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NEW YORK, Aug. 29, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that abstracts featuring ublituximab, the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of multiple sclerosis (RMS) have been accepted for presentation at the upcoming 35^th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), to be held September 11 – 13, 2019 in Stockholm, Sweden. Abstracts are now available online and can be accessed on the ECTRIMS meeting website at www.ectrims-congress.eu.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased to present the first look of demographic data from our ULTIMATE Phase 3 program, as well as continued long term follow up data from our Phase 2 MS trial during ECTRIMS 2019. The final Phase 2 efficacy data demonstrated ublituximab to be efficacious and the long-term safety data continue to demonstrate a well-tolerated safety profile, with a median duration of follow-up of 97.5 weeks.” Mr. Weiss continued, “MS represents a significant opportunity for the Company and we look forward to topline data from the Phase 3 ULTIMATE program in the middle to second half of 2020.”

Presentation Details:  

• Title:Study Design and Patient Demographics of the ULTIMATE Phase III Trials Evaluating Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Multiple Sclerosis (RMS)
   º Presentation Date & Time:Thursday, September 12, 2019; 17:15 – 19:15 CEST
   º Session Title: Poster Session 2
   º Presenter:Bruce Cree, MD, PhD, University of California San Francisco (UCSF) Weill Institute for Neurosciences

• Title:Long-term Follow-up Results from the Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Multiple Sclerosis (RMS)
   º Presentation Date & Time:Thursday, September 12, 2019; 17:15 – 19:15 CEST
   º Session Title:  Poster Session 2
   º Presenter:Sibyl Wray, MD, Hope Neurology, Knoxville, TN

A copy of the above abstracts can be found on the ECTRIMS meeting website at www.ectrims-congress.eu. Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

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 multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) 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 umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal antibody, TG-1701, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific antibody. 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 data seen in the Phase 2 and OLE MS program and performance in of ublituximab in the Phase 3 ULTIMATE clinical 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: the risk that early clinical results that supported our decision to move forward will not be reproduced in additional patients in expansion cohorts, with longer term follow-up, or in the MS Phase 3 program; the risk that ublituximab will not have a differentiated safety or efficacy profile from the other drugs in the class; the risk that the long-term safety profile presented thus far will not be replicated in the Phase 3 ULTIMATE program; the risk that the clinical results from the MS Phase 3 ULTIMATE program will not be positive and/or will not support regulatory approval of ublituximab to treat MS; the risk that the results from the Phase 3 ULTIMATE program will not available within the guided timelines; our ability to successfully and cost-effectively complete the MS Phase 3 trials; 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.

CONTACT:

Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com 

Source: TG Therapeutics, Inc.