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 25, 2018
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:
☐
Written
communications pursuant to Rule 425 under the Securities
Act.
☐
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act.
☐
Pre-commencement
communications pursuant to Rule 14d-2b under the Exchange
Act.
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange
Act.
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 25,
2018 TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release in which it announced
an update regarding the UNITY-CLL Phase 3 trial. TG also announced
that on Tuesday, September 25, 2018 at 8:30am ET, the Company would
host an investor conference call to discuss the update to the
UNITY-CLL trial. 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
25, 2018.
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
25, 2018
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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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Exhibit
99.1
TG Therapeutics Announces Update Regarding UNITY-CLL Phase 3
Trial
Conference call to be held today, Tuesday, September 25, 2018 at
8:30 am ET
NEW
YORK, September 25, 2018 - TG Therapeutics (NASDAQ: TGTX) today
announced that the independent Data Safety Monitoring Board (DSMB)
for the UNITY-CLL Phase 3 trial met to review ongoing data from the
study and advised the Company that the interim analysis of Overall
Response Rate (ORR) could not be conducted at this time as the data
were not sufficiently mature to conduct the analysis. The DSMB did
not provide any further guidance but plans to meet quarterly over
the next year to continue to monitor the ongoing progress of the
trial. Given the uncertainty surrounding the timing and the outcome
of the ORR analysis, as well as the significant regulatory hurdles
associated with accelerated approval for CLL, the Company is now
guiding that it will focus on the primary endpoint of Progression
Free Survival (PFS) to support full approval of the ublituximab
plus umbralisib (U2) combination. At this time the Company is not
planning to seek accelerated approval based on ORR. The Company
remains blinded to all efficacy data.
Additionally,
the DSMB reviewed safety data from over 600 patients , including
over 300 patients treated with umbralisib either alone or in
combination with ublituximab, of which approximately 60% were
treatment naïve. While no evaluation of PFS was conducted, the
DSMB had PFS information available to them solely for purposes of
assessing the overall benefit-risk. After review of the data, the
DSMB identified no safety concerns and recommended the trial
continue without modification. The UNITY-CLL Phase 3 trial
continues to be conducted under Special Protocol Assessment (SPA)
agreement with the Food and Drug Administration (FDA).
Michael
S. Weiss, Executive Chairman and Chief Executive Officer of TG
Therapeutics stated, "While we are disappointed that we were not
able to report positive ORR today, we feel that making the decision
to focus on PFS, the primary endpoint for the study, is an
important step to getting everyone aligned on the endpoint of this
study that matters most to the Company and its long-term
shareholders. From a timing standpoint, we could have a PFS read
out in 2019, and we remain extremely optimistic about the prospects
for a successful PFS result. Other B-Cell Receptor antagonists have
shown dramatic improvements in PFS in similarly designed studies
and we believe the umbralisib early clinical data supports our
confidence in a positive PFS outcome from
UNITY-CLL.”
Mr.
Weiss continued, “We now have 5 fully enrolled
registration-directed programs, including UNITY-CLL, UNITY-NHL
(including Follicular Lymphoma, Marginal Zone Lymphoma and Diffuse
Large B-cell Lymphoma cohorts) and the ULTIMATE Phase 3 MS program
and are awaiting pivotal data from all of them. With all of these
exciting data read-outs to come, we believe we remain well
positioned to deliver significant value for our
shareholders.”
ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL
is a global Phase 3 randomized controlled clinical trial comparing
the combination of ublituximab plus umbralisib, or U2, to an active
control arm of obinutuzumab plus chlorambucil in patients with both
treatment naïve and relapsed or refractory Chronic Lymphocytic
Leukemia (CLL). The trial randomized patients into four treatment
arms: ublituximab single agent, umbralisib single agent,
ublituximab plus umbralisib and an active control arm of
obinutuzumab plus chlorambucil. A pre-specified analysis was
conducted to assess the contribution of ublituximab and umbralisib
in the combination regimen of ublituximab plus umbralisib and
allowed for the termination of the single agent arms. Accordingly,
the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratiointo
the two combination arms: the investigational arm of U2 and the
control arm of obinutuzumab plus chlorambucil. Full enrollment
into the UNITY-CLL Phase 3 trial completed in October of 2017. This
trial enrolled approximately 60% treatment naïve CLL patients
and 40% relapsed refractory CLL patients. The primary endpoint for
this study is to demonstrate superiority in Progression Free
Survival (PFS) for the U2 combination over the control arm to
support the submission for full approval of the U2 combination in
CLL. The UNITY-CLL Phase 3 trial is being conducted under Special
Protocol Assessment (SPA) agreement with the Food and Drug
Administration (FDA).
CONFERENCE CALL INFORMATION
The
Company will host a conference call today, Tuesday, September
25, 2018 at 8:30 am ET to discuss the UNITY-CLL 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 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. 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 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 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 its anti-PD-L1 monoclonal antibody into Phase 1 development
and aims to bring additional pipeline assets into the clinic in the
future. 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 complete the UNITY-CLL trial
or deliver data on schedule as planned; the risk that the
combination of ublituximab and umbralisib referred to as
“U2” or previously as “TG-1303” 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 the UNITY-CLL ORR results are not positive; the risk
that UNITY-CLL will not demonstrate a PFS advantage and therefore
will not meet its primary endpoint; the risk that safety issues or
trends will be observed in the UNITY-CLL study or any other
on-going studies that prevent approval of either ublituximab and/or
umbralisib; the risk that 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 submission or
approval; the risk that a filing based on GENUINE, UNITY-CLL,
UNITY-NHL, ULTIMATE clinical trials or any other
registration-directed trials cannot be made on schedule as targeted
or at all; the risk that we are unable to manage cash in line with
our expectations and meet our development milestones and/or
continue our operations without raising capital; the risk that we
are unable to raise capital on acceptable terms; 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. 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
VP, Corporate Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com