Q2 2020 TG Therapeutics Inc Earnings Call

[music].

And welcome to the TG Therapeutics second quarter 2020 earnings conference call. At this time, all participants are they listen only mode. If anyone should require operator assistance. During the conference. Please press star zero under telephone Keypad, Oh question answer session will follow the formal presentation.

Operator: Welcome to the TG Therapeutics Second Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Operator: A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Jenna Bosco, Senior Vice President, Corporate Communications. Please go ahead.

As a reminder, this conference is being recorded its got my pleasure control over the Jenna Bosco Senior Vice President Corporate Communications. Please go ahead.

Thank you good morning, and welcome to our conference call to discuss TG Therapeutics second quarter, 2020, <unk> financial results and business update I'm, Jenna Bosco TG Senior Vice President of corporate Communications and I Welcome you to a conference call today.

Jenna Bosco: Thank you. Good morning, and welcome to our conference call to discuss TG Therapeutics' second quarter 2020 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 overview of the ongoing development of our lead compounds, Oogletuxim 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 provisions under the Private Securities Litigation Reform Act of 1995.

Following our safe Harbor statement, Sean Power teaches Chief Financial Officer will provide a brief overview of our financial results and then turn the call over to Michael life, The company's executive Chairman and Chief Executive Officer, who will provide an overview of the ongoing development of our lead compounds, Google It talks about and numberless it as well.

An update on our overall company standing.

Before we begin I'd like to remind everyone that there that many remarks, we make about our future expectations plans and prospects constitute forward looking statements for purposes of the safe Harbor provisions under the private Citic Securities Litigation Reform Act of 1995.

TG cautions that these forward looking statements are subject to risks and uncertainties that may cause our actual results to differ materially from those indicated factors that may affect TG therapeutics operations include various risk factors that can be found in our SEC filings.

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.

This conference call is being recorded for audio rebroadcast on teaches website www Dot TG therapeutics dotcom, where we'll be available for the next 30 days.

All participants on this call will be only 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 second quarter of 2020 as well as the company's overall financial condition.

Sean A. Power: Now, I'd like to turn the call over to Sean Power, our Chief Financial Officer, to briefly discuss the financial results for the second quarter of 2020, as well as the company's overall financial condition. 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. I'll begin with our cash position. We are happy to have bolstered our balance sheet during the quarter, raising more than $240 million through the combination of our public offering and the use of our ATM facility following the positive top-line Unity CLL Phase 3 results.

Thank you gentlemen, thanks, everyone for joining could you maybe where financial results released this morning and can be viewed any investors immediate action or website.

I'll begin with our cash because she you're happy to both your balance sheet during the quarter raising more than 240 million to the combination her public offering and the use of our ATM facility. Following the positive top line you de CLL phase three results.

Accordingly at June Thirtyth, we had cash cash equivalents investment Securities 275.6 million, which we believe these as well funded this quarter operations through 2021.

Sean A. Power: Accordingly, at June 30, we had cash, cash equivalents, and investment securities of $275.6 million, which we believe leaves us well funded to support our operations through 2021. Our net loss for the second quarter of 2020, excluding non-cash items, was approximately $45.5 million. The Gap Net Loss for the second quarter of 2020 was $52.9 million, or $0.47 per share, compared to a net loss of $36.2 million, or $0.42 per share, during the comparable quarter in 2019. Our net loss for the six months ended June 30, 2020, excluding non-cash items, was approximately $85.6 million. The gap net loss for the six months ended June 30, 2020 was $104 million or $0.95 per share compared to a net loss of $71.4 million or $0.85 per share for the six months ended June 30, 2019. For the remainder of 2020, we expect our R&D costs to decline as our pivotal programs continue to wind down, which will be partially offset by a modest increase in G&A costs as we continue to prepare ourselves for our first commercial launch. With that, I will now turn the call over to Mike Weiss, our Executive Chairman and CEO.

Our net loss for the second quarter of 2020, excluding non cash items was approximately 45.59.

GAAP net loss for the second quarter.

2020 was 52.9 million 47 cents per share compared to a net loss of 36.2 million were 42 cents per share during the comparable quarter 20 Nike.

Our net loss for the six months ended June Thirtyth 2020, excluding noncash items was approximately 85.69.

The GAAP net loss for the six months ended June Thirtyth 2020, 104 million were 95 cents per share compared to a net loss of 71.4 million worth 85 cents per share for the six months ended June Thirtyth 20 <unk>.

For the remainder of 2020, we expect our R&D R&D costs to decline that's a pivotal programs continue to wind down which will be which will be partially offset by modest increase in DNA cost as we continue to prepare ourselves for first commercial launch.

With that I'll now turn the call over to Mike Wise or executive Chairman and CEO.

Great. Thanks, Sean Thanks, Jenna and thanks, everyone for joining us this morning.

Michael S. Weiss: Great. Thanks, Sean, and thanks, Jenna, and thanks, everyone, for joining us this morning. It's been a truly amazing first half of 2020 for TG, and we're expecting exciting things for the second half, where we will announce results from our Ultimate MS studies and present detailed results from our Unity NHL and Unity CLL studies. And as we move into 2021, we could receive our first approval, propelling us forward from a development stage company to a fully integrated commercial organization. Let me start the call by highlighting some of this year's major accomplishments.

It's been a truly amazing first Asher of 2020 for TG, and we're expecting exciting things for the second half.

Where we will announce results from our ultimate M.S. studies and present detailed results from our unity NHL and unity CLL studies.

And as we move into 2021, we could receive our first approval propelling us forward from a development stage company to fully integrated commercial organization.

Let me start the call by highlighting some of this year's major accomplishments.

We completed our first rolling submission of a new drug application for single agent on Burleson.

Michael S. Weiss: We completed our first rolling submission of a new drug application for single-agent umbralisib in the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma. This was an incredible achievement for our company, and I commend our team's effort in preparing this submission under such challenging circumstances. We also announced that the Unity CLL Phase 3 trial evaluating U2 combination in both treatment-naive and previously treated CLL patients met the primary endpoint of improved progression for survival with a p-value of less than 0.0001. As Sean mentioned, we bolstered our balance sheet with over $240 million in new capital from our largest public offering to date, as well as the use of our HCM facility.

In the treatment of patients with previously treated marginal zone lymphoma, and Follicular lymphoma. This was an incredible achievement for our company and I commend our team's effort in preparing the submission under such challenging circumstances.

We also announced that you feel all phase three trial evaluating due to combination in both treatment naive and previously treated CLL patients met the primary endpoint of improved progression free survival with a P value of less than <unk> 0.0001.

As Sean mentioned, we bolstered our balance sheet with over 240 million in new capital from our largest Pablo public offering to date as well as the use of our ATM facility.

We strengthened our scientific and medical leadership team with the addition of Dr. Owen O'connor as our Chief Scientific Officer. He joins US from Columbia University Medical Center, where he most recently served US professor of Medicine, and experimental Therapeutics and the director of the center for Lymphoid malignancies, as well as co program direct.

Michael S. Weiss: We strengthened our scientific and medical leadership team with the addition of Dr. Owen O'Connor as our Chief Scientific Officer. He joins us from Columbia University Medical Center, where he most recently served as Professor of Medicine and Experimental Therapeutics and the Director of the Center for Lymphoid Malignancies, as well as Co-Program Director of the Lymphoid Development and Malignancy Program at the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center. We have also added Dr. Sagar Loneal to our Board of Directors. Dr. Loneal is currently serving as Professor and Chair of the Department of Hematology and Medical Oncology at the Emory University School of Medicine, as well as the Chief Medical Officer at the Winship Cancer Institute of Emory University. We've also been hard at work building our commercial and medical affairs organizations.

Tariff the lymphoid development and malignancy program.

