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TG Therapeutics Announces Data Presentations at Upcoming Medical Meetings

Presentations include four oral and two poster presentations across three medical meetings in June

NEW YORK, May 16, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX), today announced the schedule of upcoming data presentations at the 55th American Society of Clinical Oncology (ASCO) annual meeting, to be held May 31 – June 4, 2019, in Chicago, Illinois; the 24th European Hematology Association (EHA) annual congress, to be held June 13 – 16, 2019, in Amsterdam, Netherlands; and at the 15th International Conference on Malignant Lymphoma (ICML), to be held June 18 – 22, 2019, in Lugano, Switzerland. Details of the data presentations are outlined below. 2290083

Data to be presented at the ASCO meeting:

Oral Presentation: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open label, registration directed phase II study

  • Abstract Number: 7506
  • Session Date & Time: Tuesday, June 4, 2019 9:45 AM – 12:45 PM CT
     - Presentation Time: 11:45AM CT
  • Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
  • Location: McCormick Place, Room E451
  • Lead Author: Nathan Hale Fowler, MD, The University of Texas MD Anderson Cancer Center, Department of Lymphoma/Myeloma

The above abstract is now available via the ASCO meeting website at www.asco.org.

Data to be presented at the EHA meeting:

Poster Presentation: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL

  • Session Date & Time: Saturday, June 15, 2019 17:30 – 19:00 CEST
  • Session Title: Lymphoma Biology & Translational Research
  • Location: Amsterdam RAI, Poster Session
  • Lead Author: Marcelo Lima Ribeiro, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Autonomous University of Barcelona, Barcelona, Spain

The above abstract will be available today, May 16, 2019 via the EHA meeting website at www.ehaweb.org.

Data to be presented at the ICML meeting:

Oral Presentation: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy

  • Session Date & Time: Thursday, June 20, 2019 13:45 – 15:15 CEST
     - Presentation Time: 15:00 CEST
  • Session Title: Session 3 - CLL
  • Location: Palazzo dei Congressi, Room A – Main Hall
  • Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

Oral Presentation: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Rel/Ref CLL and Richter’s Transformation

  • Session Date & Time: Thursday, June 20, 2019 17:05 – 18:05 CEST
     - Presentation Time: 17:05 CEST
  • Session Title: Focus on Non-Clinical and Early Clinical Data with New Combinations
  • Location: Palazzo dei Congressi, Cinema Corso
  • Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

Oral Presentation: Umbralisib Monotherapy Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Registration Directed Phase 2 Study

  • Session Date & Time: Saturday, June 22, 2019 10:15 – 11:15 CEST
     - Presentation Time: 10:45 CEST
  • Session Title: Focus on Indolent Non-Follicular Lymphoma
  • Location: Palazzo dei Congressi, Room A and B 
  • Lead Author: Pierre-Luigi Zinzani, MD, University of Bologna, Institute of Hematology "L. e A. Seràgnoli"

Poster Presentation: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL

  • Session Date & Time: Wednesday, June 19 (12:00-17:00 CEST), Thursday, 20 (9:00-17:00 CEST) and Friday, June 21 (9:00-18:30 CEST)
  • Location: Palazzo dei Congressi, Marquee Parco Ciani
  • Lead Author: Marcelo Lima Ribeiro, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Autonomous University of Barcelona, Barcelona, Spain

The above abstracts will be available via the ICML meeting website at www.lymphcon.ch on June 12, 2019.

Following each 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/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
Some of the statements included in this press release or in the abstracts mentioned in this press release 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 preclinical and clinical trials; the risk that early clinical trial results (both safety and efficacy), that may have supported the acceptance of our data for presentation or influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies or in the final presentations; the risk that the combination of ublituximab (TG-1101) and umbralisib (TGR-1202), referred to as U2, and being studied in the UNITY clinical trials and other studies, will not prove to be safe and efficacious for any indication; the risk that the differentiated tolerability profile for umbralisib observed in the abstracts will not be reproduced in full presentations or later larger studies; the risk that the novel bispecific CD47-CD19 antibody, TG-1801, will not potentiate the activity of U2 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 A. Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com