TG Therapeutics, Inc.

Greetings and welcome to the TG Therapeutics third quarter earnings conference call. 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. 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 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, 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 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. Now I'd like to turn the call over to Mike Weiss, our CEO.

Thanks, Jenna, and good morning, everyone, and thanks for joining us on the call. The third quarter of 2022 was a very productive time for TG, as the team really came together to execute on our pre-launch commercialization plans. As we've mentioned previously, our goals for this year are to work toward an FDA approval for Lutuximab in relapsing forms of multiple sclerosis and to be prepared, if approved, to launch early next year. We've guided that our goal was to dedicate the resources necessary to achieve these goals and minimize or eliminate all other expenses. I'm pleased to report that our streamlining and focusing efforts have been extremely successful in reducing our overall burn while reserving our resources to support the potential approval and launch of Lubatuximab. Sean Power, our CFO, will join us shortly and provide some additional details, but our burn for the third quarter was approximately $34 million, down substantially from prior quarters. I'm proud of the hard work and team effort that was required to realize these cost savings, while ensuring we were all well-positioned financially for the potential launch of Lubatuximab. Also, in just a few minutes, Adam Waldman, our Chief Commercialization Officer, will join us to provide more details around our launch planning and progress, which from my vantage point seems to be moving along quite nicely. We believe that if approved, Ubutuximab has the potential to play a meaningful role in the treatment of multiple sclerosis and we remain committed to offering patients a highly active treatment option with the convenience of a one-hour fusion administered every six months following the first dose. With that, let me remind everyone of our phase three program that is supporting our BLA submission for Ublatuximab in relapsing forms of MS, also referred to as RMS. The ultimate one in two phase three trials evaluated Ublatuximab compared to teraflutamide enrolling approximately 1,100 patients across 10 countries and were led by Dr. Laurence Steinman of Stanford University. As noted in the past, both studies met their primary endpoint with Ubutuximab treatment demonstrating a statistically significant reduction in annualized relapse rate. It's also referred to as ARR compared to teraflutamide. In addition to the positive primary endpoint results, we've had the opportunity over the past year to present several different sub-analysis of this data set, which we believe continues to show an encouraging profile for Ubutuximab for the treatment of patients with RMS. Most recently, we had the opportunity to present five additional exploratory data sets at the 2022 Annual Congress of the European Committee for the Treatment and Research in Multiple Sclerosis, commonly referred to as ECTRIMS. The team engaged with numerous KOLs during this meeting, and the feedback we received around the profile of lubotuximab was highly encouraging, and we believe the data presented further support the potential for lubotuximab to treat patients with RMS, if approved. Now, on the regulatory front, as in the past, we will not provide color on any interactions with the FDA, but we would like to provide an update on where we are in the process. With less than two months for the target PDUFA action date of December 28, 2022, we can confirm that we have completed the late cycle meeting and labeling discussions have recently commenced. We remain hopeful that Lubletuximab will be approved, and if approved, we'll be excited to make Ubisatzimab available to the many patients with RMS that are in need of additional treatment options. I will also mention that our efforts with the EMA for EU approval are moving along, and from a timing perspective, potential approval could occur in the second half of 23. We are still assessing the go-to-market strategy in Europe, and we continue to evaluate whether to go it alone or whether to partner with XUS. So with that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, to share some thoughts on our preparations over the past quarter, as well as his thoughts on the potential commercial opportunity and plans for Ubitoximab and RMS. Adam?