Full Press Release Details
TG Therapeutics, Inc. Provides
Business Update and Reports Third Quarter 2016 Financial
Investor Conference Call to be Held Today, Monday, November 7, 2016
York, NY, (November 7, 2016)
TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the third quarter ended September 30, 2016
and recent company developments.
S. Weiss, the Company's Executive Chairman and Interim Chief
Executive Officer, stated, "The third quarter was a pivotal one for
the company, particularly with the amendment of the GENUINE Phase 3
trial that will enable the rapid conclusion of the study while also
maintaining the possibility for accelerated approval for TG-1101 in
combination with ibrutinib. Importantly, with GENUINE enrollment
wrapping up, we can dedicate our resources and focus to our
proprietary UNITY program, which we believe offers the potential
for highly active, well-tolerated therapy with certain pricing
advantages over competitors. As a result, we see our value
proposition rising as the concern around pharmaceutical pricing
continues to grow." Mr. Weiss continued, "We see important value
creating milestones over the next 12 months, including completion
of enrollment of GENUINE expected by year end 2016 to be followed
by top line data in the first half of 2017. During the course of
2017, we should also report early data from our UNITY-DLBCL study
and our MS pivotal program should take full form supported by
B-cell depletion data from our ongoing Phase 2 study in RRMS. With
all these events lining up, we believe 2017 will be our most
impactful year to date.
Third Quarter and Recent Highlights
ASH 2016: The Company looks forward to the upcoming American
Society of Hematology (ASH) Annual Meeting where data presentations
will include three oral presentations and three poster
presentations. All clinical presentations will highlight the safety
and efficacy for combinations of TGR-1202 with novel targeted
agents including oral presentations with TGR-1202 in combination
with ibrutinib and TGR-1202 in combination with
TGR-1202 Pre-Clinical
Differentiation: An October
publication in Blood presented preclinical data describing the synergy
of TGR-1202 with carfilzomib and the unique effects of the
combination to silence c-Myc in various preclinical lymphoma and
myeloma models. In addition, the publication described TGR-1202's
unique complimentary mechanism of inhibiting the protein kinase
casein kinase-1 (CK1) epsilon, which may contribute to the
silencing of c-Myc and explain TGR-1202's clinical activity in
aggressive lymphoma.
TGR-1202 + Carfilzomib:
Based on the pre-clinical work on
TGR-1202 published in Blood, a Phase 1/2 study of TGR-1202 and Carfilzomib in
patients with relapsed or refractory lymphoma was
GENUINE Study Amendment:
The Company amended the ongoing
GENUINE Phase 3 Clinical Trial by revising the primary endpoint to
Overall Response Rate (ORR), with enrollment expected to be
completed before year end 2016 and top-line data available in first
half of 2017. The study is well powered to detect a difference in
ORR, which, if successful, would potentially support a filing for
accelerated approval.
Clinical Data Presentation of
TG-1101 in NMO: During the 32nd
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis, the Company presented clinical data from the
Phase Ib study of TG-1101 in patients with NMO with TG-1101
demonstrating rapid and effective depletion of B-cells during acute
NMO relapse. The Company has an on-going Phase 2 study of TG-1101
in multiple sclerosis.
Designations: The Company
received Orphan Drug Designation for TGR-1202 for treatment of
Chronic Lymphocytic Leukemia and for TG-1101 for treatment of
Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum
Patient enrollment began for the
registration-directed UNITY-DLBCL Phase 2b clinical study
evaluating TG-1101 and TGR-1202 in combination compared to TGR-1202
monotherapy in patients with advanced relapsed/refractory
into the GENUINE Phase 3 clinical trial
into the Company's registration directed trials, including
the UNITY-CLL Phase 3, and the UNITY-DLBCL Phase 2b
into the Phase 2 clinical trial in Multiple Sclerosis
data from a variety of Phase 1 and 2 clinical trials at the
American Society of Hematology Annual Meeting in December 2016,
held in San Diego, CA
Financial Results for the Third Quarter 2016
Cash, cash equivalents, investment
securities, and interest receivable were $60.7 million as of
Research and development (R&D)
expenses were $21.8 million and $46.9 million for the three and
nine months ended September 30, 2016, respectively, compared to
$11.6 million and $32.5 million for the three and nine months ended
September 30, 2015, respectively. Included in research and
development expenses for the three and nine months ended September
30, 2016, are $10.2 million and $17.9 million, respectively, of
manufacturing and CMC expenses for Phase 3 clinical trials and
potential commercialization. The increase in R&D expenses for
both the three and nine months ended September 30, 2016, is
primarily due to the ongoing clinical development programs and
related manufacturing costs for TG-1101 and
General and administrative (G&A)
expenses were $3.2 million and $8.1 million for the three and nine
months ended September 30, 2016, respectively, as compared to $2.3
million and $13.2 million for the three and nine months ended
September 30, 2015, respectively. The period-over-period decrease