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spk04: Greetings and welcome to the TG Therapeutics fourth quarter and year-end 2021 financial results and business update call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, you may press star 1 on your telephone keypad. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms. Jenna Boscoe, Senior Vice President of Corporate Communications. Thank you. Please go ahead.
spk01: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and year-end 2021 financial results and provide a business update are Michael Weiss, our Chairman and Chief Executive Officer, 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 developments as well as an update on our current pivotal programs. Adam will then provide an update on our commercialization efforts, and Sean will provide an overview of our financial results before turning the call over to the conference operator to begin the Q&A session. Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory milestones, clinical development plans, and expectations for our marketed and pipeline products. 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 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. Now I'd like to turn the call over to Mike Weiss, our CEO.
spk10: Thanks, Jenna, and thanks to everyone for joining us this morning. Well, as everyone is aware, TG has been throwing a few curveballs over the last few months. The good news, though, for those of you who are baseball fans, I actually think these are hanging curveballs that we can hit out of the park. And if we are able to do that, I genuinely believe that we'll be in a much stronger position because of it. I'll provide more color momentarily, but let's start by reviewing some of the developments, good and bad, that occurred over the last 12 months or so. Most recently at Actrums, we presented additional analysis of the data from the ultimate one and two phase three trials of lublutuximab in relapsing forms of MS, which we believe continue to highlight and support the potential utility of lublutuximab as a treatment option for patients with RMS. We strengthened our balance sheet by expanding our term loan facility and ended 2021 with more than $350 million in cash. Toward the end of the year, we had a strong presence at the 2021 ASH conference with three oral presentations and three poster presentations, with two of the oral presentations being chosen for highlights of ASH. Just before ASH, we announced that the FDA was planning to review the CLL, BLA, and SNDA at an ODAC meeting to occur in the March-April timeframe. Related to the issues to be covered at ODAC just a few weeks ago, FDA placed studies investigating U2 and its components in CLL and NHL on a partial clinical hold. Also, in the fourth quarter of 2021, we announced our biologics license application, or BLA, for ulbituximab to treat patients with relapsing forms of multiple sclerosis was accepted by the FDA and was granted a PDUFA goal date of September 28th We also continued to advance our early stage pipeline and presented data from TG1701, our BTA inhibitor, several times throughout the year. We completed an enrollment of approximately 165 CLL patients into the UltraV Phase II trial and launched the Phase III portion of that study. We published results from some of our key trials in major publications, including an integrated safety analysis of eukonic and blood advances, Unity NHL Phase 2B trial of umbilicib monotherapy in patients with relapsed or refractory non-Hodgkin's lymphoma in the Journal of Clinical Oncology, and the Genuine trial evaluating ubituximab plus ibrutinib in patients with relapsed or refractory high-risk CLL in Lancet Hematology. And of course, in quarter one of 2021, a little over a year ago today, we received FDA approval of Uconnick to treat patients with relapsed refractory, marginal zone lymphoma, and follicular lymphoma, marking our very first FDA approval. With that, let me review our late-stage development programs, following which I will turn the call over to our Chief Commercialization Officer, Adam Waldman, to discuss some of the commercialization highlights. All right, so let's begin with the discussion of the ultimate one and two phase three trials, which evaluated ubituximab monotherapy compared to teraflunomide in relapsing forms of MS. As noted in the past, both studies met their primary endpoint with ubituximab treatment demonstrating a statistically significant reduction in annualized relapse rate, referred to as ARR, with ubituximab treatment resulting in historically low levels of annualized relapse rate. In addition to the primary endpoint, we've had the opportunity over the past year to present several different sub-analysis of this data, all of which have strengthened our confidence in the utility of ubituximab to provide a meaningful treatment option to patients with RMS, if approved. On the regulatory front, we were extremely pleased to announce the FDA accepted our BLA for ubituximab to treat patients with RMS I'm granted a PDUFA goal date, as I mentioned earlier, of September 28, 2022. Adam will discuss our launch prep activities, but let me highlight again that we have built an all-star team of MS talent from around the industry. These folks have fantastic