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 11, 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 October 11,
2018, TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release in which it announced
final results from its 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 at the 34th Congress
of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS). 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 11,
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: October 15,
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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TG Therapeutics, Inc. Announces Final Phase 2 Multiple Sclerosis
Data Presentation at the 34th Congress of
ECTRIMS
Annualized Relapse Rate (ARR) of 0.07 observed for all patients on
Phase 2 trial
ECTRIMS data review conference call to be held today, October 11,
2018, 19:30 CEST/1:30pm ET
New
York, NY, (October 11, 2018)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the final
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 an oral session at
the 34th
Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS), in Berlin,
Germany. Highlights from the presentation are outlined
below.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are extremely pleased by the
final Phase 2 MS data presented today during the annual congress of
ECTRIMS. We believe this complete dataset, which now includes all
patients through 48 weeks, confirms the efficacy and safety profile
of ublituximab and provides a compelling rationale for its use to
treat patients with MS. This final data compare very favorably with
previously presented data for ocrelizumab, the only approved
anti-CD20 for the treatment of MS. With more than 1 million
patients currently living in the United States with MS, we believe
ublituximab will become an important treatment option, representing
a major market opportunity for us.” Mr. Weiss continued,
“These data support our fully enrolled global Phase 3
ULTIMATE program, being conducted under SPA agreement with the FDA,
which if successful would support the full approval of ublituximab
in relapsing forms of MS.”
“The
final Phase 2 ublituximab data presented today is highly
encouraging and further confirms the safety and efficacy seen in
Multiple Sclerosis patients treated with ublituximab. It was
especially interesting to see that the one hour infusion was well
tolerated by patients. The approval of ocrelizumab confirmed anti-
CD20’s as an important part of the MS treatment paradigm and
ublituximab’s shorter infusion time and tolerable safety
profile offer a real advantage to our patients. We look forward to
the results of the ublituximab Phase 3 ULTIMATE program and
advancing this important treatment option forward,” stated
Edward Fox, MD, PhD, Director of the Multiple Sclerosis Clinic of
Central Texas and Clinical Associate Professor at the University of
Texas Dell Medical School in Austin, TX and the Principal
Investigator for this Phase 2 study.
The
oral presentation includes final data on all patients enrolled in
the study through 48 weeks of treatment.
Oral Presentation Highlights:
●
An
Annualized Relapse Rate (ARR) of 0.07 was observed with 93% of
subjects relapse free at Week 48
●
Median
B cell depletion was >99% at the primary analysis point of Week
4 (n=48), and maintained at Week 24 and Week 48
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Ublituximab
completely eliminated all (100%) of T1 Gd-enhancing lesions at Week
24 and maintained complete elimination at Week 48
(n=46)
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10.6%
reduction in T2 lesion volume from baseline to Week 48
(n=46)
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17%
of patients met the criteria for 24 Week Confirmed Disability
Improvement (CDI) at Week 48
●
Ublituximab was
well tolerated across all patients including those receiving rapid
infusions, as low as a one hour for the 450mg dose currently being
studied in the Phase 3 ULTIMATE Program and no study drug related discontinuations
occurred
Conference Call Details:
●
Title: TG Therapeutics ECTRIMS Data Review
Call
o
Date &
Time: Thursday,
October 11th, 2018; 19:30 CEST/
1:30pm ET
o
Dial in: 1-877-407-8029
(U.S.), 1-201-689-8029 (outside the U.S.)
o
Webcast: http://ir.tgtherapeutics.com/events
o
Presenter: Edward Fox, MD, PhD, Director, MS Clinic of
Central Texas, Central Texas Neurology Consultants, PA and Clinical
Associate Professor at the University of Texas Dell
Medical School
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.
These data support the ongoing international Phase 3 program
evaluating ublituximab (TG-1101) 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 data presented are available on the Publications page, located
within the Pipeline section, of the Company’s website
at www.tgtherapeutics.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 data seen in the Phase 2
MS trial program and performance in of ublituximab in the Phase 3
ULTIMATE clinical 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:
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 the abstract submission will not be reproduced in the
full data presentation;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 to treat MS;our ability to
successfully and cost-effectively complete the MS Phase 3
trials;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
Senior
Vice President,
Corporate
Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com