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): June 18, 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 June
18, 2018, TG Therapeutics, Inc. (the “Company”) issued
a press release announcing the oral presentation of clinical data
from its ongoing Phase 2 study evaluating umbralisib (TGR-1202),
the Company’s PI3K delta inhibitor, in patients with relapsed
or refractory Chronic Lymphocytic Leukemia (CLL) who are intolerant
to prior BTK or PI3K delta inhibitor therapy, at the 23rd Congress
of European Hematology Association (EHA). On June 18, 2018, the
Company also announced updated 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), at the 4th Congress of the European
Academy of Neurology (EAN), in Lisbon, Portugal. Copies of the
press releases are being filed as Exhibits 99.1 and Exhibits 99.2
and incorporated in this Item by reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press Release, dated June 18,
2018.
99.2 Press Release, dated June 18,
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: June 18,
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, Inc. Presents Phase 2 Data Evaluating Umbralisib
in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor
Therapy at the 23rd Congress of the
European Hematology Association (EHA)
NEW
YORK NY (June 18, 2018) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced an oral presentation of clinical data from its
ongoing Phase 2 study evaluating umbralisib (TGR-1202), the
Company’s PI3K delta inhibitor, in patients with relapsed or
refractory Chronic Lymphocytic Leukemia (CLL) who are intolerant to
prior BTK or PI3K delta inhibitor therapy. Data from this trial
were presented over the weekend during an oral session at the 23rd Congress of the
European Hematology Association (EHA).
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “We are pleased to present data evaluating
umbralisib in patients intolerant to currently approved BTK or PI3K
therapies during the EHA annual congress. While there have been
great advancements in recent years in the treatment of CLL, this
study confirms that there are many patients still in need of an
alternative treatment option and that umbralisib can be used safely
and effectively in those patients who were not able to tolerate a
prior BTK or PI3K therapy. The rate of patients withdrawing from
kinase treatment for CLL in real world settings has been estimated
to reach upwards of 40%, representing a significant unmet medical
need.” Mr. Weiss continued, “We are extremely pleased
with the data presented at ASCO and EHA this month and we look
forward to presenting the topline response rate data from the
UNITY- CLL Phase 3 trial by the end of summer
2018.”
Highlights
from the oral presentation include the following:
Oral Presentation:
A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib
(TGR-1202) In Patients with Chronic Lymphocytic Leukemia (CLL) Who
Are Intolerant to Prior BTK or PI3K-delta Inhibitor Therapy
(Abstract Number S808)
This
presentation includes data from patients with CLL who are
intolerant to prior BTK or PI3K delta inhibitor therapy who were
then treated with single agent umbralisib (TGR-1202). To be
eligible for the study patients had to have received prior
treatment with a BTK inhibitor (ibrutinib, acalabrutinib) or a PI3K
delta inhibitor (idelalisib, duvelisib) and discontinued therapy
due to intolerance within 12 months of starting treatment on this
study. Forty-seven patients were evaluable for safety of which 46
were evaluable for Progression Free Survival (PFS), (1 patient had
a confirmed Richter’s Transformation (RT) at enrollment which
did not meet eligibility criteria).
Highlights
from this presentation include:
●
Umbralisib
demonstrated a favorable safety profile in patients intolerant to
prior BTK or PI3K therapy
●
Only 13%
discontinued due to an adverse event, of which only one patient
discontinued due to a recurrent adverse event (AE) also experienced
with prior kinase inhibitor therapy
●
Median progression
free survival (PFS) and overall survival has not been reached with
a median follow-up of 9.5 months
●
In this
relapsed/refractory CLL population, of which 77% required treatment
within 6 months of prior KI discontinuation, 64% had a high-risk
molecular / genetic marker and 6% had an ibrutinib resistance
mutation, significant clinical activity has been
observed
PRESENTATION DETAILS
The
above referenced presentation is now 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
Some of the statements included in this press release or in the
abstracts mentioned 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. Among the factors that
could cause our actual results to differ materially are the
following: our ability to successfully and cost-effectively
complete preclinical and clinical trials; the risk that
early clinical trial results (both safety and efficacy), that may
have supported the acceptance of our data for presentation or
influenced our decision to proceed with additional clinical trials,
will not be reproduced in future studies or in the final
presentations; the risk that the differentiated tolerability
profile for umbralisib observed will not be reproduced in full
presentations or later larger studies; the risk that the final data
from either GENUINE or UNITY-CLL will not support a regulatory
filing or approval or that the company will choose not to file a
BLA/NDA or seek accelerated approval based on those studies; the
risk that the topline overall response rate data from the UNITY-CLL
trial is not be statistically significant 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
Exhibit 99.2
TG Therapeutics, Inc. Announces Updated Results from the Ongoing
Phase 2 Study of Ublituximab in Patients with Multiple Sclerosis at
the 4th
Congress of the European Academy of Neurology
New
York, NY, (June 18, 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 at the 4th Congress of the
European Academy of Neurology in Lisbon, Portugal, via an oral
session titled “MS and related Disorders 2”, at 17:00
CET.
Michael
S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer, stated, “We are extremely pleased to see
that the preliminary Week 48 data presented today from this Phase 2
trial supports the Week 24 data presented earlier this year at the
AAN meeting. While only an early look at the Week 48 timepoint, the
data continue to be impressive and suggestive of a highly
efficacious anti-CD20 monoclonal antibody with a manageable safety
profile that can be administered in a convenient one-hour infusion.
Mr. Weiss continued, “We look forward to presenting the final
results from this Phase 2 trial including Week 48 data on up to 48
patients at a major medical meeting later this
year.”
Oral
Presentation Title: Phase 2 Multicenter Study Results of
Ublituximab, a Novel Glycoengineered AntiCD20 Monoclonal Antibody
(mAb), in Patients with Relapsing Multiple Sclerosis
(RMS)
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 oral presentation includes Week 24 data from 48
patients with relapsing forms of multiple sclerosis (RMS) that were
treated with ublituximab across six dosing cohorts, as well as data
from the first 14 patients through Week 48.
Highlights:
●
An Annualized
Relapse Rate (ARR) of 0.07, calculated cumulatively, based on 48
subjects with a mean follow-up of approximately 11
months
●
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) and at Week 48 (n=14)
●
7.67% Reduction in
T2 lesion volume at Week 24 from baseline(n=44) and a 10.5%
reduction in T2 lesion volume at Week 48 from baseline
(n=14)
●
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 by the end of
2018.
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