TG Therapeutics Recaps Schedule of Data Presentations at the Upcoming 63rd American Society of Hematology (ASH) Annual Meeting

Rhea-AI Summary

TG Therapeutics, Inc. (NASDAQ: TGTX) announced the schedule for data presentations at the 63rd American Society of Hematology (ASH) annual meeting from December 11-14, 2021. Key oral presentations include the efficacy of U2 (Umbralisib and Ublituximab) in treating various hematologic malignancies. Presentations focus on relapsed/refractory marginal zone lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The company continues to advance its pipeline, including the accelerated FDA approval of UKONIQ® for specific lymphoma treatments.

Positive

• TG Therapeutics has received FDA accelerated approval for UKONIQ® (umbralisib) for certain lymphoma treatments.
• The company presents multiple promising data at ASH, showcasing advancements in hematologic malignancies.
• The ongoing clinical trials indicate a robust pipeline with potential future growth.

Negative

• The press release includes forward-looking statements that highlight several risks, including potential delays in clinical trials due to COVID-19.
• There is uncertainty regarding the safety and efficacy of the U2 combination therapy as more patients are exposed.

NEW YORK, Dec. 10, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today recapped the schedule of data presentations at the upcoming 63^rd American Society of Hematology (ASH) annual meeting and exposition, to be held December 11 – 14, 2021, virtually and also live at the Georgia World Congress Center in Atlanta, Georgia.

ASH Presentation Details:

Oral Presentations:
Oral Presentation Title: The Combination of Umbralisib Plus Ublituximab Is Active in Patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL): Results from the Phase 2 Global Unity-NHL Trial

• Session Date/Time: Saturday, December 11, 2021 / 10:00 AM ET
• Session Name: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Targeted Therapy in Low Grade Lymphoma
• Room: Georgia World Congress Center, A411-A412
• Lead Author: Julio Chavez, MD, MS, Moffitt Cancer Center, Tampa, FL
  

Oral Presentation Title: Efficacy and Safety of Umbralisib, Ublituximab (U2), and U2 Plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

• Session Date/Time: Sunday, December 12, 2021 / 5:30 PM ET       
• Session Name: 626. Aggressive Lymphomas Prospective Therapeutic Trials: Novel Agents and Combinations
• Room: Georgia World Congress Center, Thomas Murphy Ballroom 1-2
• Lead Author: John Burke, MD, Rocky Mountain Cancer Centers / US Oncology Research, Aurora, CO

Oral Presentation Title: A Phase 2 Study Evaluating the Addition of Ublituximab and Umbralisib (U2) to Ibrutinib in Patients with Chronic Lymphocytic Leukemia (CLL): A Minimal Residual Disease (MRD)-Driven, Time-Limited Approach

• Session Date/Time: Sunday, December 12, 2021 / 10:30 AM ET
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I
• Room: Georgia World Congress Center, B401-B402
• Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY

Poster Presentations:
Poster Presentation Title: The Selective Bruton Tyrosine Kinase (BTK) Inhibitor TG-1701 As Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-Cell Malignancies

• Date/Time: Saturday, December 11, 2021 / 5:30 PM - 7:30 PM ET
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I
• Location: Georgia World Congress Center, Hall B5
• Lead Author: Chan Y. Cheah, MBBS, DMSc, Linear Clinical Research, Nedlands, Australia; Medical School, University of Western Australia, Perth, Australia; and Department of Haematology, Sir Charles Gairdner Hospital, Perth, Australia

Poster Presentation Title: Favorable Outcomes for Patients Treated with U2 with Co-Morbidities or Concomitant Medications: A Retrospective Analysis of Unity-CLL Phase 3 Trial

• Date: Monday, December 13, 2021 / 6:00 PM - 8:00 PM
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
  Location: Georgia World Congress Center, Hall B5
• Lead Author: Javier Pinilla-Ibarz, MD, Lymphoma Section Head, Director of Immunotherapy, Malignant Hematology Division at the H. Lee Moffitt Cancer Center in Tampa, Florida
  

Poster Presentation Title: Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study

• Date/Time: Monday, December 13, 2021 / 6:00 PM - 8:00 PM
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
• Location: Georgia World Congress Center, Hall B5
• Lead Author: Ryan Jacobs, MD, Department of Hematology, Lymphoma Division, Assistant Professor of Medicine, Levine Cancer Institute/Atrium Health, Charlotte, NC

Abstracts are now publicly available via the ASH meeting website at www.hematology.org. Final presentations will be accessible at the above dates/times via the publications page of TG corporate website at http://tgtxinc.com/publications.cfm.

ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ^® (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has three programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.

UKONIQ^® is a registered trademark of TG Therapeutics, Inc.

Cautionary Statement
This press release contains 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. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially include the following: the risk that interim, top-line, or other early clinical trial results, 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 final data sets or in future studies; the risk that the safety profile observed with umbralisib, ublituximab or TG-1701, or combinations thereof, may change as additional patients are exposed for longer durations; the risk that the U2 combination will not prove to be a safe and efficacious combination, or backbone for triple therapy combinations; the risk that we will not be able to meet the regulatory submission or clinical trial timelines that we project or achieve other anticipated milestones, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones; and the risk that our compounds will not receive regulatory approval or become commercially successful products. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, our most recent Quarterly Report filed on Form 10-Q, and our other filings with the U.S. 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:

Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6

FAQ

What is the schedule for TG Therapeutics presentations at ASH 2021?

TG Therapeutics will present data from December 11-14, 2021, focusing on various hematologic malignancies.

What does the FDA approval of UKONIQ® mean for TG Therapeutics?

FDA's accelerated approval of UKONIQ® allows TG Therapeutics to market this treatment for certain lymphoma patients, enhancing its product portfolio.

What are the implications of the upcoming ASH presentations for TGTX stock?

The ASH presentations may positively influence TGTX stock by showcasing the company's advancements in treatment options for serious conditions.

What are the main focuses of TG Therapeutics' ASH presentations?

The main focuses include the efficacy and safety of U2 in treating marginal zone lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.