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TG Therapeutics, Inc. Announces Third Quarter 2015 Financial Results and Business Update Investor Conference Call to be Held Today, Monday

Key Takeaway: TG Therapeutics, Inc. Announces Third Quarter 2015 Financial Results and Business Update Investor Conference Call to be Held Today, Monday, November 9, 2015 at 8:30am ET New York, NY, (November 9, 2015) - TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its financial resu

Full Press Release Details

TG Therapeutics, Inc. Announces
Third Quarter 2015 Financial Results and Business Update
Investor Conference Call to be
Held Today, Monday, November 9, 2015 at 8:30am ET
New York, NY, (November 9, 2015)
- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its financial results for the third quarter ended September 30, 2015
and recent company developments.
Michael S. Weiss, the Company's
Executive Chairman and Interim Chief Executive Officer, stated, "During the third quarter, we achieved another major milestone
for the Company in obtaining a Special Protocol Assessment for our UNITY-CLL trial, a study evaluating the safety and efficacy
of our proprietary 1303' combination regimen in patients with front-line as well as previously treated CLL. This
is a very important and exciting clinical trial for the Company, as it represents our first pivotal trial for our proprietary
combination and, if successful, should provide a broad approval in CLL offering patients in both first-line and relapsed/refractory
setting, a novel, non-chemotherapy treatment option. Further, it would provide us a broad label for building additional three
and, possibly, four drug proprietary combinations to further improve outcomes for patients with CLL. With Phase 3 programs in
oncology now underway for both TG-1101 and TGR-1202, we're excited to begin exploring the potential of our pipeline products
for the treatment of autoimmune disease, an area where B-cell targeted therapies have proven highly effective, and anticipate
commencing our first trial in Multiple Sclerosis in the near-term." Mr. Weiss continued, "We also remain focused on
aggressively enrolling into our ongoing GENUINE Phase 3 clinical trial, and expect top-line data from this study in the second
half of 2016. Finally, from a financial perspective, with more than $115 million in cash and investments we have enough cash to
execute on our business plan."
Recent Developments and Highlights
Goals/Objectives for the Remainder
Financial Results for the
At September 30, 2015 the Company
had cash, cash equivalents, investment securities, and interest receivable of $115.4 million, which
includes approximately $67.0 million of net proceeds from the utilization
of the Company's at-the-market ("ATM") sales facility during the year (all of which was previously disclosed in connection
with our last quarterly update), as compared to December 31, 2014 when we had $78.9 million.
Our consolidated net loss for the
third quarter ended September 30, 2015, excluding non-cash items, was approximately $12.4 million, which included approximately
$6.9 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The
consolidated net loss for the third quarter ended September 30, 2015, inclusive of non-cash items, was $13.7 million, or $0.28
per diluted share, compared to a consolidated net loss of $17.5 during the comparable quarter in 2014, representing a decrease
in consolidated net loss of $3.8 million. The decrease in consolidated net loss during the third quarter ended September 30, 2015
was primarily the result of $8.1 million of expense ($4.1 million of which was non-cash stock expense) recorded during the quarter
ended September 30, 2014 in conjunction with the Company's licensing agreement for TGR-1202, and a $2.9 million decrease
in non-cash compensation expense related to equity incentive grants over the comparable period in 2014. Partially offsetting the
aforementioned decreases, other research and development expenses for TG-1101 and TGR-1202 increased $4.8 million and $2.1 million,
respectively, over the comparable period in 2014.
Our consolidated net loss for the
nine months ended September 30, 2015, excluding non-cash items, was approximately $32.5 million, which included approximately
$16.0 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization. The
consolidated net loss for the nine months ended September 30, 2015, inclusive of non-cash items, was $45.3 million, or $1.01 per
diluted share, compared to a consolidated net loss of $37.0 million during the comparable period in 2014, representing an increase
in consolidated net loss of $8.3 million. The increase in consolidated net loss during the nine months ended September 30, 2015
was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $14.6 million
and $4.5 million, respectively, over the comparable period in 2014. This was offset by $9.3 million of expense ($5.3 million of
which was non-cash stock expense) recorded in conjunction with the Company's licensing agreements for TGR-1202 and the IRAK4
inhibitors program during the nine months ended September 30, 2014, and a decrease of $3.2 million in non-cash compensation expense
related to equity incentive grants over the comparable period in 2014.
Conference Call Information
The Company will host an investor
conference call today, November 9, 2015, at 8:30am ET, to discuss the Company's third quarter 2015 financial results and
provide a business outlook for the remainder of 2015.
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 Third Quarter 2015
Earnings Call. A live webcast of this presentation 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. 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. The Company also has pre-clinical programs
to develop IRAK4 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 future clinical trials, the timing of commencing or completing
such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies
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 pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR
antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202,
the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future
studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue,
the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the
completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not
prove to be a safe and efficacious backbone for triple and quad combination therapies; 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 trials will take longer to enroll than expected; 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
Consolidated Financial Data
of Operations Information (Unaudited):
Three months ended September 30, Nine months ended September 30,
2015 2014 2015 2014
License revenue $ 38,096 $ 38,096 $ 114,286 $ 114,286
Costs and expenses:
Research and development:
Noncash stock expense associated with in-licensing agreements -- 4,138,844 -- 5,350,094
Noncash compensation 35,756 1,200,575 2,733,110 6,402,296
Other research and development 11,538,246 8,352,154 29,719,891 13,197,183
Total research and development 11,574,002 13,691,573 32,453,001 24,949,573
General and administrative:
Noncash compensation 1,204,278 2,895,997 10,106,938 9,664,560
Other general and administrative 1,085,400 889,872 3,094,362 2,500,121
Total general and administrative 2,289,678 3,785,869 13,201,300 12,164,681
Total costs and expenses 13,863,680 17,477,442 45,654,301 37,114,254
Operating loss (13,825,584 ) (17,439,346 ) (45,540,015 ) (36,999,968 )
Other (income) expense:
Interest income (55,977 ) (12,107 ) (109,660 ) (38,308 )
Other income -- -- -- (95,427 )
Interest expense 246,527 234,787 730,710 695,914
Change in fair value of notes payable (360,218 ) (210,857 ) (824,231 ) (577,299 )
Total other (income) expense (169,668 ) 11,823 (203,181 ) (15,120 )
Consolidated net loss $ (13,655,916 ) $ (17,451,169 ) $ (45,336,834 ) $ (36,984,848 )
Basic and diluted net loss per common share $ (0.28 ) $ (0.51 ) $ (1.01 ) $ (1.14 )
Weighted average shares used in computing basic and diluted net loss per common share 47,946,309 34,188,108 44,810,352 32,436,420
Condensed Balance Sheet Information:
September 30, 2015 December 31, 2014*
(unaudited)
Cash, cash equivalents, investment securities and interest receivable $ 115,409,868 $ 78,861,334
Total assets 127,407,138 86,746,890
Accumulated deficit (140,522,114 ) (95,185,280 )
Total equity 116,311,812 80,101,884
* Condensed from audited financial
Last updated: Nov 9, 2015