TG Therapeutics, Inc. (TGTX) Q1 2021 Earnings Report, Transcript and Summary

Greetings, and welcome to the TG Therapeutics Q1 2021 Earnings Conference Call and Business Update. 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. I would now like to turn the conference over to Jenna Bosco, Senior VP of Corporate Communications. Please proceed.

Thank you. Welcome everyone. And thanks for joining us this morning. I’m Jenna Bosco and with me today to discuss the first quarter 2021 financial results and provide a business update are Mike Weiss, our Executive Chairman and Chief Executive Officer; and Adam Waldman, our Chief Commercialization Officer and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate development as well as an update on our current pivotal programs and key goals for 2021. Adam will provide an update on our commercialization efforts, and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that various remarks that we make about our future expectations, plans and prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks 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 filings with the Securities and Exchange Commission including our most recent quarterly report on Form 10-Q. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. 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 Mike Weiss, our CEO.

Thank you, Jenna. And thanks everyone for joining us this morning. With the recent accelerated approval of UKONIQ, for the treatment of relapsed or refractory marginal Marginal Zone Lymphoma and Follicular Lymphoma, TG has transitioned into a full integrated commercial organization. We are extremely pleased to now have UKONIQ, the first and only dual inhibitor of PI3K-delta and CK1-epsilon available to patients. We see the approval of UKONIQ as the first step and our broader mission of developing novel treatment for patients with B-cell diseases. With successful Phase 3 studies in chronic lymphocytic leukemia refer to CLL and multiple sclerosis, MS, already completed and reported. We see the potential to positively impact, a significantly larger group patient on the horizon. Beyond that our pipeline has the potential to deliver novel combinations building up of a foundation of UKONIQ and ublituximab, our U2 combination that can further enhance outcomes for patient with B-cell diseases. Before I hand over the to our Chief Commercialization Officer, Adam Waldman to discuss the UKONIQ launch and preparations for the potential CLL and MS launches. I wanted to review some of our recent accomplishment as well as the current status of our ongoing programs. First and foremost as I mentioned at the outset of these depend remarks, in February, the FDA corrected accelerated approval of UKONIQ for the treatment of adult patients with relapsed or refractory marginal zone lymphoma, who have received at least one prior anti-CD20 base regimen and for adult patients with relapsed and refractory follicular lymphoma, who have received at least three prior lines of systemic therapy. This approval was primarily based on the results of the UKONIQ monotherapy cohorts of the UNITY-NHL Phase 2b trial. And the approval came just surely after the final results from the trial were presented at the American Society of Hematology Annual Conference, we refer to that as ASH in December 2020. Also note, within a month of approval these results were also published in the Journal of Clinical Oncology. The commercial team has been hard at work educating potential subscribers of UKONIQ and building a strong foundation which we believe will continue to translate into adoption of the UKONIQ and position us well for the plan CLL launch potentially later this year or early next. On that note, as most of you know, we presented positive results from the UNITY-CLL Phase 3 trial at the ASH Annual Meeting in December. And more recently, at the end of March, we announced the completion of a rolling submission of a Biologics License Application, referred to as a DLA to the US FDA, requesting approval of ublituximab, our investigational glycoengineered, anti CD20 monoclonal antibody in combination with UKONIQ. The combination as many of you know referred to as U2, as a treatment for patients with chronic lymphocytic leukemia. This BLA submission was based primarily on the results of the UNI-CLL trial, which was conducted under special protocol assessment. And as a reminder, the FDA previously granted Fast Track designation to the U2 combination for the treatment of adult patients with chronic lymphocytic leukemia and orphan drug designation for the U2 combination for the treatment of CLL. The next step is we expect to hear from the FDA later this month on whether they have accepted the submission for filing. With approximately 185,000 Americans living with CLL and approximately 40,000 patients seeking treatment annually, CLL remains an incurable disease and represents a large patient population where we believe U2 will provide a needed treatment option for these patients. Now, I'd like to turn to our MS program, where our BLA submission is slated for the third quarter of