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
See the original post:
TG Therapeutics Provides Business Update and Reports First Quarter 2021 Financial ResultsConference call to be held today, Monday, May 10, 2021 at...
- Rally for Multiple Sclerosis Treatment Funding - May 7th, 2011 [May 7th, 2011]
- Breakthrough Multiple Sclerosis Treatment? - May 8th, 2011 [May 8th, 2011]
- Multiple Sclerosis Treatment - Mayo Clinic - May 11th, 2011 [May 11th, 2011]
- Tracy Macchia: Controversial MS Treatment - May 14th, 2011 [May 14th, 2011]
- What is Multiple Sclerosis - May 19th, 2011 [May 19th, 2011]
- MS Multiple Sclerosis treatment testimonial from Sanoviv Medical Institute - May 20th, 2011 [May 20th, 2011]
- Patient with progressive ms(paraplegia) Fmr treatment 1/4 - May 22nd, 2011 [May 22nd, 2011]
- New Jersey Multiple Sclerosis Treatment with Chiropractic Care - May 23rd, 2011 [May 23rd, 2011]
- MS Cure - Progression - June 2nd, 2011 [June 2nd, 2011]
- CCSVI UK Multiple Sclerosis Liberation Treatment - June 2nd, 2011 [June 2nd, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl - June 3rd, 2011 [June 3rd, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach Dallas, TX 2011 - June 8th, 2011 [June 8th, 2011]
- MS treatment sees early success - June 9th, 2011 [June 9th, 2011]
- CCSVI Possible cure for Multiple sclerosis - June 10th, 2011 [June 10th, 2011]
- MS Cure - Introduction to stem cell bone marrow transplant in Australia - June 11th, 2011 [June 11th, 2011]
- (Multiple Sclerosis Cure) Change Your Thinking? (Multiple Sclerosis Cure) - June 12th, 2011 [June 12th, 2011]
- Essiac cancer treatment herbal tincture, Ms Caisse...from The Secrets of Eden - June 12th, 2011 [June 12th, 2011]
- MS walking treatment breakthrough - June 14th, 2011 [June 14th, 2011]
- multiple sclerosis natural treatment | Kathy Canada Testimonial - June 18th, 2011 [June 18th, 2011]
- CCSVI Surgery India - Liberation Procedure Multiple Sclerosis Treatment in India - June 29th, 2011 [June 29th, 2011]
- XCell-Center MS CCSVI Liberation Angioplasty Treatment Results E.Schuurman 18_01_11 - July 1st, 2011 [July 1st, 2011]
- MS Cure - 7PM Project Carmel Turner MS Stem Cell Treatment - July 9th, 2011 [July 9th, 2011]
- MS Update! Tysabri or Gilenya? - July 10th, 2011 [July 10th, 2011]
- What causes BSE, CJD - July 15th, 2011 [July 15th, 2011]
- Kath Bartlett, MS, LAc Balance Method Acupuncture - July 16th, 2011 [July 16th, 2011]
- MS Cure - 730 report ben leahy carmel turner ms stem cell treatment - July 17th, 2011 [July 17th, 2011]
- CCSVI LIberation Treatment Tokuda - July 18th, 2011 [July 18th, 2011]
- FOX News Interview on the O'Reilly Factor - Treatment of Women in Islam - July 18th, 2011 [July 18th, 2011]
- CCSVI treatment bloopers holy crap - July 18th, 2011 [July 18th, 2011]
- Tarah's CCSVI Venoplasty. Dr McGuckin Explaining procedure findings - July 19th, 2011 [July 19th, 2011]
- Cancer Cure: The One-Minute Cure For Cancer, MS - July 24th, 2011 [July 24th, 2011]
- Not Ready to Cheer CCSVI Trials - July 29th, 2011 [July 29th, 2011]
- New Oral Treatment for MS - July 30th, 2011 [July 30th, 2011]
- 27/07/2011 - MS patients seek controversial treatment - August 1st, 2011 [August 1st, 2011]
- MS Cure - 11 I am still walking - August 5th, 2011 [August 5th, 2011]
- Upcoming Treatments for MS - Pt 1 -MSRA Public Lecture - Dr Suzanne Hodgkinson - August 10th, 2011 [August 10th, 2011]
- Stem Cells for MS Community Outreach: Patient Judi Lecoq - Dallas, TX 2011 - August 18th, 2011 [August 18th, 2011]
- Stem Cell Treatment for Multiple Sclerosis - Community Outreach, San Diego: David Oliver - August 19th, 2011 [August 19th, 2011]
- New Study Tests Possible Treatment for MS - August 25th, 2011 [August 25th, 2011]
- Professor Dimitrios Karussis: Treating MS - August 26th, 2011 [August 26th, 2011]
- walking with MS before CCSVI treatment.wmv - August 27th, 2011 [August 27th, 2011]
- Suzy Cohen Discusses The Liberation Treatment for MS - September 14th, 2011 [September 14th, 2011]
