TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the final Phase 2 data from the multicenter trial of ublituximab (TG-1101), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS) has been selected for presentation at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual meeting, to be held February 28 through March 2, 2019 in Dallas, Texas. This data was previously presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting held in October of 2018.

Abstract Highlights:

An Annualized Relapse Rate (ARR) of 0.07 was observed for all patients

Ublituximab completely eliminated all (100%) of T1 Gd-enhancing lesions at week 24 (n=44) and maintained at week 48 (n=22)

Median B cell depletion was >99% at the primary analysis point of Week 4, and maintained at Week 24 (n=44) and Week 48 (n=22)

Ublituximab was well tolerated with no discontinuations due to severe adverse events (SAE's) reported and accelerated infusions times as short as 1 hour for the 450mg Phase 3 dose

Presentation Details:

Title:Final Results of a Phase 2 Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Forms of Multiple Sclerosis (RMS)

Abstract Number: 3892

Presentation Date & Time: Thursday, February 28, 2019, 6:00 PM - 8:00 PM CT

Session Title: Poster Session 1 / Opening Network Event

Location: Chantilly Ballroom, Hilton Anatole, Dallas, TX

Presenter: Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, Texas

These data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab (TG-1101) for the treatment of relapsing form of Multiple Sclerosis (RMS). The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University.

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