NEW YORK, Aug. 09, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the second quarter ended June 30, 2019 and recent company developments.

Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, stated, "As we enter into the second half of the year, we are pleased with the progress made thus far and excited for the upcoming milestones. With a well-defined path to a regulatory submission for umbralisib in marginal zone lymphoma, we feel confident that we are at a pivotal point in our Company’s lifecycle.” Mr. Weiss continued, “As we prepare for our first filing in MZL, we are also building a top-notch commercial organization which will fuel the long-term success of TG. And with pivotal data readouts also expected in CLL and MS over the next 6-12 months, we believe we are at the beginning of an extremely exciting transformational period for our Company.”

Recent Developments and Highlights

• Marginal Zone Lymphoma - Confirmed Registration Path: Announced confirmation of registration path to submit umbralisib for accelerated approval based on data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b trial.
• Positive Interim Data from MZL Cohort of UNITY-NHL Trial: Presented positive interim data from the MZL cohort of the UNITY-NHL trial during oral presentations at the 55^th American Society of Clinical Oncology (ASCO) annual meeting and the 2019 International Conference on Malignant Lymphoma (ICML).
• Ublituximab Data in Multiple Sclerosis: Presented long-term follow-up data from the Phase 2 trial of ublituximab in patients with relapsing forms of multiple sclerosis (RMS) at the 5th Congress of the European Academy of Neurology (EAN).
• Umbralisib Data in CLL and RT: Presented Phase 2 data of umbralisib in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3k delta inhibitor therapy, and also presented data from patients with relapsed/refractory CLL or Richter’s Transformation (RT) treated with the triple combination of ublituximab, umbralisib and pembrolizumab.
• TG-1801 Preclinical Data: Presented the first preclinical data of TG-1801, the Company’s first-in-class anti-CD47/CD19 bispecific antibody, at the 24th European Hematology Association (EHA) annual congress.

Remaining 2019 and Early 2020 Milestones

• Initiate a rolling New Drug Application (NDA) submission for patients with previously treated MZL
• Present final data from the MZL cohort of the UNITY-NHL registration directed trial evaluating umbralisib in MZL
• Potential top-line progression free survival (PFS) results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with CLL
• Present updated data from our pipeline products and combination studies at upcoming major medical conferences

Financial Results for the Three and Six Months Ended June 30, 2019

• R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation and non-cash in-licensing expense) was $31.4 million and $62.3 million for the three and sixth months ended June 30, 2019 compared to $34.8 million and $66.0 million for the three and six months ended June 30, 2018. The decrease in other R&D expense is primarily attributable to a decrease in clinical trial expenses of $9.7 million and $10.4 million, respectively during the three and six months ended June 30, 2019, as compared to prior periods, offset by an increase in manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization of $7.9 million and $4.7 million, respectively during the three and six months ended June 30, 2019, as compared to prior periods. The current period decrease in other R&D expenses is primarily due to full enrollment in our pivotal Phase III clinical development programs completed in the prior period. We expect other R&D expenses to decrease through the remainder of 2019.
• G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $2.3 million and $4.3 million for the three and six months ended June 30, 2019 as compared to $2.3 million and $4.4 million for the three and six months ended June 30, 2018. Other G&A expenses remained relatively flat compared to the prior period, and we expect Other G&A expenses to increase modestly through the remainder of 2019.
• Net Loss: Net loss was $36.2 million and $71.4 million for the three and six months ended June 30, 2019, respectively, compared to a net loss of $44.1 million and $85.7 million for the three and six months ended June 30, 2018, respectively. Excluding non-cash items, the net loss for the three and six months ended June 30, 2019 was approximately $34.4 million and $67.6 million. We expect our quarterly net loss to decrease through the remainder of 2019.
• Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $85.0 million as of June 30, 2019. Pro forma cash, cash equivalents and investment securities as of June 30, 2019 (excluding our third quarter 2019 operations) are approximately $96.6 million, after giving effect to $11.6 million of net proceeds from the utilization of the Company's at-the-market ("ATM") sales facility during the third quarter of 2019. The Company believes its cash, cash equivalents and investment securities on hand as of June 30, 2019, inclusive of the proceeds raised from the ATM facility subsequent to the second quarter, as well as future availability under the ATM facility, will be sufficient to fund the Company's planned operations through the third quarter of 2020.

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 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 Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. 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 Bruton’s Tyrosine Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific antibody. TG Therapeutics is headquartered in New York City.