Greetings. Welcome to the TG Therapeutics Update Call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note that this conference is being recorded. At this time, I'll now hand the call over to Jenna Bosco, Senior Vice President of Corporate Communications. Ms. Bosco, you may now begin. Thank you, and thanks, everyone, for joining us this morning. I'm Jenna Bosco, and with me today to discuss the recent regulatory updates for our oncology program, as well as provide an overview of our MS commercialization efforts and financial position are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercialization Officer; and Sean Power, our Chief Financial Officer. 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 SEC filings. 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 later date. We specifically disclaim any obligation to update our or revise our 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 thirty days. With that, I'll turn the call over to Mike Weiss, CEO. Excellent. Thanks, Jenna. Good morning, everyone, and thank you for joining us. As we announced last week, we have voluntarily withdrawn both the BLA and sNDA for U2 in CLL and SLL. Based on that, we also decided to voluntarily withdraw UKONIQ from the market in the approved indications of relapsed or refractory marginal zone lymphoma and follicular lymphoma. Accordingly, the pending ODAC scheduled for April 22nd, 2022 has been canceled. We made this decision based on a recent review of the overall survival data from the UNITY-CLL trial. As mentioned in the press release, pursuant to a recent information request made by the FDA, updated overall survival data were collected, which showed an increasing imbalance in favor of the control arm, trending closer to the original OS previously reported back in November. Recall that in February of this year, we reported that we had provided an updated OS analysis to the FDA that at that time showed an improvement from the original OS analysis provided in November 2021, which we thought was encouraging. As we have stated previously, the OS analysis of the UNITY-CLL study is underpowered and not designed to prospectively determine an OS difference. Nevertheless, we and our advisors felt, based on this new data, it was important to take a step back and withdraw the CLL BLA and sNDA. I know I speak for all of us at TG when I say this is a very disappointing outcome. From the beginning, we at TG have recognized many of the liabilities of most PI3K delta inhibitors. We have always believed, and continue to believe, that umbralisib is differentiated from the others, and we had been preparing tirelessly to make that case to the ODAC. However, successfully establishing a differentiated profile is difficult given the newly updated OS data and the growing concerns around the class. Underscoring that last point is the FDA's position, now well articulated in their recent The Lancet article, that PI3K delta inhibitors as a class, including umbralisib, may pose unacceptable toxicity to patients that can only be detected in an overall survival analysis. Accordingly, at the moment, we are considering continuing to follow the UNITY-CLL study for overall survival in the hope that we could re-engage the FDA at a future date if the OS from the longer-term follow-up of UNITY-CLL would support the differentiation of umbralisib from other members of the class on overall survival. However, for now, we will be pausing development of umbralisib and the U2 combination in oncology to focus the company on the opportunities that we believe will provide the greatest upside potential in the near term. First and foremost will be to focus on ublituximab for multiple sclerosis, for which we have a pending BLA in relapsing forms of RMS, with a PDUFA goal date of September 28th, 2022, less than six months away. We believe this has the highest potential impact for TG, and other activities will be substantially curtailed as we work toward a potential approval and launch. Following which, we will reevaluate our B-cell focused portfolio for future development. It is important to remember that TG is a fully integrated B-cell focused company, and many of the assets that we have developed or are developing are in therapeutic classes that can play a dual role in oncology and autoimmune diseases. For the near term now, our focus is on executing what we believe is the substantial opportunity immediately ahead of us with ublituximab in MS. As we move the company forward, we see a lot of potential of our B-cell platform across MS and autoimmune indications, and we will also assess further oncology development. Let's spend some time reviewing ublituximab in MS. As a reminder, ublituximab is a novel glycoengineered anti-CD20 monoclonal antibody that targets a unique CD20 epitope. The ublituximab BLA is primarily based on the ULTIMATE I and II Phase 3 trials, which evaluated ublituximab compared to the active control arm of teriflunomide in patients with relapsing forms of MS. The trials met their primary endpoint of improvement in annualized relapse rate at 96 weeks and also met key secondary endpoints. The ULTIMATE program randomized nearly 1,100 patients in two identical global trials. Dr. Lawrence Steinman, Zimmerman Professor of Neurology and Neurological Sciences and Pediatrics at Stanford University, chaired the