and then the next step.

It would be to layering.

The you two plus BTK. So again as it is a stepwise process to build toward doubles and triples combination a and we think you two clubs I 72, you know one can be really exciting.

Opportunity for patients with indolent lymphomas, where again, yes.

Brittany monotherapy in in marginal zone is pretty good it's about a mid fortys response rate.

Michael S. Weiss: It's much lower in follicular lymphoma, with the reported ratio in the 20s. So again, as a standalone, BTK is not typically regarded as the right target for indolent lymphomas. But in an add-on program, we think there's real value there. For us, again, being able to develop our BTK, next-generation BTK, as a once-daily, we think it has some real advantages when combined with umbralisib, which is a once-daily. Some of the newer BTK inhibitors that are coming to market are going to be twice a day, so that's part of how we're thinking about 1701. We also think that U2 plus 1701 in CLL is a great alternative to BTK therapy as monotherapy. So again, we've already shown that if you take Brutonib and you add U2 on top of it, you're gonna get deeper responses. The CR rates go up, and the MRD negative rates go up quite a bit.

It's much lower in ER in for like the lymphoma, and they see the reporting richer the twentys. So again as a standalone BTK is not a not typically regarded as the right target for indolent lymphomas, but in an add on a program. We think there's there's real value there for us again.

Being able to develop RBC K, a next generation BTK as they once daily.

We think has some real advantages when combined with a Melissa which is a once daily or some of the new were BTK inhibitors that are coming to market are gonna be twice, a day, which you'd be surprised.

Now that that's twice a day certainly less convenient.

For patients.

So that that's part of how we're thinking about 70 <unk>. We also think at that you too.

17, a one in CLL is a great alternative to BTK therapy, a this as a monotherapy. So again, we've already shown a that if you take a Britain, let me add you too on top of it you're going to get deeper.

Responses that CR rates go up the M or do you negative rates go up quite a bit.

So we think that long term.

Michael S. Weiss: So we think that long-term BTK plus U2 is going to be a very attractive treatment option. Pretty much any time you choose to use a BTK inhibitor, you're gonna wanna put U2 on top of that. Obviously, we're driving toward our own triple combination where we'll have our own BTK. That way, we can try to make it as affordable as possible when we put the three pieces together.

Teekay plus you to is going to be a very attractive treatment option I pretty much any time, you choose to use it BTK inhibitor or you're going to want to play a huge on top of that obviously, we're driving toward our own triple combination, where we'll have our own BTK a that way we can try to make it is as affordable.

As part of them, but the three pieces together, a and also we have the opportunity to build that combination in a way that optimizes the activity, while minimizing the toxicity of the agents and again all of the the second generation I became like the first generation of Britain. It I have the same how.

Michael S. Weiss: And also, we have the opportunity to build that combination in a way that optimizes the activity while minimizing the toxicity of the agents. And again, all of the second-generation BTKs, like the first generation of Brutonib, have the same pattern of AEs. Whether we will find out soon whether they have them to a lesser degree, but for the moment, they all carry the same risk of Afib. They all carry a risk of bleeding. Additionally, they all carry a risk of arthralgias.

Pattern of eight years, whether we will find out to another they have and to a lesser degree but for the moment. They all carry the same risk of he said they all carrier risk of bleeding the all carry risk of ophthalmologists.

Michael S. Weiss: So there's a lot of room to improve the AE profile of a second-generation BTK, and by doing it in combination with U2, we think that affords us a lot of flexibility to create an optimal regimen. So that's what we're thinking. I think we have a lot of room to operate in creating a triple combination with 1701.

So there's there's there's a lot of room to improve the E profile of a second generation be PK and by doing it in combination with you to we think that affords us a lot of flexibility to create an optimal regimen. So that's that's what we're thinking we think they have a lot of a lot of room to operate.

In creating a triple combination with 17 along.

Great. Thanks, like and then maybe just a question for a for Sean.

Sean A. Power: Great. Thanks, Mike. And then maybe just a question for Sean. So what is the current share count out now when you include the fourth quarter ATM sales? It's right around $100 million at this point.

So what does the current share count out now.

