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): October 13, 2016
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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☐
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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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Item 8.01. Other Events.
On October 13,
2016, TG Therapeutics, Inc. (the
“Company”) issued a press release announcing amendments
to the Company’s GENUINE Phase 3 clinical trial to accelerate
study completion. 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 October 13, 2016.
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: October 13,
2016
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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 October 13, 2016
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Exhibit
99.1
TG
Therapeutics, Inc. Amends the GENUINE Phase 3 Clinical Trial to
Accelerate Study Completion by Revising Primary Endpoint to Overall
Response Rate
FDA agrees that Overall Response Rate (ORR) data from revised
GENUINE study can be used to request pre-BLA (Biologics License
Application) meeting
If results
of the revised GENUINE study are positive, the Company plans to
file a BLA for accelerated approval based on the outcome of the
pre-BLA meeting
Enrollment expected to be completed before year end 2016 with
top-line data available in first half of 2017
Amendments expected to save the Company more than $10 million over
the next 2 years, and allow the Company to focus its resources on
the UNITY-CLL program
Conference call to be held today, Thursday, October 13, 2016 at
8:30am ET
New
York, NY, (October 13, 2016)
– TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that it
has filed with the FDA an amended protocol for the GENUINE Phase 3
trial. Prior to the amendments, the GENUINE study consisted of two
parts:
●
Part I to evaluate
the effect of the addition of TG-1101 to ibrutinib on overall
response rate (ORR) in approximately the first 200 patients
enrolled, to support a filing for accelerated approval of TG-1101;
and
●
Part II to evaluate
the effect of the addition of TG-1101 to ibrutinib on
progression-free survival (PFS) in all study patients
(approximately 330), to support a filing for full approval of
TG-1101.
The
amended protocol contains the following substantive
changes:
●
Part II of the
study has been eliminated, and accordingly, the study’s sole
primary endpoint will be ORR as originally contemplated in Part I;
and
●
Target enrollment
has been reduced to approximately 120 randomized
patients.
At the
new study size, the study is 90% powered to show a statistically
significant improvement in ORR, with the minimal detectable
difference of approximately 20% (absolute difference between the
arms). Additionally, patients will be followed until progression,
but the study will no longer be powered for PFS.
The
Company expects that it will complete enrollment in the revised
trial by year end 2016, and will have topline data available in the
first half of 2017. If the results of the study are positive, the
Company plans to request a pre-BLA meeting to discuss the data and
a filing strategy with the FDA. The Company has communicated with
the FDA regarding its intention to file a BLA for accelerated
approval if the results are positive and the FDA has agreed that a
pre-BLA meeting can be requested based on ORR data from the GENUINE
study. Assuming a positive outcome of a pre-BLA meeting, targeted
to occur in the fourth quarter of 2017, the Company believes it
could file a BLA in the first half of 2018.
Michael
S. Weiss, the Company's Executive Chairman and Interim Chief
Executive Officer, stated, “Today’s
announcement marks an important milestone for the Company. Given
the GENUINE enrollment challenges we’ve faced to date, we are
very excited to accelerate the trial to a rapid conclusion, while
also maintaining the ability to potentially file the data for
accelerated approval. The GENUINE study, as amended, remains a
robust, randomized clinical trial, which we believe, if positive,
could support accelerated approval for patients with
relapsed/refractory high-risk CLL. Moreover, we believe the amended
study and revised regulatory strategy is consistent with the recent
accelerated approvals for novel agents in CLL, which notably were
not pursuant to an SPA but occurred after the finding of positive
ORR results. Importantly, with completion of enrollment now
expected by year end, we and our clinical trial sites can focus our
resources on completing our UNITY-CLL Phase 3 trial as quickly as
possible. Early enrollment in UNITY-CLL is very encouraging and we
anticipate that study will be fully enrolled before filing a BLA
for the GENUINE study. UNITY-CLL remains unchanged and unaffected
by the amendments to the GENUINE study, and if positive, could
support full approval for both TG-1101 and TGR-1202 based on its
primary endpoint of PFS.” Mr. Weiss continued, “We have
greatly appreciated all of the guidance and counsel from the FDA in
designing our clinical programs and we look forward to continuing
our collaborative working relationship as we accelerate toward the
conclusion of enrollment into the GENUINE study this year and ORR
data in the first half of 2017."
Conference Call Information
The
Company will host a conference call today, Thursday, October 13,
2016 at 8:30am ET to
discuss the amendments to the GENUINE Phase 3 Trial.
In
order to participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),
Conference Title: TG Therapeutics GENUINE Update Call. A live
webcast of this presentation will be available on the Events page,
located within the Investors & Media section, of the Company's
website at www.tgtherapeutics.com. An audio recording of the
conference call will also be available for replay at
www.tgtherapeutics.com, for a period of 30 days after the
call.
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, 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 recently entering 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, particularly those with
respect to anticipating the timing of the completion of the GENUINE
study, timing of the completion of the UNITY-CLL study, timing of
filing of a BLA for TGR-1101, and projected cost savings from
amending the GENUINE study 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: our ability to successfully
and cost-effectively complete the GENUINE or the UNITY-CLL trials;
the risk that the clinical results from the GENUINE or UNITY-CLL
studies will be not positive and/or will not support regulatory
approval of TG-1101 or TGR-1202; the risk that the FDA will not
grant us a pre-BLA meeting to discuss the results of the GENUINE
study,; the risk that we will not file a BLA for TG-1101 or an NDA
for TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk
that despite early positive trends in enrollment in the UNITY-CLL
study that enrollment will be delayed beyond our projections; the
risk that the planned interim analysis will not allow early closure
of the single agent arms in the UNITY-CLL study, necessitating
enrollment beyond the projected 450 patients, which would extend
enrollment beyond our projections; the risk that safety issues or
trends will be observed in the GENUINE study or the UNITY-CLL study
that prevent approval of either TG-1101 and/or TGR-1202 or require
us to terminate either the GENUINE study or the UNITY-CLL study
prior to completion;the risk that the data (both safety and
efficacy) from future clinical trials will not coincide with the
data produced from prior pre-clinical and clinical trials; the risk
that the GENUINE study, as amended or the UNITY-CLL study, or any
of our other registration-directed clinical trials as designed or
amended may not be sufficient or acceptable to support regulatory
approval; the risk that trials will take longer to enroll than
expected;the risk that the projected cost savings to be realized by
amending the GENUINE trial will not be realized;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.
TGTX -
G
CONTACT:
Jenna
Bosco
Vice President-
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com