Greetings, and welcome to the TG Therapeutics First Quarter Conference Call. At this time, all participants are in a listen-only-mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Director of Investor Relations. Thank you. You may begin.

Thank you. Good evening, and welcome to our conference call regarding TG Therapeutics first quarter 2016 financial results and business update. I am Jenna Bosco, TG's Vice President of Investor Relations 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 Interim Chief Executive Officer, who will provide an update on the ongoing development of our novel, glycoengineered anti-CD20 monoclonal antibody, TG-1101, our novel once-daily PI3K delta inhibitor, TGR-1202, as well as a review of our pre-clinical program. Before we begin, I would like to remind everyone that various remarks that 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 and uncertainties 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 would like to turn the call over to Sean Power, our Chief Financial Officer to briefly discuss the financial results for the first quarter of 2016, 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 earlier this evening and can be viewed on the Investors & Media section of our website at www.tgtherapeutics.com. I would like to begin by providing an update on our cash position. At March 31, 2016 we had cash, cash equivalents, investment securities and interest receivable of $85.3 million, which we believe provides us with sufficient cash to fund our operations into the second quarter of 2018. With that, I'll turn to the financial results. Our net loss for the first quarter ended March 31, 2016, excluding non-cash items, was approximately $12.1 million, which included approximately $4.3 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The net loss for the first quarter of 2016, inclusive of non-cash items, was $13.8 million, or $0.28 per diluted share, compared to the consolidated net loss of $14.6 million during the comparable quarter in 2015. The decrease in consolidated net loss during the first quarter ended March 31, 2016 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2015, partially offset by an increase in other R&D expenses as a result of clinical trial expenses related to ongoing and planned future Phase 3 registration programs. I will now turn the call over to Mike Weiss, our Executive Chairman and the Interim CEO.

Thank you, Sean and Jenna, and thank you all for joining us this evening. Let me start by acknowledging that 2016 has been a challenging year thus far for biotech stocks, including ours. But, let me reassure everyone that we continue to push aggressively forward with our innovative business plan to create best-in-class combinations of targeted and immune therapies with the goal to provide patients with chronic lymphocytic leukemia and non-Hodgkin's lymphoma the best possible outcomes, ideally cures with the least toxicity. Our vision entails a number of innovative and value creation steps for our shareholders as we build toward our proprietary three drug and four drug combinations that are designed to revolutionize the treatment of CLL and NHL. With a long-term vision like that, we need long-term proprietary protection. We were excited to announce this quarter, the issuance of two important patents for our lead programs for TG-1101, a composition of matter patent was issued in the United States providing protection through 2029, plus an additional up to five years under the rules of patent term extension. For TGR-1202, a composition of matter patent was also issued in the U.S., providing protection through 2033 and similarly TGR-1202 could be eligible for patent term extension. Collectively, these patents provide long-term exclusivity for our TG-1303 combination, a foundation for future multi-drug combination fitting perfectly with our long-term vision, which leads us directly into a discussion of our UNITY program, a unique program designed to get both TG-1101 and TGR-1202 approved at the same time. These both programs start in CLL, but that is just the beginning. UNITY is designed to get TGR-1303 combination approved across non-Hodgkin's lymphoma, both aggressive forms like diffuse large B-cell and indolent forms like follicular lymphoma. In fact, our UNITY diffuse large B-cell Phase 2b registration directed…

Thank you. Ladies and gentlemen, at this time, we will now be conducting our question-and-answer session. [Operator Instructions] Our first question comes from the line of Matt Kaplan from Ladenburg Thalmann. Please go ahead.

Hey, guys. Good afternoon.

Hey, Matt. How are you?

Doing well, thanks. Thanks for the update, Mike. And I guess with respect to enrollment in your studies, I guess can you confirm that you're - I guess you remain on track to have data for the UNITY study - oh, not the UNITY study, sorry, the GENUINE study by first half of 2017?

Actually, there was a nice variance, but I'd love to have both by the first half. Yeah, I mean, again, we've been relatively cautious over the last several months because we really just haven't hit that point of the recruitment curve where it gives us the precision that we'd like in terms of the end of enrollment. But, yeah, we're still feeling good about the ability to deliver data in the first half of 2017. Again, it is obviously contingent upon getting there. We talked about a lot of these things that we've been putting in place to drive us - drive the enrollment and get us closer and closer to that. So, I do think a lot of these things will be helpful. Again, it was a bit surprising to us when we realized at the beginning of the year that folks were not screening for higher risk patients. So getting the screening protocol, and it's a simple protocol to administer, as I mentioned in the prepared remarks, in terms of ease of consenting, to consent to the full trial, really could take a doctor two hours to three hours. Consenting for the screening protocol should really be 30 minutes or less, so it really streamlines in that part of it. It's a simple blood draw, so we think that it's a very simplified approach, dovetails nicely with the UNITY program, which, again, we're extremely excited about driving that as far as the long-term broader mission of the company. So anyway, long-winded answer to I think the pieces where we put in place and we designed it now are going to help, but it does take time to get these things in place. I mean, despite the ease of use of the screening protocol, it still requires IRB approvals. In certain sites, that's easy. In certain sites, it's not that easy, then you have to have initiation visits. So, there is a logistical process and that's why we said we hope to have everyone set by that by June 30. And like I said, again, I think we put a lot of good things in place, and, hopefully, we'll be able to meet the timelines that we discussed.

