TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis to be Presented at 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

Rhea-AI Summary

TG Therapeutics (TGTX) announced that both ULTIMATE I & II Phase 3 trials of ublituximab met their primary endpoints, demonstrating a statistically significant reduction in annualized relapse rate (ARR) over 96 weeks (p<0.005). The findings will be presented at the ECTRIMS Congress on October 14, 2021. The trials involved 1,094 patients across 10 countries. Ublituximab, an investigational treatment, targets CD20+ B-cells and aims to improve outcomes for patients with relapsing multiple sclerosis (RMS). An investor event will discuss the trial data at 12:30 PM ET on the same day.

Positive

• ULTIMATE I & II trials met primary endpoints with significant ARR reduction (p<0.005).
• Demonstrates potential of ublituximab for treating relapsing multiple sclerosis (RMS).
• Presentation of findings at ECTRIMS enhances visibility and credibility.

Negative

• Pending FDA approval for ublituximab remains uncertain, with regulatory risks.
• Possible changes in data perception as further studies and analyses occur.

The ULTIMATE I & II Phase 3 trials both have met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial)

Investor & Analyst Virtual Event to be held Thursday, October 14, 2021, at 12:30 PM ET

NEW YORK, Sept. 29, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations highlighting data from the ULTIMATE I & II Phase 3 trials evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming 37^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held virtually October 13 – 15, 2021. Regular abstracts are now available through the ECTRIMS platform and late-breaking abstracts will be accessible on October 13, 2021. Additional presentation details, including a direct link to the currently available abstract is included below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to have two abstracts accepted for presentation at the upcoming ECTRIMS congress, including an oral presentation, showcasing data from the ULTIMATE I & II Phase 3 trials. While much of the data have been presented previously, we look forward to sharing some additional analyses which we believe further reinforce the potential value of ublituximab to treat patients with RMS.” Mr. Weiss continued, “We look forward to the ECTRIMS congress and hope you all can join us on October 14 to review the data and hear from key opinion leaders.”

Oral Presentation Title: Phase 3 results of the ULTIMATE I & II global studies: ublituximab versus teriflunomide in relapsing multiple sclerosis

• Presentation Date/Time: Thursday, October 14, 2021, at 11:11 – 11:18 AM ET
• Session: Free Communications 2 - Treatment trials - Immunomodulation
• Lead Author: Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University

Late Breaking ePoster Title: Ublituximab is associated with significant improvement in the multiple sclerosis functional composite (MSFC): results from the Phase 3 ULTIMATE I & II studies

• Presentation Date/Time: Available for on demand download beginning on Wednesday, October 13, 2021 at 6:00 AM ET
• Lead Author: Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University
• NOTE: This abstract was accepted as a late breaking presentation and the full text abstract will not be available until October 13, 2021
  

INVESTOR & ANALYST VIRTUAL EVENT INFORMATION
The Company will host a virtual event on Thursday, October 14, 2021, at 12:30 PM ET, to discuss the ULTIMATE I & II Phase 3 data presented during the ECTRIMS meeting.

To attend the live event, please visit the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. Following the live event, an archive file will be available for replay, for a period of 30 days after the call.

ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As previously announced, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared to terifunomide over a 96-week period (p<0.005 in each trial). Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).

ABOUT UBLITUXIMAB
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.^1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.¹

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 three 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 www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.

UKONIQ^® is a registered 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 ublituximab as a potential treatment for relapsing forms of Multiple Sclerosis (RMS), the results of the ULTIMATE I & II Phase 3 studies, and the timing of FDA review of the Biologics License Application for ublituximab in RMS.

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 U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II trials that we announce or publish may change, or the perceived product profile may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the perceived safety and tolerability profile and commercial potential of ublituximab; our ability to complete the BLA submission for ublituximab in RMS within the timeline projected and the risk that FDA will not accept the submission; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS for efficacy, safety or other issues or, if approved, that we will not receive regulatory approval within the timeline projected; the risk that if approved, ublituximab will not be commercially successful; our ability to expand our commercial infrastructure, and successfully launch, market and sell ublituximab in RMS if approved; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including ublituximab; the uncertainties inherent in research and development; and 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. 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 SEC. 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:

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

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^{1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.}

FAQ

What were the results of the ULTIMATE I & II trials for TGTX?

Both trials showed a statistically significant reduction in annualized relapse rate (ARR) with ublituximab (p<0.005).

When will the findings of the ULTIMATE I & II trials be presented?

The findings will be presented at the ECTRIMS Congress on October 14, 2021.

How many patients were involved in the ULTIMATE I & II trials?

The trials enrolled 1,094 patients with relapsing forms of multiple sclerosis across 10 countries.

What is ublituximab and what does it target?

Ublituximab is an investigational monoclonal antibody targeting CD20-expressing B-cells for treating RMS.

What is the significance of the upcoming investor event for TGTX?

The investor event will discuss the trial data and future implications for ublituximab on October 14, 2021.