relationships in the MS community, which have enabled us to gain invaluable insights. After spending several days last week at ACTRIMS in back-to-back-to-back meetings, I am more confident than ever in the potential of the bituximab in RMS. With the CD20 class already accounting for the largest portion of new starts and switches, which is sometimes referred to as the dynamic market, we see bituximab as having the potential to play an important role in the treatment of relapsing forms of MS. All right. Now, let's talk about our CLL-BLA-SNDA and the upcoming ODAC. So I just want to remind everyone, first and foremost, that the Unity CLL study, which is the primary study supporting the BLA-SNDA, was conducted under special protocol assessment and met its primary endpoint of progression-free survival and all key secondary endpoints. We submitted a BLA-SNDA for the U2 combination in the treatment of CLL and received a BDUFA goal date of March 25, 2022. In September of 2021, we received a request from the FDA to conduct analysis of overall survival. While OSS stated as a secondary endpoint, there was no plan to analyze it prior to the end of the trial, which has not yet occurred. Importantly, the UnityCLL study was not powered for overall survival, which would have required dramatically more overall survival events. And in addition, a significant number of patients on the control arm crossed over to the U2 arm, collectively making the OS results hard to interpret. Furthermore, since we were not planning an OS analysis until the end of the trial, not all the data was collected at the time FDA requested the overall survival analysis, leaving about 15% of the patients with outdated or missing survival status. Despite these material shortcomings, we conducted the analysis and sent it to the FDA as requested. As has been reported previously, that analysis showed an imbalance in favor of the control arm. The hazard ratio was 1.23, but when excluding COVID, it was 1.04. A hazard ratio above one implies potential harm of a therapy and below one a potential benefit. Given the shortcomings of the OS analysis, and similar results from other pivotal Phase III studies in CLL, we didn't see this OS imbalance as concerning. Some of those examples included the original overall survival analysis from CLL14, which was the approval study for venetoclax plus obinutuzumab. Similar to our trial, the control arm was obinutuzumab-clarambucil, and at the time of approval, the hazard ratio was 1.24, No adjustment there because, of course, that study was conducted before COVID, so that would not have been a confounding factor. We also took a look at the overall survival results from the Illuminate study, which was used for approval of ibrutinib plus abinituzumab. Again, similarly, the control arm was abinituzumab-Colambracel, same as ours. The overall survival outcome in this study was even more peculiar. the hazard ratio was 0.921, so below one at the time of approval, but in long-term follow-up, turned negative against ibrutinib with a hazard ratio of 1.083. Both of these instances highlight the challenges of using underpowered overall survival analysis. So I think everyone could imagine our surprise when in November of 2021, the FDA notified us that they plan to host a a meeting of the Oncologic Drugs Advisory Committee, referred to as ODAC, and ODAC being much easier to say, of course, in connection with its review of the BLA for ibrutuximab and the SNDA for imbilicib, stemming from the OS imbalance. It is also evident with the regulatory action seen for other PI3K inhibitors that there is a concern with the overall class that is influencing the way the FDA is viewing this data. We spent the next two months trying to close the information gap. We were pleased to report about a month ago that we're able to reduce the missing survival information from 15% down to 5%. And we were further pleased to report at a high level that the capture of the additional survival data, the overall survival analysis, both in the ITT and the COVID censored populations, the overall survival hazard ratios improved from what we had seen in the original submission to the FDA. We provided that update to the FDA late last month. We also spent a considerable amount of time doing a deep dive into the survival data, literally reviewing patient by patient to try to understand causality. For now, I will be brief and in summary will say, from THC's standpoint and that of our independent external medical and statistical advisors, that the totality of the unity cell data suggests that the overall survival safety profile is generally in line with currently available treatments for CLL, especially when focusing on treatment-related deaths. Since we received notification of the ODAC, the team has been hard at work preparing for the upcoming meeting, and we are looking forward to the opportunity to showcase under critical review that Uconic is a unique PI3K inhibitor with a differentiated toxicity and tolerability profile and with the potential to fill an unmet need in the treatment of CLL. With that, I'll turn the call over to Adam Waldman, our Chief Commercialization Officer, to share a bit about our current commercialization efforts and preparations for potential launches later this year. Adam?