program. ULTIMATE I and II are the first MS Phase 3 clinical trials to yield an annualized relapse rate of less than 0.1, a major milestone of therapy. Results from the ULTIMATE I and II studies have been the subject of podium presentations at all the major MS and neurology conferences, including ECTRIMS, ACTRIMS, and AAN. The role of the B-cell in MS has come into increasing focus over the last several years and has paved the way for the only two approved anti-CD20 agents to sell approximately $6.5 billion in 2021 global revenue, capturing approximately 50% of all new MS starts in the U.S. Finally, MS is a chronic and debilitating CNS disorder where patients are in need of new therapies that can improve their quality of life. It is estimated that there are nearly 1 million Americans living with MS, and we estimate that approximately 125,000 of them are currently on anti-B-cell therapy, representing about 1/3 of all currently treated patients, leaving room for growth as patients consider switching from legacy therapies and as newer existing patients need treatment. With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, who will walk us through our MS commercial preparation activities. Adam? Yep. Thanks, Mike. I am happy to share that our efforts to prepare for the commercialization in MS are in full swing. We believe ublituximab represents a significant commercial opportunity, and with the recent events in hematology, our attention, focus, and commercial resources will now shift to the MS launch. Let me first say that we've been able to attract top-tier talent to join our MS team. Currently, we have team members from Genentech, Roche, Novartis, Biogen, Teva, and many others, all of whom have decided to join TG because they believe in the potential of ublituximab becoming a meaningful treatment for patients with MS. We have also already built core commercial infrastructure and capabilities in market access, patient services, analytics, marketing, and medical affairs that will be leveraged to support this launch. Over the first quarter, we continued to make great strides in launch preparation for ublituximab in MS, and everything we have learned about the MS market over the past several months only increases our confidence. We have conducted market research and have had extensive engagements with stakeholders across the MS community. These interactions have been overwhelmingly positive, including our very recent engagements at the American Academy of Neurology Annual Meeting in Seattle. I thought I would highlight some of the learnings and the reasons we are so excited about this opportunity. First, our research tells us that the profile of the drug is compelling and offers meaningful differentiation for physicians and patients. Advisors are impressed with ublituximab's overall clinical profile and recognize that ublituximab is still the only agent that has demonstrated an annualized relapse rate of less than 0.1. They also see the safety profile to be on par with other CD20s and believe the absence of breast cancer risk in the ULTIMATE I and II studies could be differentiating. Second, the one-hour infusion is an important differentiator as it has the potential to provide a better patient experience, improve convenience, and enhance efficiency for busy centers of excellence. Approximately 80% of the MS specialists we surveyed felt the one-hour infusion would provide meaningful benefit to their patients. Our research also tells us that a majority of patients are still receiving the 3.5+ hour infusion of ocrelizumab. Third, the demand for CD20 remains robust and now accounts for almost 50% of the DMT market share in the U.S., meaning of all patients seeking a new treatment for MS, 50% each year will go on to a CD20. B-cell therapy has become the gold standard in efficacy, and more and more physicians are adopting a high-efficacy early treatment approach. Fourth, our pricing strategy has received very positive feedback from payers. They're eager to see ublituximab launch, which will continue to introduce healthy competition and potentially lower overall costs in the category. Finally, this is a market that is highly concentrated, with a small number of high volume centers, really driving the market. We estimate that in the U.S., the top 550 accounts represent over 70% of the patient volume, and the majority of these accounts report that they are always, or at least sometimes, operating in infusion capacity. We see these market attributes as an ideal place for a smaller disruptive player to come in and make a big impact. Let me finish by acknowledging the hard work, dedication, and contributions of our hematology team over the last two years. Obviously, the entire TG team is saddened that we will not be able to launch U2 and CLL right now. I want to thank our team for everything they've done to help establish TG as a commercial organization. With that, I'd like to turn the call over to Sean Power, our CFO, to provide a brief update on our financial position. Thanks, Adam. As you can imagine, with the shift in focus towards ublituximab in MS, we expect to see substantial OpEx cost savings as we streamline our oncology operations on both the R&D and commercial fronts. We will spend the coming weeks calculating the full impact of these factors on our overall cash burn, but they