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 5, 2017
TG Therapeutics, Inc.
(Exact Name of
Registrant as Specified in Charter)
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Delaware
(State or Other
Jurisdiction
of
Incorporation)
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001-32639
(Commission File
Number)
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36-3898269
(IRS Employer
Identification No.)
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2 Gansevoort Street, 9th
Floor
New York, New York 10014
(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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☐
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Written communications pursuant to Rule 425
under the Securities Act.
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☐
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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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☐
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Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act.
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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
☐
If an emerging
growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On
September 5, 2017, TG Therapeutics, Inc. (the
“Company”) issued a press release announcing that
target enrollment for the UNITY-CLL Phase 3 trial has been
achieved. 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.
99.1 Press
Release, dated September 5, 2017.
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.
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(Registrant)
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Date: September 5,
2017
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By: /s/
Sean A.
Power
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Sean A.
Power
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Chief Financial
Officer
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INDEX
TO EXHIBITS
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Exhibit
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Number
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Description
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Press Release,
dated September 5, 2017.
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TG Therapeutics Announces Completion of Target Enrollment in the
UNITY-CLL Phase 3 Trial
Enrollment expected to continue until mid-October to allow patients
already identified an opportunity to participate in the
trial
NEW
YORK, September 5, 2017 -- TG Therapeutics, Inc. (NASDAQ: TGTX)
today announced that target enrollment for the UNITY-CLL Phase 3
trial has been achieved. The UNITY-CLL Phase 3 trial is a
randomized study of TG-1101 (ublituximab), the Company's novel
glycoengineered anti-CD20 monoclonal antibody, in combination with
TGR-1202 (umbralisib), the Company’s PI3K delta inhibitor
(together referred to as the U2 regimen), compared to an active
control arm of obinutuzumab plus chlorambucil, in patients with
both treatment naïve and relapsed or refractory Chronic
Lymphocytic Leukemia (CLL). Per the protocol, the target enrollment
was 175 patients in each the U2 arm and the active control arm.
While target enrollment has been reached, in order to provide an
opportunity for all patients already identified to participate,
enrollment is expected to continue until mid-October. The UNITY-CLL
Phase 3 trial is being conducted pursuant to a Special Protocol
Assessment (SPA) agreement with the Food and Drug Administration
(FDA).
Michael
S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are extremely pleased to
announce the completion of target enrollment in the UNITY-CLL
clinical trial, nearly 9 months earlier than our original
projections. From the beginning, enrollment in
this study has exceeded our expectations, putting us in
position to deliver top-line data on the ORR endpoint earlier
than anticipated, now expected in the second quarter of 2018.
If positive, pursuant to our SPA, the ORR data may be used
to support a filing for accelerated approval.”
Mr. Weiss continued, “We want to thank the
UNITY-CLL Investigators, research staff, and their patients,
for their participation in this important clinical research.
Without their commitment and trust, advancing novel medicines
would not be possible.”
John
Gribben, MD, DSc, of the Barts Cancer Institute in London, UK, and
Global Study Chair for the UNITY-CLL study stated, “The
design of the UNITY-CLL trial is a paradigm shift in the way we
approach oncology research, allowing two novel drugs to be
evaluated together in a single four-arm study for potential
approval. The speed in which target enrollment has completed is
even more impressive, considering the size and scope of this
innovative study, which also underscores the need for new treatment
options despite recent advances. I am eagerly looking forward to
presenting results from this study next year.”
Ian
Flinn, MD, PhD, Director of the Blood Cancer Research Program,
Sarah Cannon Research Institute, and a lead US enroller in the
UNITY-CLL study stated, “We were pleased at Tennessee
Oncology to not only lead enrollment in the first-in-human study of
umbralisib, but to now be one of the leading enrollers to the Phase
3 UNITY-CLL trial. The rapid rate of enrollment for both the
first-in-human study of umbralisib and the Phase 3 study UNITY
study is a testament to the continued need for better,
patient-friendly, easy to use, treatment options for both treatment
naïve CLL patients and those relapsed or refractory to prior
therapy. BTK intolerance and difficulties in delivering anti-bcl2
therapy are challenges for delivering effective chemo-free
treatment options for many patients. Approval of the ublituximab +
umbralisib regimen would provide new hope to many of those
patients.
ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL
is a global Phase 3 randomized controlled clinical trial in
patients with Chronic Lymphocytic Leukemia (CLL) that includes two
key objectives: first, was to demonstrate contribution of each
agent in the TG-1101 (ublituximab) + TGR-1202 (umbralisib) or U2
regimen, and second, to demonstrate superiority in Progression Free
Survival (PFS) over the standard of care to support the submission
for full approval of the combination. In addition, upon completion
of enrollment, this trial will evaluate Overall Response Rate (ORR)
for accelerated approval. The study initially randomized patients
into four treatment arms: TG-1101 plus TGR-1202, TG-1101 single
agent, TGR-1202 agent, and an active control arm of obinutuzumab
plus chlorambucil. Pursuant to the Special Protocol Assessment
(SPA) with the U.S. Food and Drug Administration (FDA),
an early interim analysis was conducted to assess contribution of
each single agent which allowed for early termination of both
single agent arms.
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 two therapies targeting hematological
malignancies and autoimmune diseases. TG-1101 (ublituximab) 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 TGR-1202
(umbralisib), an orally available PI3K delta inhibitor. The delta
isoform of PI3K is strongly expressed in cells of hematopoietic
origin and is believed to be important in the proliferation and
survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in
clinical development for patients with hematologic malignancies,
with TG-1101 also in clinical development for autoimmune disorders.
The Company also has pre-clinical programs to develop IRAK4
inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR
antibodies. TG Therapeutics is headquartered in New York
City.
Cautionary
Statement
Some of
the statements included in this press release 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. 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 are the
following: our ability to successfully and cost effectively
complete the UNITY-CLL trial on-time or deliver data on schedule as
planned; the risk that the combination of TG-1101 and TGR-1202,
referred to as TG-1303 or “U2”, and being studied in
the UNITY clinical trials, will not prove to be a safe and
efficacious combination treatment option for any indication;the
risk that early clinical trial results, that may have influenced
our decision to proceed with additional clinical trials, will not
be reproduced in the final data presented; the risk that the final
data will not support regulatory approval. 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.
TGTX -
G
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com