Press Release
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TG Therapeutics, Inc. Announces First Quarter 2013 Financial Results and Business Update
May 13, 2013
Financial Results for the First Quarter 2013
At
The consolidated net loss for the first quarter ended
Recent Developments & Highlights
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Data for TG-1101 to be presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting being held inChicago, Illinois (May 31 —June 4, 2013 ). The following abstract was accepted for poster presentation:
-- A phase I dose-escalation trial of ublituximab (TG-1101), a novel anti-CD20 monoclonal antibody (mAb), for rituximab relapsed/refractory b-cell lymphoma patients ( Abstract #8575) -
Pre-clinical data for the combination of TG-1101 and TGR-1202 to be presented at the 12th
International Conference on Malignant Lymphoma being held in Lugano,Switzerland (June 19 — 22, 2013). The following abstract was accepted for oral presentation:
-- Novel PI3K-Delta Inhibitors Demonstrated Marked Cytotoxicity in T Cell Lymphoma Models and Were Synergistic with A Novel Anti-CD20 mAb, Ublituximab, in Lymphoma Models (Abstract #038) -
Data for both TG-1101 and TGR-1202 to be presented at the 18th
Congress of EHA (European Hematology Association ) being held inStockholm, Sweden (June 13 — 16, 2013).
2013 Milestones
Our planned upcoming clinical milestones include the following:
TG-1101:
-
Continue enrollment into the single agent
NHL study to better define the clinical activity of TG-1101 inNHL and CLL - Complete enrollment into the dose escalation component of the TG-1101+Revlimid® combination study and begin enrolling at least one expansion cohort
-
Present available clinical data from both studies at the
American Society of Hematology (ASH) Meeting inDecember 2013
TGR-1202:
- Complete enrollment into the dose escalation component of the single agent study in Q3 2013
- Present first-in-human pharmacokinetic data from 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 TGR-1202 single agent, as well as open any future combination studies
-
Present available clinical data at the ASH Meeting in
December 2013
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 First Quarter 2013 Earnings Call. 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 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 |
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2013 | 2012 | |
License revenue |
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$ -- |
Costs and expenses: | ||
Research and development: | ||
Noncash stock expense associated with in-licensing agreement | -- | 16,578,000 |
Noncash compensation | 354,703 | -- |
Other research and development | 1,215,202 | 163,353 |
Total research and development | 1,569,905 | 16,741,353 |
General and administrative: | ||
Noncash compensation | 1,530,774 | 188,509 |
Other general and administrative | 651,457 | 455,492 |
Total general and administrative | 2,182,231 | 644,001 |
Total costs and expenses | 3,752,136 | 17,385,354 |
Operating loss | (3,714,041) | (17,385,354) |
Other (income) expense: | ||
Interest income | (1,502) | (3,668) |
Interest expense | 231,472 | 220,149 |
Change in fair value of notes payable | (270,400) | (205,297) |
Total other (income) expense | (40,430) | 11,184 |
Consolidated net loss | (3,673,611) | (17,396,538) |
Net loss attributable to non-controlling interest | -- | (7,140,448) |
Net loss attributable to |
( |
( |
Basic and diluted net loss per common share |
( |
( |
Weighted average shares used in computing basic and diluted net loss per common share | 21,953,803 | 5,061,399 |
Balance Sheet Information: | ||
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(unaudited) | ||
Cash and cash equivalents |
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Total assets | 21,386,785 | 22,074,037 |
Accumulated deficit | (22,599,404) | (18,925,793) |
Total equity | 14,699,087 | 15,550,301 |
* 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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