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 26, 2017
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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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 26, 2017, TG Therapeutics, Inc. (the “Company”)
issued a press release announcing results from the Phase 2
multicenter trial of TG-1101 (ublituximab) in relapsing forms of
Multiple Sclerosis (RMS) presented during the 7th Joint ECTRIMS
– ACTRIMS meeting in Paris, France. On October 27, 2017, the
Company announced additional results from the Phase 2 multicenter
trial of TG-1101 in RMS presented during the 7th Joint ECTRIMS
– ACTRIMS meeting. Copies of the press releases are being
filed as Exhibits 99.1 and 99.2 and incorporated in this Item by
reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press Release, dated October 26,
2017.
99.2 Press Release, dated
October
27,
2017.
-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.
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TG Therapeutics, Inc.
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(Registrant)
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Date:
October
27, 2017
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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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-3-
TG Therapeutics, Inc. Announces Updated Results from the Ongoing
Phase 2 Study of TG-1101 (ublituximab) in Patients with Multiple
Sclerosis at the 7th Joint ECTRIMS
– ACTRIMS Meeting
100% reduction of T1 Gd-enhancing lesions at week 24
(n=20)
99% median B-cell depletion was observed at week 4 and maintained
at week 24 (n=24)
TG-1101 was well tolerated across all patients including those
receiving 1 hour infusions of the Phase 3 450mg dose
New
York, NY, (October 26, 2017)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced results from
the Phase 2 multicenter trial of TG-1101 (ublituximab), the
Company’s novel glycoengineered anti-CD20 monoclonal
antibody, in relapsing forms of Multiple Sclerosis (RMS). The data
is being presented today in two posters during Poster Session 1,
from 15:30 – 17:00 CEST, at the 7th Joint ECTRIMS – ACTRIMS meeting in Paris,
France.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are extremely pleased with the
data presented today demonstrating not only sustained B-cell
depletion by week 24 but even more importantly, complete
elimination of T1 Gd-enhancing lesions, as well as a well-tolerated
safety profile at our Phase 3 dose. We believe these data, although
early, compare very favorably to the results seen with other
anti-CD20s in the class, with TG-1101 exhibiting what could be a
best-in-class profile. These data support our currently enrolling
Phase 3 program in MS, which is being launched globally.” Mr.
Weiss continued, “We look forward to presenting additional
B-cell data tomorrow during the second poster session as well as
presenting updated data, including additional patients, from this
trial at conferences over the next year.”
“The
clinical and MRI data presented today is highly encouraging and
further confirms the compelling efficacy seen in Multiple Sclerosis
patients treated with ublituximab. While still early, it appears
ublituximab can be a highly competitive anti-CD20 with a shorter
infusion time, which is a great benefit to our patients. We look
forward to additional data from this Phase 2 trial and to
participating in the Phase 3 ULTIMATE trials and advancing this
important treatment option,” 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.
This Phase 2 trial is a 52-week randomized, placebo controlled,
multi-center study evaluating the safety and efficacy of TG-1101
(ublituximab) at accelerated infusion times. Today’s posters
include data from 24 patients with RMS that were treated with
TG-1101 across three dosing cohorts.
Poster Presentation Title: Patient
characteristics, safety, and preliminary results of a placebo
controlled, phase 2a multicenter study of ublituximab (UTX), a
novel glycoengineered anti-CD20 monoclonal antibody (mAb), in
patients with relapsing forms of multiple
sclerosis
Poster Highlights:
●
99% median B-cell
depletion was observed at week 4 and maintained at week 24 (6
months) (n=24)
●
96% of subjects
(23/24) were relapse free at week 24
o
One confirmed
relapse was reported in a patient 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 0.35 with 79% of subjects showing
improved or stable EDSS
●
TG-1101 was well
tolerated across all patients including those receiving rapid
infusions, as low as a one hour for the 450mg Phase 3 dose, and
produced similar levels of B-cell depletion with no identified
change in IRR or overall safety profile.
Poster Presentation
Title: Preliminary results of
phase 2 multicenter study of ublituximab (UTX), a novel
glycoengineered anti-CD20 monoclonal antibody (mAb), in patients
with relapsing forms of multiple sclerosis (RMS) demonstrates rapid
Gd-enhancing lesions decrease
●
TG-1101
completely eliminated all (100%) of T1 Gd-enhancing lesions at week
24 (n=20) (p=0.005)
●
7%
Reduction in the T2 lesion volume at Week 24 from baseline
(p=0.02), suggestive of a decrease in burden of
disease
●
6.5%
Reduction in T1 hypointense lesion volume at Week 24 from baseline
(p=0.03)
These data presentations support the recently announced
international Phase 3 program evaluating TG-1101 (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 will be led by
Lawrence Steinman, MD, of Stanford University.