will undoubtedly have a meaningful impact in the quarters ahead. With all that said, our burn for Q1 2022 was slightly north of our target of $65 million, and we feel good that our Q2 burn will be around our target of $55 million. In the third and fourth quarters of 2022, we expect to more fully see the impact of the shift in focus and related workforce and R&D reductions, which will be partially offset by increases in commercial prep for R MS launch. Our goal would be to see our burn at approximately $50 million for each of those quarters. However, we will provide further updates here as we understand the full magnitude of the OpEx reductions. With approximately $280 million in cash at the end of the first quarter, 2022, and additional capacity under our Hercules c redit facility upon MS approval, we believe we are well-positioned to launch ublituximab in MS without turning to the equity markets at this time. With that, let me turn the call back over to our CEO, Mike Weiss. Thanks, Sean. Let me reiterate a few key points that I'd like folks to take away from the call today. While we are disappointed by the withdrawal of U2 application at BLA and sNDA and UKONIQ from the market, ublituximab in MS has been taking on ever-increasing importance to TG and its shareholders over the last two years. Now ublituximab in MS will take center stage. We see ublituximab in MS as a potential best-in-class CD20 in what is expected to be the largest therapeutic class of MS treatments. The PDUFA goal date is September 28th, 2022, less than six months from today. Finally, as Sean mentioned, we believe we are well-capitalized to launch ublituximab in MS and have no plans to tap the equity markets at this time. With that, let me turn the call over to the conference operator to begin the Q&A session, and then I'll come back at the very end just for some concluding remarks. Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question today, please press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants who are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Once again, that's star one. Thank you. Once again, to ask a question, you may press star one. Our first question will be coming from the line of Chris Howerton with Jefferies. Please proceed with your questions. Good morning, Mike and team. This is Kambiz from Chris's team. I guess we're wondering how committed overall are you to CLL and umbralisib, and kinda what would it require to reinvigorate the oncology strategy? Out of these discussions with the FDA, is there absolutely no effect to the ublituximab BLA in MS? Maybe on your credit facility, how much of that is still available? Thanks so much for your time. Sure. You know, in terms of CLL going forward for the moment, you know, our focus, as I mentioned in the prepared remarks, is gonna be on MS with ublituximab. We'll revisit the CLL and other oncology opportunities probably in the, you know, six to 12-month timeframe once we get ublituximab on the market. I think for the moment, like we said in the prepared remarks, that's on hold. Most activities associated that will be curtailed, and everything is focused on getting ublituximab approved in MS. In terms of. What was the second half of your question? I think I heard something there for Sean. What- Oh, the credit facility. Sean, you wanna talk- Was there- Just mention the No. Was there any talk about the ublituximab BLA in MS from these discussions on the 10-K, 10-Q? There was no discussion about that. Thanks. On the credit facility question, there's $45 million available upon the approval of ublituximab in MS, and there's an additional $65 million that's discretionary based on both parties. Great. Thank you so much for the answers this morning. Sure. Thank you. The next question is from the line of Eric Joseph with JP Morgan. Please proceed with your questions. All right. Thanks. This is Sean on for Eric Joseph, and thanks for taking our question. You know, just a related one. Can you speak to whether there are any relevant racial concerns from UNITY to ULTIMATE at this point? How has the RMS regulatory process been proceeding? Based on your likelihood of a panel that you expect at this moment. Thanks. Sure. At this time, we are not expecting a panel for relapsing forms of MS. That's the current position of the FDA. I would put a caveat to that, which is that was the current position of the FDA for Unity CLL, and we ultimately ended up with a panel. At this time, we can say that there is not planned a panel for MS. In terms of crossover effects between MS and the Unity application, again, I think as you could see by, you know, for the folks who have read The Lancet article now that that came out just after we had put in our withdrawal notice. The FDA is really cracking down on PI3K deltas. I think our position is that the majority, vast majority, almost exclusively the issues of the FDA were associated with the PI3K-delta class. We don't see a read through from the PI3Ks and the discussions we've had with the FDA to the MS application at this time. All right. That's very helpful. Thank you. Thank you. Our next question comes from the line of Ed White with H.C. Wainwright. Please proceed with your question. Good morning. Thanks for taking my question. Mike, when you're talking about the oncology franchise, regarding, you know, TG-1701 