Herbert Irving comprehensive cancer Center at Columbia University Medical Center.

We also added Dr. saagar loan yield to our board of directors Dr. O'neill is currently.

Serving as professor and chair of the Department of Hematology and medical oncology at the Emory University School of Medicine.

[laughter].

As well as the Chief Medical Officer at Winship Cancer Institute of Emory University.

We've also been hard at work building or commercial and medical Affairs organization. This team is very impressive with deep experience launching products in the hematology oncology space.

Michael S. Weiss: This team is very impressive with deep experience launching products in the hematology oncology space and they've already made great progress advancing our launch plan. We have also had multiple data presentations and publications already this year, including the final results from the Genuine Phase III Trial presented at ASCO by Dr. Jeff Sharman, Medical Director, Hematology Research at U.S. Oncology, which demonstrated that the addition of ubutuximab to ibrutinib significantly improved progression for survival, overall response rate, complete response rate, and increased the rates of undetectable minimal residual, At EHA, Dr. Chan Chia, the Clinical Lead for Lymphoma at the Sir Charles Gardner Hospital and Director of the WA Lymphoma Center of Research Excellence, presented preliminary safety and efficacy data of our investigational highly selective BTK inhibitor, PG-1701, as a monotherapy and in combination with U2.

Already made great progress.

[laughter] advancing our launch plans.

We have also had multiple data presentations and publications already this year.

Including the final results from the genuine phase three trial presented at ASCO.

Dr. Jeffs Sharman medical director Hematology research at U.S. oncology, which demonstrated that the addition of talks enough to Britain had significantly improved progression free survival. Overall response rate complete response rate and increase the rate of undetectable minimal residual disease as compared to a bridge.

<unk> alone.

And he huh Dr. Chan Shia the clinical lead for lymphoma, the surcharge Gardner Hospital and director of the WH Lymphoma Center Research Excellence presented preliminary safety and efficacy data of our investigational highly selective BTK inhibitor TG 17 on one as a monotherapy.

And in combination with you too.

We're excited about this compound, especially in combination with you to and look forward to further data later this year and the initiation of additional combination trials like 17 on one next year.

Michael S. Weiss: We are excited about this compound, especially in combination with U2, and look forward to further data later this year and the initiation of additional combination trials with 1701 next year. And finally, Dr. Javier Pinilla and the team at the H. Lee Moffitt Cancer Center and Research Institute recently published preclinical data describing the unique immunomodulatory effects of umbilicib in Blood Advances, a journal of the American Society of Hematology. As I mentioned, it's been an exciting first half for TG.

And finally, Dr. hobby opinion here and the team at the each lean Moffitt Cancer Center and Research Institute recently published preclinical data describing the unique immunomodulatory effects of lumber illicit in blood advances the journal of the American Society of Hematology.

As I mentioned, it's been exciting first half for teaching.

Now, let me turn to our pivotal programs and provide a high level overview and status update for each.

Michael S. Weiss: Now, let me turn to our pivotal programs and provide a high-level overview and status update for each. Let's start with the Unity NHL program. As a quick reminder, the Unity NHL trial is a multifaceted program evaluating ombrelissa monotherapy as well as combinations, including the U2 combination, in a variety of diseases. The umbrellas of monotherapy cohorts evaluating patients with previously-treated marginal zone lymphoma or follicular lymphoma have met their primary endpoints of overall response rate. Based on those results, we completed our rolling NDA submission to the This is a major milestone for us and a huge step forward to bring Umbrellista to the list of patients in need. As a reminder, Umbrellista received Breakthrough Therapy designation for patients with Marginal Zoma. Next, I'd like to discuss the Unity CLL trial.

Let's start with the Unity NHL program as a quick reminder, unity NHL trial is a multifaceted program evaluating a number of this a monotherapy as well as combinations, including to you to combination in a variety of disease cohorts.

The Burleson monotherapy cohorts evaluating patients with previously treated marginal zone lymphoma, what follicular lymphoma have met the primary endpoints of overall response rate.

Based on those results, we completed our rolling NDA submission to the F.D.A. in June this is a major milestone for us and a huge step forward to bring on the list it to patients in need.

As a reminder, I'm burleson perceive breakthrough therapy designation for patients with marginal zone lymphoma.

Next I'd like to discuss the unity CLL trial.

As a reminder, unity CLL clinical trial is a global phase three randomized study of you to reverse the combination of the chemotherapy chlorambucil plus cdtwenty obinna choose a man.

Michael S. Weiss: As a reminder, the UNITY CLL clinical trial is a global Phase III randomized study of U2 versus the combination of the chemotherapy Clorambucil plus the CD20 antibody Obinutuzumab in patients with treatment-naive and relapsed or refractory chronic lymphocytic leukemia. This trial is being conducted under special protocol assessment with the FDA. In early May, we announced the Unity CLL trial met the primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant improvement in PFS, with a p-value of less than.0001, as assessed by the Independent Review Committee. You may recall that the trial enrolled approximately 60% previously untreated, or they can be referred to as treatment-native patients, and 40% who were relapsed or refrac And we are pleased to note that the PFS benefit was observed across both patient populations.

In patients with treatment naive.

And relapsed or refractory chronic lymphocytic leukemia.

This trial is being conducted under special protocol assessment with the FDA in early May we announced the unity CLL trial met the primary endpoint pre specified interim analysis, demonstrating a statistically significant improvement in PFS with a P value of less than <unk> point zero zero zero.

No one.

As assessed by Independent Review Committee.

You may recall that the trial enrolled approximately 60% previously untreated or.

You can refer to as treatment nave patients and 40% or relapsed or refractory from prior therapy.

We're pleased to note that the PFS benefit was observed across both patient populations.

Michael S. Weiss: If approved, we believe the U2 combination has the potential to be an important treatment option for patients with CLL. We are extremely pleased with the outcome of the study and look forward to presenting data from this trial by year end, with a BLA NDA submission to follow. And last but certainly not least, let me review our ultimate program in multiple scores. As a quick reminder, our ultimate 1 and 2 phase 3 trials in relapsing forms of MS are two independent, global, randomized, multi-center trials. Comparing Oobatuximab to oral Teriflunomab

If approved we believe it or you two combination has the potential to be an important treatment option for patients with CLL we.

We're extremely pleased with the outcome of the study I look forward to presenting data from this trial by year end with the B.L.A., Andy a submission to follow.

And last but certainly not least let me review our ultimate program in multiple sclerosis.

As a quick reminder, our ultimate one into phase three trials in relapsing forms of M.S., our two independent global randomized multicenter trials get parent little bit talks about to oral tariffs minimize.

Michael S. Weiss: The primary endpoint for each study is annualized relapse rate following 96 weeks of treatment, and it is designed to support submission for full approval of lupitoximab in relapsing forms of NF. These trials are fully enrolled and are being conducted under special protocol assessment with the FDA. Currently, there is only one CD20 approved for MS, which is currently tracking to have global sales in excess of $4 billion. We believe CD20 usage will continue to grow as more physicians utilize the class earlier in the treatment paradigm. If approved, we believe Ulutuximab should be an attractive treatment option in the CD20 market, offering patients with MS the convenience of a one-hour infusion every six months at a competitive price.

The primary endpoint for each study is I realize relapse rate following 96 weeks of treatment.

And is designed to support submission for full approval a little bit talks not relapsing forms than us.

These trials are fully enrolled and being conducted under special protocol assessment with the FDA.

Currently there is only one exceeding 20 approved from us.

Which is currently tracking down 2020 global sales in excess of $4 billion.

We believe Cdtwenty usage will continue to grow as more physicians utilize the class earlier in the treatment paradigm. If approved we believe well the talks and that should be an attractive treatment option in the CD 20 market.

