TG Therapeutics, Inc.

Hello, and 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. 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.

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, Bublatuximab and Umbralisib, as well as an update on 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 provisions under the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks and uncertainties that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors that can be found in our SEC filings. This conference call is being recorded for audio rebroadcast on TG's website www.tgtherapeutics.com, where we'll be available for the next 30 days. All participants on this call will be on a 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.

Thank you, Jenna, and thanks, everyone, for joining us. As you may be aware, our financial results were released this morning and can be viewed on the Investors and Media section of our website. 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. Accordingly, at June 30th, we had cash, cash equivalents, and investment securities of $275.6 million, which we believe leads 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 GAAP net loss for the second quarter of 2020 was $52.9 million, or 47 cents per share, compared to a net loss of $36.2 million, or 42 cents 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 GAAP net loss for the six months ended June 30, 2020, was $104 million, or 95 cents per share, compared to a net loss of $71.4 million, or 85 cents per share, for the six months ended June 30th, 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.

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. 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-free 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 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 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 also added Dr. Sagar Lonial to our board of directors. Dr. Lonial 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 Winship Cancer Institute of Emory University. We've also been hard at work building our commercial and medical affairs organizations. This team is very impressive with deep experience launching products in the hematology oncology space, and they have already made great progress advancing our launch plans. 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 ugletuximab to ibrutinib significantly improved progression for survival, overall response rate, complete response rate, and increased the rates of undetectable minimal residual disease as compared to ibrutinib alone. At IHA, 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 TG1701 as a monotherapy and in combination with U2. 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 Pena, and the team at the H. Lee Moffitt Cancer Center and Research Institute recently published preclinical data describing the unique immunomodulatory effects of ombrilisib in blood advances, a journal of the American Society of Hematology. As I mentioned, it's been an exciting first half for TG. 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 umbralisib monotherapy as well as combinations, including the U2 combination, in a variety of disease cohorts. The umbralisib 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 FDA in June. This is a major milestone for us and a huge step forward to bring ombrolizumab to patients in need. As a reminder, ombrolizumab received breakthrough therapy designation for patients with marginal zone lymphoma. Next, I'd like to discuss the UNITY CLL trial. As a reminder, the UNITY CLL clinical trial is a global phase 3 randomized study of U2 versus the combination of the chemotherapy chlorambucil plus the CD20-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 as assessed by independent review committee. You may recall that the trial enrolled approximately 60% previously untreated or they can be referred to as treatment naive patients and 40% who were relapsed or refractory from prior therapy. And we are pleased to note that the PFS benefit was observed across both patient populations. 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 sclerosis. As a quick reminder, our ultimate 1 and 2 Phase III trials in relapsing forms of MS are two independent, global, randomized, multi-center trials comparing ubituximab to oral teraflunomide. 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 ubituximab in relapsing forms of MS. These trials are fully enrolled and being conducted under special protocol assessment with the FDA. Currently, there is only one CD20 approved for MS, which is currently tracking to have 2020 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 Lutuximab 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. Despite some minor delays from COVID, we are pleased to report that we are still targeting releasing 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 six to 12 months. where we are targeting pivotal data from our Ultimate MS Phase III clinical program, which if positive, would lead to a BLA submission for Lubutuximab, data presentations from both Unity NHL and Unity CLL, an NDA BLA submission for the U2 combination in CLL, and if all goes well, launching our first product, Umberlicid, 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 which I will return to make some concluding remarks.

Thank you. We'll now be conducting a question and answer session. If you'd like to be placed into question Q, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question Q. 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. One moment, please, while we poll for questions. Our first question today is coming from Alethea Young from Oppenheimer. Your line is now live.

Hi, thanks. This is Emma on for Alethea. 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-V study with netto clocks in terms of just the number of stations and follow-ups? 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 it in the past and been excited about it. Specifically, I think there's one for patients who are on a DCK or metatox and haven't gotten to complete response and then adding U2 and just how that's shifting up.

