TGTX TG Therapeutics Inc.

25.91
-0.25  -1%
Previous Close 26.16
Open 26.17
52 Week Low 6.34
52 Week High 31.97
Market Cap $3,281,480,902
Shares 126,649,205
Float 99,274,796
Enterprise Value $3,078,599,202
Volume 1,086,872
Av. Daily Volume 1,786,702
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Upcoming Catalysts

Drug Stage Catalyst Date
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
Phase 3
Phase 3
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TG-1101 - ULTIMATE I
Multiple Sclerosis
Phase 3
Phase 3
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TG-1101 - ULTIMATE II
Multiple Sclerosis
Phase 3
Phase 3
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Umbralisib
Marginal zone lymphoma (MZL)
PDUFA priority review
PDUFA priority review
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Umbralisib
Follicular lymphoma (FL)
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
TG-1701
Non Hodgkin Lymphoma / Chronic Lymphocytic Leukemia
Phase 1
Phase 1
Phase 1 data presented at ASH December 9, 2019. ORR 86%.
TG-1101 (ublituximab)
Relapsing forms of Multiple Sclerosis (RMS)
Phase 2
Phase 2
Phase 2 long term follow up data presented at ECTRIMS, September 12, 2019.
Umbralisib + Ublituximab + Venetoclax
Chronic Lymphocytic Leukemia
Phase 1/2
Phase 1/2
Phase 1/2 data presented at ASH December 8, 2019 noted 100% ORR (9/9) including 44% CR after cycle 12 for the combination.
Umbralisib (TGR-1202) + Pembrolizumab + Ublituximab (TG-1101)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 1/2
Phase 1/2
Phase 1/2 updated data noted 91% ORR for CLL patients; 38% for Richter’s transformation.
TGR-1202 (umbralisib) plus obinutuzumab
Relapsing or refractory Follicular Lymphoma
Phase 2
Phase 2
Phase 2 initiation announced November 27, 2017.
TG-1801
Relapsed or Refractory B-cell Lymphoma
Phase 1
Phase 1
Phase 1 trial initiation announced February 26, 2019.
TG-1101 and IMBRUVICA (GENUINE trial)
Chronic Lymphocytic Leukemia (CLL) cancer
Phase 3
Phase 3
Phase 3 trial met primary endpoint - March 6, 2017. Data presented at ASCO 2017.

Latest News

  1. NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of ublituximab, the Company's investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

    Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL. The application…

    NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of ublituximab, the Company's investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of adult patients with chronic lymphocytic leukemia (CLL).



    Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL. The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that we announced earlier this year had met its primary endpoint of progression free survival. This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL." Mr. Weiss continued, "We look forward to presenting data from the UNITY-CLL Phase 3 trial later this year, which we plan to use as the basis of a U2 regulatory submission for CLL."



    ABOUT FAST TRACK

    Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy. 



    A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologic License Application or New Drug Application.

    ABOUT UNITY-CLL PHASE 3 TRIAL

    UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus umbralisib, or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, umbralisib single agent, ublituximab plus umbralisib and an active control arm of obinutuzumab plus chlorambucil. A prespecified analysis was conducted to assess the contribution of ublituximab and umbralisib in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Full enrollment into the UNITY-CLL Phase 3 trial completed in October of 2017 with approximately 420 subjects enrolled to the two combinations arms. This trial enrolled approximately 60% treatment-naïve CLL patients and 40% relapsed or refractory CLL patients. The primary endpoint for this study was superior Progression Free Survival (PFS) for the U2 combination compared to the control arm to support the submission for full approval of the U2 combination in CLL. Positive topline results from this trial were announced in May 2020. The UNITY-CLL Phase 3 trial is being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

    ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA

    Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and in 2020 it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States1. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.



    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 in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as "U2", targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS).  Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

    __________________________________________________

    Cancer Stat Facts: Leukemia – Chronic Lymphocytic Leukemia 

    https://seer.cancer.gov/statfacts/html/clyl.html

    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 we are not able to successfully deliver the complete data set from the UNITY-CLL trial on schedule as planned; the risk that safety issues or trends will be observed in the UNITY-CLL study when the full safety dataset is available or in any other on-going studies that prevent approval of either ublituximab and/or umbralisib; the risk that the safety and efficacy profile observed in the UNITY-CLL study is not supportive of a differentiated profile; the risk that the UNITY-CLL trial, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory submission or approval; and the risk that we are not able to achieve the milestones we project, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones. 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

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:

    Primary Logo

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  2. NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its participation at two upcoming virtual investor conferences. Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, is scheduled to participate in fireside chats during the following conferences:

    • The H.C. Wainwright 22nd Annual Global Investment Conference – fireside chat scheduled to take place on Monday, September 14, 2020 at 1:30 PM ET
    • The Cantor Fitzgerald Global Healthcare Conference – fireside chat scheduled to take place on Wednesday, September 16, 2020 at 10:40 AM ET

    A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company's website…

    NEW YORK, Sept. 09, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its participation at two upcoming virtual investor conferences. Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, is scheduled to participate in fireside chats during the following conferences:

    • The H.C. Wainwright 22nd Annual Global Investment Conference – fireside chat scheduled to take place on Monday, September 14, 2020 at 1:30 PM ET
    • The Cantor Fitzgerald Global Healthcare Conference – fireside chat scheduled to take place on Wednesday, September 16, 2020 at 10:40 AM ET

    A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events.

    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 in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as "U2", targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS). Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.



    CONTACT:

    Jenna Bosco

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:  

    Primary Logo

    View Full Article Hide Full Article
  3. NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been…

    NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.

    Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased with the FDA's acceptance of our first NDA submission and look forward to working with the FDA during the review process. This is a significant achievement in our path towards accomplishing our goal of developing novel treatments for patients with B-cell diseases." Mr. Weiss continued, "If approved, we believe umbralisib could become an important treatment option for patients with previously treated MZL and FL. We look forward to presenting the data from the UNITY-NHL trial that supported this NDA submission by year end."

    The NDA for umbralisib was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial evaluating patients with relapsed/refractory MZL or FL. The Company has previously announced that each cohort met its primary endpoint of overall response rate (ORR), meeting the Company's target guidance of 40-50% ORR, as confirmed by an Independent Review Committee (IRC). The FDA has also previously granted umbralisib Breakthrough Therapy Designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

    ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS 

    The UNITY- NHL trial is a global multicenter, open-label Phase 2b trial.

    The MZL 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. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the Company's target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) annual meeting, the American Society of Clinical Oncology (ASCO) annual meeting and the International Conference on Malignant Lymphoma (ICML).

    The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients. The results met the Company's prespecified response target of 40-50% ORR.

    On June 15, 2020, the Company announced the completion of the rolling submission of a NDA to the FDA requesting accelerated approval of umbralisib as a treatment for patients with previously treated MZL and FL.

    On August 12, 2020, the Company received notification from the FDA of its acceptance of the Company's NDA for umbralisib as a treatment for patients with previously treated MZL and FL.

    ABOUT MARGINAL ZONE LYMPHOMA

    Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) mature B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a chronic and incurable disease. With an annual incidence of approximately 7,500 newly diagnosed patients in the United States1, MZL is the third most common B-cell NHL, accounting for approximately eight percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL)2.

    ABOUT FOLLICULAR LYMPHOMA

    Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients3, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases4.

    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 in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as "U2", targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS). Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

    __________________________________________________

    12016 Lymphoid Malignancy Statistics by World Health Organization Subtypes VOLUME 66 _ NUMBER 6 _ NOVEMBER/DECEMBER 2016 https://onlinelibrary.wiley.com/doi/pdf/10.3322/caac.21357

    Lymphoma Research Foundation: Marginal Zone Lymphoma https://lymphoma.org/aboutlymphoma/nhl/mzl/

    American Cancer Society "Key Statistics for Non-Hodgkin Lymphoma"

    Lymphoma Research Foundation "Follicular Lymphoma"

    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 umbralisib may not receive regulatory approval for previously treated MZL or FL in the currently anticipated timeline or at all; the risk that the FDA may grant approval that is more restrictive than anticipated; our ability to successfully launch umbralisib for previously treated MZL or FL, if those indications are approved by the FDA; our ability to successfully and cost-effectively complete our ongoing and planned clinical trials; the risk that early clinical trial results (both safety and efficacy), which may have influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; and the risk that the COVID-19 pandemic causes unforeseen delays in the FDA timelines we have outlined or in our ability to achieve other milestones we project. 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

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:

     

    Primary Logo

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  4. NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its financial results for the second quarter ended June 30, 2020 and recent company developments.

    Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased by the progress made thus far in 2020 and are looking forward to an impactful end of year and into 2021. Completing the NDA rolling submission this past June for umbralisib in previously treated Marginal Zone Lymphoma and Follicular Lymphoma was a major milestone for our Company." Mr. Weiss continued, "With one completed NDA submission, positive topline data from our UNITY-CLL Phase 3 trial, and a healthy balance sheet with over $275 million…

    NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its financial results for the second quarter ended June 30, 2020 and recent company developments.

    Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased by the progress made thus far in 2020 and are looking forward to an impactful end of year and into 2021. Completing the NDA rolling submission this past June for umbralisib in previously treated Marginal Zone Lymphoma and Follicular Lymphoma was a major milestone for our Company." Mr. Weiss continued, "With one completed NDA submission, positive topline data from our UNITY-CLL Phase 3 trial, and a healthy balance sheet with over $275 million in cash, we are well positioned to execute on our remaining milestones for this year as well as transition from a development stage company to a fully-integrated commercial organization. For the remainder of this year, we look forward to reporting topline data from our Phase 3 ULTIMATE program in Multiple Sclerosis, full data presentations from the UNITY-NHL FL and MZL single agent umbralisib cohorts, data presentation from the UNITY-CLL Phase 3 trial, as well as updated data from our triple combination trials, which we believe set the stage for the future of U2 in CLL and non-Hodgkin's Lymphoma."

    Recent Developments and Highlights

    • Marginal Zone Lymphoma & Follicular Lymphoma:

      ° In June 2020, completed rolling submission of New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for umbralisib as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).



    • Chronic Lymphocytic Leukemia:

      ° In May 2020, reported positive topline results from the Company's UNITY-CLL Phase 3 trial evaluating U2 (the combination of umbralisib and ublituximab) in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The trial met its primary endpoint of improved progression-free survival (PFS) (p<.0001), as determined by an Independent Review Committee (IRC).

      ° In May 2020, reported final results from the GENUINE Phase 3 study evaluating the combination of ublituximab plus ibrutinib compared to ibrutinib alone in patients with relapsed/refractory CLL with high-risk cytogenetics. Results indicated the addition of ublituximab to ibrutinib as compared to ibrutinib alone improved PFS, overall response rate, complete response rate and the number of patients with undetectable minimal residual disease.



    • Multiple Sclerosis:

      ° In May 2020, announced the publication of results from the multicenter Phase 2 trial evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS) in the Multiple Sclerosis Journal.

       
    • Bolstered Balance Sheet:

      ° In May 2020, strengthened balance sheet with more than $240 million in gross proceeds through a public offering and the Company's At-the-Market (ATM) facility. 

       
    • Publication:

      ° In July 2020, published preclinical data describing the unique immunomodulatory effects of umbralisib, in Blood Advances, a Journal of the American Society of Hematology.



    • Board of Directors & Management:

      ° In May 2020, appointed Sagar Lonial, MD, FACP, Professor and Chair of the Department of Hematology and Medical Oncology at the Emory University School of Medicine, as well as the Chief Medical Officer at Winship Cancer Institute of Emory University, to the Company's Board of Directors.

      ° In May 2020, strengthened executive team with the addition of Owen A. O'Connor, MD, PhD as Chief Scientific Officer. Dr. O'Connor most recently served as a Professor of Medicine and Experimental Therapeutics, the Director of the Center for Lymphoid Malignancies, and Co-Program Director of the Lymphoid Development and Malignancy Program in the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center.

    Key Objectives for Remainder of 2020 and Early 2021

    • Report topline results from the Phase 3 ULTIMATE I & II trials in Multiple Sclerosis.
    • Present full data from the UNITY-CLL Phase 3 trial and present full data from the FL and MZL single agent umbralisib cohorts of the UNITY-NHL trial at a major medical meeting.
    • Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients)
    • Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801.

    Financial Results for the Three and Six Months Ended June 30, 2020

    • R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $34.9 million and $68.9 million for the three and six months ended June 30, 2020, respectively, compared to $31.4 million and $62.3 million for the three and six months ended June 30, 2019, respectively. The modest increase in R&D expense during the three and six month periods of 2020 is primarily attributable to our ongoing clinical development programs as well as preparations for regulatory filings and potential commercialization. We expect our R&D expenses to decrease during the remainder of 2020 as costs associated with our main pivotal clinical trials continue to decline, partially offset by expenses associated with the expected NDA/BLA filing for U2 in CLL.

       
    • G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $8.6 million and $13.8 million for the three and six months ended June 30 2020, respectively, as compared to $2.3 million and $4.3 million for the three and six months ended June 30, 2019, respectively. The increase in other G&A expenses is primarily due to increased personnel and other general and administrative costs, associated with preparations for a potential commercial launch. We expect G&A expenses to increase modestly during the remainder of 2020 in preparation for potential launch.

       
    • Net Loss: Net loss was $52.9 million and $104.0 million for the three and six months ended June 30, 2020, respectively, compared to a net loss of $36.2 million and $71.4 million for the three and six months ended June 30, 2019, respectively. Excluding non-cash compensation, the net loss for the three and six months ended June 30, 2020 was approximately $45.5 million and $85.6 million, respectively, compared to a net loss of $34.5 million and $67.7 million for the three and six months ended June 30, 2019, respectively.