Offering patients with them as the convenience of a one hour infusion every six months at a competitive price.

Despite some minor delays from coded we're pleased to report that we're still targeting releasing topline data from both studies in the fourth quarter.

Michael S. Weiss: Despite some minor delays from COVID, we are pleased to report that we are still targeting to release top-line data from both studies in the fourth quarter. We are extremely pleased with all the progress we've made thus far in 2020, despite all the challenges in this new COVID environment. And I have to say how impressed I am with the team's ability to power through and continue to achieve the ambitious milestones we've set for ourselves this year. And we're looking forward to a very exciting next 6 to 12 months, where we are targeting pivotal data from our Ultimate MS Phase III Clinical Program, which if positive will lead to a BLA submission for rubotoximab. Data presentations from both Unity NHL and Unity CLL, and NDA BLA Submission for the U2 Combination in CLL and, if all goes well, launching our first product, Fumberlicid, in the treatment of marginal zone lymphoma and follicular lymphoma. With that, I'd like to turn the call back over to the conference operator to begin the Q&A session. Following that, I will return to make some concluding remarks.

[laughter], we're extremely pleased with all the progress we made thus far and 2020. Despite all the challenges in this new kobin environment and I have to say, how impressed down but the team's ability to power through actions team to achieve the ambitious milestones we've set for ourselves this year.

And we're looking forward to a very exciting next six to 12 months, where we are targeting pivotal data from our ultimate M.S. phase three clinical program, which if positive with each would be lay submission for a little bit talks about.

Data presentations from both unity, NHL and unity CLL and.

And indeed be lay submission for you to combination in CLL and if all goes well watching our first product on burleson.

In the treatment of marginal zone lymphoma, and Follicular lymphoma.

With that I'd like to turn the call back over to the conference operator to begin the QNX session.

Following which I will turn to make some concluding remarks.

Thank you without being ducking. Your question answer session, if you'd like to be placed and good question could you. Please press star Wars under telephone keypad, a confirmation tone will indicate your line is in the question Q you May press star true if you'd like to remove your question from the Q for participants using speaker equipment to be necessary to pick up your handset before.

Operator: Thank you. We will now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd 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.

Hosting the Sarkies one moment please poll for questions.

Well first question today.

You're young from Oppenheimer. Your line is like ours.

Hi, good amount on for so congratulations on all the participants corridor.

They get closer to ask me gives us something but sort of update we might get hopefully be studies clocks in terms of number fishing and Paula.

And then also wanted to get as many of you know your company.

Operator: One moment, please, while we poll for questions. Our first question today is coming from Alicia Young from Oppenheimer. Your line is now live. Hi, thanks. This is Emma on behalf of Alethia.

Got it.

Sorry about it.

Just one for patients who were on here at box and hot.

Well I can.

And just how that's.

Sure. So in terms of ultra V. I actually don't have the exact numbers, but I would hope.

But I actually would have somewhere in the owner of.

Unknown Speaker: So, congratulations on all the progress this quarter. As we get closer to Ash, can you give us a sense of the sort of update we might get from the ULTRA-EB study, which is another level up in terms of just the number of patients and follow-up? And then also wanted to see if there's any update on some of the earlier combination studies that I know you guys have spoken about in the past and have been excited about. Like specifically, I think there's one for patients who are on D2K or Panetoclax and haven't gotten a complete response, and then adding U2 and just how that's shaping up.

At least 15 20, maybe even a few more patients who have.

We did 12 months of treatment.

I think they'll be somewhere north of 50 ish patients 40, 50 patients I started let me just take it back there it's not ultra be ultra me.

The phase two or will not be presented until complete.

Or until I guess.

Later this is the combination of I've been out of KLAX plus you too.

It's coming from our phase one trial.

And that's what I'm, referring to so let me start off for so we love Phase one data presented later this year on the phase one combination if you two plus but out of clocks and again, that's what we presented previously at Ash and the update your hopefully include like I said, yeah, let's call. It 15 to 25 patients have completed.

Michael S. Weiss: Sure. So, in terms of Ultra-V, I actually don't have the exact numbers, but I would hope by ASH we'd have somewhere in the order of at least 15, 20, maybe even a few more patients who have completed 12 months of treatment. I think they'll be somewhere in the order of 50-ish patients, 40, 50 patients. Sorry, let me just take it back.

12 months to treatment in total, though there should be a information around 40 to 50 patients. So that will include safety and some preliminary efficacy prior to the 12 month Mark.

Michael S. Weiss: It's not Ultra-V. Ultra-V, the Phase II, will not be presented until it is complete or until, I guess, the end later. This is the combination of Venatoclax plus U2 coming from our Phase 1 trial, and that's what I'm referring to. So let me start over. We will have Phase 1 data presented later this year on the Phase 1 combination of U2 plus Venatoclax. And again, that's what we presented previously at ASH, and the update should hopefully include, like I said, what's called 15 to 25 patients who have completed 12 months of treatment. In total, there should be information on around 40 to 50 patients, so that will include safety and some preliminary efficacy prior to the 12-month mark. So that's where we stand with presentations of U2 plus Banana Class.

So that's where we stand with the presentations of you two plus but not at Fox.

Oh. This the other study you mentioned a is a smaller study it's only in one or two centers. It's the study where we have you to added on top of BTK or banana clocks in patients who I've been on a beach he ever nine o'clock single agent for greater than six month ever not achieved them or the negative or.

Our.

And we don't have any update.

Affected on that trial.

Thank you.

Oh, thank you.

Our next question today is coming from Josh Schimmer from Evercore ISI. Your line is not alive.

Thanks for taking the questions.

Pret, a little bit more detail on your commercial team the relevant experience and that is all the cadence and timing of building out a full [laughter], how many reps you'll need and then given your portfolio of assets you've been focused on creating that's the class regimens for.

Michael S. Weiss: The other study you mentioned is a smaller study; it's only in one or two centers. It's a study where U2 is added on top of BTK or venatoclax in patients who have been on a BTK or venatoclax single agent for greater than six months and have not achieved an MRD negative or CR, and we don't have any update expected on that trial.

CLL Npls and flicker lymphomas are there other liquid or solid tumors, which you have insight and if so can you talk a little bit about your development strategy there. Thanks.

Sure. Thanks, Josh.

So in terms of the commercial team, we Ah we brought on Adam Wasserman, who headed up the U.S.

Joshua Elliott Schimmer: Thank you. Thank you. Our next question today is coming from Josh Schimmer from Evercore ISI. Your line is now live. Thanks for taking the questions.

Hematology franchise for Celgene and his last physician Buddy.

Went up the ranks.

And lots of different position for commercialization in at Celgene.

Michael S. Weiss: Could you provide a little bit more detail on your commercial team, the relevant experience, as well as the cadence and timing of building out a full thing, how many reps you'll need? And then, given your portfolio of assets, you've been focused on creating best-of-class regimens for CLL, MCL, and follicular lymphomas. Are there other liquid or solid tumors which you have in sight? And if so, can you talk a little bit about your development strategy for those? Thanks.

Hi, He's put together a pretty remarkable team or we have now have a heads of all functional areas for for the commercial commercialization team, including.

Oh.

Commercial operations, we have a head of.

Market access we have ahead of a medical affairs.

And hopefully soon we'll be able to announce a head of head of sales. So the whole team is coming together.

I'd say, it's a mixed the leadership and then either from primarily from Celgene or from Bristol.

ER and the teams blow them are really coming together nicely. So I don't know how much more detail you want than that but at some point I will get Adam on the road Oh. The next several months well not on the road, but virtually on the road.

