Tg Therapeutics, Inc. Q2 FY2020 Earnings Call

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 in 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 Professor and Chair of the Department of Hematology and Medical Oncology and the Emory University School of Medicine, as well as the Chief Medical Officer at Winship Cancer Institute of Emory University. We have also been hard at work building our commercial and medical affairs organizations. This team is impressive with deep experience launching products in the hematology oncology space, and they have already made great progress advancing our launch plans. We have also had multiple data presentations and publications already this year, including the final results from the GENUINE Phase 3 trial we presented at ASCO by Dr. Jeff Sharman, Medical Director Hematology Research at U.S. Oncology, which demonstrated that the addition of ublituximab to ibrutinib significantly improved progression-free survival, overall response rate, complete response rate, and increased the rates of undetectable minimal residual disease as compared to ibrutinib alone. At EHA, Dr. Chan Cheah, the Clinical Lead for Lymphoma at the Sir Charles Gairdner Hospital and Director of the WA Lymphoma Center of Research Excellence presented preliminary safety and efficacy data of our investigational highly selective BTK inhibitor, TG-1701 as a monotherapy and in combination with U2. We are excited about this compound especially in combination with U2 and look forward to further data later this year and the initiation of additional combination trials with 1701 next year. Finally Dr. Javier Pinilla and the team at the H. Lee Moffitt Cancer Center and Research Institute recently published preclinical data describing the unique immunomodulatory effects of umbralisib in Blood Advances, a journal of the American Society of Hematology. As I mentioned, it’s been an exciting first half for TG. Now let me turn to our pivotal programs and provide a high-level overview and status update for each. Let’s start with the UNITY-NHL program. As a quick reminder, the UNITY-NHL trial is a multi-faceted program evaluating umbralisib monotherapy as well as combinations, including the U2 combination in a variety of disease cohorts. The umbralisib monotherapy cohorts evaluating patients with previously treated marginal zone lymphoma or follicular lymphoma have met their primary endpoints of overall response rate. Based on those results, we completed our rolling NDA submission to the FDA in June. This is a major milestone for us and a huge step forward to bringing umbralisib to patients in need. As a reminder, umbralisib received breakthrough therapy designation for patients with marginal zone lymphoma. Next I’d like to discuss the UNITY-CLL trial. As a reminder, the UNITY-CLL clinical trial is a global Phase 3 randomized study of U2 versus the combination of the chemotherapy chlorambucil plus the CD20 obinutuzumab in patients with treatment-naïve and relapsed or refractory chronic lymphocytic leukemia. This trial is being conducted under special protocol assessment in the FDA. In early May, we announced the UNITY-CLL trial met the primary endpoint at a pre-specified interim analysis demonstrating a statistically significant improvement in PFS with a P-value of less than 0.0001, as assessed by independent review committee. You may recall that the trial enrolled approximately 60% previously untreated, or they can be referred to as treatment naïve patients, and 40% who were relapsed or refractory from prior therapy, and we are pleased to note that the PFS benefit was observed across both patient populations. If approved, we believe the U2 combination has the potential to be an important treatment option for patients with CLL. We are extremely pleased with the outcome of the study and look forward to presenting data from this trial by year end with a BLA NDA submission to follow. Last but certainly not least, let me review our ULTIMATE program in multiple sclerosis. As a quick reminder, our ULTIMATE 1 and 2 Phase 3 trials in relapsing forms of MS are two independent global randomized multi-center trials comparing ublituximab to oral teriflunomide. The primary endpoint for each study is annualized relapse rate following 96 weeks of treatment and is designed to support submission for full approval of ublituximab in relapsing forms of MS. These trials are fully enrolled and being conducted under special protocol assessment with the FDA. Currently, there is only one CD20 approved for MS, which is currently tracking to have 2020 global sales in excess of $4 billion. We believe CD20 usage will continue to grow as more physicians utilize the class earlier in the treatment paradigm. If approved, we believe ublituximab should be an attractive treatment option in the CD20 market, offering patients with MS the convenience of a one-hour infusion every six months at a competitive price. Despite some minor delays from COVID, we are pleased to report that we are still targeting releasing top line data from both studies in the fourth quarter. We are extremely pleased with all the progress we have made thus far in 2020 despite all the challenges in this new COVID environment, and I have to say how impressed I am with the team’s ability to power through and continue to achieve the ambitious milestones we’ve set for ourselves this year, and we’re looking forward to a very exciting next six to 12 months where we are targeting pivotal data from our ULTIMATE MS Phase 3 clinical program which, if positive, will lead to a BLA submission for ublituximab, data presentations from both UNITY-NHL and UNITY-CLL, and NDA BLA submission for the U2 combination in CLL, and, if all goes well, launching our first product, umbralisib in the treatment of marginal zone lymphoma and follicular lymphoma. With that, I’d like to turn the call back over to the conference operator to begin the Q&A session, following which I will return to make some concluding remarks.