this year. That BLA will be supported by the positive results from our ultimate 1 and 2 Phase 3 trials, evaluating ublituximab and relapsing forms of MS, which were presented during the AAN conference last month. Both studies met their primary endpoint with ublituximab treatment, demonstrating a statistically significant reduction in annualized relapse rate, which we call ARR annualized relapse rate over a 96-week period with a P-value of less than 0.005 in both the trials, that's compared to teriflunomide. And when you look ublituximab treatment resulted in ARR of 0.076 and Ultimate I and .091 in ULTIMATE II. For those who were on the call with the experts, which are talking about momentarily, they were very excited to see that those ARR numbers were below point one, which is never occurred before in a Phase 3 trial. So really excited about those results. We also hit key secondary MRI endpoints, including statistically significant reductions in both T1 Gd-enhancing lesions, as well as T2 lesions. Ublituximab also reduced disability progression and increased the rate of disability improvement as compared to teriflunomide. However, the former was not statistically significant. In addition to the presentation AAN, we hosted a call with leading neurologists, to review this data, and the replay of that call is available on our website. And I do encourage folks who are interested in TG, to have a listen to that call. The doctors on the call were very enthusiastic about the profile of ublituximab, and its potential in the treatment of MS. For our part, we are extremely pleased with the results from the ULTIMATE I and II trials. And believe these data showcase the potential of ublituximab and to provide a highly efficacious treatment option with a generally well tolerated safety profile. If approved, ublituximab will be the only CD20 offered in a convenient one-hour infusion every six months, of course following the first infusion, which treating physicians have shared as an important benefit for them and their patients. As a reminder, this trial was also conducted under special protocol assessment with the FDA. And as noted earlier, we are targeting a BLA submission for o ublituximab to treat patients with relapsing forms of multiple sclerosis in the third quarter of this year. The last topic I want to cover before turn the call over to Adam is our U2 plus Venetoclax program and our U2 plus 1701 program. As reminder 1701 is our internal BTK inhibitor. We view both of these programs to be an important part of the growth strategy for U2 and CLL. For the U2 plus venetoclax program, we have the Phase 1 study led by Dr. Paul Barr, Professor of Medicine and Director of the Clinical trials office for the Wilmot Cancer Center in Rochester, New York. Preliminary results from the first 27 patients in this study to complete 12 cycles of fixed duration therapy were presented at ASH this past December. In those patients, there was 100% overall response rate, and greater than 75% of those patients achieved undetectable minimal residual disease in the bone marrow. To my knowledge, that is the best reported rate of undetectable minimal residual disease in the bone marrow to-date in patients with relapsed refractory CLL. Later this year, we should have almost two times as many patients to report on through 12 cycles of treatment. So hopefully that will be something we were able to present at ASH this year. Now that Phase 1, set the foundation for Ultra-V Phase 2/3 trial, which is evaluate in the combination of U2 plus venetoclax in patients with both treatment naive CLL, as well as relapsed or refractory CLL. The Phase 2 portion of the Ultra-V trial completed enrollment with approximately 165 patients being enrolled in just 16 months. The Phase 3 portion is now open to enrollment, and there's a multicenter randomized trial, comparing you to plus venetoclax to an active control arm of U2. This trial is being led by Dr. Richard Furman, who is the Director of CLL Research Center at the Weill Cornell Medicine. We are excited about this combination and believe it can potentially offer patients a very active treatment that is of limited duration. Finally, I mentioned that our BTK inhibitor TG-1701 continues to impress us. We reported preliminary data at ASH and we'll provide another update in the coming weeks at ASCO. Our goal is to explore the potential combination of UKONIQ and U2 with 1701 to offer the benefits of the triple inhibition of BTK, PI3K and CK1 Epsilon, which would be the first of its kind. And putting them together, but also dialing down the known toxicities of each of those classes. Again, this would be a very novel first in class product. As you can see, significant progress has been made across all of our pivotal programs, setting us up for an exciting remainder of 2021 and hopefully even more impactful 2022 with the potential of expanding our commercialization efforts into CLL and MS. With that, I'm excited to turn the call over to our Chief Commercialization Officer, Adam Waldman to share some highlights from our early commercialization efforts of UKONIQ.

