Full Press Release Details
TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2016
Financial Results and Business Update
Company solidifies balance sheet with approximately $89M in gross
proceeds through the combination of $57.5M public offering and $31M
from at-the-market (ATM) sales
facility completed prior to the offering
Investor conference call to be held today, Friday March 10, 2017 at
York, NY, (March 10, 2017)
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its
financial results for the fourth quarter and year ended December
31, 2016 and provided recent company developments along with a
business outlook for 2017.
Company announced that through the combination of an underwritten
public offering, and proceeds raised through the utilization of an
ATM program, the Company raised combined gross proceeds of
approximately $89M before deducting underwriting discounts and
commissions and other estimated offering expenses. The underwritten
offering consisted of 5,128,206 shares of its common stock (plus a
30-day option to purchase up to an additional 769,230 shares of
common stock, which has been exercised) at a price of $9.75 per
share, with expected gross proceeds to TG Therapeutics of $57.5
million, less underwriting discounts and commissions. The offering
is expected to close on or about March 14, 2017, subject to the
satisfaction of customary closing conditions. Prior to the public
offering, the Company also issued approximately 3,000,000 shares
through the ATM program for gross proceeds of approximately $31
million at an average price of $10.27, these shares were issued on
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "2016 was a very productive year for the Company,
laying the foundation for pivotal data read-outs in 2017 and 2018.
The first of which were reported earlier this week, with the
announcement of the positive topline results from our Phase 3
GENUINE clinical trial. For the remainder of 2017, we look forward
to the full data presentation from the GENUINE trial in the summer
and then in the second half to a meeting with the FDA to discuss a
filing for accelerated approval. All along we will continue to
remain highly focused on enrolling into our proprietary UNITY
programs, which are proceeding nicely and on schedule. Mr.
Weiss continued, This week we also had the opportunity to
solidify our cash reserves with the recently conducted offerings,
which should provide us with sufficient capital to advance our key
programs and get us closer to our goal of bringing our novel
treatment options to patients with B-cell
enrollment in our Phase 3 GENUINE clinical trial, which resulted in
positive topline data
UNITY-CLL Phase 3 and UNITY-DLBCL Phase 2b trials for the
combination of TG-1101 + TGR-1202
positive outcome of our UNITY-CLL Phase 3 DSMB safety review
meeting, pursuant to which the study was recommended to continue
enrolling both front-line and previously treated patients with no
changes recommended to the study
clinical trial in Multiple Sclerosis (MS) for TG-1101
issuance of composition of matter patents for both TG-1101 and
TGR-1202 providing protection through 2029 and 2033, respectively,
both exclusive of available patent term extensions
publications in prestigious journals, the first in BLOOD describing a novel mechanism of
TGR-1202 with potential in cMYC driven malignancies, and the second
in the British Journal of Haematology with data from our Phase 2
clinical trial of TG-1101 plus ibrutinib in patients with Chronic
Lymphocytic Leukemia (CLL)
the ASH annual meeting including 3 oral presentations and 3 poster
presentations, with a focus on combination therapy
Key Objectives for 2017
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 GENUINE Phase 3 data and discuss suitability for
filing for accelerated approval
new and updated data from ongoing trials at various scientific
meetings throughout the year, including the ASH annual meeting in
Financial Results for the Fourth Quarter and Full Year
Cash, cash equivalents, investment
securities, and interest receivable were $45.0 million as of
December 31, 2016. During the
first quarter of 2017 the Company raised approximately $84 million of net proceeds from the
underwritten public offering of the Company's common stock
and the utilization of the Company's at-the-market ("ATM")
Research and development (R&D)
expenses were $22.3 million and $69.2 million for the three and
twelve months ended December 31, 2016, respectively, compared to
$15.3 million and $47.7 million for the three and twelve months
ended December 31, 2015, respectively. Included in research and
development expenses for the three and twelve months ended December
31, 2016, are $9.1 million and $27.0 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 twelve months ended December 31, 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 $1.8 million and $9.9 million for the three and
twelve months ended December 31, 2016, respectively, as compared to
$2.4 million and $15.6 million for the three and twelve months
ended December 31, 2015, respectively. The period-over-period
decrease in G&A expenses from three and twelve months ended
December 31, 2015 relates primarily to non-cash compensation
expenses related to equity incentive expense recognized during
Net Loss: Net loss was $23.7 million and $78.3 million for