TG Therapeutics, Inc.

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.

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.

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?