Great. Thanks, Mike. And I'm very excited to provide a commercial update on the UKONIQ launch as we report revenues for the first time. With this launch, we're not only bringing important new option to patients, but we are setting the foundation for multiple potential future approvals, including the combination of UKONIQ ublituximab known as U2 and CLL as our next major milestone. While it is still early, we are pleased with our initial launch execution and feel we have made significant progress against our initial launch objectives. These were to build awareness of UKONIQ'S differentiated profile, drive adoption with our targeted customers, ensure a positive first experience, and as I mentioned, set the foundation for TG and lymphoma as we plan for anticipated launch of U2 and CLL. In our first partial quarter, we achieved 0.8 million of net sales of UKONIQ. UKONIQ is the first and only inhibitor of PI3K delta and CK1 Epsilon is the unique treatment options for patients with relapsed follicular or marginal zone lymphoma. Consistently, we have received specific and positive feedback about its clinical profile from our customers. Through market research, advisory boards and our field team engagements we have confirmed that UKONIQ is a different -- seen as a differentiated product. We've consistently heard that the proven efficacy across marginal zone and follicular, its unique MOA, tolerable safety profile, low rates of discontinuous -- discontinuation, and a lack of a black box warning are important differentiators with healthcare providers and payers. We believe that these factors help establish your conic in a class of its own. We recognize the second line marginal zone and fourth line plus follicular lymphoma are labeled indications represent relatively small patient populations. Therefore, our strategy out of the gate has been a target the higher volume prescribers at academic centers and large community practices. Further reinforcing our strategy, we estimate that there is a roughly 85% overlap in the prescriber base between indolent non Hodgkins lymphoma, and CLL. We also view the lymphoma approval as a valuable opportunity to introduce ourselves to the treating community, and build the credibility and trust that will be critical to the CLL launch. So far, UKONIQ's initial uptake indicates that this strategy was well informed with the majority of our initial use coming from targeted customers. Uptake has been roughly 50/50 between the academic and community settings, with many of our early adopters having prior clinical trial experience with UKONIQ. While our customer facing teams have been resourceful and strategic in their approach to engage and educate our customers, COVID restrictions have posed some challenges. Physicians report being zoom fatigued after a year -- after over a year of virtual engagement. However, the good news is that we are seeing live engagements continue to increase and believe COVID restrictions will continue to dissipate over the next several quarters, which should accelerate customer engagements going forward. Our latest market research shows that over 80% of our target customers are aware of the UKONIQ approval and approximately 90% of the physicians we surveyed that have met with a TG representative either live or virtually. We view the efficacy and safety profile of UKONIQ as favorable versus available options. We believe this to be very positive and demonstrates the effectiveness of our early launch efforts. On the patient access fronts -- excuse me, on the patient access front, we work hard to provide robust service offerings immediately upon approval through our TG Patient Support Program, which we received very positive feedback from patients and healthcare providers today. free: UKONIQ is now covered for 85% to 90% of Medicare and commercial lives. Additionally, UKONIQ has been added to the U.S. Oncology Clearview pathways for follicular lymphoma consistent with our label. UKONIQ has also been added to the NCCN guidelines to 2a option for patients with fourth line follicular, fourth line plus follicular and second line plus marginal zone lymphoma. Together with the payer coverage these inclusions further enable patient access at institutions and practices. Overall, we are pleased with the launch progress to date and we are positioning ourselves for success as we prepare to potentially launch U2 and CLL. We have some of the most talented commercial people in the industry at TG and despite launching during a global pandemic, I believe we have made great progress with UKONIQ launch today. With that, I'll turn it over to Sean Power.

Thank you, Adam. And thanks again to everyone for joining us. Earlier this morning, we reported our details first quarter 2021 financial results, which can be viewed on our website@www.tgtherapeutics.com. For today's call, I'll touch on a few highlights from the quarter. Beginning with our cash position. We ended the first quarter with approximately $525 million in cash, which we believe will be sufficient to take us into 2023. As Adam noted earlier, following the FDA's accelerated approval of UKONIQ on February 5, we were pleased to report $0.8 million of UKONIQ net revenue in the first quarter. Our net loss for the first quarter of 2021, excluding non-cash items was approximately $74 million, compared to approximately $40 million in the first quarter of 2020. The increase we've seen in net loss as compared to the first quarter of 2020 is primarily related to increased selling, general and administrative expenses associated with the preparations for and now execution of the commercial commercialization and launch of UKONIQ, which occurred in the first quarter of 2021. Additionally, during the first quarter of 2021, we saw an increase in R&D expenses over the 2020 period, which was primarily driven by one time licensing milestone payments of approximately $14 million, consisting in large part of a $12 million mile due on approval of UKONIQ. Our GAAP net loss for the first quarter of 2021, inclusive of non-cash items was $90.6 million or $0.69 per share, compared to a net loss of $51.1 million or $0.48 per share during the comparable quarter in 2020. With that, I'll now turn the call back over to the conference operator to begin the Q&A.

Thank you. At this time, we will conduct a question and answer session. [Operator Instructions] Our first question comes from Alethia Young with Cantor Fitzgerald. Please proceed.

