NEW YORK, May 10, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the first quarter ending March 31, 2021 and recent company developments, along with a business outlook for 2021.
Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer, stated, "2021 has been an incredibly impactful year, kicking off with our first approval coming ahead of schedule for UKONIQ to treat both relapsed or refractory Marginal Zone Lymphoma and Follicular Lymphoma. That was followed by the completion of a BLA submission for ublituximab in combination with UKONIQ (U2) to treat patients with CLL, and the full presentation of positive results from the ULTIMATE I & II Phase 3 trials in relapsing forms of MS. As a fully integrated commercial organization we are pleased with our progress thus far with the UKONIQ launch and we look forward to continuing to build our commercial infrastructure to support the potential approval and commercialization of U2 in CLL and ublituximab in RMS.
2021 Highlights & Recent Developments
UKONIQTM (umbralisib) in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic Leukemia
Ublituximab in Multiple Sclerosis
TG-1701 in B-cell Malignancies
Remaining Key Objectives for 2021
Financial Results for the Three Months Ended March 31, 2021
CONFERENCE CALL INFORMATION The Company will host a conference call today, May 10, 2021, at 8:30 AM ET, to discuss the Companys first quarter ended March 31, 2021 financial results and provide a business outlook for the remainder of 2021.
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. 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 a period of 30 days after the call.
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 two 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 http://www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.
UKONIQ is a 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. Such forward looking statements include but are not limited to statements regarding the Companys plans, goals, strategies, timelines, anticipated milestones, and expectations for our current or future approved drugs and drug candidates, including the continued U.S. approval and commercialization of UKONIQTM (umbralisib); plans and timelines for marketing applications and review expectations for ublituximab in combination with UKONIQ in CLL or ublituximab monotherapy in RMS and, if approved, commercializing the combination regimen in CLL or ublituximab monotherapy in RMS; the initiation of clinical trials or the results of ongoing and planned clinical trials; the potential benefits of any of the Companys current or future approved drugs or drug candidates in treating patients; and financial guidance regarding the period in which we will have sufficient capital resources to fund our operations.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. 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: our ability to establish, maintain and enhance our commercial infrastructure, and to successfully market and sell UKONIQ or future products, if approved; our ability to meet post-approval regulatory requirements for UKONIQ and future products, including submission of sufficient data from a confirmatory clinical study, and post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the potential for variation from the Companys projections and estimates about the potential market for UKONIQ or the Companys product candidates due to a number of factors, including for example, limitations that regulators may impose on the required labeling for the product; our ability to reach certain regulatory milestones at all or within the timelines projected; our ability to submit a BLA for ublituximab in RMS within the timeline projected; our ability to obtain, or to obtain within the timeline projected, marketing authorization for our product candidates, including ublituximab in combination with UKONIQ in CLL and ublituximab monotherapy in RMS; our ability to successfully complete analyses of our clinical study results and present data within the timeframes projected; the risk that the interim, top-line and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be impacted, as more patient data or additional endpoints are analyzed; the risk that preclinical and clinical results for the Companys drug candidates may not support further development of such drug candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; the Companys reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for its clinical and commercial products, including UKONIQ; the uncertainties inherent in research and development; the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; and the sufficiency of our existing capital resources to fund our future operating expenses. 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 and in 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 http://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
TG Therapeutics, Inc. Selected Condensed Consolidated Financial Data
Statements of Operations Information (in thousands, except share and per share amounts; unaudited):
Condensed Balance Sheet Information (in thousands):
* Condensed from audited financial statements
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TG Therapeutics Provides Business Update and Reports First Quarter 2021 Financial ResultsConference call to be held today, Monday, May 10, 2021 at...
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