and TG-1501, the trials that are ongoing, will you continue following patients and just stop enrolling new patients, or how should we be thinking about that? And also, you've always talked about triplet and potentially quad formulations. You know, if you can give us your thoughts maybe on are you now thinking of monotherapy indications or other combinations? Thank you. Yeah. Thanks, Ed. For the moment, certainly all new enrollment in those trials will be paused. I assume we'll continue to follow the patients that are in those trials that you refer to. In terms of triple and quad therapies going forward, all that is on hold, and we're gonna take a look at that at a future date and see where we are. Again, I think we need to line up all the opportunities that are in front of us for the molecules that we have in the portfolio and determine whether our next moves are expanding the portfolio into MS and autoimmune diseases, and/or into oncology indications. We could do, you know, any or all of the above, but I think we need to line up everything with a fresh look. I mean, without U2 as the backbone, that definitely changes a lot of how we think about our oncology business. For the moment, like I said in the prepared remarks, all that is on pause. We're gonna be curtailing everything that we can to keep our focus on MS, ublituximab in MS, and we'll revisit at a later date. For the moment, I would say everything's on pause. Okay. Thanks for taking my question, Mike. Yep. Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question. Hey, good morning. Thanks for taking the questions. Just wanted to focus a little bit more on kind of your decision to move to focus on autoimmune and MS. Can you describe beyond ublituximab what other assets you have in autoimmune inflammation outside of ublituximab and your plan is for them currently? Sure. Again, I think our plans are in the works. Like I said, I think we're gonna do a full portfolio evaluation once we have approval and launch of ublituximab in MS. In the meantime, I'll just note that obviously BTKs can be used in autoimmune diseases. There's no reason CD19, CD47 can't be used in autoimmune diseases. I think we have a portfolio that can be translated from oncology to autoimmune diseases if when we go ahead and do a full review, that makes the most sense. I think that's what we're implying when we talk about a B-cell platform, and most of the drugs that we're working with can translate over to autoimmune MS. Again, I think it's just all about what's the best opportunity, the highest impact and return to shareholders, to augment what we're doing with ublituximab in MS. Okay. That's helpful. Secondly, you mentioned this in some of your prior remarks, but with respect to ublituximab in MS, can you touch on its you know, clinical profile and how it differentiates and potential in the MS anti-CD20 class, how it differentiates there? Yeah, sure. You know, Adam's obviously been working closely with the team and is in closer contact with the market research. Maybe, Adam, you wanna answer that question? Sure, Matt. I think a lot of what I said in the prepared remarks sort of outlines it, but you know, ublituximab from a market research that we've done is quite compelling and differentiating to physicians. Still the only agent that has shown in two Phase 3 trials to have that annualized relapse rate of less than 0.1. A safety profile that seems on par and the one-hour infusion does seem to be quite attractive to both physicians and to patients. And I think so you got, you know, best in class efficacy, convenience. As I mentioned, we are, you know, pretty far down the line on our pricing strategy, and accelerating and making sure that we do what we can to create the broadest access as possible is the overall profile of the drug. Thanks, Adam, and thanks Mike for taking questions. Thanks, Matt. Our next question comes from the line of Mayank Mamtani with B. Riley. Please proceed with your questions. Good morning, team. Thanks for taking my questions. Just maybe a quick follow-up on the ODAC preparation briefing package. Would there be any disclosures, as was expected before the ODAC panel? You know, that may still happen this week. Just curious if there was any assessment made on the individual impact of ublituximab monotherapy, just the individual component, as I'm sure you know, FDA likes to break down what was ublituximab monotherapy versus the umbralisib monotherapy in UNITY-CLL. Then I have a follow-up. Sure. Thanks, Mayank. I don't believe the briefing materials will be available for the April 22nd meeting, but there will be a PI3K meeting on April 21st, which I'm sure will contain plenty of information about all drugs in the PI3K class. We understand that umbralisib will be included in that discussion. In terms of single agent ublituximab, I guess in the review of the UNITY-CLL package, single agent ublituximab you know was included. There were 90 patients that were in that arm. I, you know, in terms of, I'm not really sure what the question is, but in terms of the review, like I said, most of the focus has been on the PI3K class. Okay, great. And then you guys being really active at recent neuro medical meetings. Just curious if, Adam, you can comment on the importance of the disability data. You know, how useful or differentiated by