Full Press Release Details
TG Therapeutics, Inc. Provides Business Update and Reports First
Quarter 2017 Financial Results
Investor Conference Call to be Held Today, Friday, May 5, 2017 at
York, NY, (May 5, 2017)
TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the first quarter ended March 31, 2017 and
recent company developments.
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, 2017 has been an exciting and busy year for
us already, with both the announcement of the positive topline data
from the Phase 3 GENUINE trial and the subsequent $89M capital
raise. Having achieved these two important milestones, we believe
the company is well positioned for a successful remainder of the
year and beyond. Mr. Weiss continued, We plan to
focus our attention on advancing our clinical programs towards
success and look forward to a data and news rich summer where we
will be presenting a more detailed analysis of the GENUINE data,
announcing the interim analysis data from both our UNITY-CLL Phase
3 trial and UNITY-DLBCL trial, as well as commencing our global
Phase 3 program in MS.
Recent Developments and Highlights
Received orphan drug designation for the combination of TG-1101 and
TGR-1202 for the treatment of CLL and DLBCL
publication of clinical data from the Phase 1/2 trial of TG-1101
monotherapy in the British Journal of Haematology
topline data from Phase 3 GENUINE study of TG-1101 in combination
with ibrutinib in patients with high risk CLL.
Company's balance sheet raising approximately $89M in gross
proceeds through the combination of a public offering and an
at-the-market sales facility
preclinical data on our anti-PD-L1 monoclonal antibody at the
Association for Cancer Research (AACR) annual
preliminary results, including B-cell depletion data from ongoing
Phase 2 study of TG-1101 in patients with MS at the American
Academy of Neurology (AAN) annual meeting
Reaffirming 2017 Milestones
clinical data including the full Phase 3 GENUINE data at a major
medical meeting in the first half of 2017
data from the Phase 2 Multiple Sclerosis (MS) trial
interim analysis in the UNITY-CLL Phase 3 trial
interim analysis in the UNITY-DLBCL trial
to review the Phase 3 GENUINE data and discuss suitability for
filing for accelerated approval
updated data from ongoing trials at various scientific meetings
throughout the year, including the American Society of Hematology
(ASH) annual meeting in December
Financial Results for the Third Quarter 2016
Cash, cash equivalents, investment
securities, and interest receivable were $109.5 million as of March
and development (R&D) expense was $22.7 million for the three
months ended March 31, 2017 compared to $11.6 million for the three
months ended March 31, 2016. Included in research and development
expense for the three months ended March 31, 2017 and 2016, was
$5.3 million and $4.3 million, respectively, of manufacturing and
CMC expenses for Phase 3 clinical trials and potential
commercialization. The increase in R&D expenses for the three
months ended March 31, 2017, is primarily due to the ongoing
clinical development programs and related manufacturing costs for
TG-1101 and TGR-1202.
Expenses: General and administrative (G&A) expense was
$5.0 million for the three months ended March 31, 2017 as compared
to $2.4 million for the three months ended March 31, 2016. The
period-over-period increase in G&A expenses for the three
months ended March 31, 2017 relates primarily to non-cash
compensation expenses related to equity incentive grants
recognized during 2017. Other G&A
expenses for the three months ended March 31, 2017 remained
relatively flat compared to the first quarter of 2016, and we
expect G&A expenses to remain relatively constant through the
Net Loss: Net loss was $27.7 million for the three months
ended March 31, 2017 compared to a net loss of $13.8 million for
the three months ended March 31, 2016.
Company believes its cash, cash equivalents, investment securities,
and interest receivable of $109.5 million as of March 31, 2017 will
be sufficient to fund the Company's planned operations
Conference Call Information
Company will host an investor conference call today, May 5, 2017,
at 8:30am ET, to discuss the Company's first quarter 2017
financial results and provide a business outlook for the remainder
order to participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),
Conference Title: TG Therapeutics First Quarter 2017 Earnings Call.
A live webcast of this call will be available on the Events page,
located within the Investors & Media section, of the Company's
website at www.tgtherapeutics.com. An audio recording of the
conference call will also be available for replay at
www.tgtherapeutics.com, for a period of 30 days after the
ABOUT TG THERAPEUTICS, INC.
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. TG-1101 (ublituximab) 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 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 TG-1101 and TGR-1202 are in clinical