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 3, 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 4, 2018, TG
Therapeutics, Inc. (the “Company”) issued a press
release announcing updated 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 presented during the 54th American Society
of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. A copy
of the press release is being filed as Exhibit 99.1 and
incorporated in this Item by reference. Filed as Exhibit 99.2 and
incorporated in this Item by reference are slides utilized at the
Company’s Investor and Analyst event on June 3,
2018.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press Release, dated June 4,
2018.
99.2 Slides from Analyst
and Investor Event, dated June 3, 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 4,
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. Announces Umbralisib Clinical Data Presentation at the 54th Annual Meeting of the American Society of Clinical Oncology
CHICAGO,
IL (June 4, 2018) - TG Therapeutics, Inc. (NASDAQ: TGTX), today
announced updated 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 are being presented
today during the 54th American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago,
IL.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “We are extremely pleased with the data
presented today during the ASCO annual meeting. We believe there is
a need for novel treatment options for patients who are intolerant
to the currently approved BTK and PI3K therapies and believe the
data shown today demonstrates that umbralisib can be used
effectively in these patients.” Mr. Weiss, continued,
“We continue to be pleased with the safety and efficacy
profile of umbralisib and believe umbralisib single agent, or
umbralisib plus ublituximab referred to as ‘U2’, can
become important treatment options across multiple b-cell
malignancies. We also look forward to presenting updated umbralisib
integrated safety data at the European Hematology Association (EHA)
annual congress in a couple of weeks, as well as the topline
response rate data from the UNITY-CLL Phase 3 trial by the end of
summer 2018.”
Highlights
from today’s presentation include the following:
Poster
Presentation: KI Intolerance Study: 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
4314)
This
poster 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 poster 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 KI therapy
●
Nodal reductions
were seen in nearly all patients evaluable for response with 3
patients achieving complete resolution of nodal disease, of which 1
patient with 17p del achieved a bone marrow confirmed Complete
Response (CR)
●
Median progression
free survival (PFS) 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, 68% 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
combination of ublituximab (TG-1101) and umbralisib (TGR-1202),
referred to as U2, and being studied in the UNITY clinical trials
and other studies, will not prove to be safe and efficacious for
any indication; the risk that the differentiated tolerability
profile for umbralisib observed will not be reproduced in full
presentations or later larger studies; the risk that umbralisib
will not be proven to be effective in the treatment of patients
intolerant to prior kinase inhibitors; 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
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