When you include the [noise] fourth quarter ATM sales.

Unknown Executive: Okay. Thank you, Sean. As a reminder, to ask a question, you may press Star 1. The next question comes from the line of Chris Howerton with Jeffries. Please proceed with your question.

It's right around 100 million up.

Okay. Thank <unk>.

As a reminder to ask the question any press Star one. The next question comes from a lot of Chris Howerton with Jefferies. Please proceed with your question.

Chris Howerton: Great. Thanks for taking the questions. So, Mike, maybe for the triple combination data at ASH, maybe you could help us just contextualize those data within the context of what competing therapies have shown, maybe what you hope to see in the current trial, and what kind of regulatory hurdle might be in terms of clinical relevance.

Great. Thanks for taking the questions. So Mike maybe where the triple combination data at ash or maybe you could help us just contextualize those data within the context of were competing therapies have shown.

Maybe what you hope to see in the current trial and what what kind of the regulatory hurdle might be in terms of clinical relevance.

Michael S. Weiss: Sure, so when, I guess, let's look at the triple therapy of U2 plus venaticlax, published, and recall, these are patients that are in relapse, so these are relapsed refractory scale patients. The best data to date for any treatment regimen in relapsed fracture of a patient is for approved agents such as venatoclax plus rituximab. That data comes from the Morano trial. The CR rate for that study was around 10 percent, and the MRD negative rate in peripheral blood was somewhere between 40 and 50 percent. So again, I think what we're seeing and, you know, that this is a handful of patients, but we are seeing the potential emergence of a treatment regimen that can substantially outperform what exists today. So we do think that this is a pretty significant potential improvement. We obviously need to put more patients on, which we are.

Oh sure so [laughter] win or I guess, so let's look at the Triple therapy of you two plus banana Cox publishing and Emory recall. These are patients that are in relapsed. After these relapsed refractory CLL patients the best in data to date.

Or any treatment regimen in relapsed refractory patient is that have approved agents as banana KLAX plus for talks about that data comes from the Murano trial.

The CR rate or for that study was around 10%.

And the M. R&D negative rate in the peripheral blood a was somewhere between 40 and 50%.

So again I think what we're seeing in you know that's.

200, plus patients and this is a handful of patient.

But we're seeing the potential emergence of a treatment regimen that can you know substantially outperformed what exists today.

So we do think that this is a pretty significant potential improvement. We we obviously need to put more patients on which we are we've got more patients.

Coming through the the phase one that's being run by a factor or bar.

Michael S. Weiss: Dr. Paul Barr, and we also have the ULTRA-V study that's open and enrolling, and we're looking for a nice number of patients there, I think somewhere close to 100 patients. So, we are going to enhance that patient population and continue to see how that data evolves. From a registration standpoint, I think in relapsed or fractured patients, again, the comparator out there is Rituxan plus Venetoclax. I've just described that data to you. Assuming that our data continues to perform in relapsed patients the way it did in the first handful of patients, then we certainly would be comfortable at least having a conversation with the FDA about the usability of our collective data from the Phase I and Phase II studies for an accelerated approval. Again, that would be on the backdrop of a U2 already approval. It wouldn't be possible unless U2 and the Unity Cell trial are positive, but once it is positive, I think that does enable us to have that conversation about this data set.

We also have the ultra V study, that's open a enrolling and looking for a nice number patient there I think.

Somewhere close to 100 patients so.

Ah. So we're we're we're going to enhance that that patient population and.

We continue to see how that data evolves.

From a registration standpoint.

I think in relapsed refractory patients again, you know the comparator are out there is.

We're tux influx of an adequate Alex I've just described that data to you a assuming that our data continues in relapsed patients to perform the way it's performed in the first handful of patient.

Then, we certainly would be comfortable leased having conversation.

With the up day about of usability of of our collective data from the phase one phase two.

For for accelerated approval again that we'd be on the backdrop of Oh like you to already approval it wouldn't be I wouldnt be possible unless a huge human unity CLL trial, a positive but once it is positive I think that does enable us to have that conversation about this data set.

