UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
_____________
FORM
8-K
_____________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of report
(Date of earliest event reported): September 12,
2019
(Exact Name of
Registrant as Specified in Charter)
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(State or Other
Jurisdiction
of
Incorporation)
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(Commission File
Number)
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(IRS Employer
Identification No.)
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(Address of
Principal Executive Offices)
(212 )
554-4484
(Registrant's
telephone number, including area code)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
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Written
communications pursuant to Rule 425 under the Securities
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Soliciting material
pursuant to Rule 14a-12 under the Exchange Act.
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Pre-commencement
communications pursuant to Rule 14d-2b under the Exchange
Act.
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange
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Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR
§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR §240.12b-2). Emerging growth company
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If an emerging
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Item 8.01 Other Events.
On
September 12, 2019, TG Therapeutics, Inc. (“TG” or the
“Company”) presented the ULTIMATE I & II Phase 3
trial design and demographic data and updated Phase 2 extension
trial data for Ublituximab (TG-1101), the Company’s novel,
glycoengineered anti-CD20 monoclonal antibody, in relapsing forms
of multiple sclerosis (RMS) at the 35th Annual Congress of
the European Committee for Treatment
and Research in Multiple Sclerosis (ECTRIMS), being held in
Stockholm, Sweden. A copy of the
press release is being filed as Exhibit 99.1 and incorporated in
this Item by reference.
Item
9.01 Financial Statements And Exhibits.
(d)
Exhibits.
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99.1
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Press release
issued by TG Therapeutics, Inc., dated September 12,
2019.
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SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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TG
Therapeutics, Inc.
(Registrant)
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Date: September 12,
2019
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By:
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/s/ Sean A.
Power
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Sean A.
Power
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Chief Financial
Officer
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Exhibit 99.1
TG Therapeutics Presents Data for Ublituximab at the 35th Annual Congress of
the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS)
New
York, NY, (September 12,
2019) TG Therapeutics, Inc. (NASDAQ: TGTX), today presented
the first look at the ULTIMATE I & II Phase 3 trial design and
demographic data and updated Phase 2 extension trial data for
ublituximab, the Company’s novel, glycoengineered anti-CD20
monoclonal antibody, in relapsing forms of multiple sclerosis (RMS)
at the 35th Annual Congress of
the European Committee for Treatment
and Research in Multiple Sclerosis (ECTRIMS), being held in
Stockholm, Sweden.
Michael
S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are pleased to present the
first look at the study design and patient demographics data from
our Phase 3 ULTIMATE program. Importantly, the population enrolled
appears consistent with a typical RMS population and similar to the
patient populations enrolled in other CD20 Phase 3 trials.”
Mr. Weiss continued, “We are also highly encouraged by the
Phase 2 long-term safety data demonstrating ublituximab continues
to be very well tolerated with a median duration of follow-up of
124.7 weeks and no discontinuations due to AEs reported. We look
forward to continuing to follow our Phase 2 patients and to topline
results from our Phase 3 trial in the middle to second half of
2020. If successful, we believe ublituximab will represent an
important anti-CD20 treatment option for patients with RMS that can
be delivered in a convenient one-hour infusion every six
months.”
The
following summarizes the highlights from each presentation during
the 35th
ECTRIMS meeting:
Title: Study Design and
Patient Demographics of the ULTIMATE Phase III Trials Evaluating
Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal
Antibody (mAb), in Patients with Relapsing Multiple Sclerosis
(RMS)
This presentation includes the study design and demographic data
from ULTIMATE I & II, two identical, randomized, international,
multi-center, double-blinded, double dummy, active controlled Phase
3 trials, evaluating a twice per year one-hour 450mg infusion of
ublituximab in RMS. These trials are being conducted under Special
Protocol Assessment (SPA) agreement with the U.S. Food and
Drug Administration (FDA) and are being led by Lawrence
Steinman, MD, of Stanford University.
Presentation Highlights:
●
Patient recruitment
for ULTIMATE I & II was successfully completed in the second
half of 2018.
●
Baseline
characteristics of patients enrolled in ULTIMATE I & II are
consistent with a typical RMS population.
●
The ULTIMATE I
& II trials are expected to elucidate the therapeutic potential
of a one hour, 450mg infusion of ublituximab in patients with RMS.
Topline results are expected in the second half of
2020.
Title: Long-term Follow-up
Results from the Phase 2 Multicenter Study of Ublituximab (UTX), a
Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in
Patients with Relapsing Multiple Sclerosis
(RMS)
This presentation includes long-term follow-up data for 45 patients
from the Phase 2 trial that enrolled into the Open Label Extension
(OLE) trial and recaps the final efficacy data on patients enrolled
in the Phase 2 study through 48 weeks of treatment.
Presentation Highlights:
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Ublituximab
continues to be well tolerated, with a median duration of follow-up
of 124.7 weeks.
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No subjects
discontinued due to an Adverse Event (AE) related to ublituximab on
the Phase 2 or during the OLE.
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AEs deemed at least
possibly related to ublituximab were infrequent during the OLE with
all patients dosed at 450mg of ublituximab administered in a
one-hour infusion (Phase 3 dose).
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Infusion Related
Reactions (IRRs) were rare during the OLE, occurring in only 5
patients (11%), all Grade 1 or 2.
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An Annualized
Relapse Rate (ARR) of 0.07 was observed with 93% of subjects
relapse free at Week 48.
The
above referenced data presented are available on the Publications
page, located within the Pipeline section, of the Company’s
website at www.tgtherapeutics.com/publications.cfm.
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 developing multiple therapies targeting hematological
malignancies and autoimmune diseases. Ublituximab (TG-1101) is a
novel, 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 inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. 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
Statements
included in this press release, particularly those with respect to
anticipating the benefit of the data seen in the Phase 2 and OLE MS
program and performance of ublituximab in the Phase 3 ULTIMATE
clinical program may be 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. Among the factors that could cause our actual
results to differ materially are the following: the risk that early
clinical results that supported our decision to move forward will
not be reproduced in additional patients in expansion cohorts, with
longer term follow-up, or in the Phase 3 ULTIMATE program; the risk
that ublituximab will not have a differentiated safety or efficacy
profile from the other drugs in the class; the risk that the
long-term safety profile presented thus far will not be replicated
in the Phase 3 ULTIMATE program; the risk that the clinical results
from the Phase 3 ULTIMATE program will not be positive and/or will
not support regulatory approval of ublituximab to treat MS; the
risk that the results from the Phase 3 ULTIMATE program will not
available within the guided timelines; our ability to successfully
and cost-effectively complete the Phase 3 ULTIMATE program; our
ability to achieve the milestones we project over the next year;
our ability to manage our cash in line with our projections, and
other risk factors identified from time to time in our reports
filed with the 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 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:
ir@tgtxinc.com