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): January 22, 2019
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 January 22,
2019, TG Therapeutics, Inc. (the “Company”) issued a
press release announcing that the U.S. Food and Drug Administration
(FDA) has granted Breakthrough Therapy Designation for umbralisib
for the treatment of adult patients with marginal zone lymphoma
(MZL) who have received at least one prior anti-CD20 regimen. 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 January 22, 2019
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: January 22,
2019
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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 Receives Breakthrough Therapy
Designation from the U.S. Food and Drug
Administration for Umbralisib for the Treatment of
Marginal Zone Lymphoma
Breakthrough Therapy Designation granted based on interim data from
the Marginal Zone Lymphoma cohort of the UNITY-NHL
trial
NEW
YORK, NY (January 22, 2019) – TG Therapeutics, Inc.
(NASDAQ: TGTX), a biopharmaceutical company dedicated to developing
medicines for patients with B-cell mediated diseases, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation for umbralisib (TGR-1202)
for the treatment of adult patients with marginal zone
lymphoma (MZL) who have received at least one prior anti-CD20
regimen. There are currently no fully approved agents for
MZL.
The
Breakthrough Therapy Designation was based on interim data from the
MZL cohort evaluating umbralisib monotherapy in the ongoing
UNITY-NHL Phase 2b registration-directed clinical
trial.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer stated, “We look forward to working closely
with the FDA to bring umbralisib, our novel PI3K-delta
inhibitor to patients as quickly as possible. MZL patients who fail
initial chemo-immunotherapy are left with limited treatment
options. We believe umbralisib can play an important role in
fulfilling this unmet medical need. The MZL single agent umbralisib
cohort of the UNITY-NHL study is fully enrolled and we look forward
to reporting top-line results from this cohort by mid-year and
presenting the data at a major medical meeting in
2019.”
About Breakthrough Therapy Designation
The
FDA’s Breakthrough Therapy designation is intended to
expedite the development and review of a drug candidate that is
planned to treat a serious or life-threatening disease or condition
and preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement on one or more clinically
significant endpoints over available therapies.
About Marginal Zone Lymphoma
Marginal zone lymphoma (MZL) comprises a group of
indolent (slow growing) B-cell non-Hodgkin lymphomas
(NHLs) that
begin forming in the marginal zone of lymphoid tissue. With an
annual incidence of approximately 7,500 newly diagnosed patients,
MZL is the third most
common B-cell NHL accounting for
approximately eight percent of all NHL cases.i
MZL
consists of three different subtypes: extranodal MZL of the
mucosal-associated lymphoid tissue (MALT), nodal marginal zone
lymphoma (NMZL), and splenic marginal zone lymphoma
(SMZL).
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 oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. 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, TG-1501, as well as its
covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701,
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 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. In addition
to the risk factors identified from time to time in our reports
filed with the Securities and Exchange Commission, 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 the interim
clinical trial results from the UNITY-NHL MZL cohort that supported
this Breakthrough Therapy Designation (BTD) will not be reproduced
in the final data, or if positive, will not be sufficient to
support a filing for approval, the risk that the interim data from
the UNITY-NHL MZL cohort will not be reproduced in future studies
or in other cohorts of the UNITY-NHL study;the risk that umbralisib
will not receive accelerated approval based on data from the
UNITY-NHL MZL cohort, the risk that the differentiated tolerability
profile for umbralisib observed thus far in clinical trial will not
be reproduced in the UNITY-NHL study, the UNITY-CLL study or any
other on-going studies;the risk that the combination of ublituximab
(TG-1101) and umbralisib (TGR-1202), referred to as U2 and being
studied in the UNITY-CLL clinical trial, will not prove to be a
safe and efficacious combination, or approved for any indication.
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
i Denlinger
NM, Epperla N, William BM. Management of relapsed/refractory
marginal zone lymphoma: focus on ibrutinib. Cancer Manag Res. 2018
Mar 27;10:615-624. doi: 10.2147/CMAR.S133291. eCollection
2018