Michael S. Weiss: Sure, okay, great. All right, and then maybe just another one for the genuine results, obviously, you know, positive PFS, but how should we think about that fitting into your CLL and, I guess, broader into your lymphoma strategy?

Sure Okay great.

Right and then maybe just another one where the genuine results. Obviously, you know a positive PFS, but how we should we think about that fitting into your CLL and and I guess broader indolent lymphoma strategy.

Michael S. Weiss: Yeah, look, I think it's another important piece of information showing that one of our drugs, in that case, ubatuximab, can enhance abrutinib in a challenging patient population. That group, particularly the 17Ps and the P53s, continue to underperform all other patient populations when treated with BTK inhibitors. So the response rates are all quite good, but they tend to have a shorter progression for survival.

Yeah look I think it say a it's a another important piece of information.

Showing that one of our drugs in that case, but talks and can enhance a bruton it in a challenging patient population that group, particularly the 17 p. than the P. 53 is a continued to underperform all other patient populations when treated with BTIG.

Inhibitors. So the response rates are all quite good but they tend to have a shorter progression free survival. So the fact that you can add in the second generation, a highly ADCC cdtwenty and enhance PFS in this patient.

Michael S. Weiss: So the fact that you can add a second generation highly ADCC CD20 and enhance PFS in those patients is another very important piece of information for us and for patients, and for physicians. That is in contrast, I will note, to the studies that have been run with rituximab plus abrutinib, where none of them have been able to show that rituximab has added anything on top of abrutinib. So, again, I think these are all layers of importance we have, so we now have data showing that if you take Lutoximab alone and you put it with a BTK inhibitor, certainly in high-risk patients, the BTK inhibitor is going to perform better. We've also shown that if you take Umbrolisib, and this has also been published, I believe, in Lancet Oncology, if you take Umbrolisib, our PI3K Delta, and combine it with BTK, in that case, Brutinib, you're going to also enhance the outcome for patients.

It is another very important piece of information Oh for for us than for patients and for physicians a that is in contrast, I will note.

To the studies that have been wrong with Rituxan, plus a burden that where none of them and been able to show a that reduction has added anything on top of style of Britain. So I can't I forget. The these are all layers of importance. We have so we we now have data showing that if you take.

Well the talks about alone and you put it would have BTK inhibitor.

Certainly in the high risk patients. The beat you can't number is going to perform better. We've also shown that if you take.

Burleson and this is also published I believe lancet oncology can take on Burleson bariatric, a delta and combine it would be teekay in that case a burden there.

You're gonna also enhance.

The outcome for patient you're going to get more patients into CR and more patients with longer remissions and we have a third piece of information, which shows that if you take you too. So the combination of both of those he added on top of the BTK again.

Michael S. Weiss: You're going to get more patients into CR and more patients with longer remissions. And we have a third piece of information, which shows that if you take U2, so the combination of both of those, and you add it on top of BTK, again, Abrutinib, in that case, published in Lancet Hematology. Again, we showed that you can drive deeper responses, MRD negatives, in patients, and ideally, that will lead to getting patients off therapy.

Burden of in that case publish and that's it hematology again, we showed you can drive deeper responses emerging negative.

Patients and ideally that will lead to getting patients on therapy. So again I think all this is a leading to you know ideally a place, which we kind of alluded to in the prepared remarks or that you too or is it can be a treatment option, assuming the utilities bother, which we believe will be in its approved you to be treatment arms.

Michael S. Weiss: So again, I think all of this is leading to, you know, ideally a place which we kind of alluded to in the prepared remarks, that U2 is, you know, it's going to be a treatment option assuming the immune cell is positive, which we believe it will be, and it's approved. U2 will be a treatment option to be used on its own, and then we're building toward what could be better triple combinations using U2 plus BTKs, and U2 plus venaticlax. So the utility of U2 is not just as U2 as a stand-alone basis, which we think will be a very important treatment option, particularly for patients in the community, particularly for patients who have already seen a BTK inhibitor. There's a pool of over 50,000 of those patients out there that are going to potentially come back into the system over the next 5 to 10 years, for which U2 alone will be very interesting.

