TG Therapeutics, Inc.

Greetings and welcome to the TG Therapeutics Second Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Please press star 1 on your telephone keypad to enter the queue. 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. I would now like to turn this conference over to your host, Ms. Jenna Bosco.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second quarter of 2022 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, Adam will 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. In addition to 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 we'll be available for the next 30 days. Now I'd like to turn the call over to Mike Weiss, our CEO.

Thanks, Jenna, and good morning, everyone, and thank you for joining us. No doubt, the second quarter of 2022 was a challenging one for us at TG, but one also that has provided us with a renewed sense of purpose and focus. Nearly all our efforts are now directed toward gaining FDA approval for lituximab and relapsing forms of multiple sclerosis, which has a target PDUFA goal dated December 28, 2022, and if approved, being prepared to successfully launch. We are dedicated to MS patients and the entire MS community, Levobituximab has the potential to offer a valuable treatment alternative with an added convenience of a one-hour infusion after the first dose. So while 2022 has not gone as expected, we believe there's an exciting opportunity ahead of us that can provide great value to our shareholders. Let me get started off here by providing a brief regulatory update. As many of you know, a couple of months ago at the end of May, we announced that the FDA extended our BDUFA goal date to December 28, 2022. As we shared at the time, the FDA extended the BDUFA goal date to allow time to review a submission provided by us in response to an information request from the FDA. The submission comprised an integration summary of certain existing clinical information that was previously provided to the FDA. Since this submission, as is customary during a BLA review process, we have continued to respond to additional FDA information requests, none to my knowledge specifically related to the submission that resulted in the delay. Generally speaking, my team tells me that they believe the process is moving forward as expected. With that, let's talk a little bit about the commercial opportunity and some market dynamics. It's estimated that nearly one million Americans are currently living with MS, and approximately 70 to 75,000 of them are relapsing MS patients that will be seeking a new treatment each year. Currently, about half of those seeking a new treatment are receiving CD20-based therapy. We do recognize that we are competing against some larger competitors in this marketplace, but we believe our smaller size and nimbleness will play to our advantage. And most importantly, given the size of the market, there's room for all three CD20s to participate at meaningful levels. as each offers patients and physicians unique attributes, which we see as only enhancing the patient experience. In our discussions with MS-focused healthcare providers, we almost uniformly hear that they believe early treatment with CD20s will dramatically change the long-term outcome for these patients, which we see as enhancing the future demand for CD20s. Accordingly, we are optimistic that if Lubitoxibab is approved, we'll competitive in the CD20 RMS marketplace. Adam Waldman, our Chief Commercial Officer, will join us shortly to share his thoughts on the commercial opportunity as well as our plans for commercialization. We will also be joined by Sean Power, our Chief Financial Officer, to discuss our financial position. However, I wanted to highlight that the efforts we have taken as an organization to reduce our burn and ensure our current cash position will take us through the potential launch of Rubituximab have thus far been very successful. Our Q2 burn was even lower than we had projected, coming in around 48 million for the quarter. This was truly a company-wide effort, and I commend the entire TG team for tightening their belts, rolling up their sleeves, and rallying around our near-term goal of approval and launch of Ubitoximab and RMX. To get there, we closed or paused nearly all our oncology programs in order to focus our resources and energy on Ubitoximab and RMX. We expect to revisit our pipeline and the potential for our drug candidates across a variety of B-cell diseases, including oncology, in the first half of next year, ideally on the heels of an ubutuximab approval and launch in RMS. So with that, let me turn the call over to Adam Wallman, our chief commercialization officer, to share some insights on our commercialization plans for ubutuximab. Adam?