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): April 24, 2018
TG
Therapeutics, Inc.
(Exact
Name of Registrant as Specified in Charter)
|
Delaware
(State
or Other Jurisdiction
of
Incorporation)
|
001-32639
(Commission File
Number)
|
36-3898269
(IRS
Employer Identification No.)
|
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
April 24, 2018, TG Therapeutics, Inc. (the “Company”)
issued a press release announcing results from the Phase 2
multicenter trial of ublituximab (TG-1101), the Company’s
novel glycoengineered anti-CD20 monoclonal antibody, in relapsing
forms of Multiple Sclerosis (RMS) presented during the American
Academy of Neurology 70th Annual Meeting in
Los Angeles, CA. A copy of the press release is being filed as
Exhibits 99.1 and incorporated in this Item by
reference.
Item
9.01
Financial
Statements And Exhibits.
(d)
Exhibits.
99.1 Press
Release, dated April 24, 2018.
-
2
-
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.
TG
Therapeutics, Inc.
(Registrant)
Date: April 24,
2018
By:_/s/ Sean A.
Power__________
Sean A.
Power
Chief
Financial Officer
-
3
-
TG Therapeutics, Inc. Announces Updated Results from the Ongoing
Phase 2 Study of Ublituximab (TG-1101) in Patients with Multiple
Sclerosis at the American Academy of Neurology 70th Annual
Meeting
Data on now up to 48 patients through 24 weeks confirms previously
reported positive results
New
York, NY, (April 24, 2018)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated
results from the Phase 2 multicenter trial of ublituximab
(TG-1101), the Company’s novel glycoengineered anti-CD20
monoclonal antibody, in relapsing forms of Multiple Sclerosis
(RMS). The data is being presented today during Poster Session P3,
from 5:30 PM – 7:00 PM PT, at the American Academy of
Neurology 70th Annual Meeting in
Los Angeles, California.
Michael
S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer, stated, “We are extremely pleased by the
data presented today which now includes a total of 48 patients
across six dosing cohorts for a period of up to 24 weeks. With more
patients now through 24 weeks of follow-up, the data continue to
confirm the efficacy of ublituximab with sustained B-cell
depletion, 100% reduction in T1 Gd-enhancing lesions, and most
importantly, an annualized relapse rate (ARR) that remains below
the ARR observed with ocrelizumab, the only approved anti-CD20
monoclonal antibody for MS, in its similarly sized Phase 2 study.
ARR is the primary endpoint of our Phase 3 trial, which was modeled
and powered based on the results from the ocrelizumab pivotal
trial. We are excited by the emerging clinical profile of
ublituximab that appears to have comparable to better activity than
ocrelizumab, with a manageable safety profile and the convenience
of a one hour infusion.” Mr. Weiss continued “We look
forward to presenting additional data from this Phase 2 trial
including 48 week data on up to 48 patients at major medical
meetings later this year.”
This Phase 2 trial is a 48-week randomized, placebo controlled,
multi-center study evaluating the safety and efficacy of
ublituximab at accelerated infusion times as fast as one hour.
Today’s poster includes 6 month (24 week) data from 48
patients with relapsing forms of multiple sclerosis (RMS) that were
treated with ublituximab across six dosing cohorts.
Poster
Title: Final MRI
Results At 6 Months From A Phase 2 Multicenter Study Of
Ublituximab, A Novel Glycoengineered Anti-CD20 Monoclonal Antibody
(mAb), In Patients With Relapsing Forms Of Multiple Sclerosis
(RMS), Demonstrates Complete Elimination Of Gd-Enhancing Lesions
(Abstract # 3253)
Poster Highlights:
●
An Annualized
Relapse Rate (ARR) of 0.05 was observed at Week 24
(n=48)
●
99% median B-cell
depletion was observed at week 4 and maintained at Week 24
(n=44)
●
Ublituximab
completely eliminated all (100%) of T1 Gd-enhancing lesions at Week
24 (n=44) (p=0.003)
●
98% of subjects
were relapse free at Week 24
o
One confirmed
relapse was reported, in Cohort 1. The patient was initially
randomized to the placebo arm. The relapse occurred shortly (12
days) after crossover to active treatment of 150mg of ublituximab.
The patient remains on study and has received the second and third
infusions of ublituximab and to date has remained relapse
free.
●
83% of subjects
showed improved or stable EDSS with a mean EDSS improvement from
baseline of 0.29
●
Ublituximab was
well tolerated across all patients including those receiving rapid
infusions, as low as a one hour for the 450mg Phase 3
dose
These data presentations support the international Phase 3 ULTIMATE
program evaluating ublituximab for the treatment of relapsing forms
of Multiple Sclerosis (RMS). The Phase 3 trials, entitled ULTIMATE
I and ULTIMATE II, 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. The ULTIMATE trials are currently enrolling
and complete enrollment is expected in the first quarter of
2019.
POSTER
A copy
of the above poster can be found on the Publications page, located
within the Pipeline section, of the Company’s website at
www.tgtxinc.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 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
Statements
included in this press release, particularly those with respect to
anticipating the benefit of the early data seen in the Phase 2 MS
trial and anticipating the timing of our MS Phase 3 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: our ability to successfully and cost-effectively
complete the MS Phase 2 and Phase 3 trials; the risk that early
clinical results that supported our decision to move forward will
not be reproduced in additional patients in expansion cohorts or in
the MS Phase 3 program;the risk that data included in any poster
presentation will not be reproduced in subsequent data
presentations;the risk that the clinical results from the MS Phase
3 program, will not be positive and/or will not support regulatory
approval of ublituximab for MS; the risk that ublituximab will not
have a differentiated profile from the other drugs in the class and
that early signs of best-in-class attributes will not be supported
by future results; the risk that trials will take longer to enroll
than expected; 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
SVP, Corporate
Communications
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com