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): August 10, 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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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
August 10, 2017, TG Therapeutics, Inc. (the “Company”)
issued a press release announcing that the independent Data Safety
Monitoring Board (DSMB) of the UNITY-NHL Phase 2b registration
directed trial has successfully completed the first pre-specified
interim analysis to evaluate the Overall Response Rate (ORR) in the
cohort enrolling patients with relapsed or refractory Diffuse Large
B-cell Lymphoma (DLBCL) that are not eligible for high-dose
chemotherapy or transplant. 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 August 10, 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: August 10,
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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99.1
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Press Release,
dated August 10, 2017.
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TG Therapeutics, Inc. Announces Successful Outcome from the First
Pre-Planned Interim Analysis by Independent DSMB of the DLBCL Cohort in the
UNITY-NHL Phase 2b Trial
Based on pre-set hurdles of Overall Response Rate (ORR) the DSMB
recommends continued enrollment in the TGR-1202 + TG-1101
(“U2”) arm and no further enrollment into the single
agent TGR-1202 arm
As set forth in the protocol, single agent TGR-1202 arm will be
replaced with the triple combination of TG-1101, TGR-1202 and
bendamustine
New
York, NY, (August 10, 2017)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the
independent Data Safety Monitoring Board (DSMB) of the UNITY-NHL
Phase 2b registration directed trial has successfully completed the
first pre-specified interim analysis to evaluate the Overall
Response Rate (ORR) in the cohort enrolling patients with relapsed
or refractory Diffuse Large B-cell Lymphoma (DLBCL) that are not
eligible for high-dose chemotherapy or transplant. Upon review of
the available ORR data, based on pre-specified efficacy thresholds
of ORR, the DSMB recommended the Company cease enrollment into the
single agent TGR-1202 arm, while continuing enrollment into the
TG-1101 + TGR-1202 arm which has demonstrated an acceptable level
of efficacy to warrant continued evaluation. Per the UNITY-NHL
protocol, the single agent TGR-1202 arm will be replaced by an arm
evaluating the triple combination arm of TG-1101, TGR-1202, and
bendamustine.
Michael
S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “The DLBCL cohort in our UNITY-NHL
trial was designed to evaluate the contribution of TGR-1202 in our
combination ‘U2’ regimen. We are extremely pleased that
the DSMB has recommended continued enrollment in the U2 arm, while
allowing us to proceed with replacing the single agent TGR-1202 arm
with the triple combination of TG-1101, TGR-1202, and bendamustine
(also referred to as U2 + Benda) as planned. As recently presented,
the triplet combination of U2 + Benda was highly active, with a 50%
ORR in patients with refractory DLBCL and a 100% ORR in relapsed
DLBCL patients. We have long believed that patients with aggressive
DLBCL in particular are best treated with combination therapy
rather than single agents and are pleased to see our UNITY-NHL
study advancing to the next level.”
ABOUT UNITY-NHL PHASE 2b TRIAL
UNITY-NHL
is a global Phase 2bclinical trial evaluating TG-1101 and TGR-1202,
(“U2”), in patients with various types of B-cell
lymphoma. The trial consists of three independent cohorts enrolling
patients with relapsed or refractory Diffuse Large B-cell Lymphoma
(DLBCL), Follicular Lymphoma (FL), Small Lymphocytic Lymphoma
(SLL), and Marginal Zone Lymphoma (MZL). The study is evaluating
the U2 combination and the combination of U2 + bendamustine in
patients with DLBCL; TGR-1202 monotherapy and in the U2 combination
in patients with FL and SLL; and TGR-1202 monotherapy in patients
with MZL.
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 enroll
and complete the UNITY-NHL trial on-time or at all or deliver data
on schedule; the risk that early clinical trial results, that may
have influenced our decision to proceed with additional clinical
trials, will not be reproduced in future studies; the risk that
safety and/or efficacy data from the interim analyses from the
DLBCL cohort of the UNITY-NHL trial will not be consistent with the
final results and/or that the final data will not support
regulatory approval; 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.
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