Hey, guys. Thanks for taking my questions. And Congrats with the launch. A couple. One, can you talk maybe a little bit about the breakout, roughly in kind of between MZL and follicular, just that you're seeing. I know it's a small number, but I just wanted to kind of get a feel for which way the tide was cutting on that? And then, I was curious, just on obviously, kind of early feedback around some of the -- with GI tox that have been seen in the past. And what people have -- what initially physicians have been seeing and patients have been seeing there? And then my third question is just, was there any inventory stocking? Thanks.

Adam, do you want to-- if you -- I don't know if you have any information yet on breakout between follicular marginal zone and stocking question?

Sure. Yes. So from what we've seen so far, and it's early. But what we've seen demand for both marginal zone and follicular. It's hard to estimate exactly the breakdown. But we've seen usage in both. So, we were very happy to see that. As far as the stocking questions, given that there are many practices, we only see a few follicular marginal zone patients per year. We anticipate pharmacy ordering generally to be on an as needed basis. So we have placed some inventory with distributors to fulfill pharmacy orders consistent with industry norms for a product like UKONIQ. And then, I think the third question was GI tox.

Yes. That's one.

Yes. So far, so good. It's obviously still early. But the reaction to the profile has been very good. Obviously, we've been educating customers to stay on top of it and be ready for it and know how to treat it if they see it. But so far, so good.

Great. Thank you.

Our next question comes from Chris Howerton with Jefferies. Please proceed.

Hi, good morning. Congratulations on all the progress, obviously, commercial and R&D. And thanks for taking the questions.

Thanks, Chris.

Yes, absolutely. And so let's see, I guess, first off for the -- I just don't recall, what the status was and maybe some information around the designs for the confirmatory studies for follicular and marginal zone, just maybe some updates or some color on that side of the story? And then, moving towards the end of the year. So I just maybe wanted to get a little bit of a level set in terms of what kind of information we can get from the pipeline. I know that you said, 1701 at ASCO. But just maybe what are kind of the key highlights and data expectations for ASH at the end of this year, if you might? Thanks.

Sure. So, on the confirmatory trial, don't want to say too much yet. We have noted in the last part of the approval, we had a basic design discuss with the FDA, but we do need to finalize that. So I think it's going to be in and around what other companies have announced previously from their confirmatory trials. And our hope is to get it up and running before year end. And we'll give a lot more detailed of time. But again, there's a relatively standard trial design that's out there, that other companies within [Indiscernible] panelists and then journalists have announced. And I think we'll be sort of closer mindset to those kinds of studies. In terms of pipeline updates this year. So, as I noted, we'll have some more information on 1701 at ASCO. And I've been relatively vocal that I was pretty pleased with the results that we saw at ASH. I've encouraged folks to take those results and line them up with other BTKs both covalent and non-covalent, and see for themselves, if they're seeing the same thing I'm seeing. Like I said, we'll have some more of that information available at ASCO. And I imagine we'll have even more available at ASH later this year. For ASH as well, as I noted in my prepared remarks, we do hope to have twice as many patients or approximately twice as many patients. So nearly 50-ish patients available for that 12 months end point for U2 plus venetoclax Phase 1 trial. So that is what I'd say is the goal for U2 plus venetoclax would be that data set. The Phase 1 follow up on -- I assume that to follow-up on all patients to that point, or close to all patients. And then for the Ultra-V Phase 2 portion, as we noted and we finished the enrollment in early this year -- earlier this year. So we don't have all 165 patients enrolled through 12 months at that time. So the question is going to be whether any of it gets presented in a partial format, or it's held to a full presentation. That will be primarily an investigator driven decision. For me, personally, I guess it doesn't matter all that much. We're going to have plenty of the data from the Phase 1. And then in the Phase 2 we'll come on in TEN. If we can get some from Ultra-V at the ASH conference we'll do it if not, that will be a pretty fulsome data set available for ASCO, we are approach in the June timeframe of next year. So that's, that's the Ultra-V. And then 1801, we've got our fingers crossed. We'd like to present some early data at ASH this year. So 1801 is our CD-47, CD-19 based specific antibody. We've just opened up the trial here in the U.S. We were -- because we started to study ex-U.S., we weren't able to move as fast as we'd have liked. I think things are going to start to accelerate. But we're already and may -- having said that, the goal is to get some information out on that compound by year end. And I think that's probably what we have to offer for the moment. There may be other cuts of data that we look at and we present. But I'd say those are probably the major updates for later this year.

