On November 10, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX) reported 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 (Press release, TG Therapeutics, NOV 10, 2022, View Source [SID1234623751]).
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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, 2022
Strengthen 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 was $20.8 million and $95.7 million for the three and nine months ended September 30, 2022, respectively, compared to $52.0 million and $159.9 million for the three and nine months ended September 30, 2021, respectively. The prior period had higher costs associated with the submission of our BLA for ublituximab in RMS, increased manufacturing and clinical trial related expenses, as well as an increased non-cash compensation R&D expenses during the three and nine months ended September 30, 2021.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was $14.3 million and $47.5 million for the three and nine months ended September 30, 2022, respectively, compared to $34.9 million and $95.7 million for the three and nine months ended September 30, 2021, respectively. The decrease was due primarily to decreased selling, general and administrative costs, including personnel, associated with the withdrawal of UKONIQ during the three and nine months ended September 30, 2022. We expect our selling, general and administrative expenses to increase for the remainder of 2022 as we prepare for the potential launch of ublituximab in RMS.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $197.7 million as of September 30, 2022. The Company believes its current cash, cash equivalents, investment securities and capital available under its debt facility on ublituximab’s approval will be sufficient to fund our planned operations into 2024.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, November 10, 2022, at 8:30 AM ET, to discuss the Company’s third quarter 2022 financial results.
In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.