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TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2013 Financial Results and Business Update
Mar 05, 2014
Financial Results for the Fourth Quarter and Full Year 2013
At
The consolidated net loss for the year ended
The consolidated net loss for the fourth quarter ended
Recent Developments & Highlights
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Presented clinical data for TGR-1202 demonstrating promising clinical activity at the 2013
American Society of Hematology (ASH) Annual Meeting
-
Launched combination trial of TG-1101 and ibrutinib in patients with Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL)
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Commenced first combination trial of TG-1101 and TGR-1202 in patients with relapsed and/or refractory CLL and Non-Hodgkin's Lymphoma ("NHL") being led by Dr.
Susan O'Brien from theMD Anderson Cancer Center
Key Objectives for 2014
- Determine optimal single-agent dose for TGR-1202
- Present updated single agent data for TG-1101 and TGR-1202 by mid-year
- Complete enrollment into TG-1101 and ibrutinib combination trial, and present available data at major medical meetings throughout 2014, with initial preliminary data expected by mid-year
- Complete enrollment into TG-1101 and TGR-1202 combination trial, and present available data at major medical meetings throughout 2014, with initial preliminary data expected by mid-year
- Commence one or more registration trials for TG-1101 or TGR-1202 or both before year-end
The Company will host an investor conference call
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 2013 Earnings Call. A live webcast of the call will be available at www.tgtherapeutics.com on the Events page. The audio recording of the conference call will be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.
ABOUT
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials, the timing of commencing or completing such 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 pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; 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 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
TGTX - G
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Selected Consolidated Financial Data |
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| Statements of Operations Information (Unaudited): | ||||
|
Three Months Ended |
Year Ended |
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| 2013 | 2012 | 2013 | 2012 | |
| License revenue | $ 38,095 | $ 19,048 | $ 152,381 | $ 19,048 |
| Costs and expenses: | ||||
| Research and development: | ||||
| Noncash stock expense associated with in-licensing agreement | -- | -- | -- | 16,578,000 |
| Noncash compensation | 149,206 | 219,520 | 1,041,519 | 455,809 |
| Other research and development | 3,606,385 | 860,222 | 12,621,161 | 3,994,182 |
| Total research and development | 3,755,591 | 1,079,742 | 13,662,680 | 21,027,991 |
| General and administrative: | ||||
| Noncash compensation | 797,942 | 1,024,072 | 4,161,629 | 2,966,373 |
| Other general and administrative | 662,728 | 501,123 | 2,496,461 | 1,815,083 |
| Total general and administrative | 1,460,670 | 1,525,195 | 6,658,090 | 4,781,456 |
| Impairment of in-process research and development | 2,797,600 | 1,104,700 | 2,797,600 | 1,104,700 |
| Total costs and expenses | 8,013,861 | 3,709,637 | 23,118,370 | 26,914,147 |
| Operating loss | (7,975,766) | (3,690,589) | (22,965,989) | (26,895,099) |
| Other (income) expense: | ||||
| Interest income | (15,768) | (3,076) | (30,822) | (15,787) |
| Other income | (108,894) | -- | (108,894) | (272,232) |
| Interest expense | 240,872 | 228,901 | 952,888 | 905,744 |
| Change in fair value of notes payable | (2,428,124) | (744,360) | (3,300,951) | (1,659,872) |
| Total other income | (2,311,914) | (518,535) | (2,487,779) | (1,042,147) |
| Consolidated net loss before income taxes | (5,663,852) | (3,172,054) | (20,478,210) | (25,852,952) |
| Income taxes | -- | 330,000 | -- | 330,000 |
| Consolidated net loss | (5,663,852) | (3,502,054) | (20,478,210) | (26,182,952) |
| Net loss attributable to non-controlling interest | -- | (42,317) | -- | (8,110,233) |
|
Net loss attributable to |
$ (5,663,852) | $ (3,459,737) | $ (20,478,210) | $ (18,072,719) |
| Basic and diluted net loss per common share | $ (0.19) | $ (0.17) | $ (0.81) | $ (1.38) |
| Weighted average shares used in computing basic and diluted net loss per common share | 29,440,013 | 19,776,138 | 25,413,964 | 13,113,758 |
| Balance Sheet Information: | ||
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| (unaudited) | ||
| Cash, cash equivalents, long-term investment securities and interest receivable | $ 45,431,532 | $ 16,455,995 |
| Total assets | 48,112,390 | 22,074,037 |
| Accumulated deficit | (39,404,003) | (18,925,793) |
| Total equity | 40,054,492 | 15,550,301 |
| * Condensed from audited financial statements. |
CONTACT:Jenna Bosco Director- Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4484 Email: ir@tgtxinc.com
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