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TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2012 Financial Results and Business Update
Mar 12, 2013
Financial Results for the Fourth Quarter and Full Year 2012
At
The consolidated net loss for the year ended
The consolidated net loss for the fourth quarter ended
Recent Developments & Highlights
-
In
February 2013 , the first expansion cohort was opened in the Company's Phase I/II trial of TG-1101 in patients with relapsed or refractory B-cellNHL -
In
January 2013 , a first-in-human Phase I clinical trial was initiated for TGR-1202, the Company's novel PI3K-Delta inhibitor -
In
December 2012 , data for both TG-1101 and TGR-1202 was presented at the 2012American Society of Hematology (ASH) Annual Meeting -
In
December 2012 , a Phase I/II clinical trial of TG-1101 in combination with lenalidomide (Revlimid®) was initiated for patients with relapsed or refractory B-cell malignancies -
In
November 2012 , a sublicensing agreement was entered into with Ildong Pharmaceutical Co., Ltd. for development of TG-1101 inSouth Korea andSoutheast Asia for a$2.0 million upfront payment, in addition to future milestone and royalty payments -
In
September 2012 , a Phase I/II clinical trial of single agent TG-1101 was initiated for patients with relapsed or refractory B-cellNHL -
In
August 2012 , TGTX entered into a Joint Venture withRhizen Pharmaceuticals for TGR-1202, the Company's second product in development, a novel PI3K delta inhibitor
Potential 2013 Milestones
TG-1101:
-
Complete enrollment into the dose escalation component of the single agent
NHL study and complete enrollment into at least one expansion cohort - Complete enrollment into the dose escalation component of the TG-1101+Revlimid® combination study and complete enrollment into at least one expansion cohort
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Present available clinical data at medical meetings throughout 2013, including
American Society of Clinical Oncology (ASCO) inJune 2013 ,International Conference on Malignant Lymphoma (Lugano) inJune 2013 , andAmerican Society of Hematology (ASH) inDecember 2013
TGR-1202:
- Complete enrollment into the dose escalation component of the single agent study in Q3 2013
- To the extent active and well tolerated doses are identified, open expansion cohorts in the 1202 single agent, as well as open any future combination studies
- Present available clinical data at medical meetings throughout 2013 (Lugano, ASH)
The Company will host an investor conference call tomorrow,
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 Fourth Quarter and Year-End 2012 Earnings Call. The audio recording of the conference call will be available for replay at http://www.tgtherapeutics.com, for a period of 30 days after the call.
ABOUT
The
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for TG-1101 and TGR-1202 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 and TGR-1202; the risk that early clinical results that supported our decision to move forward into expansion cohorts will not be reproduced once additional patients are treated with TG-1101; 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; 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
TGTX - G
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Selected Consolidated Financial Data | ||||
Statements of Operations Information (Unaudited): | ||||
Three Months Ended |
Year Ended |
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2012 | 2011 | 2012 | 2011 | |
License revenue | $ 19,048 | $ -- | $ 19,048 | $ -- |
Costs and expenses: | ||||
Research and development: | ||||
Noncash stock expense associated with in-licensing agreement | -- | -- | 16,578,000 | 297,000 |
Noncash compensation | 219,520 | -- | 455,809 | -- |
Other research and development | 860,222 | 14,343 | 3,994,182 | 30,283 |
Total research and development | 1,079,742 | 14,343 | 21,027,991 | 327,283 |
General and administrative: | ||||
Noncash compensation | 1,024,072 | 86,494 | 2,966,373 | 86,494 |
Other general and administrative | 501,123 | 454,022 | 1,815,083 | 468,197 |
Total general and administrative | 1,525,195 | 540,516 | 4,781,456 | 554,691 |
Impairment of in-process research and development | 1,104,700 | -- | 1,104,700 | -- |
Total costs and expenses | 3,709,637 | 554,859 | 26,914,147 | 881,974 |
Operating loss | (3,690,589) | (554,859) | (26,895,099) | (881,974) |
Other (income) expense: | ||||
Interest income | (3,076) | -- | (15,787) | -- |
Other income | -- | -- | (272,232) | -- |
Interest expense | 228,901 | 7,097 | 905,744 | 7,097 |
Change in fair value of notes payable | (744,360) | -- | (1,659,872) | -- |
Total other (income) expense | (518, 535) | 7,097 | (1,042,147) | 7,097 |
Consolidated net loss before income taxes | (3,172,054) | (561,956) | (25,852,952) | (889,071) |
Income taxes | 330,000 | -- | 330,000 | -- |
Consolidated net loss | (3,502,054) | (561,956) | (26,182,952) | (889,071) |
Net loss attributable to non-controlling interest | (42,317) | (19,592) | (8,110,233) | (35,997) |
Net loss attributable to |
$ (3,459,737) | $ (542,364) | $ (18,072,719) | $ (853,074) |
Basic and diluted net loss per common share | $ (0.17) | $ (0.17) | $ (1.38) | $ (0.44) |
Weighted average shares used in computing basic and diluted net loss per common share | 19,776,138 | 3,207,634 | 13,113,758 | 1,926,198 |
Balance Sheet Information: |
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(unaudited) | ||
Cash and cash equivalents | $ 16,455,995 | $ 9,748,491 |
Accumulated deficit | (18,925,793) | (853,074) |
Total equity | 15,550,301 | 9,636,202 |
* Condensed from audited financial statements. |
CONTACT:Source:Jenna Bosco Director - Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4484 Email: ir@tgtxinc.com
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