Great. Thanks for the detail. Going back to the question associated with TGR-1202 and the data that you had at AACR, it seems as though with that pre-clinical data that has a differentiated profile versus idelalisib and duvelisib. Can you talk a little bit about how - what you've been seeing clinically dovetails with the pre-clinical findings and differentiation there?

Yeah. I mean, it's more, I think I can only respond qualitatively today. I think we'll have more data at ASCO that we will be reviewing, but the T-cell effect that people believe is responsible for the idelalisib and duvelisib toxicities are - when they have been, they seem to be really virulent and happen in some cases very quickly. So for instance, Dr. Jennifer Brown from Harvard had presented some data on idelalisib in front-line patients taking single agent idelalisib and very rapidly they had raging liver tox issue attributed to T-cell, Treg down-regulation and T-cell over-activation. So, we just don't observe - and that was not just one patient, that was I think almost every patient. And so, you see that again even with the colitis, the prevalence seems to be quite high with these other drugs if you look at the number of true patients that really make it out six months or more, and, again, those are all - and some I believe to be Treg related. So, again, I think qualitatively we continue to maintain that the profile when you give a patient this drug, for the most part you're getting a different reaction from the patient from the side effect profile, and, again, it could be just differential effect on Tregs. It could be, again, associated with the structural differences in the compounds which we also believe is important to why it has a differential safety profile.

Okay, that's helpful. Thank you. And then last question, in terms of, you mentioned in your press release that updated data from your ongoing studies at upcoming conferences throughout 2016, do you expect to have additional data perhaps at EHA and ASH later in the year?

So, EHA is in I think mid-June and we will have a presentation there as well. And then in terms of later in the year, at ASH, obviously, we don't know, but we will be putting in abstracts, I'm sure to update data.

Okay, great. Thanks for taking my questions.

Thanks, Matt.

Thank you. Our next question comes from the line of Jonathan Aschoff from Brean Capital. Please go ahead.

Thanks. Good afternoon, guys, and congrats on the progress.

Thanks, Jonathan.

I was wondering what would define success for you guys in the Phase 2 MS trial, and when do you expect some guidance from the FDA on the Phase 3 design?

Sure. So, first, obviously, we're super excited about the MS program. It's growing a lot of interest and lots of different - from lots of different fronts for us. So, we could tell that that's an area that's super exciting to others as well. In terms of success in the Phase 2 study, we're really focused on B-cell depletion as a marker for activity of these agents. The B-cell depletion is highly correlated with GAG lesion effects and ultimately with reductions in annual relapse rate. So, the earliest PD marker we have is B-cell depletion. We really get that literally within days of the patient being treated. I think for us, we'll look at that early B-cell depletion will be important, and then the rate of recovery of B-cells is also going to be important to us. We will, of course, look at GAG lesions after scans, I believe we have scans every six months for potentially up to two years. So, our assumption is that we'll have some GAG lesion data relatively early, whenever that means I got to think through what that means exactly. But then, during the course of the conduct of our Phase 3 trial, we'll end up presenting what could be a reasonably robust Phase 2 dataset showing effects on GAG lesions and even some probably preliminary effects on annual relapse rates. But for us, success will be a very consistent and profound, rapid reduction in B-cells, so we'll be looking for on average about a 99% reduction. Most patients will be below the detectible level. There probably will be a few patients that are slightly above, but, on average, we expect to see around a 99% reduction, I think that's what we saw from the okra trials. So we'll identify dose that gives us a very consistent, deep reduction in B-cell count and then we'll be looking at the recovery rates. Our thesis is that, we should see similar to okra, very nice depletion that carries for six months or more so we can work with a six-month dosing schedule. And then the other I think part of success for us will be the ability to dose 450 milligrams and/or 600 milligrams in less than one hour. It's an aggressive schedule most in terms of okra and 600 milligrams is the limit three hours to four hours, but we've had very good success and tolerability of this antibody. And so, we're feeling pretty good about the prospects. We do know that we can give a 900-milligram dose in the cancer setting in 90 minutes, so you can extrapolate that we can probably get 450 milligrams to 600 milligrams in less than an hour in our MS patients.

