TG Therapeutics Provides Business Update and Reports Third Quarter 2022 Financial Results

About this update from Tg Therapeutics, Inc.

[{"type":"text","content":"Conference call to be held today, November 10, 2022 at 8:30 AM ET\nNEW YORK, Nov. 10, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the third quarter ended September 30, 2022 and recent company developments, along with a business outlook for the remainder of 2022. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, \"Over the course of the third quarter we focused on preparing for the potential launch of ublituximab to treat patients with RMS in early 2023. This will continue to be our primary focus for the remainder of 2022 as we head toward the ublituximab PDUFA goal date of December 28, 2022.” Mr. Weiss continued, “If approved, we believe ublituximab has the potential to be a meaningful treatment option for patients with relapsing forms of multiple sclerosis.” Business Highlights Ublituximab in Multiple Sclerosis A Biologics License Application (BLA) for ublituximab, to treat patients with relapsing forms of multiple sclerosis (RMS) has been accepted by the Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2022.Most recently, at the 2022 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, new exploratory analyses from the ULTIMATE I and II Phase 3 trials were presented. As previously reported, both trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared to teriflunomide in patients with RMS. Key Objectives for 2022 Obtain FDA approval of ublituximab to treat relapsing forms of multiple sclerosis by the PDUFA goal date of December 28, 2022Strengthen our commercial infrastructure to support the potential launch of ublituximab Financial Results for the Three and Nine Months Ended September 30, 2022 Net Loss: Net loss was $35.8 million and $145.3 million for the three and nine months ended September 30, 2022, respectively, compared to $85.6 million and $254.8 million for the three and nine months ended September 30, 2021. The decrease in net loss in both periods is primarily the result of our cost-savings measures implemented and the withdrawal of UKONIQ from the market.R&D Expenses: Total research and development (R&D) expense ...

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