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 there'll be somewhere in the order of 50-ish patients, 40, 50 patients. Sorry, let me just take it back. It's not Ultra-V. Ultra-V, the Phase II, will not be presented until complete or until, I guess, later. This is the combination of venetoclax plus U2 is coming from our Phase I trial, and that's what I'm referring to. So let me start over. So We will have phase one data presented later this year on the phase one combination of U2 plus venetoclax. And, again, that's what we presented previously at ASH. And the update should hopefully include, like I said, you know, let's call it 15 to 25 patients who have completed 12 months of treatment. In total, though, 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 venetoclax. The other study you mentioned is a smaller study. It's only in one or two centers. It's a study where we have U2 added on top of BTK or venetoclax in patients who have been on a BTK or venetoclax 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.

Thank you. No problem. Thank you.

Thank you. Our next question today is coming from Josh Shimmer from Evercore ISI. Your line is now live.

Thanks for taking the questions. 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 set of 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 there? Thanks.

Sure. Thanks, Josh. So in terms of the commercial team, we brought on Adam Waldman, who headed up the USDA, hematology franchise for Celgene in his last position, but he went up the ranks in 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 the leadership have been either primarily 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. Well, not on the road, but virtually on the road at some point. And he can give, obviously, more details and chat in depth. But if you want more details, just let me know. And then in terms of other areas, obviously, our core focus has been the 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 opportunities or studies going on in diffuse large B cell and in mantle cell lymphoma, which are, I'd say, again, earlier and more exploratory, 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, we're excited about our anti-CD47, CD19 bispecific antibody that can be certainly used in diffuse large B cells 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. And, you know, we know that BTK inhibitors work in mantle cells, so that's something we'll be exploring as we move forward. So, again, we're sticking, you know, pretty close to our core of our indolent diseases, but in terms of B-cells, you know, on the docket certainly we'll be looking at diffuse large B-cell and mantle cells as some future potential. Obviously too early to say too much.

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 effect in some large indications like myelofibrosis or myeloma or either of those on your radar screen as well.

Yeah, so I'll take the second question first because I've before I forget it, and then I'll go back to the Salesforce sizing. In terms of multi-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. Loni on the board, who's a recognized expert in multi-myeloma. So 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, we've already presented some pretty interesting and compelling data of umbralisib in combination with ruxolitinib in myelofibrosis. And so that's an area that we are taking a more serious interest in. We're starting to explore that somewhat seriously. 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 nice in combination with ruxolitinib. I would argue that our on the list of data in combination with ruxolitinib 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 ruxolitinib is something that we're excited about, we're thinking about, and could be started in the relatively near term. In terms of Salesforce sizing, I think the The general idea is that I think we want to probably grow to a sales force at CLL launch, and this is approximate because we haven't completed the sizing studies, but just give or take 75-ish on the sales team. And then so as we launch with margins on a follicular, our plan is at the time of launch, 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, we will not wait until – until after the approval, those people will be on board in advance of the PDUFA date. Like I said, those numbers 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.

Thanks very much for the color.

Yep.

Thank you. Our next question today is coming from Ed White from H.C. Wainwright. Your line is now live.

Good morning. Thanks for taking my call. My question. Good morning. Good morning, Mike. So just a couple. Maybe, you know, if you could review what you think your biggest challenge to launching Uvalysib is going to be. You know, is it going to be convincing them that the tolerability is better than others in the class, or is it going to be on efficacy? Just how you're going to be approaching that. And then also, I'm sure you're having conversations with payers right now if you're seeing any issues or pushback coverage there. And then lastly, just if you can discuss your European strategy. Thank you.