Michael S. Weiss: So in terms of the commercial team, we brought on Adam Waldman, who headed up the U.S. hematology franchise for Celgene in his last position, but he went up the ranks and lots of different positions in commercialization at Celgene. He's put together a pretty remarkable team. We now have heads of all functional areas for the commercialization team, including Commercial Operations, we have a head of... Market Access, we have a head of Medical Affairs, and hopefully soon, we'll be able to announce a head of sales. So the whole team is coming together. I'd say it's the leadership has been either from Celgene or from Bristol, and the teams below them are really coming together nicely. So, I don't know how much more detail you want than that, but at some point, we'll get Adam on the road in the next several months.

At some point it and you can give obviously you know more details and chat in depth, but if you want more detail. This let me now and then in terms of other areas obviously our core.

Core focus has been the indolent.

Lymphomas and leukemias, that's obviously chronic lymphocytic leukemia.

Is the largest and then we have flicker lymphoma that marginal zone lymphoma.

Outside of that we do have exploratory.

Opportunities are studies going on in diffuse large b cell and mantle cell lymphoma, which are I'd say getting earlier and more exploratory budget as possible. I mean, we certainly are have have the notion that we will push into those areas eventually whether it's with you to or with.

Michael S. Weiss: www.youtube.com The core focus has been indolent lymphomas and leukemia, so that's obviously chronic lymphocytic leukemia is the largest, and then we have follicular lymphoma and marginal zone lymphoma. Outside of that, we do have exploratory studies, opportunities, or studies going on in diffuse large B-cell and in mantle cell lymphoma, which are, I' But it is possible. I mean, we certainly have a notion that we will push into those areas eventually, whether it's with U2 or with other pieces of our portfolio.

Other pieces of our portfolio.

We are we're excited about Orients excuse me 47, a CD 19, a bi specific antibody that can be certainly used in a in diffuse large b cells well is the indolent diseases that we're currently covering.

We think theres an opportunity for PDL, one to work in combination with somebody agents in the portfolio.

More aggressive lymphomas as well.

So that guns diffuse large b cell impossible mantle cell there.

And yeah, we know the BTK inhibitors are working mantle cell. So that's something we'll be.

Michael S. Weiss: We're excited about our anti-CB47, CB19 bispecific antibody that can be certainly used in diffuse large B-cell as well as the indolent disease that we're currently covering. We think there's an opportunity for PD-L1 to work in combination with some of the agents in the portfolio in more aggressive lymphomas as well, so that, again, diffuse large B-cell and possibly mantle cell there. Transcripts provided by Transcription Outsourcing, LLC. Pretty close to the core of our indolent diseases, but in terms of B-cells, you know, on the docket, certainly we'll be looking at Diffusory B-cell Mammal Cells as some future potential. Obviously, it is too early to say too much.

Exploring a as we look forward. So again, we're sticking you know.

Pretty close to our core of our indolent diseases, but in terms of B cells. Yeah on the docket certainly we'll be looking at that if you started be something that the cells at some future potential obviously too early for her to say too much.

Maybe a couple of specific follow ups, if I can in terms of a number of sales reps you expect to be launching with and whether you will hire them prior to approval or or subsequent and then.

Additional indications or some other pithree kinase.

What are some should affect in some large indications like myelofibrosis or myeloma are either of those on your radar screen as well.

Joshua Elliott Schimmer: Maybe a couple of specific follow-ups if I can. In terms of the number of sales reps you expect to be launching with and whether you'll hire them prior to approval or subsequent, and then on additional indications, some other PI3 kinase inhibitors have shown effects, and in some large indications like myelofibrosis or myeloma, are either of those on your radar screen as well?

Yes, so I'll take the second question first as I forget it and then I'll go back to the ourselves for sizing.

In terms of a multiple myeloma, we haven't you know do done too much you yet but.

Michael S. Weiss: Yeah, so I'll take the second question first before I forget it, and then I'll go back to Salesforce sizing. In terms of multiple myeloma, we haven't done too much yet, but obviously, the team, Adam, and some of the other folks that have come over from Celgene are very familiar with the myeloma market, and we do have Dr. Loney on the board, who is a recognized expert in multiple myeloma. I think we'll start to think about if there's an opportunity for us in myeloma, and we've got some pieces in place to at least do a pretty good exploration of that. In terms of myelofibrosis, you know, we've already presented some pretty interesting and compelling data of umbralicid in combination with ruxolitinib in myelofibrosis, and so that's an area that we are taking a more serious interest in, somewhat seriously.

I see the team a Adam in some of the other folks that have come over from Celgene are very familiar with the myeloma market and we do have a doctor long on the board Who's a recognized expert in most of my long and so I think we'll start to think about if there's an opportunity for us in myeloma.

And we've got some people in place it leads to a pretty good exploration of that.

In terms of myelofibrosis, we've already presented some pretty interesting and compelling data of Underlift said.

In combination with Ruxolitinib in myelofibrosis, and so that's an area that we are.

Taking a more serious interest and we're starting to explore that somewhat seriously or the other part of that I would I would note is that we do have a b C inhibitor or that is a ready to enter the clinic as soon as we we.

Michael S. Weiss: The other part of that I would note is that we do have a BET inhibitor that is ready to enter the clinic as soon as we can get there, which could be very soon. So we do think there's an opportunity. There's been some data that's presented where a BET inhibitor has worked well in combination with buxalitinib. But I would argue that our illicit data in combination with buxalitinib is just as good as the BET data that's been presented. But the possibility of putting all three together, our PI3K, our BET in combination with buxalitinib is something that we're excited about, we're thinking about, and could be started in the relatively near future. In terms of Salesforce sizing, I think the, The end. That's a wrap. We'll be back next week. We'll see you next week.

Can get there, so which it'd be very soon so.

We do think there's an opportunity a there's been some data. That's presented were BTK inhibitor has worked a nice in combination with Ruxolitinib I would argue that our Oh Melissa data in combination with Ruxolitinib is just as good as the B T data that's been presented.

But the possibility of putting all three together or are you have three k., our b T with in combination with Ruxolitinib.

Something that we're excited about we're thinking about and a and could be started in the relatively near term.

In terms of Salesforce sizing.

I think yeah.

The.

The general idea is that I think we want to probably grow to a sales force.

Michael S. Weiss: The general idea is that I think we want to probably grow to a sales force at CLL launch of, and this is an approximate number because we haven't completed the sizing studies, but just give or take, you know, 75-ish on the sales team. And that... And then, so, as we launch with margins on a Curricular, our plan is, at the time of the launch itself, we would expect to have probably half of that 75 in place for a follicular marginal launch and then grow the sales force to that full size by the time of the CLL launch. It's kind of a staged approach, and in terms of we won't wait to hire the first, call it, 30 or 35 people; we will not wait until after the approval; those people will be on board in advance of the PDUFA date. And like I said, those numbers are not, don't lock me in, but those are in the range of, could be plus or minus 5 or so or 10 or so in each of those numbers. And like I said, Adam will probably give some more color over the coming months as the Salesforce sizing exercise is complete.

At CLL launch.

And this is approximately the we haven't completed the out of the sizing studies, but just give or take 75 ish on the sales team.

And that.

And then so as we launch with margins on a slick your our plan is as at the time of Ah.

At the time of the launch itself, we would expect to to have probably half of that 75 in place for fully through a marginal launch and then grow the sales force to that full size by the time of the CLL launch just kind of a staged approach or so and in terms of.

We won't wait to hire the first call it.

30, or 35, we will not wait.

Until until after the approval those people will be onboard a in advance of the PDUFA date I make said those numbers are not don't don't walkman, but those are in the range of could be plus or minus five or so or 10 or so in each of those numbers.

And like I said, Adam will probably give some more color over the coming months as a as yourselves for sizing.

Edward Patrick White: Thank you very much for the color. Thank you. Our next question today is coming from Ed White from H.C. Wainwright.