Have you given that to your healthy volunteers yet, Mike, that dose in that timeframe?

We have not treated any healthy volunteers with this drug, but I think there is no reason to believe that a healthy patient with a significantly lower B-cell count than a cancer - than a hematological cancer patient with CLL or even NHL would have any greater risk of infusion-related reaction. So the lower the circulating B-cell count, the less likely a patient is to have an infusion-related reaction. So, again, we do think we can accelerate in a healthy volunteer even more easily than one could accelerate in a cancer patient.

Okay. And then the timing on any sort of Phase 3 guidance from the FDA?

Guidance?

On the Phase 3.

Yeah, so we are just at the beginning of our dialogue with the FDA. So, yeah, we are at the beginning of May. Six months to eight months, we do think by end of the year into early next year, the latest we should have a good sense of what their expectations are. We don't know offhand. We know that most of the companies have done large Phase 3 programs, two trials, the okra studies were two studies of approximately 800 patients each. That's a large program. If we look at that study and when we look at the power assumptions, we would require significantly less patients. If we were purely powering the study for efficacy the way we normally would, we would require significantly less patients. So, we do think that there is a chance that they ran those studies with much larger patient populations because they had much more conservative efficacy assumptions before they got started. They had no idea really what to expect so they had to overpower those studies. We now have two very large studies that show us about what the activity level we should expect is from a CD20. So, I do think we have a great advantage following them and be able to design a program that again would have substantially fewer patients. But the real question will then be, does the FDA have an opinion on the size of the data - a safety database, where do the patients with cancer fit into that database? We have a good number of patients on the drug for quite a while at much higher doses, so we do think that will be helpful. And when you look at the ICH guidelines, it does not require 800 patients on drug in the low 100 to 200s for over a year. So I think we have a good discussion to have with the agency, but until we really sit down and [indiscernible] expectations, we can't fully design the program. But like I said, I think from a pure powering standpoint, we could design a clinical program that has probably even less than half of the patients involved that were involved in the okra studies and be successful.

That size will be great. Can I ask one last question. Can you shed any light now on the pivotal indolent NHL trial design, or is that premature?

That's a bit premature. We're still getting the idea that we are currently working with the few of the KOLs to make sure people feel that their studies are recruitable and the design that we're thinking about, we think they are. But I think that probably would be getting a bit out over my skis to say too much about that study design until we know more. So, let's reserve that question Jonathon maybe for the next quarter of the conference call, where I can probably give little more detail.

Okay. Thanks a lot, Mike.

Thanks, Jonathon.

Thank you. [Operator Instructions] Our next question comes from the line of Ren Benjamin from Raymond James. Please go ahead.

Hey, good afternoon, guys. Thanks for taking the questions.

Hi, Ren.

Maybe just - hey, Mike. I guess just a couple in regards to the GENUINE study, can you give us any color regarding - do you know if there has been any dose reductions or holidays, and do you use any sort of prophylaxis for the patients today?

In the GENUINE study, so I really don't know any of that, but I could check on prophylaxis. I doubted it's not very common for ibrutinib, I don't know. I have to check on that. In terms of - yeah, I just - I don't think the prophylaxis is something that is used in that kind of a trial.

Right. So I would ask about UNITY as well, but I feared it was too early, but maybe that, do you have a sense for the UNITY study there?

So, probably a better question for UNITY. So we do not in any of our TGR-1202 based studies, we do not require prophylactic antibiotics or antivirals, but we do recommend it. Most doctors we talk to are already doing it. So, we don't have it, it's not mandated, and it's really up to the physician. During our SAE visits, I believe we do recommend that they do that, but we don't actually require it.

And do you happen to have a sense of maybe in the high-risk patients, how many might in fact be getting prophylactic treatments?

I think that on the GENUINE study, I don't think at all, though I don't know for sure how doctors are treating it. It'd really be how they're working with ibrutinib at this point, if there is any risk. I mean, there is a reasonable level of pneumonitis, I think it's 10% to 15% pneumonitis with ibrutinib on its own, so it could be that doctors are starting to do some prophylaxis with ibrutinib as well, but it wouldn't be something that we really have even discussed on that trial.

Got it. You had mentioned that the 70 patients or so have been on - I think it's TGR-1202 or maybe the combination for over a year. Was that just the one drug or the combination, and what's the - I guess what's the contact, like what's the total number of patients that so we can get a percentage that have been over a year?