spk09: Yep. Thanks, Mike, and good morning, everyone. I'm excited to provide an update on our commercial performance and execution in Q4. as well as our plans for expansion and potential commercialization of U2 and CLL and Ublatuximab in relapsing forms of MS in 2022. First, for Uconic, we just passed the one-year anniversary of the approval, and we continue to see broadened usage and positive feedback amongst prescribers in the U.S. market. Our team's done an excellent job working through the challenges in the quarter to increase awareness and educate healthcare providers on Uconic's unique profiles. It is clear that Uconic gives healthcare providers a novel treatment option for patients who have seen multiple previous therapies for marginal lymphoma and follicular lymphoma. And with the recent withdrawals of idelalysib and dubalysib from the lymphoma market, Uconic is now the only oral PI3K approved for these patients. Despite the continued COVID headwinds in the quarter, we continue to see progress. Net sales grew 14%. with $2.3 million in net revenue in Q4, bringing the full year 2021 net revenue to $6.5 million. Interestingly, overall demand for Uconic increased 25% quarter over quarter. However, we also continue to see Uconic demand and revenue impacted by patient affordability issues. As a result, we provided free drug to about 37% of Uconic-treated patients through our TG patient support program in Q4 and throughout 2021. What remains encouraging is that Uconic awareness and familiarity among targeted treaters remains high, and prescribers continue to cite strong Uconic performance across key product attributes. Additionally, the Uconic prescriber base continues to increase, and we are observing new patient starts in both new and existing accounts. We have also seen greater uptake in the community setting, which accounted for an estimated 65% of new patient starts in Q4. We are very encouraged by the feedback from healthcare providers and third-party research regarding Uconic use, which continues to remain very positive. Physicians that have used Uconic reported an appreciation for its differentiation, and they see the benefit that it brings to patients. We also know the continued positive experience across a broadened prescriber base in the community will help lay the foundation for a successful CLL launch in the future. Our hematology teams are continuing our planning efforts to focus on the U2 CLL launch objectives. The U2 CLL launch will be an important milestone for our hematology franchise, and we remain confident that we can leverage the experience from the UConnica launch, along with the enhancement of internal commercial capabilities, to deliver a successful CLL launch. Our commercial execution efforts continue to improve, which has led us to optimize account segmentation, prioritization, and solidified relationships in the hematology community. Now, turning to MS, we just, as Mike mentioned, we just returned from the ACTRA meetings last week, and the feedback from thought leaders and the overall energy around uvotuximab data was incredibly exciting. Over the fourth quarter and early part of this year, we continue to make great strides in launch preparation for MS. We're actively building and expanding our MS focused field-based roles with remarkable talent with extensive MS experience and deep relationships with the MS community. These team members are focused on continued engagement with the MS stakeholders, including prescribing healthcare providers, their staff, payers, and advocacy groups to gather insights through advisory boards, one-on-one personalized meetings, and at conferences, including the recently held conference last week. During these engagements, we consistently hear positive feedback in ubutuximab's clinical profile. Regarding the efficacy, the annualized relapse rate of less than 0.1 differentiates ubutuximab amongst others in the class. On the safety front, the incidence of infections and serious infusion-related reactions seen in the clinical trials appears to be differentiating based on physician feedback. Finally, in terms of convenience, the shorter infusion is seen as a competitive advantage among existing anti-CD20s. Healthcare providers, specifically advanced practice providers, reference the shorter infusion time as a benefit to their patient infusion experience, highlighting that almost 80% of people living with MS struggle with spasticity or tightness or stiffness of the muscles and bladder dysfunction, urinary urgency. meaning sitting in the chair for an extended period of time is obviously not ideal. Our research also indicates that the majority of top MS centers of excellence experience capacity constraints with infusions, making a shorter infusion potentially attractive. Over the coming months, we will continue our pre-launch activities and preparations to launch Ubiproximeb, which will lever a customer-focused commercialization strategy that we believe will enable Ubotuximab to become a meaningful treatment option for relapsing MS patients. With that, I'll hand it over to Sean Power, our CFO.