Exercise is complete.

It is very much for the color.

Yeah.

Thank you for next question today is coming from and wait for H.C. Wainwright. Your line is alive.

Good morning, Thanks for taking my call My question [laughter] running it.

Unknown Speaker: Your line is now live. Good morning. Thanks for taking my call. Good morning, Mike.

Good morning, like but just a couple maybe you know if you review your what you think your biggest challenge to launching Youve a list of the going to be a you know is it going to be convincing them that the tolerability was better than than others in the class words gonna be an advocacy just how you're going to be approaching that.

Unknown Speaker: [inaudible]

Unknown Speaker: You know, if you could review your, what you think your biggest challenge to launching Ubilicive is going to be, you know,

Unknown Speaker: [inaudible]

Then also I'm sure you're having conversations with payers right now you're seeing any.

Unknown Speaker: are having conversations with payers right now, so if you're seeing any issues or pushback coverage there,

Issues or pushed back coverage there and then lastly, just discuss your your strategy. Thanks.

Michael S. Weiss: And then lastly, just if you could discuss your European strategy. Thank you.

Yeah got I'm going to go a reverse Ron.

Michael S. Weiss: Yeah, I'm going to go reverse cron on the question. So European strategy, we're still trying to figure that out. So I don't have any updates there. We are studying whether it makes sense for us to partner or go alone in Europe.

On the question so European strategy, we're still trying to figure that out so I don't have any updates there.

Where we are studying whether it makes sense for us to partner or to go it alone in Europe.

Michael S. Weiss: And I think TBD is the best I can offer today. Give me another quarter, and we'll give you a little more information, perhaps. In terms of the number two question, which was payers, we don't expect to have any payer issues. We have been engaging with payers. To my knowledge, I'm not on the front lines of that exercise, but to my knowledge, we're not seeing any pushback on coverage. Typically, you know, cancer drugs don't see too much pushback in payer coverage, but again, we don't expect to see issues, and engagement has begun. And so then the number one question, which is obviously, no, they're all important questions.

And I think TBD is the best I can offer today so what's.

Can you give me another quarter and we'll give you a little more information than perhaps a in terms of.

The number two question, which was out payers or we don't expect to have a any payer and you payer issues, we have been engaging with payers to my knowledge I'm not on the front lines of that exercise.

But to my knowledge or we're not seeing any any push back to coverage or.

Typically you know the cancer drugs don't see too much pushback and in a in payer coverage, but again, we don't expect to see issues and engagement has has begun.

And so then the I'd say the number one question, which is obviously the no they're up no important questions. A minimum question is a any you know what's going to be our greatest challenge and commercializing.

Michael S. Weiss: The number one question is, you know, what's going to be our greatest challenge in commercializing umbilicib and marginal zone and follicular? Look at, you know, personally, I don't see too many barriers. We've done a lot of ad boards with community oncologists to try to get a feel for the marketplace. You know, there are some folks who have some remaining negative impressions of PI3K deltas. I'd say, you know, once you show them the data and explain to them the fundamental differences between this molecule and the first generation PI3K inhibitors, their concerns melt relatively quickly. And then there are some folks who are, you know, just completely open to a novel treatment option. So I think, you know, our greatest challenge is just getting out there and educating folks. You know, we're, I feel like, in my head, we're like the size Sims of biotech.

Commercializing unsolicited bid margins on inflict color.

Look I.

Personally I don't see too many bearings, we've done a lot of of AD boards with community oncologists to try to get it feel for the marketplace. Yeah. There's there's some folks who have some negative.

Remaining negative impression of theatrical deltas, Oh, I'd say you know once you show them the data and explain some of the fundamental differences between this molecule in the first generation pithreek inhibitors or that their concerns melt relatively quickly.

And and then there's some folks who are you know just completely open to two novel treatment option. So I think you know a greater challenge is just getting out there in educating folks you know the.

We're feel like you know my head were were like the size Sims of Ah of of biotech we need to make sure you know and educated consumers are best consumer the better people understand a the value proposition that I'm burleson brings to them and their patient the better off we're gonna be and you know, we just got to get folks to try.

Michael S. Weiss: We need to make sure, you know, an educated consumer is our best consumer. The better people understand the value proposition that umbilicib brings to them and their patients, the better off we're going to be. And, you know, we've just got to get folks to try umbilicib. And once they do, you know, again, relatively immediately, the vast, vast majority will notice that this is a very different compound and a different profile in their patients. And it's not a perfect drug. Let me just be clear that there are going to be some folks who don't have a good experience with the drug. But the vast majority will, and that's in contrast to the first generation where it was kind of the reverse, right? Most people had a bad experience.

I'm Burleson a once they do you know again relatively immediately the vast vast majority will notice that there is a very different compound and a different profile with their patients. It's not a perfect drug let me just be clear. That's there are gonna be some folks who don't have a good experience on the drug but the vast majority will not some cost.

Tries to the first generation, where it was kind of the reverse right. Most people had a bad experience.

So.

Michael S. Weiss: So our goal is to get folks to try it. We feel like we've got a really good lead because of our clinical trial sites. We have so many community oncologists who have used the compound already and have been participating in our studies. Obviously, that's the place we're going to start. We're going to work with those folks, make sure that they're engaged and are interested in treating the patients with the drug, which so far has come back very positively. It represents typically a lot more than the clinical investigators who participate in the trial. So, you know, it's leveraging the relationships in those clinical trial sites to get their co-investigators or partners to also try umbilical cord blood in their practice. We're feeling good about it. I'm feeling great. From what I've seen and what I've heard, I feel, you know, we're going to do quite well. Again, look, the marjor zone and follicular are not the biggest indications.

Our goal is to get folks to try we feel like we've got a really good lead and because of our clinical trial sites. We had so many community oncologists, who use the content already and have been.

Oh participating in our studies a that obviously takes place we're going to start we're going to work with those folks make sure that they're engaged and and are interested in treating patients with the drug which so far has come back very positively.

And then you know each one of those clinical trial sites.

Represents typically a lot more than the clinical investigators who participate in the trial. So no. It's it's leveraging the relationships in those clinical trial sites or to get there. Their co investigators are partners to also try I'm bullish in their practice.

We're feeling good about I'm feeling great from what I've seen in what I've heard a I feel we're gonna do quite well again like Mars and figuring out the biggest syndication. So obviously, we have we have realistic expectations of what early sales can be in those indications, but I think in terms of getting a really great start into CLL launch by getting more people.

Michael S. Weiss: So obviously, we have realistic expectations of what early sales can be in those indications. But I think in terms of getting a really great start on a CLL launch by getting more people to try the drug and use it and get comfortable with it is just going to make us, you know, that much more successful once we get to CLL. So you know, education, education, education. Once people understand this compound and try it, we're going to be in a better position.

To try the drug and use it and get comfortable with it it's just going to make US you know that much more successful once we get to she also I <unk> education education education. Once people understand this compound and try it we're going to be in a better position.

Great. Thanks, Mike and then they got to react.

Michael S. Weiss: Great. Thanks, Mike.

Michael S. Weiss: You got it. And maybe just the last question: on 18.01, you're going to have your first date at ASH. Can you give us a little hint as to what we can expect, what kind of data we're going to see at ASH?

Maybe just the last question on it you know one you're gonna have your first data at Ash can you give us a little hint as to what we can expect what kinda data, we're going to see that thank you.

Ah, yes, so I'm not sure what.

Michael S. Weiss: Yeah, so I'm not sure what we'll be seeing at ASH for the CD7, for CD19, by specific. I'm not sure we're presenting data this year; I have to double check with my guys. I'm not sure where you got that from if you're talking to someone else, but our big presentations for ASH, outside of the pivotal presentations, are focused on U2 plus Monadoclax and U2 BTK alone and Switch 17.01 and U2 plus 17.01. In terms of some of the earlier stuff for PD-L1 and for CD47, I think we'll have to wait on that, but I'll double check. Okay, thank you.