That's a toughie there, Ren. So the 70 patients represent patients that have been on TGR-1202, a single agent or TG-1303, I think it might also include the Gazyva front-line combination. So, it comes from those studies. And in terms of the N and then we could probably go study-by-study [indiscernible], most of them were dose escalation. I think probably the Gazyva one is probably the most interesting. I think probably majority of more than half the patients are out over a year on that study. The other ones remember TGR-1202 single agent was a long-dose escalation trial with many patients under therapeutic doses and TG-1303 too with as well as a dose escalation trial. So, it is a bit harder for a [indiscernible] on those, but I think the majority of the patients on the Gazyva study are out over a year.

Great. That's helpful. Maybe just two other questions. The progress on the rest of the pipeline, for example, IRAK4 and the checkpoint inhibitors. And maybe one for, Sean, I think you mentioned that $4.3 million was related to the manufacturing of the drug as well as some CMC activity. Should we be considering that as a one-time expense, and so a substantially lower operating expense number in the second quarter for this year?

Okay. So I'll go first, but now you made me forget what you were asking.

Just the progress on the rest of the pipeline like IRAK4 or the checkpoint inhibitor?

If we start talking about manufacturing, I kind of glaze over it a little bit.

Right.

So, in the pipeline, Ren, so I'd say the good news is that the PDL1 program is moving along quite nicely. I think we're all very excited about the profile of that PDL1 for those of you who don't recall, or I will mention that the PDL1 as a class, there is I think three PDL1s or four PDL1s working their way into late-stage clinical trials. Most of the PDL1s like the PD-1s were engineered to have no ADCC. So, no cell turn effects on their own, there is design, it's just to block the interaction between PD-1 and PDL1. Merck KGaA and Pfizer are developing one that did not engineer out the ADCC, so they left it in, and their drug also seems to be doing quite well. There was originally a concern that without engineering out the ADCC, you may end up killing T-cells, whereas PDL1 is a target on cancer cells and more so than PD-1, which is a target of T-cells, where you might be very concerned about that. PDL1, in our view, is actually an excellent candidate to have ADCC. So we would be only one of two molecules in the PDL1 or PD-1 space, that's actually been not engineered. So, it does have ADCC and then we've gone one step further, we're also developing another version of our antibody that will be glycoengineered to basically optimize to ADCC like we've done with ublituximab. My guess is that the first version that goes into clinical would be basic one with ADCC and then will pause follow-up, with the one that has the high ADCC or low focus, that's been engineered. So, we're excited about the profile, we still think probably early next year we'll be able to get into the clinic. The program is moving along quite well in all respects. So, that's the good news. On the IRAK4 side, I think it's no mystery that we have been kind of quiet on that. We've been trying to get out of the therapeutic window of the molecules that we're using. We're in the middle of doing one more in vivo experiment to try to give us a better sense of the therapeutic window on the molecules. If that's positive, we can actually move pretty rapidly into the clinic. We've done most of the work to get there. If it's not, we're going to reevaluate and figure out what we need to do next with that program.

Got it. And just the $4.3 million in manufacturing, should we be thinking about that as a more of a one-time charge?

Yeah, so that's a good question, Ren. I think the reason we break that out on a quarterly basis is those dollars have been somewhat inconsistent for us on a quarter-to-quarter basis. So, if you exclude that certainly from the quarterly burn, it gives a better sense of where we are. In second quarter, early on I would gauge to be a little bit lower on that front than the first quarter was.

Great. Thanks, guys, and good luck going forward.

Thanks, Ren.

Thank you. Ladies and gentlemen, we have no further questions in queue at this time. I would like to turn the floor back over to management for closing comments.

Thank you very much. And I just want to thank everyone for joining us on the call today. Let me just conclude by reviewing some of our key goals and objectives. Our top priority for the year remains aggressive recruitment into our GENUINE Phase 3 clinical trial, as well as our UNITY-CLL Phase 3 trial and our soon-to-be-open registration-directed UNITY diffuses large B-cell Phase 2b study. We are also keenly focused on opening our registration-directed UNITY trial in indolent lymphomas, the commencement of which will complete our UNITY program and put us in full execution mode to get our platform doublet TG-1303 approved across B-cell malignancies sending us up to then commence our triplet Phase 3 program. For MS program, our goal is to develop key Phase 2 data to identify an optimal dose for Phase 3 and develop an MS Phase 3 regulatory strategy that we can implement next year. Finally, as usual, we plan to update our programs at all the major hematology and oncology conferences during 2016. On behalf of all of us at TG Therapeutics, I'd like to thank our investigators and their patients as well as all of our shareholders for their continued support. Thanks, again, for joining us. And have a great evening.

Thank you, ladies and gentlemen. This does conclude our teleconference for today. You may now disconnect your lines at this time. Thank you for your participation, and have a wonderful day.