that's found by opinion leaders, target prescribers, payers, et cetera. Just maybe remind us where you are with the ex-U.S. filing for MS, particularly in Europe. Sure, yeah. The disability data seen is very positive. I know it didn't hit the statistical significance, but the number of patients that have progressed was very low and physicians see the number of patients that, or the percentage of patients that have actual improvements as being quite encouraging. The feedback we've received on that particular point has been very positive. Mike, you wanna take the ex-U.S. question? Yeah. In terms of ex-U.S., it's progressing at probably six plus month lag behind the U.S. application, possibly even nine months. It's in the works and we'll keep you posted. Again, our focus, you know, almost exclusive at this point, is to work on making sure we get ublituximab approved in MS in the United States. Oh, great. Thanks for taking the question. Okay. Thank you. Thank you. Our final question this morning comes from the line of Josh Schimmer with Evercore ISI. Great. Thanks for taking the questions. I guess first, since there really isn't a worse outcome than withdrawing the product and application, what did you have to lose by not trying to at least defend UKONIQ and U2, and at least trying to have a panel discussion to sway the committee? I mean, we believe that, you know, our credibility was in objectively looking at the data. We had promised both the FDA and investors that if we saw something that did not jive with our position, that we, you know, we believed at that moment, then we couldn't go forward. We just didn't have the OS data to support everything that we were trying to prove. When we had the improved OS, we were really excited. We felt we had extremely strong grounds to support our position. When the FDA came back and asked us for an update and we put that update together, when the data came in, it just wasn't there. We just didn't think we could credibly stand in front of a panel and ask. We had, you know, multiple experts lined up, and we just didn't feel we put them in a position to stand up in front of the ODAC and push for something that on its face did not look like it should. You know, I don't think. Again, in hindsight, you know, we have a lot more information now. We did not know at the time we put in the withdrawal that The Lancet paper was literally coming out hours later. But I could assure you that the FDA was is pretty well dug in on their position. They wrote it up in a paper. Everyone can read it. I think there's no question we made the right decision. Again, I think we made a commitment to both the FDA and to shareholders that if we saw something that was not to our expectations, we wouldn't move forward. Can you provide any color on the causes of mortality in the UNITY-CLL trial that point to or away from a PI3K inhibitor mechanism? That point away from a PI3K mechanism. Were they infection-related mortalities? Was there colitis-related mortality? You know, it was primarily. I think the issues that were most concerning to the FDA were associated with infections. I think that's something that they've been on since the idelalisib days when they pulled it for undue or excess infections. I think that's where they focused most of their attention. Look, when I look at the results, again, even to the very end, there's a lot of noise in the system. It's an underpowered trial. You know, trying to argue the noise-to-signal ratio in a underpowered study where the FDA has a thesis and they're strongly committed to that thesis, again, made it extremely challenging. Yeah, I think across the board there's lots of causes of death, including progressive disease in both arms, you know, secondary cancers, you know, evenly balanced cardiovascular thing. I mean, it's a lot. You know, you're looking at patients that have probably an average lifespan from point of treatment of anywhere from probably 7-15 years. Lots of things can happen in that timeframe. Again, if you're underpowered, imbalances can easily be seen. Yeah, I think in terms of overall concerns, the PI3K class and the things they focused in on were infection. Got it. Thank you. Yep. Thank you. At this time, I'll turn the floor back to Mike Weiss for closing remarks. Great. Thank you, operator. Thanks, again everyone for participating in today's call. I know this is a disappointing day for our employees and shareholders alike. Nevertheless, I wanna assure you that TG is well-positioned to drive shareholder value over the short term with our ublituximab BLA pending for patients with relapsing forms of multiple sclerosis and a PDUFA goal date of September 28th, 2022. Longer term, we plan to continue our B-cell focused mission with our robust portfolio, a portfolio of B-cell targeted agents. I wanna thank the patients, physicians, nurses, and site personnel for their participation in our clinical trials with the hopes of finding better treatments for patients with B-cell malignancies. Finally, I wanna thank the science team at TG that has worked tirelessly year over year and poured their hearts and souls into the development of U2. Your efforts are much appreciated. Thank you and have a good day. This will conclude today's conference and webcast. You may disconnect your lines at this time. Thank you for your participation.