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 is 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, ublituximab 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 this indicated. Factors that may affect TG Therapeutics’ operations include various risk factors that can be found in our SEC filings. This conference call is being recorded for audio rebroadcast on TG’s website, www.tgtherapeutics.com where it will be available for the next 30 days. All participants on this call will be on a listen-only mode. Now I’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 were 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 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 GAAP 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 GAAP 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.

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. 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 naïve 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…

[Operator instructions] Our first question today is coming from Alethia Young from Oppenheimer. Your line is now live.

Hi, thanks. It’s [indiscernible] on for Alethia. 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 venetoclax in terms of just the numbers of patients in 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 spoke about in the past and getting excited about it specifically.I think there’s one for patients who are on BTK or venetoclax and haven’t gotten to a clear response and then adding U2, and just how that’s shaping 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 will be somewhere in the order of 50-ish patients, 40, 50 patients--sorry, let me just take that back. It’s not ULTRA-V. ULTRA-V, the Phase 2 will not be presented until complete or until, I guess, later. This is the combination of venetoclax plus U2, is coming from our Phase 1 trial, and that’s what I’m referring to, so let me start over. So, we will have Phase 1 data presented later this year on the Phase 1 combination of U2 plus venetoclax, and again that’s what we presented previously at ASH, and the update should hopefully include, like I said, let’s call it 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 venetoclax. The other study you mentioned is a smaller study. It’s only in one or two centers. It’s the 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. The next question today is coming from Josh Schimmer 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, their relevant experience, as well as the cadence and timing of building out a full [indiscernible] how many reps you’ll need? Then given your portfolio of assets, you’ve been focused on creating best-in-class regimens for CLL and CL 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 U.S. hematology franchise for Celgene in his last position, but he went up the ranks in lots of different positions and 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 has 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 detail, just let me know. 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 bi-specific antibody that could 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 PDL1 to work in combination with some of the agents in the portfolio in more aggressive lymphomas as well, so again diffuse large B cell and possible mantle cell there, and we know that BTK inhibitors work in mantle cell so that’s something we’ll be exploring as we move forward. Again, we’re sticking pretty close to our core of our indolent diseases, but in terms of B cells on the docket, certainly we’ll be looking at diffuse large B cell and mantle cell as some future potential. It’s 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. Are either of those on your radar screen as well?

Yes, so I’ll take the second question first before I forget it, and then I’ll go back to the sales force 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. Lonial on the board, who is a recognized expert in multiple myeloma, so I think we will start to think about if there is 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, 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 BET inhibitor has worked nicely in combination with ruxolitinib. I would argue that our umbralisib 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 sales force sizing, I think the general idea is that I think we’d 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 marginal zone and follicular, our plan is at the time of the launch itself, we would expect to have probably half of that 75 in place for our 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. In terms of--we won’t wait to hire the first, call it 30 or 35, we will not wait until after the approval. Those people will be on board in advance of the PDUFA date. Like I said, those numbers are not--don’t lock me in, but those are in the range of. It 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 the sales force sizing exercise is complete.

Okay, thanks very much for the color.

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

Good morning, thanks for taking my questions. Just a couple, maybe if you could review what you think your biggest challenge to launching umbralisib I going to be. 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 payors right now, if you’re seeing any issues or pushback to coverage there. Then lastly, just if you can discuss your European strategy. Thank you.

Yes, I’m going to go reverse chron on the questions. 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. Give me another quarter and we’ll give you a little more information perhaps. In terms of the number two question, which was payors, we don’t expect to have any payor issues. We have been engaging with payors. 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 the cancer drugs don’t see too much pushback in payor coverage, but again we don’t expect to see issues and engagement has begun. Then I’d say the number one question, which is obviously--well, they’re all important questions, the number one question is what’s going to be our greatest challenge in commercializing umbralisib in marginal zone and follicular. Look - 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. 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 PI3K inhibitors, that their concerns melt relatively quickly. Then there’s some folks who are just completely open to novel treatment options, so I think our greatest challenge is just getting out there and educating folks. I feel like in my head, we’re like the five sins of biotech - we need to make sure--you know, an educated consumer is our best consumer. The…

Great, thanks Mike. Maybe just a last question on 1801. You’re going to have your first data 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.

