TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2019 Financial ResultsConference call to be held today, Tuesday,…

NEW YORK, March 03, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the fourth quarter and year ended December 31, 2019 and recent company developments, along with a business outlook for 2020.

Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, stated, "2019 was a transformational year for TG as we were able to report positive outcomes for umbralisib in both previously treated marginal zone lymphoma and follicular lymphoma from the UNITY-NHL trial. We also confirmed a submission pathway with the FDA and early this year commenced a single rolling submission based on these data, which we hope to complete in the first half of this year. Mr. Weiss continued, Looking forward, we expect 2020 to be yet another impactful year as we await the topline results from our Phase 3 programs in CLL and MS and potentially our first FDA approval around year-end.

2019 Highlights & Recent Developments

Key Objectives for 2020

Financial Results for the Fourth Quarter and Full Year 2019

Conference Call Information

The Company will host a conference call today, March 3, 2020, at 8:00 AM ET, to discuss the Companys fourth quarter and year-end 2019 financial results and provide a business outlook for 2020.

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 Year-End 2019 Earnings Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for replay at http://www.tgtherapeutics.com, for a period of 30 days after the call.

ABOUT TG THERAPEUTICS, INC.

TG Therapeuticsis 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 Therapeuticsis also developing umbralisib (TGR-1202), an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon, which may lead to a differentiated safety profile.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 Brutons Tyrosine Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific antibody.TG Therapeuticsis headquartered inNew York City.

Cautionary Statement Some of the statements included 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. In addition to the risk factors identified from time to time in our reports filed with theSecurities and Exchange Commission, factors that could cause our actual results to differ materially are the following: the risk that the interim data (the Interim Results) from the UNITY-NHL MZL cohort will not be reproduced when the final analysis is conducted on all patients, including the risk that the final results will demonstrate a lower ORR and/or enhanced toxicities, which may not support a filing for accelerated approval; the risk that the final analysis of the UNITY-NHL MZL or FL cohorts will be insufficient to support a filing for accelerated approval; the risk that umbralisib will not receive accelerated approval based on data from the UNITY-NHL MZL or FL cohorts even if the final results are deemed positive by the Company and support a filing for accelerated approval; the risk that duration of response or progression free survival data from the UNITY-NHLcohort when available for all patients will not be positive; the risk that safety issues will arise when the final safety data are cleaned and analyzed for all patients in the UNITY-NHL MZL or FL cohorts; the risk that the positive InterimResults from the UNITY-NHL MZL or FL cohorts will not be reproduced in other cohorts of the UNITY-NHLstudy or in other studies being conducted by the Company; the risk that our belief that umbralisib has a differentiated safety profile will not be shared by physicians or theFDAor will not be reproduced in the final analysis of the UNITY-NHL MZL or FL cohorts, in other cohorts of the UNITY-NHLstudy, in the UNITY-CLL study or in any other of our on-going studies; the risk that PFS data from UNITY-CLL will not be positive or, if positive, will not be accepted for filing by the FDA, or ultimately receive approval for the combination of U2 in CLL; the risk that the anticipated timeline for completing the submission of the umbralisib NDA in MZL and FL based on the UNITY NHL data or for regulatory review of such submission and the timeline for data releases, submission, and regulatory approval for UNITY-CLL and ULTIMATE-MS trials, or the projected advancements of our early pipeline will be delayed due to a variety of factors, including, without limitation, available resources, program reprioritization, slower than expected event rates for UNITY-CLL and/or requests fromFDAor foreign regulators; the risk that we are not able to successfully and cost effectively complete all the preclinical, clinical and CMC requirements necessary to support accelerated approval; the risk that we are unable to manage cash in line with our expectations and meet our development milestones and/or continue our operations without raising capital; the risk that we are unable to raise capital on acceptable terms; the risk that early clinical trial results that may have influenced our decision to proceed with additional clinical trials may not be replicated; and other risk factors identified from time to time in our reports filed with theSecurities 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 atwww.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 Senior Vice President, Corporate Communications TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com

TG Therapeutics, Inc. Selected Consolidated Financial Data

Statements of Operations Information (in thousands, except share and per share amounts; unaudited):

$(1.96

)

$(2.30

)

Consolidated Balance Sheet Information (in thousands):

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TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2019 Financial ResultsConference call to be held today, Tuesday,...