Okay. All right. Well, that's certainly a lot going on. And then, I mean, maybe just to remind us the Phase 2 portion of the Ultra-V study, that does have the possibility to have a registrational implication. Is that right?

Yes, it is possible. It's something that's probably going to be somewhat challenging as a single arm with multiple drugs. But once we have all the data put together, we'll definitely have a conversation with the FDA and see what their appetite is for an accelerated approval. We know that accelerated approvals in CLL are challenging these days for them. But we do feel that the data will be quite encouraging. So we'll take our shot. No guarantees for sure, no guarantees, but we'll take our shot. If not, again, we think it's a very robust data set that should provide potential update to the NCCN guidelines. Our Phase 3, when we roll into the enrollment phase, and so that'll be ongoing. And both drugs are approved. And obviously, we would not be marketing at all, to U2 plus venetoclax. Both physicians are capable of making their own decisions. And again, both drugs would be approved in the indications that someone might use them. So, again, we'll at best have something that's useful for Companhia listing. I mean, best case scenario would be approval. But the second option would be, it'll be useful for Companhia listing. And that's pretty good, too. And then like I said, the registration trial is ongoing.

Yes. Okay. All right. Very good. Well, thanks again, Mike. Appreciate it.

Thanks, Chris.

Our next question comes from Josh Schimmer with Evercore. Please proceed.

Thanks for taking the questions. A few primarily housekeeping questions. For SG&A, the non cash comp cadence. Can you help us understand, it looks like a second half loaded at least over the last 18 months? Is that by designers or is that coincidence? And then for the R&D milestones that you had recorded in the first quarter, are there any additional ones that you would expect to be booking in 2021? And then last question, if you can update us on your plans for ex-U.S. commercialization for territory is for to have the rights for a number? Thanks.

Thanks, Josh. Sean, do you want to hit on the SG&A and R&D milestones? And I'll talk about the ex-U.S.?

Sure. I think the SG&A non-cash account being back loaded last year. So, we're certainly not by design. I think it was a function of the commercial build. Certainly last year prepping for the UKONIQ launch. I think it'll probably be a bit more level in 2021. Although as we do continue to ramp for a potential CLL launch. You might see a slight trend upward again in the second half. In terms of R&D milestones left for potentially 2021. There is a milestone due to LFB on the approval of ublituximab. So should that -- should we be fortunate enough for that to come in 2021? That would be a 2021 milestone.

Okay. What's approximate that milestone, Sean.

Low double-digit.

Okay. Excellent. Okay. And then in terms of ex-U.S, Josh, we are we're still working out the details there. Adam and his team have been doing kind of impressive [ph] evaluation of what's the best approach there. We've given ourselves a little bit of time to make those applications after the approvals for U2 and for ubli and MS. So we're going to focus here in the U.S. We're working towards approvals here. And then we'll work towards the approvals abroad. So, a little bit of time to make that call. But I would say, and Adam can confirm that this team is leaning towards keeping it internal, and launching ourselves at least in the major European markets. And then I think opportunistically, we'd look for partnerships in places like Japan or China to see if there's some value to be extracted, but probably the major European markets that lien today is toward doing it ourselves.

And what are the timelines for registration in Europe?

So, I think the filings will remain probably six to 12 months after we have the approvals here in the U.S.

Thanks very much.

Thanks Josh.

Our next question comes from Eric Joseph with JPMorgan. Please proceed.

Hi, good morning. Thanks for taking the question. The couple. First on UKONIQ commercials. Do you have a sense of repeat prescribing patterns so far? And what are you unsure -- what are you anticipating in terms of growth in new patient adds, and duration on therapy over the course of 2021? And then just following up on the question about the registration potential Ultra-V. Again, how should you be thinking about approval timeline to the Phase 3 trial if the Phase 2 in and itself isn't strong enough for approval. And the Phase 3 trial represented at all headwind to U2 commercial, assuming they will do expansion at the start of the year? Thanks.

Sure. Thanks. answer those questions. Adam, you want to tackle the first to the UKONIQ commercial.

Yes, certainly. Eric, it is still early, but the good news is we have seen refills. And we've also seen physicians prescribing for more than one patient. So we think this is a really positive indicator. But it is still early as far as duration goes, we'll see. Obviously, we're doing everything we can to educate physicians and healthcare providers on managing patients and keeping a month therapy. We think that is key to our future success.