spk05: Thank you. Thank you, Adam, and thanks again, everyone, for joining us. Earlier this morning, we reported our detailed financial results, which can be viewed on the Investors and Media section of our website. I'll begin with our cash position. As Mike highlighted, we were happy to have strengthened our balance sheet in the fourth quarter of 21 with the upsizing of our term loan facility, allowing us to end the year with approximately $350 million in cash, cash equivalents, and investment securities. And as Adam just discussed a few moments ago, we reported $2.3 million of UConn net product revenue in the fourth quarter, resulting in cumulative net product revenue of $6.5 million for 2021, the first 10 months of our product launch. Our net loss for the fourth quarter of 2021, excluding non-cash items, was approximately $79 million, in line with our expectations, which was an increase of $7 million quarter over quarter from Q3 of 21, where we saw a net loss, excluding non-cash items, of approximately $72 million. As compared to the third quarter of 2021, the increase was primarily driven by an uptick in research and development costs, which pertained primarily to CMC expenses incurred in the fourth quarter of 2021. Our gap net loss for the fourth quarter of 2021, inclusive of non-cash items, was 93.3 million, or 70 cents per share, compared to a net loss of 88.2 million, or 71 cents per share, during the comparable quarter in 2020. Our net loss for the full year ended December 31st, 2021, excluding non-cash items, was approximately $287 million, compared to $199 million for the 2020 year end. The year-over-year increase in net loss is primarily driven by an increase in SG&A expenses associated with the launch of ECONIC and planning for the potential future launches of U2 in CLL and uvlutuximab in RMS. Additionally, we saw an increase in our R&D expenses year over year, which was primarily attributable, again, to CMC expenses in preparation for commercialization and for our Phase III clinical trials. The gap net loss for the year ended December 31st, 2021, inclusive of non-cash items, was $348.1 million, or $2.63 per share, compared to a net loss of $279.4 million, or $2.42 per share, for the year ended December 31, 2020. In terms of what we expect moving forward, as we've previously disclosed following our company's streamlining efforts, we project our burn in the first two quarters of 2022 to be between $55 and $65 million. down rather sharply from where it's been trending. With that, we believe our current cash will take us well out into 2023. With that, I will now turn the call back over to the conference operator to begin the Q&A.
spk04: Thank you. The floor is now open for questions. If you would like to ask a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star one to register a question at this time. Our first question is coming from Chris Howerton of Jefferies. Please go ahead.
spk06: That's great. Thank you so much for taking the questions and obviously look forward to all the more positive curveballs and for you to hit those hanging curveballs, Mike, so appreciate it. Thank you. I guess for me, two questions would be one is I know, Adam, you started to describe some of the efforts with respect to MS commercialization. I guess I'm curious if you can provide a little more thoughts in terms of how you're thinking about the size of that sales force and Maybe if you could give us some initial thoughts around spending towards either direct-to-patient or DTC type of spending in this setting. The second question would be if you could give us some indication as to what you think the confirmatory trials might look like for follicular and marginal zone. And if I have any follow-ups, I'd appreciate it. Thanks.
spk10: Great. Adam, you want to go ahead first, and I'll jump in on the confirmation trial.
spk09: Sure. So, Chris, thanks for the question. On the first part of the question, which was the Salesforce size, we've benchmarked other companies. We know generally what the size of their forces are. We have not finalized our commercial engagement model quite yet. But, you know, I think the range that I've been saying before is anywhere between 80 and 100 people. This market is incredibly concentrated. A vast majority of the patients are being seen at 550 centers across the U.S. and centers of excellence. You do not need a huge team to be able to do this. And also being the third CD20 to market, you know, we think we can come in an existing and growing market and do quite well. On the patient, the second question was around patient or direct-to-consumer. We do not anticipate. We think Novartis and Roche are doing a great job on commercials, expanding the CD20 market, and we believe we will not have to do commercials, but certainly some directives to patient through digital channels and social channels will be part of our plan going forward.
spk06: Excellent. Thanks, Adam.
spk10: And then Chris, as far as the confirmation trial from Arizona Follicular, we've been in discussions with the FDA for a decent amount of time. We've been back and forth with them a number of times. I think we're getting close to a trial design, but not very different. I mean, there's been studies that are out there that are being conducted or were being conducted, you know, looking at compared to either chemoimmunotherapy or I mean that's pretty much been the model to date so not really much of an update there unfortunately but we're getting to my knowledge we talked to the team recently we're getting closer I think we're hopefully going to get down to the nitty gritties and get that up and running as soon as we can okay alright well that's very good I will hop back in the queue to let my colleagues ask questions and I really appreciate it thank you
spk06: Thanks, Chris.
spk04: Thank you. Our next question is coming from Eric Joseph of JPMorgan. Please go ahead.
