TG Therapeutics Announces Data Presentations from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis to be Presented at the American Academy of Neurology Annual Meeting

Rhea-AI Summary

TG Therapeutics (TGTX) announced data presentations from the ULTIMATE I and II Phase 3 trials for ublituximab, targeting relapsing forms of multiple sclerosis (RMS), to be showcased at the AAN annual meeting from April 2-7, 2022. Highlights include an oral presentation on reduced relapse rates compared to teriflunomide, alongside three poster presentations focused on disability improvements, disease activity, and infusion-related reactions. The trials involved 1,094 patients across 10 countries, demonstrating statistically significant results supporting ublituximab's potential approval.

Positive

• Significant reduction in annualized relapse rate (ARR) with ublituximab vs teriflunomide (p<0.005).
• Oral presentation awarded for detailed relapse rate data.
• Multiple presentations scheduled at a notable neurology conference.

Negative

• Potential regulatory approval risks for ublituximab.
• Dependence on third-party entities for manufacturing and distribution.

NEW YORK, March 04, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations, including one oral and three poster 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 American Academy of Neurology (AAN) annual meeting, being held April 2 – 7, 2022, in Seattle, Washington. Abstracts are now available online and can be accessed on the AAN meeting website at www.aan.com. Details of the presentations are outlined below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to be presenting additional data from the ULTIMATE I & II Phase 3 trails at the 2022 AAN annual meeting. We are particularly excited to see Dr. Steinman’s abstract be awarded an oral presentation, to showcase detailed relapse rate data highlighting that in the ULTIMATE trials both relapse rate and cumulative probability of relapse were significantly reduced with ublituximab compared to teriflunomide.” Mr. Weiss continued, “We look forward to the conference next month and to sharing more data from the ULTIMATE trials that continues to support the potential approval of ublituximab to treat patients with relapsing forms of multiple sclerosis.”

Oral Presentation Title: Relapse Rate and Time to First Relapse Were Improved With Ublituximab vs Teriflunomide in the Phase 3 ULTIMATE I and ULTIMATE II Studies in Patients With Relapsing Multiple Sclerosis (RMS)

• Presentation Date/Time: Tuesday, April 5, 2022 at 10:15 AM PT
• Session: Clinical Trials Plenary Session – Oral Presentation
• Abstract Number: 1011
• Lead Author: Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University

Poster Presentation Title: Disability Improvements With Ublituximab in Relapsing Multiple Sclerosis (RMS): Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) Evaluations From the Phase 3 ULTIMATE I and II Studies

• Presentation Date/Time: Sunday, April 3, 2022 at 11:45 AM-12:45 PM PT
• Session: Neighborhood 4 - P5: MS Clinical Trials and Therapeutics 1
• Abstract Number/Poster Number: 963/009
• Lead Author: Bruce A. C. Cree, MD, PhD, MAS, UCSF Weill Institute for Neurosciences, University of California San Francisco

Poster Presentation Title: Ublituximab Treatment Is Associated With a Significant Proportion of Patients Achieving No Evidence of Disease Activity (NEDA): Results From the Ultimate I and Ultimate II Phase 3 Studies of Ublituximab vs Teriflunomide in Relapsing Multiple Sclerosis (RMS)

• Presentation Date/Time: Sunday, April 3, 2022 at 5:30-6:30 PM PT
• Session: Neighborhood 4 - P6: MS Clinical Trials and Therapeutics 2
• Abstract Number/Poster Number: 992/005
• Lead Author: Enrique Alvarez, MD, University of Colorado, Aurora, CO

Poster Presentation Title: Infusion-Related Reactions (IRRs) With Ublituximab in Patients With Relapsing Multiple Sclerosis (RMS): Post Hoc Analyses From the Phase 3 ULTIMATE I and II Studies

• Presentation Date/Time: Sunday, April 3, 2022 at 5:30–6:30 PM PT
• Session: Neighborhood 4 - P6: MS Therapeutics MOA and Safety 1
• Abstract Number/Poster Number: 1017/010
• Lead Author: Edward J. Fox, MD PhD, Central Texas Neurology Consultants, Round Rock, TX

Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

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 teriflunomide 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 the results of the ULTIMATE I & II Phase 3 studies and ublituximab as a potential treatment for relapsing forms of Multiple Sclerosis (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; 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, 2021 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 are the ULTIMATE I and II trials for TGTX?

The ULTIMATE I and II trials are Phase 3 studies evaluating ublituximab's efficacy in treating relapsing forms of multiple sclerosis.

What results will be presented by TGTX at the AAN annual meeting?

TGTX will present data demonstrating significant reductions in relapse rates and improvements in disability for ublituximab compared to teriflunomide.

When will TGTX's data be available?

Data from the presentations will be available on the Company's website following the AAN annual meeting.

What is the significance of the oral presentation for TGTX?

The oral presentation highlights crucial relapse rate data, showcasing the effectiveness of ublituximab in RMS treatment.

How many patients were involved in the ULTIMATE trials?

A total of 1,094 patients were enrolled across 10 countries in the ULTIMATE I and II trials.