Our first question today is coming from Alethia Young from Oppenheimer. Your line is now live.

Hi, thanks. Congratulations on all the progress this quarter. As we approach ASH, could you provide an update on the ULTRA-V study with venetoclax, specifically regarding the number of patients in follow-up? Additionally, is there any news on the earlier combination studies you previously discussed? I’m particularly interested in the study for patients on BTK or venetoclax who have not achieved a clear response and the addition of U2, and how that is developing.

I don't have the exact numbers for ULTRA-V, but I hope that by ASH we will have at least 15 to 20 patients who have completed 12 months of treatment. We expect to provide data on about 40 to 50 patients, but let me clarify that ULTRA-V, the Phase 2 trial, won’t be presented until it's complete. The data I’m referring to is from the Phase 1 trial combining venetoclax with U2, which we will present later this year. The update should include 15 to 25 patients who have completed a year of treatment, along with safety information and preliminary efficacy for around 40 to 50 patients prior to the 12-month mark. As for the smaller study you mentioned, it involves U2 added to BTK or venetoclax in patients who haven't reached a minimal residual disease negative or complete response after more than six months on a single agent. We do not have any updates expected from 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.

Thank you for taking my questions. Can you provide more details about your commercial team, their relevant experience, and the timeline for fully building out the team, including how many representatives you will need? Considering your portfolio of assets, you've been focused on establishing top-notch regimens for CLL, CL, and follicular lymphomas. Are there other liquid or solid tumors you are considering, and if so, could you discuss your development strategy for those? Thank you.

Sure, thanks Josh. Regarding the commercial team, we've brought on Adam Waldman, who previously led the U.S. hematology franchise for Celgene and has extensive experience in various roles and commercialization at Celgene. He has assembled an impressive team, and we now have leaders for all functional areas, including commercial operations, market access, and medical affairs. We are also looking to soon announce a head of sales, which will complete the team. The leadership comes mostly from Celgene and Bristol, and the teams are integrating well. We plan to have Adam engaged virtually in the coming months to provide more details and answer questions. In terms of our focus, we are concentrating on indolent lymphomas and leukemia, specifically chronic lymphocytic leukemia, which is the largest segment, followed by follicular lymphoma and marginal zone lymphoma. We are also exploring options in diffuse large B cell and mantle cell lymphoma, which are still in early stages, but we have intentions to expand into those areas eventually, either with U2 or other parts of our portfolio. We are enthusiastic about our anti-CD47/CD19 bi-specific antibody, which has potential applications in diffuse large B cell as well as the indolent diseases we're addressing. We believe there may be opportunities for PDL1 to work alongside some of our agents in more aggressive lymphomas such as diffuse large B cell and mantle cell lymphoma. Additionally, we recognize that BTK inhibitors are effective in mantle cell, which we will examine as we progress. While we are primarily focused on our indolent diseases, we will keep diffuse large B cell and mantle cell on our radar for future potential. It's still early to provide extensive details.

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?

