TG Therapeutics, Inc.

Greetings and welcome to the TG Therapeutics third quarter 2021 earnings call and business update. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Senior Vice President, Corporate Communications. Thank you, Jenna. You may begin.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the third quarter 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 provide an update on the current pivotal programs and key remaining goals for 2021. Adam will then provide an update on our commercialization efforts, and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that we'll be making some 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 operations 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, including our most recent reports on Forms 10-K and 10-Q. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG's website at www.tgtherapeutics.com, where it will be available for the next 30 days. All participants on this call will be on a listen-only mode. Now, I would like to turn the call over to Mike Weiss, our CEO.

Thank you, Jenna, and good morning, everybody, and thanks for joining us. 2021 has been a pivotal year for TG as we transition from a purely development stage company into a fully integrated commercial organization. With the launch of Uconic and the continued build of our commercial platform, TG has grown tremendously this year. I'm incredibly impressed with the team we've built and excited to see everyone working so closely together toward our common goal of developing and commercializing novel treatments for patients with B-cell diseases. The team's hard work and effort this year have established our commercial footprint that I believe will pay dividends in the coming years as we intend to leverage our commercial platform for multiple potential future launches, including, of course, U2 and CLL and Ubotuximab and RMS, both of which we are targeting for 2022. And beyond that, from our robust B-cell pipeline that we will touch briefly on later. Since this call is occurring hot off the heels of our live participation in the Consortium of Multiple Sclerosis Clinics annual meeting, referred to as CMSC, and ASH abstracts won't be available for another 20 minutes or so, I thought I'd kick off the call by discussing our multiple sclerosis program. Perhaps the most exciting news from this past quarter was that we completed our biologic license application, or BLA, submission to the U.S. FDA for rublotuximab, a glycoengineered anti-CD20 monoclonal antibody to treat patients with relapsing forms of MS. We submitted this application in late September, and we look forward to hearing back from the FDA in late November on whether they have accepted this application for filing. Assuming all goes well, we would anticipate a target PDUFA date in late September of 2022. This past quarter, we also presented at the ECTRIMS conference and shared additional data from the ultimate one and two phase three trials, which supported our BLA submission to the FDA. As a reminder, these trials were conducted under special protocol assessment with the FDA, and importantly, as noted in the past, both studies met their primary endpoint with ubutuximab treatment demonstrating a statistically significant reduction in annualized relapse rate, sometimes referred to as ARR, with ubutuximab treatment resulting in historically low levels of annualized relapse rate. At the EFTRIMS meeting, we also shared data on additional secondary, tertiary, and even some post hoc endpoints to offer the MS community additional color around the highly successful primary endpoint. We believe the additional data presented further demonstrates the potential benefit of Upatuximab to treat patients with RMS with a one-hour infusion every six months following the initial starting dose. As a reminder, we also hosted a virtual event during the ECTRIMS conference And I encourage anyone who is interested in TG to go to our website to listen to a recording of this event and listen to the KOLs provide their thoughts on Ubituximab and the data presented thus far. Furthermore, at the recent CMSC annual meeting, I personally had the opportunity to meet with a number of key opinion leaders, and I have to say the feedback was overwhelmingly positive and provided tremendous insights to help us best position Ubituximab for success in MS. Next, let's review the UnityCLL Phase 3 program. As you may recall, we submitted and received a PDUFA goal date of March 25, 2022, for a BLA and an SNDA, requesting approval of the combination of Uconic plus Ublatuximab, for those of you who knew, referred to as the U2 combination, for treatment of patients with CLL. These applications were supported by the the data from the Unity CLL Phase 3 program, which achieved its primary endpoint and showed patients treated with U2 achieved a statistically significant improvement in progression-free survival as compared to patients who received chemoimmunotherapy. This trial was conducted under a special protocol assessment with the FDA. With many CLL patients seeking a new treatment each year, we are excited about the potential to leverage the commercial platform we built this year around Uconnick to commercialize U2 for patients with CLL, if approved. In particular, for those patients who may not be good candidates for current standards of care, as well as those who have failed currently available options and are in need of an alternative treatment. Now, let me turn to Uconnick. As a