Right. Thanks, Adam. And in terms of the approval timelines for Ultra-V Phase 3. We think there's probably going to be 12 to 18 months approval period. And that'll be followed by similar probably 12 to 18 months of follow up. Now, there's two groups here that -- so we have to separate. This is separate studies almost built into the one study. So we have a cohort for relapsed, refractory. We have a cohort for frontline. So they could enroll at different paces. And certainly the follow up on the relapsed, refractory side will be shorter. So it's altogether possible that -- and they're separately powered. So the studies can be completed independently. The study can be completed in two parts. So we think there's probably a greater chance that the relapsed, refractory would go to the FDA more quickly, potentially, in sort of 24 to 36 month timeframe. And the frontline probably a little bit longer. I don't think there's really too much in terms of headwinds. Recall that, venetoclax is still not a fully accepted regimen and using being generous fully accept the regimen in the community, right. It's pretty -- it's used in the community still very limited. And like I said, we were said previously, not today, but previously, we said, we do you think that in time, we'll get there. And our focus has been, we want to make sure we have a label within the next three to five years to meet the meet the move of venetoclax into the community setting. The academic centers, we see -- we definitely see nice uptake of venetoclax in the first line patients. So that's the market that we'd like to be in. And again, I think the academic centers are very familiar with venetoclax. And they will be familiar with U2. And with Companhia listing, like I said, they will do as they wish, and the communities is not quite there yet anyway. And we're still fingers crossed, we're still going to have our first initial launch of U2 later this year, potentially early next year. And we've definitely want some time to build the U2 as U2 before we move on to the combination. So I think the timing, I don't perceive it any headwinds. I think the timing is working out exactly where we'd want it to. We think there's a lot of value to be derived for U2 as U2, particularly in the community, particularly in patients who are either poor candidates for BTK therapy or have already seen BTK therapy. We think a lot of patients out there that will benefit from U2. And then as the data evolves, and we move into a world where venetoclax is more broadly available, then U2 plus venetoclax should be labeled to that point. And that we believe has a shot at becoming a standard of care for first line treatment and certainly in patients who've already seen a BTK across both academic and community center. So it's time for this market to evolve. And we're going to be -- I think, lined up perfectly in a timeframe for that. So I don't think there's any headwinds in my opinion.

Okay. Got it. Thanks for taking the question. Maybe one quick follow up if I could. In terms of site locations or geographies that the Ultra-V Phase 3 is recruiting some. Do you -- is it primarily in the U.S. or including patients ex-U.S. as well?

So currently, it's exclusively in the U.S. We are looking at some very high enrolling centers Ex-U.S. that we potentially may add to the trial. But currently, it's exclusively U.S. trial. And those sites are primarily major academic centers. So which is very nice. We have a good -- very group of academic centers. We've expanded even beyond those that were involved in Phase 2 portion. And for the Phase 2, we've also included large community centers that do use venetoclax. And so, we're excited to have those folks as part of the trial as well.

Okay, great. Thanks for taking the question.

Thanks, Eric.

Our next question comes from Ed White with HC Wainwright. Please proceed.

Good morning. Thanks for taking my question. And just a follow-up on your European strategy. What you're saying about doing alone in Europe and partner in Japan in China. Does that apply for the MS opportunities as well?

As of the moment, yes, it does.

Okay. Thanks again.

Again, for lean, it's not -- we haven't confirms yet it’s a lean right now, just to be clear. We're leaning in that direction.

Okay. And then maybe a question for Sean. And just following up about the non cash compensation. You had discussed that line item for SG&A. I was curious about R&D as well as non cash compensation was up 30%. about quarter-over-quarter. I'm just wondering if there was something one time in nature in there, or if that's sort of the new base?

Yes. Thanks, Ed. I think the -- this is probably the new base for R&D. I think the change there was likely a function of change in stock price and a slight add in headcount. But this is probably the new base.

Thanks, Sean. And then probably last question, Mike gave updates on a few of the products. Can you just give us an update on 1501?

Yes. So, 1501 is in a Phase 1 here in the U.S. right now and Hem obviously, the drug itself is getting close to a registration and in the non-hem area, being developed by another company, but for us, we are we are in the Phase 1. We're collecting data. It's still very early. I will say that we've had some challenges with enrollment because PD-1 PDL-1 is not viewed very attractively in hem malignancies, which is unfortunate. I think there is a role is to be vetted out. I just think some early work was not overly positive compared to other agents. But I do think in combinations, that's a mechanism that that actually could be very interesting. So we're continuing to proceed with adding some additional combinations to help enrollment. And we'll keep you posted.

