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| 8-K - 8-K - TG THERAPEUTICS, INC. | v031017_8k.htm |
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
8:30am ET
New
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.
The
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
March 9, 2017.
Michael
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
malignancies.”
2016 Highlights
●
Completed
enrollment in our Phase 3 GENUINE clinical trial, which resulted in
positive topline data
●
Launched the
UNITY-CLL Phase 3 and UNITY-DLBCL Phase 2b trials for the
combination of TG-1101 + TGR-1202
●
Announced the
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
●
Launched our first
clinical trial in Multiple Sclerosis (MS) for TG-1101
●
Announced the
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
●
Announced two
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)
●
Presented data at
the ASH annual meeting including 3 oral presentations and 3 poster
presentations, with a focus on combination therapy
Key Objectives for 2017
●
Present updated
clinical data including the full Phase 3 GENUINE data at a major
medical meeting in the first half of 2017
●
Present clinical
data from the Phase 2 Multiple Sclerosis (MS) trial
●
Initiate a global
Phase 3 trial in MS
●
Complete the first
interim analysis in the UNITY-CLL Phase 3 trial
●
Complete the first
interim analysis in the UNITY-DLBCL trial
●
Meet with the FDA
to review the GENUINE Phase 3 data and discuss suitability for
filing for accelerated approval
●
Present
new and updated data from ongoing trials at various scientific
meetings throughout the year, including the ASH annual meeting in
December
Financial Results for the Fourth Quarter and Full Year
2016
●
Cash Position:
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")
sales.
●
R&D Expenses:
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
TGR-1202.
●
G&A Expenses:
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
2015.
●
Net Loss: Net loss was $23.7 million and $78.3 million for
the three and twelve months ended December 31, 2016, respectively,
compared to a net loss of $17.6 million and $62.9 million for the
three and twelve months ended December 31, 2015,
respectively.
●
Financial Guidance:
The Company believes its cash, cash
equivalents, investment securities, and interest receivable on hand
as of December 31, 2016 combined with the additional capital raised
in the first quarter of 2017 will be sufficient to fund the
Company’s planned operations for approximately the next 24
months.
Conference
Call Information
The
Company will host an investor conference call today, Friday, March
10, 2017 at 8:30am ET, to discuss the Company’s 2016
financial results and provide a business outlook for
2017.
In
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 Year-End 2016 Earnings Call. A
live audio webcast of this conference 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
call.
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. 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
development for patients with hematologic malignancies, with
TG-1101 also in clinical development for autoimmune disorders. The
Company also has pre-clinical programs to develop IRAK4 inhibitors,
BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG
Therapeutics is headquartered in New York City.
Cautionary Statement
Some of
the statements included in this press release, particularly those
with respect to anticipating the timing of the completion of the
GENUINE study, timing of presentation of the data for the GENUINE
study, the timing of meeting with the FDA to discuss the GENUINE
data, the usability of the results from GENUINE for accelerated
approval, timing of initial data from the UNITY-DLBCL study, timing
of the interim analysis from the UNITY-CLL, timing of the release
of Phase 2 data and commencement of our MS pivotal program and the
timing of how long our cash resources will carry the Company 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: our ability to successfully and cost-effectively
complete the GENUINE, the UNITY-CLL or the UNITY-DLBCL trials; the
risk that the clinical results from the GENUINE, UNITY-CLL and/or
UNITY-DLBCL studies will be not positive and/or will not support
regulatory approval of TG-1101 or TGR-1202; the risk that
the FDA will not grant us a pre-BLA meeting to discuss
the results of the GENUINE study; the risk that we will not file a
BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE
or the UNITY-CLL; the risk that despite early positive trends in
enrollment in the UNITY-CLL study that enrollment will be delayed
beyond our projections; the risk that the planned interim analysis
will not allow early closure of the single agent arms in the
UNITY-CLL study, necessitating enrollment beyond the projected 450
patients, which would extend enrollment beyond our projections; the
risk that safety issues or trends will be observed in the GENUINE
study, the UNITY-CLL and/or the UNITY-DLBCL study that prevent
approval of either TG-1101 and/or TGR-1202 or require us to
terminate either the GENUINE study or the UNITY-CLL or the
UNITY-DLBCL study prior to completion; the risk that the data (both
safety and efficacy) from future clinical trials will not coincide
with the data produced from prior pre-clinical and clinical trials;
the risk that the GENUINE study, as amended or the UNITY-CLL or the
UNITY-DLBCL studies, or any of our other registration-directed
clinical trials as designed or amended may not be sufficient or
acceptable to support regulatory approval; the risk that trials
will take longer to enroll than expected; the risk that the
projected cost savings to be realized by amending the GENUINE trial
will not be realized; 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.
TGTX -
G
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com
TG Therapeutics, Inc.
Selected Consolidated Financial Data
Statements of Operations Information
(Unaudited):
|
|
Three Months Ended December
31,
|
Year Ended December
31,
|
||
|
|
2016
|
2015
|
2016
|
2015
|
|
License
revenue
|
$ 38,095
|
$ 38,095
|
$ 152,381
|
$ 152,381
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development:
|
|
|
|
|
|
Noncash
compensation
|
868,624
|
1,528,296
|
2,742,354
|
4,261,406
|
|
Other
research and development
|
21,414,723
|
13,725,926
|
66,489,820
|
43,445,817
|
|
Total research and
development
|
22,283,347
|
15,254,222
|
69,232,174
|
47,707,223
|
|
|
|
|
|
|
|
General and
administrative:
|
|
|
|
|
|
Noncash
compensation
|
459,975
|
1,328,748
|
4,767,645
|
11,435,686
|
|
Other general and
administrative
|
1,322,831
|
1,095,126
|
5,121,690
|
4,189,488
|
|
Total general and
administrative
|
1,782,806
|
2,423,874
|
9,889,335
|
15,625,174
|
|
|
|
|
|
|
|
Total costs and
expenses
|
24,066,153
|
17,678,096
|
79,121,509
|
63,332,397
|
|
|
|
|
|
|
|
Operating
loss
|
(24,028,058)
|
(17,640,001)
|
(78,969,128)
|
(63,180,016)
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
Interest
income
|
(57,576)
|
(64,993)
|
(323,032)
|
(174,653)
|
|
Other
(income) expense
|
(296,339)
|
36,804
|
(393,202)
|
(56,717)
|
|
Total other
(income) expense
|
(353,915)
|
(28,189)
|
(716,234)
|
(231,370)
|
|
|
|
|
|
|
|
Net
loss
|
$ (23,674,143)
|
$ (17,611,812)
|
$ (78,252,894)
|
$ (62,948,646)
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$ (0.48)
|
$ (0.37)
|
$ (1.60)
|
$ (1.38)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
49,278,068
|
48,127,335
|
49,041,354
|
45,646,414
|
Balance Sheet Information:
|
|
December
31, 2016
(Unaudited)
|
December
31, 2015
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$ 44,968,992
|
$ 102,416,894
|
|
Total
assets
|
54,781,547
|
113,473,201
|
|
Accumulated
deficit
|
(236,386,820)
|
(158,133,926)
|
|
Total
equity
|
35,867,802
|
101,573,302
|