reminder, in February of this year, the FDA granted accelerated approval of Uconnick as a single agent for the treatment of adult patients with a relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen, and for adult patients with a relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy. This approval was based primarily on the results from the UNITY NHL trial, which were subsequently published in the Journal of Clinical Oncology. As for the launch, I'll keep my comments brief and let our Chief Commercialization Officer, Adam Waldman, provide the details. Despite the challenges posed by COVID, I've been very pleased with the performance of our team. I got a chance to meet most of our sales team in person recently, and I have to say, what an impressive group. True professionals with vast experience, working hard to establish our commercial footprint by introducing Uconic and TG to the broader community of oncologists. One of the team's key goals has been to educate and build awareness with as many healthcare professionals who treat MZL and follicular as possible, keeping in mind that most of our current target prescribers are also the clinicians who treat patients with CLL. So, all the hard work building prescriber base with experience with single-agent Uconic and MZL and follicular should bolster our launch efforts for U2 and CLL, if approved. Through their efforts, our teams have engaged live and virtually thousands of healthcare providers, and the Econic prescriber base continues to grow, and importantly, we are seeing increasing uptake in community practices, which we believe will be integral for the potential success of U2. Lastly, I wanted to spend a few minutes discussing a couple of additional pipeline programs, which we hope will drive better outcomes for patients and become future drivers of growth and expansion of our hematology oncology commercial platform. Starting with U2 plus venetoclasts. As a reminder, the Ultra V phase three trial evaluating this triple combination is now enrolling patients with treatment naive and relapsed or refractory CLL. The phase two portion of this study completed enrollment with approximately 165 patients earlier this year. Most recently, at the IWCLL conference, Dr. Paul Barr of the Wilmot Cancer Center in Rochester, New York, presented updated results from his phase one U2 plus ven combination, which now includes approximately 47 patients treated with the triplet regimen. Best overall response was 100% among the valuable patients, including a 37% complete response rate. Importantly, at cycle 12, 91% of the 34 patients achieved undetectable minimal residual disease in the peripheral blood and 72% of 32 patients achieved undetectable minimal residual disease in the bone marrow. We see these data as highly encouraging, and we look forward to providing updates from the Phase I and Phase II studies next year. Also, at IWCLL, we presented data on TG1701, our investigational BTK inhibitor, as a monotherapy and in a triple combination with Mu2. We were pleased to see that with additional patients TG1701 continued to show encouraging clinical activity paired with what appears to be a tolerable safety profile. Also, important to note, we hosted a virtual event during the IWCLL conference, and again, I encourage those of you who are interested in TG to go to our website and listen to the feedback directly given by the KOLs about this novel regimen. These are exciting combinations, and I believe not only speak to the utility of U2 as a backbone in triple combinations, but also highlight the potential benefits of our combination approach and our B-cell platform that should provide us with a steady stream of commercial opportunities. To wrap up, I wanted to quickly review some upcoming goals and objectives for the remainder of 2021 and into 2022. First, we look forward to hearing from the FDA regarding our BLA submission to treat patients with relapsing forms of MS. We also will continue to work with the FDA on the YouTube BLA slash SNDA for patients with chronic lymphocytic leukemia, which has a BDUFA target goal date of March 25th, 2022. We plan to have an exciting ASH conference in December, so next month, and we're looking forward to having a live presence there. So that's going to be very exciting. As mentioned, in just a few minutes at 9 a.m., so about 12 minutes from now, the abstracts will go live. We think this will be a great conference for us as we're presenting data showcasing the potential value and utility of U2 as a doublet combination therapy and also as a backbone of triple combinations. Of course, we will continue to focus on the commercialization of Uconic and relapsing refractory marginal zone and follicular lymphoma and expand our commercial footprint in preparation for potential future launches, including U2 in CLL and uvlutuximab in relapsing forms of MS. We are continuing to drive enrollment into our Ultra V Phase III trial, evaluating the triple combination of U2 plus venetoclasts in both treatment-naive and relapsed refractory CLL, and we plan to continue to advance our early pipeline candidates including TG71, our BTK inhibitor that we've been talking quite a bit about, but some earlier stage compounds as well, including TG1801, our anti-CD47, CD19 bispecific, and TG151, our anti-PD01 antibody. With that, I'm excited to turn the call over to our Chief Commercialization Officer, Adam Wallman, to share some highlights from our early commercialization efforts. Adam?