I'll address the second question first. Regarding multiple myeloma, we haven't made significant progress yet, but our team, including Adam and others from Celgene, is quite knowledgeable about the myeloma market. We also have Dr. Lonial on our board, who is an expert in this area, so we are starting to consider potential opportunities for us in myeloma and have some resources in place to explore it further. For myelofibrosis, we've presented some compelling data on umbralisib combined with ruxolitinib, which is an area we are increasingly interested in. We're diving into this with more seriousness. Additionally, we have a BET inhibitor ready to enter the clinic soon, and there is encouraging data showing the effectiveness of a BET inhibitor in combination with ruxolitinib. I believe our data for umbralisib in that combination is equally strong, and the prospect of combining our PI3K, BET, and ruxolitinib is something we are enthusiastic about and could initiate relatively soon. Regarding sales force sizing, we plan to grow our sales team around the launch of CLL, estimating around 75 representatives based on preliminary sizing studies. For the launch of marginal zone and follicular cancers, we aim to have about half of that team ready for the launch, ramping up to the full size by the CLL launch. It's a phased approach. We will not wait to hire the first 30 or 35 representatives until after approval; they will be onboard before the PDUFA date. These figures are approximate and could vary by a few reps in either direction, and Adam will provide more details as our sales force sizing study progresses.

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 is 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.

I will address the questions in reverse order. Regarding our European strategy, we are still evaluating our options and have no updates at this time. We are assessing whether to partner or operate independently in Europe, and I can't provide further details just yet. Please check back in another quarter for more information. On the topic of payors, we do not anticipate experiencing any issues. We have been in discussions with payors, and while I’m not directly involved, I believe we are not encountering any resistance to coverage. Typically, cancer drugs do not face significant pushback in this area, and we expect engagement to continue positively. Now, concerning our biggest challenge in commercializing umbralisib for marginal zone and follicular lymphoma, personally, I don't see many obstacles. We have conducted numerous advisory boards with community oncologists to gauge the market. Some individuals still hold negative perceptions about PI3K delta inhibitors, but I find that once they review the data and understand the key differences between our drug and the first-generation inhibitors, their concerns tend to dissipate quickly. Others are more open to new treatment options. Thus, our primary challenge will be educating the market. Essentially, an informed consumer is our best advocate. The more people comprehend the benefits of umbralisib for themselves and their patients, the more successful we will be, and we need to encourage them to try the medication. Once they do, most will realize it's a significantly different compound with a unique patient profile. While it’s not a perfect solution and some individuals may not have a favorable experience, the majority will, contrasting the first-generation products where many had negative experiences. Our aim is to get people to give it a try. We have a strong foundation thanks to our clinical trial sites, where numerous community oncologists have previously used the compound and participated in our studies. We will work closely with these oncologists to ensure they are engaged and willing to treat their patients with the medication, and feedback thus far has been very positive. Each trial site usually connects to a broader network beyond the clinicians directly involved, allowing us to leverage these relationships to encourage additional practices to explore umbralisib. We are optimistic and confident in our prospects. From what I've observed and heard, I believe we will perform well. While marginal zone and follicular lymphoma may not be the largest markets, we have realistic expectations for our initial sales in those areas. However, establishing a strong footing for a future CLL launch by encouraging more people to try and become comfortable with the drug will enhance our success when we reach that stage. Therefore, education is key. Once people understand and experience this compound, we will be in a stronger position.

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.

I'm not certain what to expect at ASH for the CD7/CD19 bi-specific. I need to confirm whether we're presenting data this year. I'm unsure of where that information came from. Our major presentations for ASH, besides the pivotal ones, will focus on U2 plus venetoclax, U2-BTK alone and its switch to 1701, as well as U2 plus 1701. Regarding some of the earlier topics, such as PDL1, we will have to wait for more information, but I will verify that.

Okay, thanks Mike.

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

Hi, good morning everyone. Mike, I wanted to ask about when we can expect to hear 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 monoclonal antibody.

Perhaps your phone is on mute?

Hello?