We'll be seeing it asked for a for the city seven CD 19 by specific.

I'm not sure we're presenting data this year I actually double checking my guys I'm.

Not sure where you've got that from if you're talking to someone else but.

You know our big presentations for for Ash outside of the pivotal presentations are focused on you know you two plus went out of clocks and Ah you too.

Okay alone and that switch 17, a one and you two plus 17 no one.

In terms of some of the earlier suffered PDL one in for Cdforty seven I think we'll have to wait on that but I'll double check what religion.

Okay. Thanks Bye.

Michael S. Weiss: Okay, thanks, bye. Thank you. Thank you. Our next question today is coming from Matt Kaplan from Lattinburg. Your line is now live. Hi, good morning guys. Mike, I wanted to talk a little bit about when we should hear about the PICUFA date for the NDA for Umbilicis and Marshalls and Flippula and Fumble.

Okay Yeah.

Your next question today is coming from that capital from Ladenburg. Your line is I life.

Hi, good morning, guys I'm.

Right.

Talk a little bit about the when when we should hear about that you could do for C and D.A. for unsolicited Marshalls and and flip them from.

[noise] Yeah sure. So typically it's a 60 day.

Matthew Lee Kaplan: Yeah, sure. So typically, it's a 60 day process.

Unknown Speaker: Timeframe, so you file your submission once it's complete. Obviously, the rolling submission for us was complete around mid-June.

<unk>.

Time frame. So you file your you follow your your submission once that's complete obviously the rolling submission for US was complete around mid June.

Michael S. Weiss: So one would expect about a 60 day time frame, that's what the regulations say, 60 days, then they will either accept or issue a refusal to file. So, yeah, I guess that's around August 15th, give or take a day or two is the current expectation we hear back from him.

So one more.

No one would expect about a 60 day timeframe. That's what the regulation say 60 days, then they will either except or a issue refusal to file.

So yeah I guess, that's around August 15th give or take a day or two is is the current expectation with your back from them.

[laughter].

Michael S. Weiss: Great. Okay. Thank you. And then, just looking at your pipeline a little bit, I want to dig into your current thoughts for kind of the regulatory path forward or development path forward for your PCK inhibitor.

Right. Okay. Thank you and then just looking at your pipeline along that wanted to dig.

Into your current thoughts or kind of their regulatory path forward or development paths or your BTK inhibitor.

Matthew Lee Kaplan: and your anti-ICD-4719 bispecific monoclonal antibody.

And your anti CD 47 19.

Unknown Speaker: Thank you for joining us for this webinar. For extra photos, I'll mute. [inaudible]

I just had a monoclonal antibody.

Perhaps your photos on mute.

Michael S. Weiss: I'm sorry. Sorry, Matt. Somehow, my phone got on mute.

Oh I'm.

I'm, sorry sign that somehow my phone going I mean, yeah. So.

Michael S. Weiss: Yeah, so... So what I was saying is that, in terms of regulatory strategy, CLL is an area of great interest, and then obviously Marginal Zona FOMA is one, you know, in both those indications. I mean, we've treated a number of patients with U2 plus Brutonib, and we've treated a number of patients with U2 plus 1701. I think between CLL and the marginal zone of basically U2 plus BTK, I think it's a 100% response rate across both those indications thus far. Now, of course, larger trials will bring that down, and I doubt it won't be 100%, but I can be confident of that, but it's going to be very high response rates when we use U2 plus BTK. So that's something that we are excited about for both those indications where...

So what I was saying is for the BTK.

In terms of regulatory strategy CLL is a a is an area of great interest and then obviously marginal zone lymphoma is one you know in both those indications.

Uh huh.

<unk>.

I mean, we've treated a number of patients with a U two plus Bruton every trees number patients with you two plus 17, a one I think between CLL and marginal zone.

Of basically you to post P.T.K. I don't I think it's 100% response rate across both those indications. Thus far now of course larger trials will will bring that down and I doubt it won't be 100% to give you confidence that but to me very high response rates. When we use you to close P.T.K.

So that's something that we are.

Excited about for for both those indications where Uh huh.

Michael S. Weiss: Transcribed by https://otter.ai

Where a P.T.K.'s or indicated and you to ought to be indicated, let's say that a and then there's a follicular lymphoma, where I'd be t. doesn't have as much activity, but could be interesting on top of you to a those mantle cell lymphoma, where BTK alone is interesting and potentially you two plus P.T.K.

Michael S. Weiss: Where BTKs are indicated and U2 ought to be indicated, let's say that. And then there's follicular lymphoma where BTK doesn't have as much activity but could be interesting on top of U2. There's mantle cell lymphoma where BTK alone is interesting, and potentially, U2 plus BTK could be interesting.

Could be entering so we think there's registration opportunities across a those indications.

Michael S. Weiss: So we think there are registration opportunities across those indications. In terms of CD47, CD19, it's way too early, but we would certainly start targeting diffuse large B cell and follicular with that agent. The earlier data with the competitive compound did look quite interesting in both follicular and diffuse large B cells once it was combined with the CD20, so that's something we'll try to get a look at as early as we can. Hopefully, at some point next year, we'll be expanding that program.

In terms of CD 47, she may two two way too early but you know we would certainly start targeting into diffuse large b cell and follicular with that is in the earlier data with the competitive compound I did look quite interesting in both.

Fully feeling diffuse large b cell once it was combined with the CD 20.

So that's something we'll we'll try to get to look out as early as we can.

Hopefully at some point next year, we'll be expanding that program.

Hi, Thanks.

Matthew Lee Kaplan: Thanks a lot for taking the questions and congrats on the progress. Yep.

Machines and congrats on the progress.

Yep. Thanks Bye.

Roger Song: Thanks, Pat. Thank you. Our next question today is coming from Roger Song from Jefferies. Your line is now live.

Thank you. My next question today is coming from Roger song from Jefferies. Your line is that a lot.

Roger Song: Good morning. Thank you. Thank you for taking my question, Mike. So, maybe just two quick ones. So, one is for the follicular. Obviously, we noticed a few kind of developments recently, like the epigenetic metametastat approval in the launch, and we had some kind of quality kind of positive readout, and of course, the specific. So, just curious about your thoughts evolving, given the evolving landscape, and what is the treatment sequence, kind of, you think, and where is it well-fitting in the future kind of landscape? I will have a quick follow-up after that. Thank you.

[noise] combining thank you I think it for taking my question. My so maybe just two quick ones on the one it's for the full your color. So obviously, we know there's a few kind of <unk> [noise] development recently like a de epigenetic then mathematics that approval.

I'm in the launch and though we had some kind of a car T kind of very hard to read out enough cost that I specific so just curious to young.

Soc evolving given the evolving landscape and to what they are actually I'm in a sequence or kind of where you think.

Brett list at the well fitting the future kind of a landscape I will however, my follow up time. Thank you.

Sure Roger.

Michael S. Weiss: Sure, Roger. Yeah, so, you know, it's interesting you brought up two new modalities that are starting to take hold in follicular. So you've got EZ-H2, which is what I would describe as a pretty mild treatment option. It's an oral therapy with a pretty good safety profile. And then on the other side, you have very high efficacy, high toxicity CAR-Ts and bi-specifics. I think, you know, generally speaking, for umbilicid, it's a, you know, we believe a very nice level of activity with a

Yeah. So you know and fishing you brought up two new modalities that are starting to take hold and ER in follicular. So you've got easy h. to which is.

What I was just kind of is a pretty mild treatment option, it's an oral therapy with the pretty good safety profile, a and then on the other side do you have.