spk03: Oh, hi. This is Sean. I am for Eric. So thanks for taking our question. And we first want to dig a little bit into the actress data that you shared recently. So more specifically on the neutralizing antibodies and anti-drug antibodies from the automated trial. Basically, can you help us to put these data into the context of other existing anti-CD20s in the market? And then as a follow-up, how or if the differences we see here could have any meaning for longer-term efficacy implications and just want to pick up your thoughts on that. Thanks.
spk10: Sure. Sure. Yeah, I mean, that data is quite similar to what you'd expect to see with Rituxan, which obviously has years and years of experience in the marketplace. The data is pretty clear that none of it had any impact on safety or efficacy, and we wouldn't anticipate it to have any impact going forward.
spk03: All right. Thanks. Thank you.
spk04: Thank you. Our next question is coming from Althea Young of Cantor. Please go ahead.
spk02: Hey, guys. I like the name change. A couple questions for me. Can you talk a little bit about, I guess it's a little trickier, but with the panel and the upcoming discussions around, you know, whatever the FDA is kind of looking for, PI3 kinase, like, you know, what kind of evidence do you think provide? Like, can you give us any kind of more color on kind of numerical trends that you're seeing as it stands right now? And then I guess, you know, just a question that I kind of get and just wanted to, you know, have you opine on it for the record is, you know, is there any concern of flow back read through to ongoing MS, even though obviously different regimen? Thank you.
spk10: Yeah. Thanks, Alethea. So I mean, I'll start with the second half. No, I mean, we don't anticipate any blowback for MS. I mean, most of the concerns that have been addressed, not all, have been focused on the PI3K. That seems to be an area that the FDA has expressed significant concerns across the entire class. As you know, we've maintained that we believe that our PI3K is different. And the safety and tolerability profile is different in our opinion, and we think the data supports that. So, yeah, I think we're going to – we're pulling out, you know, every piece of data that we'll be sharing with ODAC. Like I said in the prepared remarks, we've, you know, we've gone patient by patient to understand what happened to just – to double, triple check that, you know, that the drug wasn't causing harm to patients, but when you're dealing with an underpowered OS analysis, there's going to be a lot of noise in the data. Obviously, we had to deal with COVID, which CLL patients are generally immunocompromised. They're at high risk to begin with. Anytime you're treating them, they're going to be at higher risk. We think that obviously in a world where COVID didn't exist, the data would be pretty non- non-meaningful, and particularly, you know, now that we have the missing data that we didn't have when we did the first look at the OS, you know, you do a COVID adjustment, and, you know, I can assure you that there is no survival issue there. Again, you know, unfortunately for us, you know, the classes come under attack, We've been lumped into that class, but I do think that given the opportunity to spend time with the ODAC panel and make them aware of the fundamental differences of this molecule versus the others, and then share with them the safety data in as much detail as we have time to provide, plus the comparisons I mean, when you look at the comparisons to the approved agents, I can assure you that the U2 regimen in terms of, you know, SAEs, grade threes, and treatment-related deaths does not stand out. Might be slightly higher on the grade threes and SAEs, but, you know, middle of the pack in treatment-related deaths. So, again, it's not like there's some some obvious issue. And like I said, we've been patient by patient. The good news is, look, we've shared all that data now with the FDA. And, you know, my assessment of the situation is they are taking it very seriously. They're, you know, they are working to, what I can tell is they're working very hard to find the truth. And that's all we could ask for. So our fingers are crossed. We've sent them a lot of information, a lot of new data over the last, you know, two, three, four weeks. They've been back to us with multiple rounds of follow-up questions, so they're working hard on it. Again, my assessment is that they're looking for the truth. We feel comfortable that there's no major concern here, and hopefully the FDA will see it that way, and hopefully we'll have that opportunity to share that with ODEC as well.
spk02: Awesome. Thank you very much.
spk10: Thank you.
spk04: Thank you. Our next question is coming from Mayank Mamthani of B Reilly. Please go ahead.
spk07: Hi, good morning team. This is Sahil on for Mayank. Congratulations on all the progress. Maybe just a brief follow up from the from the previous question. Could you clarify how much, if any, of the data package for MS is going to be considered at the U2 ODAC meeting, with that obviously being a component of the therapy? And then also, is there an adcom anticipated for the MS opportunity prior to the September PDUFA date?