Okay, Thanks, Mike. That's all I have.

Our next question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed.

Hi. Good morning, guys, and thanks for taking the questions. Just wanted to focus a little bit on the initial use you're seeing of UKONIQ, I guess in the community versus the academic setting. You're saying that it was about 50/50? Initially, do you, I guess expect that to change over time? And when you add kind of U2 to the commercial profile, how do you think that will roll out in terms of community versus academic?

Adam? Do you want to take that one?

Yes, sure. So yes, we were very pleased to see the split between academic and community and the initial uptake, which we think is good. As you know, when we said before, the vast majority of these patients are treated in the community, but it dispersed amongst many, many community physicians, where in the academic centers, it is concentrated. So we certainly have focused on the academic centers, but also getting out in the community. I will say that this split seems about right to me. I think we will continue to track it and see as far as your question about what we see how this will change going forward? I think it could -- as the product becomes more widespread use across the community, it could go up across community centers, if anything. Was there a second question beyond that?

No You covered. And then I guess maybe, I know, this to you, Adam. But I guess you mentioned in your prepared remarks that you're getting good payer coverage, 85%, 90%. Has there been any issue in terms of patient access, even though with that coverage in place? Are you seeing any access issues with patients either getting coverage or reimbursement and that kind of thing?

Nothing, that is not typical for a launch product. So I think everything that we've seen is normal as we'd get on formularies. And so, no, we've not seen any, any issues.

And then, I guess, last question, in terms of the ULTIMATE I and II, Phase 3 trials, as you're thinking about commercialization preparation there, how should we think about that product has differentiating in the marketplace?

So Thanks, Matt, for that. Yes. So obviously, we were super pleased with the results from ULTIMATE I and ULTIMATE II. The easiest differentiator in the marketplace would be certainly the one-hour infusion. We're also working. Our pair group is actively studying and meeting with payers to better understand what it will take to create the best access possible for patients with ublituximab. So, as we've noted multiple times that if we can identify a price that will enhance access for patients, we will do that. So we think that there's a price differentiator. And then on the on the clinical profile, look, we'll leave it to the experts to say. But in our opinion, we've got some of the best data that's ever been seen in the treatment of MS. We think that the annualized relapse rates are incredibly low in ublituximab arm under .10, which is, as many of you have heard and listened to the calls, its a pretty big hurdle in the MS landscape. With relapses, the lower patients who see lots of relapses, it's usually connected with disability progression. These are relapsing remitting disease. We have a relapse. Not every relapse results in disability progression. So -- but very few patients will progress with their disability without the absence of relapse. So keeping those relapses down is obviously super important. That's why it's primarily for these trials. So yes, we think that-- the profile across the board, everyone in the influence on the efficacy side looks as good, if not better than anything else that's out there today. So we feel that safety and efficacy will look quite good. We got really nice differentiation on convenience. And hopefully we'll have a differentiate on price.

Thanks, Mike. That's very helpful. And congrats on the progress again.

Thanks, Matt.

Our next question comes from Mayank Mamtani with B. Riley. Please proceed.

Hi. Good morning. This is Sahil Kazmi on from Mayank. Thanks for taking our questions. Just a quick one from us maybe. As it relates to the Phase 3 Ultra-V study. Could you talk about the kind of thought process and rationale about having U2 as the active competitor arm? And kind of any underlying assumptions on surrogates, like our ORR, PFS and maybe any key learnings from the CLL-14 program with venetoclax and GAZYVA?

Yes. I mean, I think we -- from the studies that are being run are currently, I think the venetoclax was ibrutinib trial or using GAZYVA chlorambucil as the control still. So we think U2 is a based on our studies, very active control arm. It's also a control arm that we're familiar with. We understand the properties profiles and we've run clinical trials with U2 before quite extensively. So for us it was kind of a natural go-to. The expectation of course is that U2. By the time the study would read out, will be at a an approved regiment in CLL, both in frontline and relapse settings. So it seems kind of a natural and for us it does help to separate. Obviously, it's U2 plus venetoclax versus U2 alone. So we get to see a very nice comparison to the control arm, versus using a sort of a non-regimented control arm that we're testing. So I think for us, it was kind of natural to us U2. And we think going forward, other companies are likely to use U2 as a control arm as well as GC becomes less usable, going forward.

Absolutely, definitely makes sense. That's it from us. Thanks very much for taking the questions and congrats on the quarter.