A very high efficacy high toxicity, Cartesian bi specifics or <unk> I think generally speaking for from the listed a it say you know we believe they.

Very nice level of activity with a very nice safety profile, a that fits well into you know treatment of earlier lines of Follicular lymphoma. So typically you know you want to treat these patients with the the drugs that are easiest to handle early on and see if you can get.

Michael S. Weiss: Very nice safety profile that fits well into treatment of earlier lines of follicular lymphoma. So typically, you want to treat these patients with the drugs that are easiest to handle early on and see if you can get the maximum amount of benefit out of those agents. And later on, you will look at potentially using more aggressive therapies like CAR-T's. So I think there's room for all these therapies across the line, but typically, it's your milder, less toxic therapies early, and your more aggressive treatments later on for these patients. They're not currently curable, so in that light, you want to make sure you try something that's easy for them to handle, and gives them the best quality of life I think we're going to fit in very nicely in the first few lines of therapy.

The maximum amount of benefit out of those agents and later on you will look at potentially using more aggressive therapies.

Like the car T is or the bi specifics.

So I think there's there's room for for all these therapies across the line, but typically it's your your milder I'm less toxic therapies early and you're more aggressive treatments later on.

For these patients a there they're not currently curable selling that light.

You want to make sure you try something that's that's easy for them to handle give him the best quality of life.

For the longest period of time, so I I think we're going to fit in a very nicely in the first few lines of therapy I think once you get into what sums describe sort of salvage setting is you'll start to see people using cartoons and bi specifics.

Michael S. Weiss: I think once you get into what some describe as sort of salvage settings, you'll start to see people using Cartiza and Bi-Specifics. In terms of EZ-H2, I think as a standalone agent, it certainly has activity, but I think they'll find their home at some point in combination, and obviously, we think Umbralisib is a very nice standalone agent. U2, over time, we think U2 will be more efficacious than Umbralisib alone, and U2+, whether it's PTK or some other combination, or U2+. CD47 or U2 plus PD-L1 or something even external to the portfolio could be interesting. But again, our goal is to layer as many of what I've described as lower toxicity agents together to come up with a highly efficacious regimen that still maintains a low overall toxicity profile. So that's always been our plan; we've tried to avoid, you know, nuclear bombs. And we've chosen to use multiple treatments at once to try to triangulate the tumor.

In terms of easy age to yeah, I think as a standalone age and it has certainly has activity, but I think they'll find their home at some point in combination.

And you know obviously, we think unsolicited is a is a very nice standalone agent and to overtime. We think you to would be more more efficacious. Then then realism alone and you two plus or whether it be teekay or some other combination where you two plus.

Cdforty seven or you to PDL, one or something even external to the portfolio could be interesting, but again our goal is to layer a as many.

What I'm, just I was lower toxicity agents together to come up with a highly efficacious regiment.

That's still maintains a low overall toxicity profile.

So that's that's always been our plan we've.

We've tried to avoid a you know nuclear bombs.

And Weve chosen to use your multiple therapies at wants to try to triangulate the tumor.

Roger Song: Got it. Yeah, very helpful. And that's it. Thanks for all the color.

Got it got better help on that thanks for the color on so maybe a then my follow up question is the tied to what you have.

Roger Song: So maybe my follow-up question is the type two you have alluded to. So basically, you already have for multiple kinds of magnum action and BTK PD one and CD for. And I'm just curious, any other kind of BD opportunity you're looking for? Some other interesting mechanism you probably want to lay on to the current portfolio?

New that basically you already have for multiple kind of very mechanism action and I'd be T.K. you won 40.

Seven Nike and that just curious on any other kind of they're asking the opportunity youre looking for them rather than just came back and it then you probably one or they are you the current portfolio.

I mean, we continuously.

Michael S. Weiss: I mean, we continuously scan the landscape looking for validated targets in the treatment of B-cell malignancies, and I think, you know, we are always interested. If there's a target out there that has validation in this area, we're definitely interested in trying to bring that in-house.

Scan the landscape looking for validated targets in the treatment of B cell malignancies, and I think you know we are always interested.

If there was a target out there that has.

Validation of this area, we're definitely interested in trying to bring that in house, if it makes sense.

Roger Song: Thank you for taking the questions. Congratulations. Sure Roger, thank you.

I think you recognize question correct.

Operator: Thank you.

Operator: Thank you. As a reminder, that's star number one to be placed in the question.

Sure I wasn't thinking.

Thank you as a reminder, that star one to be placed them to question Q. Our next question to be coming from my Oakmont hobby from B. Riley FBR. Your line is Ohio.

Mayank Mamtani: Our next question today is coming from Mayank Mamtani from B Riley FBR. Your line is now: Hi, good morning. This is Saul Hillong from IUNCA.

Hi, Good morning. This is thought along for my own congrats on a really strong first half of the or just a couple of question from again, starting on the pivotal programs could you provide any additional color on the hazard ratio for unity CLL now that you've had a chance to kind of dig into that itself are you sensing it tracking a certain way I'm, giving the revised.

Unknown Speaker: Congratulations on a really strong first half of the year. Just a couple of questions from us, starting on the Pivotal programs. Could you provide any additional color on the hazard ratio for Unity CLL now that you've had a chance to kind of dig into the dataset?

Michael S. Weiss: Are you sensing it tracking in a certain way?

Unknown Speaker: Yeah, well, this answer will be briefcase. We don't have any additional callers at this time, and the presentations will be coming up soon. I think we're all just going to have to wait for that at this moment.

Terming out the and then I'll be brief follow up on the ultimate programs.

Yeah, well this answer I'll be brief too. So we don't have any additional color a at this time then that the presentations will be coming up soon I'm I think for all just kind of to wafer for that at this at this moment.

Unknown Speaker: Okay, great. Thanks.

Okay, great. Thanks, and then just want to understand how you try to manage the last cohort of patients going through their 96, we follow up a in a that's trial amid.

Unknown Speaker: And then just wanted to understand how you kind of managed the last cohort of patients going through their 96-week follow-up in the MS trial amid, you know, COVID-19. Any changes, if any, that might be going into the efficacy analysis? And then also your thoughts on some of the recent competitive readouts on the oral side, thinking of Principia, BCK, and maybe Immunix product as well.

<unk>, who closed the value that might be going into the efficacy analysis.

And then also your thoughts on some of the reporting competitive read outs on the oil side, but principally as BK, maybe in the next call it as well.

Oh, yeah, so in terms of ER.

Michael S. Weiss: Yeah, so in terms of the study conclusion and COVID, yeah, so, as we mentioned, I think, on our last conference call, we were definitely impressed by the fact that, you know, 90, 95 percent of patients did come in relatively on time for their visits. There were some stragglers.

In terms of the study conclusion and cope with.

Yeah. So as we mentioned I think on our last conference call. You know we were we were definitely a impressed by the fact that you know 90, 95% of patients did come in relatively on time for their visit there was some stragglers a and that carried forward you know into both you know, but whatever they had left in terms of 84.

Michael S. Weiss: And that carried forward, you know, into both, you know, whatever they had left in terms of 84 and 96-week visits. I think for the first trial, we ended up getting the last visit in about two or three weeks after the expected time frame. So, pretty darn good, all things considered. And so, we have the second one coming up, and we expect potentially the same or maybe a little bit better, given that most of Europe is doing pretty well right now.

96 week visits I think for the first trial, a we ended up getting last visit in about two or three weeks. After a the expected time from so pretty darn good all things considered and so we've got the second one coming up.

And we expect could potentially.

The same or maybe a little bit better given a than most of most of Europe is doing pretty well right now so.

