TG Therapeutics, Inc.

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, 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 and 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 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 30 days. With that, I'll turn the call over to Mike Weiss, CEO.

Excellent and 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 As we announced last week, we have voluntarily withdrawn both the BLA and SNDA for U2 in CLL and SLL.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 Uconic from the market in the approved indications of relapsed or refractory marginal zone lymphoma and follicular lymphoma. Accordingly, pending ODAC scheduled for April 22, 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 at that time that showed an improvement from the original OS analysis provided in November of 2021, which we thought was encouraging. As we've stated previously, the OS analysis of the unique 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 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 UNITYCEL 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 UNITYCEL would support the differentiation of umbilicib from other members of the class on overall survival. However, for now, we will be pausing development of umbilicib 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, we'll be to focus on Ubutuximab for multiple sclerosis, for which we have a pending BLA in relapsing forms of MMS with a BDUFA goal date of September 28, 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 Oobly and MS. And 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. So let's spend some time reviewing Ubituximab and MS. As a reminder, Ubituximab is a novel glycoengineer anti-CD20 monoclonal antibody that targets a unique CD20 epitope. The Ubutuximab BLA is primarily based on the ultimate one and two phase three trials, which evaluated Ubutuximab compared to the active control arm of terflunomide in patients with the 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. Lauren Steinman, Zimmerman Professor of Neurology and Neurological Sciences and Pediatrics at Stanford University, chaired the program. ULTIMATE 1 and 2 are the first MS Phase III clinical trials to yield an annualized relapse rate of less than 0.1, a major milestone of therapy. Results from the ultimate one in two studies have been the subject of podium presentations at all the major MS and neurology conferences, including 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 one-third 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?