I apologize for the interruption. What I was saying is that in terms of our regulatory strategy for BTK, CLL is a significant area of interest, along with marginal zone lymphoma. We have treated several patients with U2 combined with ibrutinib and several others with U2 combined with 1701. Between CLL and marginal zone lymphoma, we have observed a remarkable response rate across both indications when using U2 with BTK. While we know that larger trials will likely lower this response rate, we expect it to remain very high. This gives us excitement for both indications where BTKs can be used alongside U2. For follicular lymphoma, while BTK may not be as effective, there is potential for interesting combinations with U2. Additionally, in mantle cell lymphoma, BTK alone appears promising, and the combination of U2 with BTK could provide exciting opportunities as well. We see potential for registration across these indications. Regarding CD47/CD19, it's still early in the process, but we plan to start targeting diffuse large B cell and follicular lymphoma with that agent. The preliminary data from a competing compound looked promising in both follicular and diffuse large B cell lymphoma when combined with CD20, so we intend to investigate further as soon as possible, with hopes of expanding that program sometime next year.

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 for taking my questions. I have a couple of quick ones. First, regarding follicular lymphoma, we have seen some recent developments like the approval and launch of epigenetic tazemetostat, along with some positive readouts, so I’m curious about how you see the treatment landscape evolving and where you believe umbralisib will fit in this future landscape. I'll 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.

Thank you for the information. I have a follow-up question related to what you mentioned. You currently have several mechanisms of action in BTK, including CD47 and CD19. Are there any other interesting opportunities you are considering to add to your 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. Congratulations on a really strong first half of the year. I have a couple of questions, starting with the pivotal programs. Can you provide any additional insights on the hazard ratio for UNITY-CLL now that you’ve had a chance to analyze the data set? Are you seeing any trends based on the revised interim analysis? I will also have a brief follow-up regarding 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, regarding the study conclusion and COVID, as we discussed last time, we were quite impressed that 90 to 95% of patients attended their visits on time. There were a few who were late, which affected the remaining 84 and 96-week visits. For the first trial, we managed to conduct the last visit only two or three weeks later than initially planned, which is quite good under the circumstances. We have the second trial coming up and expect similar or possibly better results since most of Europe is currently performing well. However, we should anticipate potential delays of two to three weeks for final visits. That said, these delays shouldn’t impact the trial’s closeout timeline. Data cleaning is ongoing, so the few late patient visits don't significantly alter the overall timeline. The overall timeline could be affected by site access for data cleaning and to lock the database, but fortunately, most sites are open for this purpose. A few sites are handling some activities virtually, which I believe is steering us towards a typical conclusion without significant impact from COVID. On the topic of BTK inhibitors in multiple sclerosis, current interactions with key opinion leaders indicate that these treatments aren't seen as direct competitors to CD20s due to their lower efficacy. These compounds are interesting for their developers and will compete in the oral therapy market, which includes various underlying mechanisms. However, the first data we reviewed on the Merck compound was not very compelling based on feedback from KOLs. We gathered insights at a conference, and the general opinion was it was adequate but not remarkable in the competitive oral space, especially not on par with CD20s. Regarding the oral BTK that can cross the blood-brain barrier, while this scientific concept excites some KOLs and potentially big pharmaceutical companies, its practical application might primarily be limited to primary progressive disease, possibly extending to secondary progressive disease. In contrast, the complete blockade of B cells by CD20 is very active in relapsing forms of MS, and while the idea of a molecule crossing the blood-brain barrier is intriguing scientifically, its clinical efficacy in improving outcomes for patients with compounds that may have marginal effects in relapsing forms is questionable. There are indeed large clinical trials aimed at testing this hypothesis, but ultimately, it's not a direct competitor to our work. Our competition lies within the CD20 class, which consists of two agents: one intravenous and one oral. We are aware of the current and future development plans for both of these agents and believe we have a strong position in the CD20 marketplace, which is expected to approach $10 billion. This presents a significant opportunity for TG and for ublituximab.

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.