Michael S. Weiss: So, you know, again, we're talking about potential delays in final visits of, you know, two, three weeks. Having said that, none of this really will affect or should affect the timing of the closeout of the trial because they're still cleaning data. So, the fact that one or two patients come in a little bit late; they're still – it's not like everything else is clean at that point. So, the stragglers don't really impact the overall timeline. What could affect the overall timeline is, again, just access to sites to clean data to get to a locked database. And that's something we don't have a good handle on, you know? Well, actually, most of the sites are open for cleaning.

Yeah, Yeah, there's we're talking about you know potential delays in final visits of the two three weeks, having said that none of it really will affect a where should affect the timing of the a of the close out of the trial because it's still there's still cleaning data. So the fact that one or two patients come in a little bit lead there's still.

It's not like everything else is clean at that point.

So the stragglers don't really impacts the overall timeline.

What could affect overall timeline is again just access to sites to clean data to to get to get to lock database.

And that's something we.

Don't have a good yeah. So.

Actually most of the stuff is most of the sites are open for cleaning. So that's good there's a few sites that are not would turn some stuff virtually so.

Michael S. Weiss: So, that's good. There are a few sites that aren't, and we're doing some stuff virtually. So, it's, in my opinion, heading toward a pretty typical conclusion to the trial without too much of an impact or not much at all from COVID. In terms of the BTK inhibitors in multiple sclerosis, the current KOL interactions we've had tell us that these are not competitors to CD20s. They're not viewed as being near the efficacious level.

Its a.

All all in my opinion heading toward a a pretty typical conclusion to the trial without too much of an impact or not much at all from from Cowen.

In terms of the the BTK inhibitors in in multiple sclerosis.

They are the current kaombo interactions Weve had tell us that these are not competitors to cdtwentys, they're not viewed as a near the efficacious levels. These are Ah interesting compounds I'm sure for their developers.

Michael S. Weiss: These are interesting compounds, I'm sure, for their developers, and they will compete in the world of oral therapy. So I think the world of oral therapies includes multiple underlying mechanistic agents, but they all compete for the oral marketplace. And that's what we've heard about. The first data that came out on the Merck compound was not overly impressive from the KOL perspective that we spoke to, so we spoke to a number of KOLs when that data came out. I forgot which conference, but we had the opportunity to spend a lot of time with a bunch of folks, and the general consensus was, it's okay, nothing too spectacular in terms of its competition in the oral space, and certainly not in the same class as the power of a CD20. In terms of the version of the oral BTK that crosses the blood-brain barrier, again, it's one of those scientific stories that gets a bunch of K The practical application of crossing the blood-brain barrier is... Primary Progressive Disease may have some applications in Secondary Progressive Disease.

And they will compete in the world of oral therapy. So I think the the world of oral therapies includes multiple underlying mechanistic agents, but they all compete for for the oral marketplace and that's what we've heard about about.

The I.P.T.K.'s the first data they came out on the Merck compound.

It was not overly impressive from the K Walt perspective that we spoke to this always talked a number of K wells that data came out.

I forget which conference, but we had the opportunity to spend a lot of time with a bunch of folks and ER and the general consensus was it's okay nothing to spectacular in terms of.

It's it's can competition in the oral space and certainly not in the same class with the power of other cdtwenty.

In terms of the diversion of who oral BTK that club crosses the blood brain barrier Oh again, it's one of the scientific story as it gets a bunch of K wells excited which then gets maybe some big pharma excited now the practical application of crossing the blood brain barrier is.

Probably limited to primary progressive disease.

May have some applications in secondary progressive disease.

Michael S. Weiss: But as you can see in relapsing forms of MS,

But as you can see in relapsing forms of M.S.

Michael S. Weiss: The complete blockade of B-cells by CD20 is super active. The concept of a molecule, BTK or otherwise, crossing the blood-brain barrier is, like I said, scientifically interesting, the clinical likelihood that that's going to make a material difference in the overall outcome for patients with a compound that is, you know, with a BGK effect that, at least in the first go around, was marginally active in relapsing forms, to think it's going to have some miraculous effect Again, it's just a hypothesis. Clearly, someone is spending a lot of money to test that hypothesis in large clinical trials, and we'll get the answer.

Yeah, the complete blockade of a b cells by Cdtwenty is super active and.

You know the concept of a have a molecule beach care otherwise crossing the blood brain barrier.

Right.

Is like I said, it scientifically interesting but.

Yeah it'd be the clinical.

Likelihood that that's going to making material difference in the overall outcomes for patients.

With a compound that is you know, but the BTK effect that at least in the first go around was marginally active and relapsing forms to think it's gonna have some are miraculous affecting in progressive forms again, it's a it's hypothesis clearly someone is spending a lot of money too.

Got that hypothesis and large clinical trials and we'll get the answer but.

Michael S. Weiss: But in the end, it's not really a competitor to what we're doing. Our competition is in the CD20 class. We know what that class looks like. You've obviously got two agents, one IV, one oral. We know, you know, the current development plans for both and future development plans. We think we're going to have a really nice role to play in the CD20 marketplace, which alone is expected to be closer to $10 billion. So I think it's a big market and a great opportunity for TG and for Obitux Mamm.

In the end, it's it's not really a competitor to what we're doing arc or competition is in the Cdtwenty class a we know what that class looks like.

He's got obviously to agents one Ivy on oral we know you know the current development plans on both in future drilling plans.

We think we're going to have a really nice role to play in a in the CD 20 marketplace, which alone is expected to be closer to a $210 billion. So think it's a big market integrate opportunity for teaching intra will become Smith.

Great really appreciate that color. Thanks for taking my questions and are looking forward to the second half.

Michael S. Weiss: Great, really appreciate that Keller. Thanks for taking our questions and looking forward to the second half. All right. Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Mike for any further closing comments.

Great. Thank you and we've returned about question answer session well, that's it from a floor back over to my free for closing comments.

Sure. Thank you.

Michael S. Weiss: Sure, thank you. I'd like to wrap up the call once again by reiterating our upcoming goals and objectives for the remainder of this year and early next year. So first, we are targeting top-line data from the ultimate phase three trials and relapsing forms of multiple sclerosis in the fourth quarter. Then, in December, we are looking forward to presenting pivotal data from both the Unity NHL and Unity CLL trials, as well as updated data from our ongoing triple combination therapy trial. Toward the end of the year or early next year, we're also targeting regulatory submissions for U2 for the treatment of patients with chronic lymphocytic leukemia. And around the same time, we could potentially have our first FDA approval for umbralicit in previously treated marginal zone lymphoma and follicular lymphoma.

So I'd like to Iraq, the call once again by reiterating our upcoming goals and objectives for the remainder of this year and early into next year.

So first we are targeting a topline data from the ultimate phase three trials and relapsing forms of multiple sclerosis in the fourth quarter. Then in December we were looking forward to presenting pivotal data from both the unity NHL and unity CLL trial has all the updated data from our ongoing triple combination.

Therapy trials.

Towards the end of the year early next year. We're also targeting regulatory submissions for you to for the treatment of patients with chronic lymphocytic leukemia.

And around the same time, we could potentially have our first FTC approval from the illicit it previously treated marginal zone lymphoma and Follicular lymphoma.

We have an amazing 2020, thus far with so many attack from milestones to come we believe we're well positioned for success I'm back from all of US a teaching I'd like to thank our investigators and their <unk> patients for participating in these important clinical programs as well as our employees and shareholders for their continued support.

Michael S. Weiss: We have had an amazing 2020 thus far; with so many impactful milestones to come, we believe we are well positioned for success. On behalf of all of us at TG, I'd like to thank our investigators and their patients for participating in these important clinical programs, as well as our employees and shareholders for their continued support. And again, thank everyone for joining us. Have a great day.

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

Operator: Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Thank you that does conclude today's teleconference. You may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.

[noise].