Yeah. Again, 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 to go it alone in Europe. And I think TBD is the best I can offer today. So 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 to coverage. Typically, you know, the 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 I'd say the number one question, which is obviously the most No, they're all important questions. The number one question is any, you know, what's going to be our greatest challenge in commercializing on the list of marginal zone and follicular? Look, 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's some folks who have some negative, remaining negative impression of PI3K deltas. I'd say once you show them the data and explain to them the fundamental differences between this molecule and the first generation PF3K inhibitors, that their concerns melt relatively quickly. And then there's some folks who are just completely open to a novel treatment option. So I think our greatest challenge is just getting out there and educating folks. I feel like in my head we're like the size Sims of biotech. We need to make sure an educated consumer is our best consumer. The better people understand the value proposition that Umbralisa brings to them and their patients, the better off we're going to be. And we just got to get folks to try Umbralisa. Once they do, again, relatively immediately, the vast, vast majority will notice that this is a very different compound and a different profile with their patients. Again, 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 on 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. So our goal is to get folks to try. We feel like we've got a really good lead-in because of our clinical trial sites. We had 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. And then each one of those clinical trial sites represents typically a lot more than the clinical investigators who participate in the trials. So it's leveraging the relationships in those clinical trial sites, to get their co-investigators or partners to also try umbralisib 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 we're going to do quite well. Again, look, marginal zone and follicular are not the biggest indications, 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 into 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 that much more successful once we get to CLL. So 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 maybe just the last question on 1801. 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?

Thank you. Yeah, so I'm not sure what we'll be seeing at ASH for the CD7, 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 You know, our big presentations for ASH, outside of the pivotal presentations, are focused on, you know, U2 plus 100 clocks and U2 BTK alone and Switch 1701 and U2 plus 1701. 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. I'll double-check.

Okay.

Thanks, Mike. Okay. You got it.

Thank you. Our next question today is coming from Matt Kaplan from Lattenburg. Your line is now live.

Hi. Good morning, guys. Mike, I wanted to talk a little bit about when we should hear about the due for date for the NDA for Umbilicib and Marshall Zone and Flippantum.

Yeah, sure. So typically, it's a 60-day deadline. So you file your submission once it's complete. Obviously, the rolling submission for us was complete around mid-June. So one would expect about a 60-day timeframe. That's what the regulations say, 60 days. Then they will either accept or issue a refusal to file. So, you know, I guess that's around August 15th, give or take a day or two, is the current expectation. We'd year back for them.

Great. Okay. Thank you. And then just looking at your pipeline a little bit, I wanted to dig into your current thoughts for kind of the regulatory path forward or development path forward for your PTK inhibitor and your anti-ICD-4719 inhibitor. by specific monoclonal antibody.

Helen? Perhaps your phone is on mute. Helen?

I'm sorry. Sorry, Matt. Somehow my phone got on mute. Yeah, so what I was saying is for the BTK In terms of regulatory strategy, CLL is an area of great interest, and then obviously marginal zone lymphoma is one. In both those indications, we've treated a number of patients with U2 plus ibrutinib. We've treated a number of patients with U2 plus 1701. I think between CLL and marginal zone of basically U2 plus BTK, I don't know. I think it's 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%. I can be confident of that. But it's going to be very high response rates when we use U2 plus PTK. So that's something that we are excited about for both those indications where PTKs 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. So we think there's registration opportunities across those indications. In terms of CD47 cementing way too early, but we would certainly start targeting into 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 cell once it was combined with the CB20. 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.

Thanks a lot for taking the questions and congrats on the progress. Yep, thanks Matt.

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

Good morning. Thank you. Thank you for taking my question, Mike. So maybe just two quick ones. So one is for the follicular. So obviously we noticed a few kind of development recently, like the epigenetic methametastat approval. in the launch and we have some kind of a CAR-T kind of a positive readout and of course the specific. So just curious to your thoughts evolving, given the evolving landscape and what did the treatment sequence kind of where you think Embry-Lisip will fit in the future kind of a landscape. I will have a quick follow up after that. Thank you.

