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TG Therapeutics, Inc. Announces Upcoming Data Presentations at the 54th Annual Meeting of the American Society of Clinical Oncology and the 23rd Congress of the European Hematology Association
[May 17, 2018]

TG Therapeutics, Inc. Announces Upcoming Data Presentations at the 54th Annual Meeting of the American Society of Clinical Oncology and the 23rd Congress of the European Hematology Association


NEW YORK, May 17, 2018 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that abstracts featuring umbralisib (TGR-1202), the Company's once-daily PI3K delta inhibitor, and TG-1701, the Company’s orally available BTK inhibitor, have been selected for presentation at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held from June 1 - 5, 2018, in Chicago, Illinois and at the 23rd Congress of the European Hematology Association (EHA), to be held June 14 - 17, 2018, in Stockholm, Sweden. Details of the data presentations are outlined below.

Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, stated, “We look forward to an impactful summer conference season with presentations at both the ASCO annual meeting and the EHA annual congress. The data at these two conferences continue to demonstrate a differentiated tolerability profile for umbralisib both in the long-term follow-up of our previously reported integrated analysis and in patients intolerant to prior BTK and PI3K delta inhibitors. As we near the ORR read-out from UNITY-CLL, a potential BLA/NDA submission and completion of enrollment in UNITY-NHL, we can feel the momentum building toward achieving our goal of bringing important new treatment options for patients with B-cell malignancies.”

Data being presented at the ASCO meeting:

  • Poster Presentation Title: A phase 2 study to assess the safety and efficacy of umbralisib (TGR-1202) in patients with CLL who are intolerant to prior BTK or PI3Kd inhibitor therapy
    — Date & Time: Monday June 4, 2018; 8:00 AM – 11:30 AM CT
    — Abstract Number: 7530
    — Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
    — Location: McCormick Place South, Exhibit Hall A
    — Presenter: Anthony R. Mato, MD

The above abstract was released publicly, yesterday, May 16, 2018 at 5pm ET through the ASCO meeting website at www.asco.org.

Data being presented at the EHA meeting:

  • Oral Presentation Title: A Phase 2 Study to assess the safety and efficacy of umbralisib (TGR-1202) in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy
    — Date & Time: Saturday June 16, 2018; 12:30 – 12:45 CEST
    — Abstract Number: S808
    — Session Title: Combination treatment with targeted agents in CLL
    — Location: Stockholmsmässan, Victoria Hall 
    — Presenter: Anthony R. Mato, MD

  • Oral Presentation Title: Resurrecting response to ruxolitinib: a phase I study testing the combination of ruxolitinib and the PI3Kdelta inhibitor umbralisib in ruxolitinib-experienced myelofibrosis
    — Date & Time: Friday June 15, 2018, 12:30 – 12:45 CEST
    — Abstract Number: S133
    — Session Title: Myeloproliferative neoplasms - Clinical
    — <>Location: Stockholmsmässan, Room A7


    — Presenter: Tamara Kay Moyo, MD, PhD

  • Poster Presentation Title: Long term integrated safety analysis of umbralisib (TGR-1202), a PI3K delta/CK1-epsilon inhibitor with a differentiated safety profile in patients with relapsed/refractory lymphoid malignancies
    — Date & Time: Friday June 15, 2018; 17:30 – 19:00 CEST
    — Abstract Number: PF444
    — Session Title: Indolent Non-Hodgkin lymphoma – Clinical
    — Location: Stockholmsmässan, Poster Area
    — Presenter: Matthew S. Davids, MD


  • Poster Presentation Title: TG-1701 a novel, orally available, and covalently-bound BTK inhibitor
    — Date & Time: Friday June 15, 2018; 17:30 – 19:00 CEST
    — Abstract Number: PF638
    — Session Title: Non-Hodgkin lymphoma Biology & Translational Research
    — Location: Stockholmsmässan, Poster Area
    — Presenter: Emmanuel Normant, PhD

The above abstracts were released publicly, today, May 17, 2018 at 9am ET through the EHA meeting website at www.ehaweb.org.

Following each presentation, the data presented will be available on the Publications page, of the Company's website at www.tgtxinc.com/publications.cfm.

TG THERAPEUTICS INVESTOR & ANALYST EVENT at ASCO

TG Therapeutics will also host a reception on Sunday, June 3, 2018 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:15pm CT. The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2017 Investor & Analyst Event.

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. 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 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 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 its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. 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 final data from either GENUINE or UNITY-CLL will not support a regulatory filing or approval or that the company will choose not to file a BLA/NDA or seek accelerated approval based on those studies 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
SVP, Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: [email protected]

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