TG Therapeutics, Inc. Announces Clinical Data Presentations at the Upcoming 7th Joint ECTRIMS – ACTRIMS Meeting

NEW YORK, Sept. 01, 2017 -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that data from the Phase 2 multicenter trial of TG-1101 (ublituximab) in relapsing forms of Multiple Sclerosis (RMS) have been selected for presentation at the upcoming 7^th Joint ECTRIMS – ACTRIMS meeting, to be held from October 25 – 28, 2017, at the Le Palais de Congrès de Paris, in Paris, France. Details for the poster presentations are as follows:

• Title: Patient characteristics, safety, and preliminary results of a placebo controlled, phase 2a multicenter study of ublituximab (UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb), in patients with relapsing forms of multiple sclerosis
  • Presentation Date & Time: Thursday, October 26^th, 2017; 15:30-17:00 CEST
  • Session Title:  Poster Session 1
  • Presenter: Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, Texas
    
    
• Title: Preliminary results of phase 2 multicenter study of ublituximab (UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb), in patients with relapsing forms of multiple sclerosis (RMS) demonstrates rapid Gd-enhancing lesions decrease
  • Presentation Date & Time: Thursday, October 26^th, 2017; 15:30-17:00 CEST
  • Session Title:  Poster Session 1
  • Presenter: Matilde Inglese, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, NY
     
• Placebo controlled, phase 2a multicenter study of ublituximab (UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb), in patients with relapsing forms of multiple sclerosis (RMS): 6 months analysis of B cell subsets
  • Presentation Date & Time: Friday, October 27^th, 2017; 15:30-17:00 CEST
  • Session Title:  Poster Session 2
  • Presenter: Amy E. Lovett-Racke, PhD, The Ohio State University, Columbus, OH

These data presentations support the recently announced international Phase 3 program evaluating TG-1101 (ublituximab) for the treatment of relapsing form of Multiple Sclerosis (RMS).  The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, will be conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and will be led by Lawrence Steinman, MD, of Stanford University. These trials are expected to commence before the end of Q3 2017.

A copy of the above abstracts will be made available on October 15^th, 2017, on the ECTRIMS meeting website at www.ectrims-congress.eu. Following each poster presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com. 

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 also in clinical development for autoimmune disorders. The Company also has preclinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

Cautionary Statement

Statements included in this press release, particularly those with respect to anticipating the benefit of the early data seen in the Phase 2 MS trial and anticipating the timing of commencement of our MS Phase 3 program may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the MS Phase 2 trial; the risk that early clinical results that supported our decision to move forward will not be reproduced in additional patients in expansion cohorts or in the MS Phase 3 program; the risk that data included in the abstract submission will not be reproduced in the full data presentation; the risk that the clinical results from the MS Phase 3 program, will be not positive and/or will not support regulatory approval of TG-1101 for MS; the risk that TG-1101 will not have a differentiated profile from the other drugs in the class; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission.  Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

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CONTACT:

Jenna Bosco
Vice President, Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: [email protected]