Sure. Thank you.

Our next question comes from [Indiscernible] with Goldman Sachs. Please proceed.

Thank you very much. Good morning, everyone. Thanks for taking my questions. I've got maybe two. One, just as we think about the current uptake, and congrats, I'm saying for sales. Any color, and I think you've provided some high level comments early in your prepared remarks just have to think about progression of the uptake throughout the balance of the year, particularly around kind of expectations on post COVID vaccination world and kind of when you expect to kind of function, if there is going to be one? And then second, for me, it would be just thinking about your product portfolio in terms of having products in two different therapeutic areas, oncology, and then MS. And just wondering if you could provide your perspective around kind of where you see the most tangible synergy between those two, if there are any, and maybe it's more back end versus obviously, sales reps, tactics or strategy? Thanks.

Sure. Thanks Craig. Adam, you want to talk about the uptake of UKONIQ and maybe progression and potential inflection points?

Sure. Yes. I mean, I think it's still early, obviously, we're enthused by the positive reactions we're seeing to UKONIQ profile. However, these are small patient populations than we've had a limited time so far too definitive to determine any definitive trends. But, I think with increase of live engagements, and restrictions sort of loosening, hopefully over the next few quarters, we hope that increased engagements will lead to meaningful discussions about the product and hopefully adoption. So I think it's just to summarize, I think it's a little too early to say, and we'll see how it goes. But we were enthused that we can get in front of physicians and have these conversations moving forward.

Thanks Adam. And to your point on the portfolio in the two therapeutic areas, I guess, first and foremost, it starts with the science, right? So these are all diseases that are characterized by aberrant B-cells. Obviously, in cancer you've got malignant B cells and on the MS and autoimmune side, you've got these aberrant B-cells that are part of the immune autoimmune cascade. So I think scientifically, there's a big overlap and sort of a natural, the ability to maneuver our compounds in both therapeutic areas, because of their underlying sciences is, I think, important to us and, and important for why we're doing this. In terms of other tangible synergies. I think in terms of the commercial side, we're going to we're going to obviously need to build a sales and medical team that are focused on MS. But I do think that a lot of the commercial pieces that we've built in terms of operations and organization will support the focus in both therapeutic areas. So there's, there's more to build. But the over overlay into the current organization, I think has pretty nice synergy across both indications. Adam, I don't know if you have anything more to add on the commercial side?

No, Mike. I think you covered it.

Okay.

Okay. Thanks so much.

Thank you. At this time, I would like to turn the call back over to Mr. Mike Weiss for closing comments.

Great. So, just want to again, thank everyone for joining us. We had a nice start to the year. And we're looking forward to some exciting additional things to come since the remainder of the year. So let me just summarize some of those. First, we're going to continue to execute on the commercial of UKONIQ, commercialization of UKONIQ in both relapsed and refractory marginal zone and follicular lymphoma. As sort of a next potentially big thing coming up is we're waiting to hear from the FDA whether they've accepted our BLA for filing for U2 both previously untreated Relapsed and refractory CLL. And then assuming positive news and they accept that filing, we'll be looking for working closely with the agency to get that application approved just quickly as we can. We're going to complete the BLA submission for ublituximab and RMS, again, that's targeted for the third quarter of this year. And as part of that, and we're going to be preparing our commercial organization for potential launching in CLL. And obviously, we're going to be working also on the build out for ublituximab and RMS. which we got a little more time for and if the third quarter is the target for the filing, the target for approval would be about 12 months after that. So 4Q of 2022 would be the target there's. And so when we get the application and after Q [ph] to this year. So a little bit of time. But again, we're working on that as well. And then beyond that we're continue to advance our pipeline. We've got Ultra-V Phase 3 trial. We're looking to potentially move TG 7101 into a Phase 3 this year as well. And then the earlier pipeline, we've got 1801 and 1501, that continue to progress. As asked one of the questions later this year, we're looking forward to presenting data on the U2 plus venetoclax combination, more data from 1701 or BTK inhibitor both at ASCO and later this year. And as I noted, possibly Phase 1 data from TG 1801 and our CD-47, CD-19 bi-specific antibody. So very busy remainder of the year. We've got a lot to execute on. We've got a great team coming together on all fronts. So that is our update. So on behalf of everyone here at TG, again want to thank everyone of you for the support, and for joining us today. Have a great day.

Thank you This does conclude today's teleconference. You may disconnect your lines at this time. And thank you for your participation. And have a great day.