Sure, Roger. Yeah, so it's interesting. You brought up two new modalities that are starting to take hold in follicular. So you've got EZH2, 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 bispecifics. I think, you know, generally speaking for umbilicid, it's a, you know, we believe a very nice level of activity with a very nice safety profile 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 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 the CAR-Ts or the bispecifics. So I think there's room for all of 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, give them the best quality of life for the longest period of time. So I think we're going to fit in very nicely in the first few lines of therapy. I think once you get into what some describe as sort of salvage settings, you'll start to see people using CAR-T and bispecifics. In terms of EZH2, I think as a standalone agent, it certainly has activity, but I think they'll find their home at some point in combination. Obviously, we think Umbralisib is a very nice standalone agent. Two, over time, we think U2 will be more efficacious than Umbralisib alone, and U2 plus, whether it's PTK or some other combination, or U2 plus 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 what I'd describe 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 nuclear bombs and we've chosen to use multiple therapies at once to try to triangulate the tumor.

Got it. Yeah, very helpful. Thanks for all the colors. So maybe my follow-up question is tied to what you have alluded. So basically you already have for multiple kind of mechanism action like BTK, PD1, and CD47, CD19. 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?

I mean, we continuously... scan the landscape looking for validated targets in the treatment of B-cell malignancies. And I think 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 if it makes sense.

Got it. Thank you. Thank you for taking the question. Congrats.

Sure, Roger. Thank you.

Thank you. As a reminder, that's star one to be placed into question queue. Our next question today is coming from Mayank Mantani from B-Reilly FBR. Your line is now live.

Hi, good morning. This is Sahil on for Mayank. Congrats on a really strong first half of the year. Just a couple of questions from us, maybe 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 data set? Are you sensing it? tracking a certain way given the revised interim analysis, and then I'll have a brief follow-up on the ultimate programs.

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

Okay, great. Thanks. And then I just wanted to understand how you're kind of manage 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's BTK and maybe Immunix product as well?

Yeah, so in terms of – in terms of the study conclusion and COVID. Yeah, so as we mentioned, I think, on our last conference call, you know, we were definitely impressed by the fact that, you know, 90-95% of patients did come in relatively on time for their visits. There were some stragglers, and that carried forward, you know, into both, you know, whatever they had left in terms of 84-96 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've got 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. So, you know, again, we're talking about, you know, potential delays in final visits of, you know, two or three weeks. Having said that, none of it 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, 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 information. to get to a locked database. And that's something we don't have a good, you know, well, actually most of the stuff, most of the sites are open for cleaning. So that's good. There's a few sites that are not, and we're doing some stuff virtually. So it's all, 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 near the efficacious level. These are interesting compounds, I'm sure, for their developers, 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 the oral marketplace. And that's what we've heard about the IPTKs. 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 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 with 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 KOLs excited, which then gets maybe some big pharma excited. The practical application of crossing the blood-brain barrier is probably limited to primary progressive disease. It may have some applications in secondary progressive disease. But as you can see in relapsing forms of MS, the complete blockade of B cells by CD20 is super active. And the concept of a molecule, BTK or otherwise, crossing the blood-brain barrier is, like I said, it's scientifically interesting, but 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 BTK 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 in progressive forms. Again, it's a hypothesis. Clearly someone is spending a lot of money to to vet that hypothesis in large clinical trials, and we'll get the answer. 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. We've got, obviously, two agents, one IV, one oral. We know the current development plans on 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 success. $10 billion. So I think it's a big market and a great opportunity for TG and for Obituximab.

Great. Really appreciate that, Keller. Thanks for taking our questions, and I'm looking forward to the second half. Great.

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.

Sure. Thank you. So 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 into next year. So first, we are targeting top-line data from the ultimate Phase III 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 trials. 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 umbilicit and previously treated marginal zone lymphoma and follicular lymphoma. We have 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 TEG, 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, thanks everyone for joining us. Have a great day.

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.