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): May 7, 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 May 7, 2019, TG
Therapeutics, Inc. (the “Company”) issued a press
release announcing the presentation of long-term follow-up data
from the Phase 2 and Open Label Extension (OLE) trial of
ublituximab (TG-1101), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody, in relapsing forms of Multiple
Sclerosis (RMS). The data are being presented at the American
Academy of Neurology 71st Annual Meeting. 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 May 7,
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: May 7,
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 Announces Long-term Follow-up Data from the Phase 2
Trial of Ublituximab in Patients with Multiple Sclerosis at the
American Academy of Neurology 71st Annual
Meeting
Ublituximab treatment continues to be well tolerated with a median
duration of follow-up of 97.5 weeks
New
York, NY, (May 7, 2019) TG
Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company
dedicated to developing medicines for patients with B-cell mediated
diseases, today announced the presentation of long-term follow-up
data from the Phase 2 and Open Label Extension (OLE) trial of
ublituximab (TG-1101), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody, in relapsing forms of Multiple
Sclerosis (RMS). The data are being presented today at the American
Academy of Neurology 71st Annual Meeting
taking place in Philadelphia, PA. Highlights from the presentation are outlined
below.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are highly encouraged by the
long-term safety data presented today at AAN, demonstrating that
ublituximab continues to be well tolerated with no patients
discontinuing treatment due to a drug related AE at a median
follow-up of 97.5 weeks. These data support our ongoing Phase 3
ULTIMATE program which is fully enrolled with data expected next
year.”
Today’s
presentation includes long-term follow-up data for 45 patients from
the Phase 2 that enrolled into the OLE and recaps the final
efficacy data on patients enrolled in the Phase 2 study through 48
weeks of treatment.
Presentation Highlights:
●
Ublituximab
continues to be well tolerated, with a median duration of follow-up
of 97.5 weeks.
●
No
subjects discontinued due to an Adverse Event (AE) related to
ublituximab on the Phase 2 or during the OLE.
●
Infusion
Related Reactions (IRRs) were rare during the OLE, occurring in
only 4 patients (9%), all Grade 1 or 2.
These long-term safety data, and the Phase 2 efficacy data support
the ongoing, fully enrolled, international Phase 3 program
evaluating ublituximab (administered in a rapid one-hour infusion)
for the treatment of 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 today 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 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’s Tyrosine Kinase (BTK) inhibitor,
TG-1701, as well as its anti-CD47/CD19 bispecific antibody,
TG-1801, 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.
Statements
included in this press release, particularly those with respect to
anticipating the benefit of the data seen in the Phase 2 and OLE MS
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, with
longer term follow-up, or in the MS Phase 3 program; the risk that
ublituximab will not have a differentiated safety or efficacy
profile from the other drugs in the class; the risk that the
long-term safety profile presented today will not be replicated in
the Phase 3 ULTIMATE program; the risk that the clinical results
from the MS Phase 3 ULTIMATE 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; 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