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TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2015 Financial Results and Business Update
Mar 07, 2016
Ended 2015 in a Strong Financial Position, With More Than
Investor Conference Call to be Held Today,
2015 Highlights
- Expanded our product portfolio through a global collaboration with Checkpoint Therapeutics to develop and commercialize anti-PDL1 and anti-GITR antibody research programs from
Dana Farber Cancer Institute in hematologic malignancies - Commenced enrollment into the GENUINE Phase 3 clinical trial, which is now open in over 150 sites throughout the US
- Presented the first data from the triple combination study of TG-1101 + TGR-1202 + ibrutinib showing not only that the combination was well tolerated, but produced a 100% ORR in patients with high-risk CLL/SLL and a 75% ORR in indolent
NHL , which includes Follicular Lymphoma and Marginal Zone Lymphoma - Obtained an SPA for the UNITY-CLL Phase 3 clinical trial of the Company's proprietary combination of TG-1101 + TGR-1202 (aka "TG-1303")
- Launched a new Phase 1/2 triple therapy study of TG-1101 + TGR-1202 + the PD-1 checkpoint inhibitor pembrolizumab, the first clinical trial to evaluate the safety and efficacy of the triple combination of a PI3K delta inhibitor with an anti-CD20 mAb and an anti-PD-1 checkpoint inhibitor
- Announced key data updates at the major medical conferences throughout 2015
Key Objectives for 2016
- Aggressively recruit into the GENUINE Phase 3 clinical trial
- Aggressively enroll into the UNITY-CLL Phase 3 clinical trial
- Commence the UNITY- DLBCL Phase 2b clinical trial
- Initiate a Phase 2 clinical trial in Multiple Sclerosis (MS)
- Commence a registration trial for iNHL
- Present updated data on the Phase 1 and 2 clinical trials at major hematology/oncology conferences during 2016
Financial Results for the Fourth Quarter and Full Year 2015
At
Our consolidated net loss for the year ended
Our consolidated net loss for the fourth quarter ended
Conference Call Information
The Company will host an investor conference call today,
In order to participate in the conference call, please call 1-877-407-8029 (
ABOUT
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 possible success of those trials and business prospects for TG-1101, TGR-1202, TG-1303, 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, TG-1303, 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, TG-1303, 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 and TG-1303 will not continue, the risk that TGR-1202 or TG-1303 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 studies; the risk
that the combination of 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
TGTX - G
Selected Consolidated Financial Data | ||||||||||||
Statements of Operations Information (Unaudited): | ||||||||||||
Three Months Ended | Year Ended | |||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||
License revenue | $ | 38,095 | $ | 38,095 | $ | 152,381 | $ | 152,381 | ||||
Costs and expenses: | ||||||||||||
Research and development: | ||||||||||||
Noncash stock expense associated with in-licensing agreements | -- | -- | -- | 5,350,094 | ||||||||
Noncash compensation | 1,528,296 | 2,329,270 | 4,261,406 | 8,731,566 | ||||||||
Other research and development | 13,725,926 | 12,807,504 | 43,445,817 | 26,004,687 | ||||||||
Total research and development | 15,254,222 | 15,136,774 | 47,707,223 | 40,086,347 | ||||||||
General and administrative: | ||||||||||||
Noncash compensation | 1,328,748 | 2,709,166 | 11,435,686 | 12,373,726 | ||||||||
Other general and administrative | 1,095,126 | 913,279 | 4,189,488 | 3,413,400 | ||||||||
Total general and administrative | 2,423,874 | 3,622,445 | 15,625,174 | 15,787,126 | ||||||||
Total costs and expenses | 17,678,096 | 18,759,219 | 63,332,397 | 55,873,473 | ||||||||
Operating loss | (17,640,001 | ) | (18,721,124 | ) | (63,180,016 | ) | (55,721,092 | ) | ||||
Other (income) expense: | ||||||||||||
Interest income | (64,993 | ) | (16,741 | ) | (174,653 | ) | (55,049 | ) | ||||
Other income | -- | -- | -- | (95,427 | ) | |||||||
Interest expense | 242,026 | 234,787 | 972,736 | 930,701 | ||||||||
Change in fair value of notes payable | (205,222 | ) | (142,741 | ) | (1,029,453 | ) | (720,040 | ) | ||||
Total other (income) expense | (28,189 | ) | 75,305 | (231,370 | ) | 60,185 | ||||||
Net loss | $ | (17,611,812 | ) | $ | (18,796,429 | ) | $ | (62,948,646 | ) | $ | (55,781,277 | ) |
Basic and diluted net loss per common share | $ | (0.37 | ) | $ | (0.48 | ) | $ | (1.38 | ) | $ | (1.64 | ) |
Weighted average shares used in computing basic and diluted net loss per common share | 48,127,335 | 38,913,211 | 45,646,414 | 34,068,926 |
Balance Sheet Information: | |||||||
(Unaudited) | |||||||
Cash, cash equivalents, investment securities and interest receivable | $ | 102,416,894 | $ | 78,861,334 | |||
Total assets | 113,473,201 | 86,746,890 | |||||
Accumulated deficit | (158,133,926 | ) | (95,185,280 | ) | |||
Total equity | 101,573,302 | 80,101,884 |
* Condensed from audited financial statements.
CONTACT:Source:Jenna Bosco Director- Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
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