On March 29, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, reported that interim data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial to be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting has an updated embargo date and time of Monday, April 1, 2019 at 8:30am ET (Press release, TG Therapeutics, MAR 29, 2019, View Source [SID1234534782]). At that time, the abstract will be available via the AACR (Free AACR Whitepaper) meeting website at www.aacr.org, and the data which will be presented during an oral session later that day (details below) will be available on the Company’s website at www.tgtherapeutics.com/publications.cfm.

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The Company will also host a conference call with Dr. Nathan Fowler of the MD Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort at 12:00pm (noon) ET on Monday April 1, 2019 to review the UNITY-NHL MZL interim data.

Details are provided below outlining the Company’s schedule of events for April 1, 2019.

CONFERENCE CALL INFORMATION
The Company will host a conference call on Monday April 1, 2019, 12:00pm (noon) ET. Michael S. Weiss, Chief Executive Officer of TG Therapeutics, will host the call, and Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, will review the UNITY-NHL interim MZL data.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics AACR (Free AACR Whitepaper) Update Call.

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

2019 AACR (Free AACR Whitepaper) ORAL PRESENTATION DETAILS

Title: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study
– Session Date and Time: Monday April 1, 20193:00 PM – 5:00 PM ET
– Presentation Time:4:20 PM ET
– Session Title: The Next Generation of Clinical Trials in Molecularly-driven Therapy
– Session Location: Marcus Auditorium- Bldg A-GWCC
– Presenter: Nathan Fowler, MD, Associate Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
– Abstract Number: 7821
ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort
The multicenter, open-label, UNITY-NHL Phase 2b study – Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.

The MZL cohort completed enrollment in August 2018 with a total of 69 patients enrolled and receiving at least one dose of umbralisib. In February of 2019, the Company announced that the MZL cohort met its primary endpoint of ORR as determined by central IRC for all treated patients (n=69). While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted later this year once all treated patients have had at least 9 cycles (Cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

ABOUT BREAKTHROUGH THERAPY DESIGNATION

The Company announced in January of 2019 that the U. S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20 regimen.

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies