NEW YORK, Nov. 11, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX), an innovative clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced its results for the third quarter ended September 30, 2013 and recent company developments.
Financial Results for the Third Quarter 2013
At September 30, 2013 the Company had cash and cash equivalents of $50.2 million, as compared to $16.5 million at December 31, 2012.
The consolidated net loss for the third quarter ended September 30, 2013 was $4.6 million, or $0.16 per diluted share, compared to a consolidated net loss of $2.7 million during the comparable quarter in 2012, representing an increase in consolidated net loss of $1.9 million. The consolidated net loss for the third quarter ended September 30, 2013 included an increase in other research and development expenses of $1.7 million, principally related to the TG-1101 and TGR-1202 clinical development programs and drug supply costs. The consolidated net loss for the third quarter ended September 30, 2013 also included approximately $1.0 million of non-cash compensation expense related to equity incentive grants.
The consolidated net loss for the nine months ended September 30, 2013 was $14.8 million, or $0.62 per diluted share, compared to a consolidated net loss of $22.7 million during the comparable nine months in 2012, representing a decrease in consolidated net loss of $7.9 million. Included in the consolidated net loss for the nine months ended September 30, 2012 was $16.6 million in noncash stock expense recorded in conjunction with the license for TG-1101, which was partially offset in the nine months ended September 30, 2013 period by an increase in other research and development expenses of $5.9 million, principally related to the TG-1101 and TGR-1202 clinical development programs and drug supply costs. The consolidated net loss for the nine months ended September 30, 2013 also included $4.3 million of non-cash compensation expense related to equity incentive grants.
Recent Developments & Upcoming Milestones
- Pre-clinical data on TGR-1202 in 17p and non-17p deleted CLL patients cells were presented at the 15th Annual International Workshop on Chronic Lymphocytic Leukemia (iwCLL) held in Cologne, Germany.
- Preliminary analysis of the first-in-human clinical trial of TGR-1202 confirms:
-- Once per day dosing (QD) is appropriate with a steady state half-life exceeding 24 hours;
-- Rapid absorption and linear pharmacokinetics (PK) have been observed through the 800mg QD dose cohort;
-- No drug-related liver toxicity has been observed; and
-- Investigators have reported what they believe to be signs of delta related activity (i.e. lymphocytosis and nodal reductions).
- In July 2013, we announced the completion of an underwritten public offering providing net proceeds to the Company of approximately $37.6 million.
- The Company looks forward to the following upcoming milestones:
-- Commencement of combination trials for TG-1101, the Company's novel glycoengineered anti-CD20 mAb, in combination with novel small molecule BTK and/or PI3K delta inhibitors; and
-- Presentation of Phase 1 safety, efficacy and PK data of TGR-1202, the Company's novel PI3K delta inhibitor at the upcoming 55th American Society of Hematology Meeting (ASH), being held December 7 – 10, 2013 in New Orleans, LA.
Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, stated, "During the third quarter we focused on preparing to launch our combination trials of TG-1101 with BCR targeted kinase inhibitors, a core strategy since the Company's inception. We have also been aggressively driving our TGR-1202 dose escalation Phase 1 trial, and are encouraged by the early data seen thus far. We look forward to presenting more comprehensive data from this first-in-human clinical trial at ASH in December." Mr. Weiss continued, "From a financial perspective, the Company is well capitalized to sufficiently fund the development of both of our drugs through what we believe will be substantial value-creating milestones."
The Company will host an investor conference call tomorrow, November 12, 2013, at 8:30am EDT, to discuss the Company's third quarter 2013 financial results and provide a business outlook for the remainder of 2013.
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 Third Quarter 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 TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two therapies targeting hematological malignancies. 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. TG Therapeutics is headquartered in New York City.
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 pre-clinical and early 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 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; 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 only.
TGTX - G
|TG Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (Unaudited):|
|Three months ended September 30,||Nine months ended September 30,|
|License revenue||$38,096||$ --||$114,286||$ --|
|Costs and expenses:|
|Research and development:|
|Noncash stock expense associated with in-licensing agreement||--||--||--||16,578,000|
|Other research and development||3,138,119||1,433,711||9,014,776||3,133,960|
|Total research and development||3,309,561||1,560,802||9,907,089||19,948,249|
|General and administrative:|
|Other general and administrative||550,639||462,425||1,833,733||1,313,960|
|Total general and administrative||1,375,952||1,153,424||5,197,420||3,256,261|
|Total costs and expenses||4,685,513||2,714,226||15,104,509||23,204,510|
|Other (income) expense:|
|Change in fair value of notes payable||(319,377)||(227,659)||(872,827)||(915,512)|
|Total other income||(91,222)||(4,025)||(175,865)||(523,612)|
|Consolidated net loss||(4,556,195)||(2,710,201)||(14,814,358)||(22,680,898)|
|Net loss attributable to noncontrolling interest||--||(247,962)||--||(8,067,916)|
|Net loss attributable to TG Therapeutics, Inc. and subsidiaries||$(4,556,195)||$(2,462,239)||$(14,814,358)||$(14,612,982)|
|Basic and diluted net loss per common share||$(0.16)||$(0.16)||$(0.62)||$(1.34)|
|Weighted average shares used in computing basic and diluted net loss per common share||27,684,802||15,810,299||24,057,200||10,901,070|
|Balance Sheet Information:|
|September 30, 2013||December 31, 2012*|
|Cash and cash equivalents||$50,183,397||$16,455,995|
CONTACT: Jenna Bosco Director-Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4484 Email: firstname.lastname@example.org
Source:TG Therapeutics, Inc.