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TG Therapeutics, Inc. Announces Data Presentations at the Upcoming 57th American Society of Hematology Annual Meeting

Company to Host Third Quarter Earnings Conference Call to Review Financial Results, Business Updates as well as Provide an Overview of the ASH Abstract Data, on Monday November 9, 2015 at 8:30 am ET

Investor Reception to be Held on Monday December 7, 2015 from 7:45 pm - 9:00 pm ET at the Hyatt Regency Orlando with Presentations by Leading Clinical Investigators

NEW YORK, Nov. 05, 2015 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that updated data for TG-1101 (ublituximab), the Company's novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company’s next generation PI3K delta inhibitor, has been selected for presentation at the upcoming 57th American Society of Hematology Annual Meeting (ASH), to be held December 5-8, 2015, at the Orange County Convention Center in Orlando, Florida.

Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated “We are very excited to be able to provide updates on our key Phase 1 and 2 clinical studies for TG-1101 and TGR-1202 at the upcoming ASH conference. With patients now on once-daily TGR-1202 for durations of over 2.5 years, we and our investigators continue to believe that TGR-1202 has a differentiated safety profile in comparison to other PI3K delta inhibitors and continues to pair nicely with TG-1101 in our proprietary “TG-1303” regimen, which we believe exhibits best-in-class attributes that not only supports our recently announced Phase 3 UNITY-CLL study, but provides a safe and highly active backbone for building novel triple and potentially quad therapies. We are also excited to report data from the first triple therapy of TGR-1202 plus chemotherapy plus a glycoengineered anti-CD20 monoclonal antibody (obinutuzumab) which appeared to be well tolerated with a high level of activity in both front-line CLL patients and patients refractory to BTK inhibitors. We believe these data further support our UNITY-CLL study and also provide a nice comparison to TG-1303, especially from a safety standpoint. Finally, there will be one pre-clinical oral presentation that elucidates a very novel and exciting mechanism of TGR-1202, that is unique to TGR-1202 as opposed to other PI3K delta inhibitors and could have broad ranging implications for certain combinations in both liquid and solid tumors," stated Michael S. Weiss, the Company's Executive Chairman and Interim CEO. He continued, "We are looking forward to sharing the full datasets for these presentations in a few weeks, which will contain more detailed data and additional patients than included in the abstracts."

Presentations on TG-1101 and TGR-1202 at the ASH meeting include the following:

Clinical Posters:

  • Title: Ublituximab + TGR-1202 Demonstrates Activity and Favorable Safety Profile in Relapsed/Refractory B-Cell NHL and High-Risk CLL: Phase I Results
    • Abstract Number: 1538
    • Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
    • Date and Time: Saturday, December 5, 2015; 5:30 PM- 7:30 PM ET
    • Location: Orange County Convention Center, Hall A
    • Presenter: Matthew Lunning, DO
  • Title: A Phase I Trial of TGR-1202, a Next Generation Once Daily PI3K-Delta Inhibitor in Combination with Obinutuzumab Plus Chlorambucil, in Patients with Chronic Lymphocytic Leukemia
    • Abstract Number: 2942
    • Session: 642. CLL: Therapy, excluding Transplantation: Poster II
    • Date and Time: Sunday, December 6, 2015; 6:00 PM-8:00 PM ET
    • Location: Orange County Convention Center, Hall A
    • Presenter: Daruka Mahadevan, MD, PhD


  • Title: Ublituximab (TG-1101), A Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Combination With Ibrutinib is Highly Active in Patients With Relapsed And/Or Refractory Mantle Cell Lymphoma; Results of a Phase II Trial
    • Abstract Number: 3980
    • Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III
    • Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
    • Location: Orange County Convention Center, Hall A
    • Presenter: Kathryn Kolibaba, MD


  • Title: TGR-1202, a Novel Once Daily PI3K-Delta Inhibitor, Demonstrates Clinical Activity with a Favorable Safety Profile in Patients with CLL and B-Cell Lymphoma
    • Abstract Number: 4154
    • Session: 642. CLL: Therapy, excluding Transplantation: Poster III
    • Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
    • Location: Orange County Convention Center, Hall A
    • Presenter: Owen O'Connor, MD, PhD

Non-Clinical Oral Presentation:

  • Title: Disruption of the mTOR-eIF4F Axis By Selectively Targeting PI3Kdelta and Proteasome Potently Inhibits Cap Dependent Translation of c-Myc in Aggressive Lymphomas
    • Abstract Number: 593
    • Oral Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Novel Therapies and Targets in Lymphoma
    • Date and Time: Monday, December 7, 2015; 10:30 AM - 12:00 PM ET
    • Presentation Time: 11:30 AM ET
    • Location: Orange County Convention Center, Tangerine 1 (WF1)
    • Presenter: Changchun Deng, MD, PhD

A copy of the above referenced abstracts can be viewed online through the ASH meeting website at www.hematology.org.

TG Therapeutics will also host a reception on Monday, December 7th, 2015 beginning at 7:45pm ET, with featured presentations beginning promptly at 8:00pm ET. The event will take place at the Hyatt Regency Orlando. This event will be webcast live and will be available on the Events page, under the Investors & Media tab, 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. 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. The Company also has a pre-clinical program to develop IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies 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 pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; 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 Director- Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com

Source:TG Therapeutics, Inc.