POSTERS
A copy of the above posters 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. 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 (umbralisib), 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, or the combination of which is referred to as "U2", are
in Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 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 the posters presented will 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 TG-1101 for MS; the risk that TG-1101 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.
TGTX -
G
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com
TG Therapeutics, Inc. Announces Additional Updated Results from the
Ongoing Phase 2 Study of TG-1101 (ublituximab) in Patients with
Multiple Sclerosis at the 7th Joint ECTRIMS
– ACTRIMS Meeting
99% median B-cell depletion was observed at week 4 and maintained
at week 24 (6 months) (n=24)
TG-1101 was well tolerated across all patients including those
receiving 1 hour infusions of the Phase 3 450mg dose
New
York, NY, (October 27, 2017)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced additional
results from the Phase 2 multicenter trial of TG-1101
(ublituximab), the Company’s novel glycoengineered anti-CD20
monoclonal antibody, in relapsing forms of Multiple Sclerosis
(RMS). This data is being presented today during Poster Session 2,
from 15:30 – 17:00 CEST, at the 7th Joint ECTRIMS – ACTRIMS meeting in Paris,
France. Data from this trial was also presented at the conference
yesterday.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are extremely pleased by the
data presented today showing not only rapid and near complete
B-cell depletion at week 4, as previously presented, but that these
levels of depletion are also sustained nearly 6 months later with
no additional infusions of ublituximab. Today’s data coupled
with yesterday’s presentations showing complete elimination
of T1 Gd-enhancing lesions in the first 20 patients treated, a
well-tolerated safety profile, and improvements in EDSS give us
increased confidence in our currently enrolling Phase 3
program.” Mr. Weiss continued, “With what we believe to
be an appealing and differentiated profile in MS we look forward to
strong enrollment into our Phase 3 program and future presentations
from the Phase 2 study as the data continues to
mature.”
"This updated data presentation on the robust B-cell depletion
occurring with ublituximab therapy is impressive in that the
antibody appears to be extremely effective at rapidly depleting
B-cells while maintaining those levels of depletion through 24
weeks. It is also very encouraging to see that the remainder of the
immune system – NK cells, T-cells, and monocytes are able to
return to a state of homeostasis shortly following ublituximab
infusions. B-cell depleting agents have become an important
treatment option for patients suffering from MS, and provided
future data presentations and analysis continue to demonstrate the
effects seen in the Phase 2 study, ublituximab could be an
attractive treatment option for patients," stated Amy
Lovett-Racke, PhD, Professor of the Department of Microbial
Infection and Immunity at the Ohio State University
Medical Center in Columbus, OH.
This Phase 2 trial is a 52-week randomized, placebo controlled,
multi-center study evaluating the safety and efficacy of TG-1101
(ublituximab) at accelerated infusion times. Today’s posters
include data from 24 patients with RMS that were treated with
TG-1101 across three dosing cohorts.
Poster
Presentation Title: Placebo
controlled, phase 2a multicenter study of ublituximab (UTX), a
novel glycoengineered anti-CD20 monoclonal antibody (mAb), in
patients with relapsing forms of multiple sclerosis (RMS): 6 months
analysis of B cell subsets
Poster Highlights:
●
TG-1101 was well
tolerated and demonstrates rapid and robust B-cell depletion with
rapid infusions, as low as a one hour for the 450mg Phase 3
dose
●
B-cells are
efficiently depleted in most patients within 24 hours of receiving
the first dose of TG-1101, with 99% depletion observed at week 4
and maintained at week 24 (6 months) (n=24)
●
The fluctuation in
NK cells, T-cells and monocytes that occurred in response to B-cell
depletion is corrected within 4 weeks post initial TG-1101
treatment
●
No significant
effect of TG-1101 treatment was observed at Week 24 on the NK
cells, T-cells or monocytes, illustrating immune homeostasis in
non-B cells
These data presentations support the recently announced
international Phase 3 program evaluating TG-1101 (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 will be led by
Lawrence Steinman, MD, of Stanford University.
POSTERS
A copy of the above posters 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. 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 (umbralisib), 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, or the combination of which is referred to as "U2", are
in Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 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 the posters presented will 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 TG-1101 for MS; the risk that TG-1101 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.
TGTX -
G
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com