Yes, so I’m not sure what we’ll be seeing at ASH for the CD7 for CD19 bi-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 were talking to someone else, but our big presentations for ASH outside of the pivotal presentations are focused on U2 plus venetoclax and U2--BTK alone and switch to 1701, and U2 plus 1701. In terms of some of the earlier stuff, PDL1 and [indiscernible], I think we’ll have to wait on that, but I’ll double check. I’ll double check.

Okay, thanks Mike.

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

Hi, good morning guys. Mike, wanted to talk a little bit about the--when we should hear about the PDUFA date for the NDA for umbralisib in marginal zone and follicular lymphoma.

Yes, sure. Typically it’s a 60-day time frame, 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 time frame, that’s what the regulations say, 60 days, then they will either accept or issue a refusal to file, so I guess that’s around August 15 give or take a day or two is the current expectation we’d hear back from them.

Okay, thank you. Then just looking at your pipeline a little bit, wanted to dig into your current thoughts for the regulatory path forward or development path forward for your BTK inhibitor and your anti-CD47/19 bispecific monoclone antibody.

Perhaps your phone is on mute?

Hello?

I’m sorry. Sorry Matt, somehow my phone got on mute. Yes, 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--I think it’s 100% response rate across both those indications thus far. Now of course, larger trials will bring that down - it won’t be 100%, we 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 BTKs are indicated and U2 ought to be indicated, let’s say that. Then there is 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 is registration opportunities across those indications. In terms of CD47/CD19, it’s way too early, but we would certainly start targeting into diffuse large B cell and follicular with that agent. The earlier data with a competitive compound did look quite interesting in both follicular and diffuse large B cell once it was combine with a 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.

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

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 questions. Maybe just two quick ones. One is for the follicular, so obviously we noticed a few developments recently like the epigenetic tazemetostat approval and launch, and we had some [indiscernible] positive readouts [indiscernible], so just curious your thoughts evolving--given the evolving landscape and what the treatment sequence you think umbralisib will fit in the future landscape. I will have a quick follow-up after that. Thank you.

Sure, Roger. Yes, so you brought up two 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 generally speaking for umbralisib, it’s a, we believe, a very nice level of activity with a 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’ll look at potentially using more aggressive therapies like the CAR Ts or the bispecifics. I think there is 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, giving 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 Ts 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, 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 plus, whether it’s BTK or some other combination, or U2 plus CD47 or U2 plus PDL1, 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. 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, very helpful. Thanks for all the color. Maybe my follow-up question is tied to with you have alluded, so basically you already have for multiple mechanism of action in BTK, [indiscernible] CD47, CD19, and just curious any other [indiscernible] opportunity you’re looking for, some other interesting mechanisms you probably want to lay onto the current portfolio?

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 questions. Congrats.

Sure Roger, thank you.

Thank you. As a reminder, that’s star, one to be placed into the question queue. Our next question today is coming from Mayank Mamtani from B. Riley FBR. Your line is now live.

Hi, good morning. This is [indiscernible] on for Mayank. Congrats 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 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.

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

Okay, great. Thanks. 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 COVID-19. Any changes that might be going into 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 Immunex’s product as well.

Yes, so in terms of the study conclusion and COVID, as we mentioned, I think on our last conference call, we were definitely impressed by the fact that 90, 95% of the patients did come in relatively on time for their visits. There were some stragglers, and that carried forward into 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, 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. Again, we’re talking about potential delays in final visits of the two, three weeks. Having said that, none of it really will affect or should affect the timing of the closeout of the trial. 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 have an effect on 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--you know? Actually most of the sites are open for cleaning, so that’s good. There’s a few sites that are not and they’ve been doing some stuff virtually, so it’s all, in my opinion, heading towards 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…

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

Thank you. We have reached the end of our question and answer session. I’d like to turn the floor back over to Mike for any further or closing comments.

Sure, thank you. I’d like to wrap the call once again by reiterating our coming goals and objectives for the remainder of this year and early into next year. First, we are targeting top line data from the ULTIMATE Phase 3 trials in relapsing forms of multiple sclerosis in the fourth quarter, then in December we’re 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 umbralisib in previously treated marginal zone lymphoma and follicular lymphoma. We’ve 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 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.