- Multiple Sclerosis MS People - Amazing New Treatment - September 15th, 2011 [September 15th, 2011]
- Multiple Sclerosis Alternative Treatment - September 17th, 2011 [September 17th, 2011]
- CLEAR scoliosis treatment, Dr. Culpepper (MS) - September 22nd, 2011 [September 22nd, 2011]
- Liberation treatment for MS - September 23rd, 2011 [September 23rd, 2011]
- 44b - My Lyme disease and rheumatoid arthritis journey - Miraculous CCSVI treatment for MS sufferers - September 24th, 2011 [September 24th, 2011]
- A Closer Look at Gilenya - The First Oral Treatment for MS - September 28th, 2011 [September 28th, 2011]
- Unequal Treatment Drives Disability Rights Movement - September 28th, 2011 [September 28th, 2011]
- Multiple Sclerosis - The Nebraska Medical Center - September 29th, 2011 [September 29th, 2011]
- Testimonial for CCSVI Treatment Excel Heart Center Mexico -- Tanya Reay - September 30th, 2011 [September 30th, 2011]
- Current thinking on what causes MS - Pt 1 - MSRA Public Lecture -Prof Graeme Stewart - October 2nd, 2011 [October 2nd, 2011]
- Current and emerging therapies in MS - Part 02 (How do these treatments work?) - October 2nd, 2011 [October 2nd, 2011]
- MS Richard Humphries before and after treatment for Multiple Sclerosis with stem cells - October 3rd, 2011 [October 3rd, 2011]
- Matthew - CCSVI and his Liberation Treatment - October 8th, 2011 [October 8th, 2011]
- Multiple Sclerosis - Myelin Repair - Video - October 14th, 2011 [October 14th, 2011]
- MS Auto Immune vs CCSVI Treatment Simple Pictures by Berukoff - Video - October 23rd, 2011 [October 23rd, 2011]
- New Promising Treatment for Those Living with Multiple Sclerosis - Video - October 29th, 2011 [October 29th, 2011]
- Stem cells to treat MS - Pt 2 - MSRA Public Lecture - A/Prof Richard Burt - Video - October 30th, 2011 [October 30th, 2011]
- New hope for treating multiple sclerosis - Video - October 31st, 2011 [October 31st, 2011]
- CCSVI Multiple sclerosis Breakthrough/cure - Video - October 31st, 2011 [October 31st, 2011]
- Inhuman Treatment of Wheelchair bound Multiple Sclerosis Patient in Canadian Care Home - Video - November 9th, 2011 [November 9th, 2011]
- MS treatment movie Cells4health.mp4 - Video - November 10th, 2011 [November 10th, 2011]
- Racing to the Cure for MS: Myelin Repair Foundation Celebrates MS Awareness Week - Video - November 12th, 2011 [November 12th, 2011]
- [Symptoms of Multiple Sclerosis] - Video - November 12th, 2011 [November 12th, 2011]
- Multiple Sclerosis Treated with Adult Stem Cells - Video - November 13th, 2011 [November 13th, 2011]
- Stem cells to treat MS - Pt 1 - MSRA Public Lecture - A/Prof Richard Burt - Video - November 16th, 2011 [November 16th, 2011]
- Multiple Sclerosis A Natural Treatment - Video - November 16th, 2011 [November 16th, 2011]
- My MS and Stem Cell Treatment - Video - November 16th, 2011 [November 16th, 2011]
- CCSVI Liberation News Reports - Video - November 20th, 2011 [November 20th, 2011]
- Stem Cells for MS Community Outreach: Patient Sam Harrell - Dallas, TX 2011 - Video - November 21st, 2011 [November 21st, 2011]
- Arthur S13 E2-1 - The Silent Treatment - Video - November 27th, 2011 [November 27th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach San Diego CA - Video - December 3rd, 2011 [December 3rd, 2011]
- CCSVI - Video - December 3rd, 2011 [December 3rd, 2011]
- My Sister's Experience with Liberation Treatment for Multiple Sclerosis PART 2/2 - Video - December 5th, 2011 [December 5th, 2011]
- Multiple Sclerosis -- Treatment LDN story - Video - December 7th, 2011 [December 7th, 2011]
- ABC News - Multiple Sclerosis effectively treated by a new acoustic medical device. - Video - December 9th, 2011 [December 9th, 2011]
- MS Patient After Stem Cell Therapy - Video - December 10th, 2011 [December 10th, 2011]
- Multiple Sclerosis - Video - December 12th, 2011 [December 12th, 2011]
- Journey of Connective Tissue, Autoimmune disease, steroid treatment updates. - Video - December 22nd, 2011 [December 22nd, 2011]