Full Press Release Details
TG Therapeutics, Inc. Announces First Quarter 2016 Financial
Results and Business Update
Investor Conference Call to be Held Today, Tuesday, May 10,
New York, NY, (May 10, 2016) - TG Therapeutics,
Inc. (NASDAQ:TGTX) today announced its financial results for the first quarter ended March 31, 2016 and recent company developments.
Michael S. Weiss, the Company's Executive Chairman and Interim
Chief Executive Officer, stated, "The first quarter was another productive one for TG with
the issuance of long term patent protection for both TG-1101 and TGR-1202, the presentation of data at AACR providing a scientific
rationale for the observed safety differences seen with TGR-1202 in comparison to other PI3K delta inhibitors, and continued enrollment
into our CLL Phase 3 trials, which remains our top priority for the year. More recently, we announced the commencement of our first
Phase 2 study in Multiple Sclerosis, and plans to enter Phase 3 for MS next year." Mr. Weiss continued, "We have a
long term vision to build best-in-class combination treatments across B-cell malignancies and our Phase 3 CLL trials are just the
beginning as we look forward to announcing the opening of our UNITY-DLBCL program toward the end of this month and launching UNITY-iNHL
before year-end. Our financial resources remain strong, leaving us well positioned to execute on our aggressive business plan."
Recent Developments and Highlights
Financial Results for the First Quarter 2016
At March 31, 2016 the Company had cash, cash equivalents, investment
securities, and interest receivable of $85.3 million, which we believe will be sufficient to fund our operations into the second
Our net loss for the first quarter ended March 31, 2016, excluding non-cash items, was approximately $12.1 million, which included
approximately $4.3 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and potential commercialization.
The net loss for the first quarter ended March 31, 2016, inclusive of non-cash items, was $13.8 million, or $0.28 per basic and
diluted share, compared to a net loss of $14.6 million during the comparable quarter in 2015, or $0.35 per basic and diluted share.
The decrease in net loss during the first quarter ended March 31, 2016 was the result of a decrease in non-cash compensation expense
related to equity incentive grants over the comparable period in 2015, partially offset by an increase in other research and development
expenses as a result of clinical trial expenses related to ongoing and planned future Phase 3 registration programs.
Conference Call Information
The Company will host an investor conference call today, May
10, 2016, at 4:30pm ET, to discuss the Company's first quarter 2016 financial results and provide a business outlook for
the remainder of 2016.
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 First Quarter 2016 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
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 recently entering clinical development
for autoimmune disorders. 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
Director- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com
Selected Consolidated Financial Data
of Operations Information (Unaudited):
| Three months ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| License revenue | $ | 38,095 | $ | 38,095 | ||||
| Costs and expenses: | ||||||||
| Research and development: | ||||||||
| Noncash compensation | 386,925 | 1,337,908 | ||||||
| Other research and development | 11,230,415 | 8,279,431 | ||||||
| Total research and development | 11,617,340 | 9,617,339 | ||||||
| General and administrative: | ||||||||
| Noncash compensation | 1,312,040 | 4,019,120 | ||||||
| Other general and administrative | 1,100,871 | 1,004,487 | ||||||
| Total general and administrative | 2,412,911 | 5,023,607 | ||||||
| Total costs and expenses | 14,030,251 | 14,640,946 | ||||||
| Operating loss | (13,992,156 | ) | (14,602,851 | ) | ||||
| Other (income) expense: | ||||||||
| Interest income | (84,862 | ) | (22,132 | ) | ||||
| Interest expense | 242,405 | 237,657 | ||||||
| Change in fair value of notes payable | (301,037 | ) | (240,641 | ) | ||||
| Total other income | (143,494 | ) | (25,116 | ) | ||||
| Net loss | $ | (13,848,662 | ) | $ | (14,577,735 | ) | ||
| Basic and diluted net loss per common share | $ | (0.28 | ) | $ | (0.35 | ) | ||
| Weighted average shares used in computing basic and diluted net loss per common share | 48,908,278 | 41,088,752 |
Condensed Balance Sheet Information:
| March 31, 2016 | December 31, 2015* | |||||||
| (unaudited) | ||||||||
| Cash, cash equivalents, investment securities and interest receivable | $ | 85,325,010 | $ | 102,416,894 | ||||
| Total assets | 100,062,519 | 113,473,201 | ||||||
| Accumulated deficit | (171,982,588 | ) | (158,133,926 | ) | ||||
| Total equity | 89,445,768 | 101,573,302 |