spk10: So the answer to the first question is zero. And as of now, the FDA has said on the MS side that they are not planning to host an ODAC. Again, as we've learned from the CLL side, that as they review the data, they may come to a different conclusion. At the outset, they noted that they were not planning to host an ODAC, but an advisory panel for the neurology division.
spk07: Okay, great. Thank you. And then maybe one more from us. Could you talk about your latest thoughts on the you know, 2025 revenue guide of $1 billion and how that mix might now be viewed between oncology and MS?
spk10: Yeah, I mean, I think until we know where we are with the UNICEF application, I don't think we can update that guidance. So for the moment, we will just leave that as an open question until we see the results of the ODAC and, more importantly, beyond that, the decision of the FTA. Okay.
spk07: Yeah, absolutely. That makes sense. All right, thanks for taking our questions. Appreciate it. You got it.
spk04: Thank you. Our next question is coming from Ed White of HC Wainwright. Please go ahead.
spk08: Hi, this is Steve on for Ed. Thanks for taking our question. Can you provide your thoughts on your European strategy and timing for MS?
spk10: Yeah, so... We are currently fully evaluating that opportunity. We're in the process. We've got a small team that's already set up, sort of a SWAT team in Europe, that's modeling out how we plan to approach the European theater, as one might say. So we don't have any details beyond that, but we are mapping it out, and I think the timing would be probably six months or so beyond that, the approval for MS in the U.S.
spk08: All right, thank you.
spk04: Thank you. Our next question is coming from Matt Kaplan of Ladenburg-Bauman. Please go ahead.
spk11: Hi, good morning. Good morning, Matt. Just wanted to back up to the OS analysis a little bit. You know, thanks for all of the detail you provided there. So given your interaction with the FDA since you submitted, I guess, the data in late January, what do you think, how is the FDA going to handle this? Will this be viewed as a major amendment, push out the PDUFA date, or will it just be, they'll be able to complete their analysis in a faster timeline than that?
spk10: So we don't know. given the stated time frame for the ODAC of March-April time frame, we have always assumed, again, with no further information from the FDA, this is just us sitting around spitballing, that the PDUFA date would not likely be met. We've said that publicly. Having said that, the FDA does have the right at any time to call any of the data submissions that we've provided as major amendments, which would give them the opportunity to push the PDUFA date back, I think, three months. So, you know, we don't know exactly what the FDA is thinking on that one. They haven't spoken to us about it at all, but certainly that is a possibility that they can take the updated data that we've provided to them, declare it as a major amendment, and push the PDUFA date back. That would give them plenty of time to host the ODAC and not have to miss their PDUFA date. So, again, we don't know. We have no further information than what we've shared and what I've said here today. But, again, those are all logical possibilities that could occur. Okay.
spk11: Helpful. And I guess now that we're in March – When do you expect the FDA to give you an indication on the timing for the potential ODAC meeting?
spk10: The last I heard is that the FDA will post it publicly for all to see, and at that point, everyone will know the date of the ODAC.
spk11: Okay. And then just lastly on the new OS data that you submitted, you mentioned that there was kind of a positive response once you're able to decrease the number of patients that had missing data to 5% or less. Can you give us a little bit more detail in terms of the improvement in OS that you observed when you did that?
spk10: So you would like the actual numbers, Matt?
spk00: Yes.
