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): February 2, 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
February 2, 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
3rd Annual
Americas Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2018 in San Diego, CA. A copy of the press release
is being filed as Exhibits 99.1and incorporated in this Item by
reference.
Item
9.01
Financial
Statements And Exhibits.
(d)
Exhibits.
Press Release,
dated February 2, 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:
February 2, 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 Third Annual ACTRIMS Forum 2018
100% reduction of T1 Gd-enhancing lesions at week 24
(n=38)
99% median B-cell depletion was observed at week 4 and maintained
at week 24 (n=40)
TG-1101 was well tolerated across all patients including those
receiving 1 hour infusions at the Phase 3 dose
New
York, NY, (February 2, 2018)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced 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
was presented last night during Poster Session 1, from 6:00 PM
– 8:00 PM PT, at the 3rd Annual Americas
Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2018, in San Diego, California.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer, stated, “We are very pleased with the
updated Phase 2 data presented last night which now includes 5
cohorts, totaling 40 patients. It’s exciting to see that with
more patients through 6 months of treatment, the data remain
consistent with the earlier results presented at the 2017
ECTRIMS-ACTRIMS meeting. The data continue to demonstrate the
positive effects of ublituximab with sustained B-cell depletion
through Week 24, complete elimination of T1 Gd-enhancing lesions
and 97.5% of subjects without a relapse at Week 24. Importantly,
the 1 hour infusion appears to be well tolerated and could
represent a more convenient alternative to the currently marketed
anti-CD20 monoclonal antibody.” Mr. Weiss continued,
“We look forward to presenting additional updated Phase 2
data, including data from all 48 patients enrolled in the Phase 2
study through 52 weeks, while we continue to enroll into our global
Phase 3 ULTIMATE trials.”
This Phase 2 trial is a 52-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 data from the first 40
patients (of 48 enrolled, 8 too early to evaluate) with RMS that
were treated with ublituximab across five dosing
cohorts.
Poster
Presentation Title: 6 Month Results of a Phase 2a
Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20
Monoclonal Antibody, in Relapsing Multiple Sclerosis
Poster Highlights:
●
99% median B-cell
depletion was observed at week 4 and maintained at week 24 (6
months) (n=40)
●
Ublituximab
completely eliminated all (100%) of T1 Gd-enhancing lesions at week
24 (n=38) (p=0.0005)
●
97.5% of subjects
(39/40) 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 12 days after
the patients’ first infusion of 150mg of TG-1101. The patient
remains on study and has received the second and third infusions of
TG-1101 and to date has remained relapse free.
●
Mean EDSS
improvement from baseline of 0.3 with 78% of subjects showing
improved or stable EDSS
●
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 form
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
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com