       
    • Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $275.6 million as of June 30, 2020. The Company believes its cash, cash equivalents and investment securities on hand as of June 30, 2020, as well as future availability under the Company's debt and ATM facility, will be sufficient to fund the Company's planned operations through the end of 2021.

    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 in late stage clinical development with two investigational therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a 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, dual inhibitor of PI3K-delta and CK1-epsilon. 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.

    Cautionary Statement

    This press release includes 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 are the following: the risk that the final analysis of the UNITY-NHL MZL or FL cohorts will be insufficient to support FDA approval of umbralisib, or, if supportive of approval, will not be supportive of a differentiated profile; the risk that we are unable to successfully deliver the complete data set from the UNITY-CLL trial or prepare a regulatory submission on schedule as planned; the risk that the final analysis of the UNITY-CLL study will be insufficient to support FDA approval of the combination regimen of umbralisib and ublituximab in CLL or, if supportive of approval, will not be supportive of a differentiated profile; the risk that any of our other registration-directed clinical trials, including the ULTIMATE I & II trials, as designed or amended may not be positive, or if positive, may not be sufficient or acceptable to support regulatory submission or approval of ublituximab in relapsing forms of MS; the risk that achievement of the clinical development and regulatory milestones we project will be delayed due to a variety of factors, including, without limitation, the evolving and unpredictable COVID-19 pandemic, available resources, program reprioritization, and feedback from the FDA or foreign regulators; the risk that we are not able to successfully or cost effectively complete all the preclinical, clinical and CMC requirements necessary to support regulatory submissions; the risk that early clinical trial results that may have influenced our decision to proceed with additional clinical trials may not be replicated; 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; and the risk that we are unable to raise capital on acceptable terms. . 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

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:



    TG Therapeutics, Inc.

    Selected Condensed Consolidated Financial Data

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

     

    Three months ended

    June 30,
     Six months ended

    June 30,


      2020  2019   2020  2019 
          
    License revenue$38 $38  $76 $76 
          
    Costs and expenses:     
    Research and development:     
    Noncash stock expense associated with in-licensing agreements --  100   --  100 
    Noncash compensation 1,553  1,352   3,532  2,841 
    Other research and development 34,896  31,414   68,939  62,310 
    Total research and development 36,449  32,866   72,471  65,251 
          
    General and administrative:     
    Noncash compensation 5,817  405   14,906  797 
    Other general and administrative 8,617  2,311   13,789  4,260 
    Total general and administrative 14,434  2,716   28,695  5,057 
          
    Total costs and expenses 50,883  35,582   101,166  70,308 
          
    Operating loss (50,845)  (35,544)   (101,090)  (70,232) 
          
          
    Other expense (income):     
    Interest expense 2,228  1,077   3,429  1,851 
    Other income (189)  (408)   (519)  (715) 
    Total other expense (income), net 2,039  669   2,910  1,136 
          
    Net loss$(52,884) $(36,213)  $(104,000) $(71,368) 
          
    Basic and diluted net loss per common share$(0.47) $(0.42)  $(0.95) $(0.85) 
          
    Weighted average shares used in computing basic and diluted net loss per common share 112,353,414  86,800,017   108,926,690  84,002,700 
                  



    Condensed Balance Sheet Information (in thousands):

     June 30, 2020

    (Unaudited)
    December 31, 2019*
    Cash, cash equivalents and investment securities$275,570 $140,435 
    Total assets 294,621  163,014 
    Accumulated deficit (805,215)  (701,216) 
    Total equity 194,227  38,615 

    * Condensed from audited financial statements

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  5. NEW YORK, Aug. 06, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that a conference call will be held on Monday August 10, 2020 at 8:30 AM ET to discuss results for the second quarter of 2020 and provide a business outlook for the remainder of the year. Michael S. Weiss, Executive Chairman and Chief Executive Officer, will host the call.

    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 Second Quarter 2020 Business 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…

    NEW YORK, Aug. 06, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced that a conference call will be held on Monday August 10, 2020 at 8:30 AM ET to discuss results for the second quarter of 2020 and provide a business outlook for the remainder of the year. Michael S. Weiss, Executive Chairman and Chief Executive Officer, will host the call.

    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 Second Quarter 2020 Business 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.

    TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

    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 in late stage clinical development with two investigational therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a 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, dual inhibitor of PI3K-delta and CK1-epsilon. 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.

    CONTACT:



    Jenna Bosco

    Senior Vice President,

    Corporate Communications

    TG Therapeutics, Inc.

    Telephone: 212.554.4351

    Email:

    Primary Logo

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