spk10: I would love to share the numbers, but we made a decision that we did not want to do that until the FDA had full opportunity to review all the information that we provided them. But what I can say, which I've said qualitatively, is that both the 1.23, which was the ITT, went down, and the 1.04 for the COVID went down. So both those numbers are lower than they were. And again, we're seeking the truth, right? So At the time we presented the first analysis to them, we were missing 15% of the information. So what we brought to them was what we knew at the time, but not everything. So we were able to close that information gap down to 5%. So we're still missing 5%, so we got closer to the truth of what the OS analysis was at the time. Now, again, which is great. So in actuality, had we had all the information at the time we submitted it, the numbers we had presented to the FDA would have been lower. That's still not, you know, because of the fact that the OS is underpowered, understanding the truth of whether U2 provides a benefit in over survival or does not is a far way off no matter what, right? Because when you're looking at underpowered analysis, you don't have, essentially the answer is you don't have enough information to get above the noise. And as I mentioned in my prepared remarks, you see these things will swing back and forth because every time you pick another new cutoff date, there's going to be a lot of randomness, particularly if, again, you're not powered for it. So, you know, I think we mentioned this in maybe one of the previous conference calls, but, you know, we really would need, you know, minimum, minimum, of 600 events, and that would be a pretty nice improvement in overall survival. And it could be as high as, I think, 2,000 events for what is most likely the improvement in survival, given all the current new standard of cares that are out there. Again, you're not expecting the same level of improvement in survival that you would see in PFF. So we're looking at about 100 events, give or take, maybe 110, 120, And to get even reasonable information would be 600 to 2,000. Knowing the truth, and particularly again in light of the crossover, knowing what the truth is of whether there's a true benefit or not is extremely challenging to glean from this kind of information. So again, that's why I think it is important that we've gone patient by patient And again, to the FDA's credit, we do appreciate that they're taking great time and care to look at the information on a patient-by-patient basis to get a better sense of what's going on with you two and these patients. So very long answer, Matt, but I can't give you the number that you've asked for, but I can assure you that the numbers are lower than they were.
spk11: Okay, now the added detail is very helpful. Just shifting gears to MS, previously you've spoken about going to market with a competitive price strategy. Given your interaction and ongoing interaction with potential payers and the profile of the drug, what are your current thoughts on that right now?
spk10: Yeah, so again, we continue to evaluate. I mean, this will come down to the wire amount. I mean, we are constantly engaging with payers to try to refine that pricing model that will optimize the access for, for Ubley in MS. And that is, you know, more and more as we do more ad boards with the physicians, all they care about is will their patients have access to the drug, right? So they just, as long as they can write the script and have a high level of confidence that they're going to get the drug, they're going to be on board with Oobly, in many cases, as their primary CD20. So our job continues to be to find the right pricing strategy that makes the most sense. And I think there's probably some component that includes lower price, some component that includes some discount, and there's a balance out there. But, again, it's too early to tell even now because we continue to go back and forth and discuss with the payers. But, yeah, it's important. We continue to believe it. We continue to feel confident that we can work with Price to make a difference and, again, make sure that OOBLI is accessible to as many patients as possible across the country. Okay.
spk11: And last question. I guess given that the ultimate studies were wrapped up some time ago, Can you talk about any potential exposure you have given the current war in Ukraine and the review ongoing at FDA? Does that pose any problems?
spk10: Oh, the war in Ukraine? Is that what you're asking about, Matt? Yeah, any issues with MS? Yeah, I wouldn't think so. The studies obviously completed a while ago All that data has been extracted, cleaned, and brought to the U.S., so I'm not concerned about that. In terms of potential FDA inspections, to my knowledge, they've chosen sites that are not in the Ukraine to inspect at this moment, so unless something changes and they decide they need to get to the Ukraine, which obviously would be a challenge under the current circumstances. I don't see that there's any barrier to the FDA's review process from that standpoint. So, no, I'm not seeing anything that's concerning from our standpoint with what's going on over there. Obviously, there's lots of things to be concerned about for the patients and everyone else there. Okay, great, great. Thank you.
spk04: Thank you. This brings us to the end of our question and answer session. I would like to turn the floor back over to Mr. Weiss for closing comments.
spk10: Great. I just want to thank everyone again for joining us. To wrap up, I'll just quickly review some of the upcoming goals and objectives for 2022. Obviously, preparing for the upcoming ODAC has been a big effort for the company, as I mentioned in the prepared remarks. And we're looking forward to hopefully obtaining a favorable outcome and ultimately obtaining approval for you to treat patients with CLL. We're looking forward to presenting additional analysis from the ultimate one and two trials across a number of different conferences for the remainder of this year. And hopefully obtaining FDA approval by the target BDUFA date of September 28, 2022. We'll continue preparing for the potential launches of U2 and CLL and iblituximab and RMS. We'll continue to work on our early pipeline candidates. And, of course, during the course of the year, we'll have opportunities to provide updated oncology data at major medical meetings. So looking forward to a very pivotal year for us. Obviously, these two approvals being of utmost importance for us, and we'll continue to work toward those. So I just want to thank everyone again for joining us. Have a great day.
spk04: ladies and gentlemen thank you for your participation this concludes today's event you may disconnect your line to log off the webcast at this time and enjoy the rest of your day
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