TG Therapeutics, Inc.

Greetings. Welcome to TG Therapeutics' second quarter 2021 earnings call and business update. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll now turn the conference over to Jenna Bosco, Senior Vice President, Corporate Communications. Jenna, you may now begin. Thank you.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second 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 an update on our current pivotal programs and remaining key 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 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, 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, 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.

Great. Thank you, Jenna, and thanks, everyone, for joining us today. During the first half of 2021, we hope that our long-term goals and vision for TG have really come into focus for investors. With the first phase of our multi-phase strategy now complete, with the accelerated approval of Uconic, the first and only dual inhibitor of PI3K delta and CK1 epsilon, and the treatment of relapsed or refractory marginal zone lymphoma and follicular lymphoma. We are very proud of these accelerated approvals for patients who have failed prior therapies and have limited treatment options. We estimate approximately 8,000 patients each year will be seeking treatment in our approved MZL and follicular indications, which we see as an excellent starting point for our commercial efforts. Building on the momentum from our Uconic launch, we have submitted and received a PDUFA target goal date of March 25, 2022, for a BLA application requesting approval of the combination of Uconic plus Ubutuximab, our novel glycoengineered anti-CD20 monoclonal antibody, the combination of which we refer to as U2, for the treatment of patients with chronic lymphocytic leukemia. We have also submitted a supplemental new drug application, SNDA, for Uconic for the same indication and have received the same PDUFA date for the SNDA. We are excited about the potential to bring our novel U2 combination to CLL patients, especially those who have failed or who are not good candidates for current standards of care. CLL is a significantly larger patient population than marginal zone and follicular. We currently estimate that approximately 30,000 to 40,000 patients will be seeking a new treatment each year in a proposed CLL indication. Not only is CLL multifold larger patient population than marginal zone and follicular, but we would expect the median duration of treatment to be longer in CLL as well. One other important factor to note is that we believe about 85% of our target prescribers for marginal and follicular lymphoma are the same prescribers that we will be targeting for chronic lymphocytic leukemia. So the significant efforts our team has made in building relationships for the marginal zone of follicular launch should translate nicely into our potential CLL launch. Next up in our multi-phased approach is the largest patient population we will be addressing, which is patients with relapsing forms of MS, with ubutuximab as a single agent. We are targeting a submission of a BLA for MS this quarter and hope to receive a target BDUFA date in the third quarter of next year. We believe our Phase III data supports an attractive treatment option for patients with relapsing forms of MS. Entering MS will also raise our commercial profile significantly, as we expect to participate as one of only three anti-CD20 monoclonal antibodies in what has been projected to become a $10 to $15 billion per year market just for anti-CD20 monoclonal antibodies in the treatment of MS. While the core focus will be on the regulatory and then commercial execution of these first three opportunities, especially the larger market opportunities in CLL and MS, we will continue to seek to enhance our hematology oncology franchise by broadening the potential U2 label to new indications such as in marginal zone and follicular lymphoma, and also into new combination uses of U2 in CLL, for example, in combination with venetoclax and our very own TG1701. The ability to combine with standard of care agents in CLL, we hope will bring better outcomes to patients and should also broaden the potential penetration of U2 in CLL. On the MS side, we will seek to build on ubutuximab potentially in other autoinflammatory diseases, as well as seek to build additional programs in MS. With that, let me provide some recent highlights related to our initial commercial launch efforts with Uconic and our key regulatory efforts and development programs. First, let me just remind everyone and restate that in February, the FDA granted accelerated approval of Uconic for the treatment of adult patients with a relapsed or refractory marginal zone lymphoma whoever received at least one prior anti-CD20-based regimen, and for adult patients with a relapsed or refractory follicular lymphoma, whoever received at least three prior lines of systemic therapy. This approval was based primarily on the results from the UNITY NHL trial, which were recently published in the Journal of Clinical Oncology. On the commercial side, Uconic became commercially available a few weeks following approval, And overall, I can say we're extremely pleased with the performance of the commercialization efforts to date. Launching during a global pandemic is no easy task, but under the circumstances, the team has done a really nice job in engaging target prescribers, both commercially and educationally, under the leadership of our Chief Commercialization Officer, Adam Waldman. Adam will join us shortly to discuss some launch metrics and give some high-level qualitative assessments of the launch thus far. I don't want to steal his thunder, but again, from where I sit, the launch is going well. I believe it's positioning us for future success with the potential approval of U2 for CLL early next year. Speaking of which, and as noted above, the BLA and SNDA for U2 and CLL have both been granted a BDUFA target goal date of March 25th, 2022. For the MS program, we were pleased in the second quarter to be able to present the positive results from our ultimate one and two phase three trials, evaluating lupotuximab in relapsing forms of MS at two major conferences, the American Academy of Neurology Annual Meeting and the European Academy of Neurology Annual Meeting. As mentioned during our last call, both studies met their primary endpoint with lupotuximab treatment demonstrating a statistically significant reduction in annualized relapse rate, referred to as ARR, with lubotuximab treatment resulting in historically low levels of ARR. We believe these results are highly encouraging and showcase the potential of lubotuximab to provide an efficacious treatment option in a one-hour infusion every six months following the first dose. The expert feedback we have received thus far has been very positive, and our one-hour infusion is viewed as an important benefit for both physicians and especially their patients. These trials were conducted under special protocol assessment with the FDA, and we are on track to complete a BLA submission for lupotuximab to treat RMS this quarter. And briefly, before I turn the call over to Adam, I want to provide a quick update to our combination and pipeline programs that we hope will be drivers of future growth, starting with U2 plus venetoclax, which has moved forward now into phase three for patients with CLL within the Ultra V trial. The Phase II portion of the UltraV study completed enrollment earlier this year. You may recall that at last ASH in December, Dr. Paul Barr of the Wilmot Cancer Center in Rochester, New York, presented preliminary results from his Phase I study of the U2 plus venetoclax combination, which included results from the first 27 patients in the study to complete the 12 cycles of fixed-duration therapy. In those patients, there was 100% overall response rate, and greater than 75% of the patients achieved undetectable MRD in the bone marrow. We view these results as highly encouraging and we look forward to presenting updated data from this phase one trial later this year with approximately double the number of patients through 12 cycles of treatment. Next, let's discuss TG1701, our investigational BTK inhibitor. We were pleased to present updated results from the phase one trial of TG1701 as a monotherapy and in combination with U2 last month during the summer oncology meetings, including ASCO, EHA, and ICML. We were pleased to see that with additional patients treated with TG1701, it continued to show encouraging clinical activity paired with what appears to be a tolerable safety profile. As I mentioned earlier, we view these triple therapy trials as a way to enhance the utility of U2 in the treatment of CLL. Further in the clinical pipeline are our CD19, CD47 bispecific antibody referred to as TG1801 and our PD-L1 antibody referred to as TG1501 or Cozumab. Both are moving through early stages of testing with the possibility of data later this year or next. 2021 has been a very busy year for us as we've made significant progress on both the clinical and regulatory fronts and look forward to an impactful end of year and into 2022 as we strive to expand our commercialization efforts into CLL and MS. With that, I'm excited to turn the call over to our Chief Commercialization Officer, Adam Waldman, to share some highlights from our early commercialization efforts. Adam.