And debuts on its own and number building toward what could be better triple combination using you two plus be Teekays you took place banana KLAX.

So the utility of you too is not just as you too as a standalone basis, which we think is they will be a very important treatment option, particularly for patients in the community, particularly for patients who have already seen a BTK inhibitor, which again, there's a pool of over 50000 those patients out there.

Our that are going to potentially come back into the system over the next five to 10 years.

For which you to alone.

We'll be very interesting, but in up from patient then we start to think about driving toward deeper responses in getting patients. All BTK inhibitors I don't want to stay on them. If you don't have to for life.

Michael S. Weiss: But an up-front patient, as we start to think about driving toward deeper responses and getting patients off BTK inhibitors, you don't want to stay on them if you don't have to for life, and certainly you don't want to stay on them for progression. So layering something on top of a BTK inhibitor when that is your first choice is going to be extremely important, and we think U2 could be an ideal partner for that. Again, we've got to do the clinical trials, which we are doing, to build toward layering U2 on top of some of these other agents.

Certainly don't Wanna found them to progression, so layering something on top of Oh.

The BTK inhibitor.

That is your first choice is gonna be extremely important we think you too could be an ideal a partner for that again, we got to do the clinical trials, which we're doing to build toward.

Layering you too on top of somebody's other agents.

Chris Howerton: Got it. Okay. Well, I really appreciate the extra cover, and congrats again on the call.

Got it okay, well I'm really appreciate the extra color and congrats again on the quarter. Thank you.

Great. Thanks Russ.

Unknown Executive: http://TheBusinessProfessor.com

Thank you okay.

Unknown Executive: Thank you. Okay. I'm sorry.

Probably please go ahead.

Michael S. Weiss: Go ahead. So let me, I guess, conclude the call by making some final remarks. I think I cut off the coffee shopper, and he was going to turn the call back over to me, but I'll just take it myself.

Go ahead so.

So let me I guess conclude the call by making some final remarks and got cut off the cuff sovereign it was going to turn the call back over to me, which I'll just take it myself.

Michael S. Weiss: So, first, again, let me thank everyone for joining us on the call today. I'll do a quick final review of the key objectives and goals for the remainder of the year, and it's rolling next year, with regard to our pivotal programs. So, first, and very excitedly, in the short term, around the end of the year, we should be initiating our first rolling NDA submission for patients with previously treated marginal zone lymphoma. Also, around year-end and into the first quarter of 2020, as we've just been discussing, we're hoping to have the top-line announcement for our progression-free survival from the Phase 3 UNDCLL trial. We also plan to share the results from the follicular lymphoma cohort with the FDA again to determine the optimal follow-up approach, which we can just discuss.

So at first again, let me thank everyone for joining us on the call today, Oh I'll do a quick final review on the key objectives and goals are for the remainder of.

The year in its early next year in or <unk>. The regard tropical programs. So first and very excited lean short term around the ended the year, we should be initiating a first rolling India submission for patients with previously treated marginal zone lymphoma.

Also.

Around year end a in into the first quarter of 20 as we've just been discussing a we're hoping to have the topline announcement for our progression free survival from the phase three unity CLL trial. We also plan to share results from the flicker lymphoma cohort.

With the FDA again to determine the optimal falling approach, which you can just discussed a lot and then are you know we're targeting a topline data from the ultimate phase three trials and relaxing a M.S. middle to second half 2020.

Michael S. Weiss: And then we're targeting top-line data from the ultimate Phase 3 trials and relapsing MS in the middle to second half of 2020. And finally, if all goes well, we could see our first approval for umbralisthid and modular zone lymphoma by the year-end 2020. So, on behalf of all of us at TG, I'd like to thank our investigators and their patients for participating in our trials, as well as our shareholders for their continued support.

And finally.

If all goes well, we could see our first approval from Burleson and modules on lymphoma by the year end 2020.

On behalf of all of us at TG I'd like to think our investigators and their patients after participating our trials.

As well as our shareholders for their continued support.

Unknown Executive: Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

And thanks again, everyone for joining us and have a great day.

Thank you. This concludes today's conference you may disconnect. Your life. This time, thank you for your participation.