UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________
FORM 8-K
_____________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): November 8, 2012
TG Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
|
Delaware (State or Other Jurisdiction of Incorporation) |
001-32639 (Commission File Number)
|
36-3898269 (IRS Employer Identification No.) |
787 Seventh Ave, 48th Floor
New York, New York 10019
(Address of Principal Executive Offices)
(212) 554-4484
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| £ | Written communications pursuant to Rule 425 under the Securities Act. |
| £ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
| £ | Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act. |
| £ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
| Item 2.02. | Results of Operations and Financial Condition. |
On November 8, 2012, TG Therapeutics, Inc. (“TG” or the “Company”) issued a press release announcing results of operations for the third quarter ended September 30, 2012. TG also announced that on Friday, November 9, 2012 at 8:30am EST, TG will host an investor conference call during which the Company will provide a brief financial overview of its third quarter financial results and a business outlook for the remainder of 2012. A copy of such press release is being furnished as Exhibit 99.1.
| Item 9.01 | Financial Statements And Exhibits. |
| (d) | Exhibits. |
| 99.1 | Press release issued by TG Therapeutics, Inc., dated November 8, 2012. |
| - 2 - |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TG Therapeutics, Inc. | |||
| (Registrant) | |||
| Date: November 8, 2012 | |||
| By: | /s/ Sean A. Power | ||
| Sean A. Power | |||
| Chief Financial Officer | |||
| - 3 - |
INDEX TO EXHIBITS
Exhibit
| Number | Description |
| 99.1 | Press release issued by TG Therapeutics, Inc., dated November 8, 2012. |
| - 4 - |
TG Therapeutics, Inc. Announces Third Quarter 2012 Financial Results and Business Update
Investor Conference Call to be held Tomorrow, Friday, November 9, 2012 at 8:30am EDT
New York, NY, (November 8, 2012) – TG Therapeutics, Inc. (TGTX), an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative and 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, 2012 and recent company developments.
Financial Results for the Third Quarter 2012
At September 30, 2012, the Company had cash and cash equivalents of $17.4 million, as compared to $9.7 million at December 31, 2011.
The consolidated net loss for the third quarter ended September 30, 2012 was $2.7 million, $2.5 million or $0.16 per diluted share, which was attributable to TG Therapeutics, Inc. and subsidiaries. The consolidated net loss for the third quarter ended September 30, 2012 included a $1 million upfront milestone payment to our partner Rhizen Pharmaceuticals in conjunction with the signing of our global collaboration agreement for TGR-1202, our novel P13K delta inhibitor. The consolidated net loss for the third quarter ended September 30, 2012, also included $0.8 million of non-cash compensation expense related to equity incentive grants.
The consolidated net loss for the nine months ended September 30, 2012 was $22.7 million, $14.6 million or $1.34 per diluted share, which was attributable to TG Therapeutics, Inc. and subsidiaries. The consolidated net loss for the nine months ended September 30, 2012, included $16.6 million in noncash stock expense associated with in-licensing arrangements recorded in conjunction with the stock issued in connection with the license for TG-1101. The consolidated net loss for the nine months ended September 30, 2012, also included $2.2 million of non-cash compensation expense related to equity incentive grants.
Commenting on the quarter, Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, said, "During the third quarter, we made substantial progress with our lead drug TG-1101, commencing our first U.S. based clinical trial in patients with relapsed or refractory B-cell Non-Hodgkin’s lymphoma. We were also able to acquire a complementary drug for our pipleline, our novel P13K delta inhibitor, which was acquired in a partnership with Rhizen Pharmaceuticals.” Mr. Weiss continued, “Our cash position remains strong with sufficient capital to execute our business plan and bring the Company to substantial value creating milestones over the next 12-18 months.”
Recent Developments & Highlights
| · | Data from studies for both TG-1101 and TGR-1202 to be presented at the American Society of Hematology (ASH) Annual Meeting being held in Atlanta, Georgia (December 8-11, 2012). These abstracts have been published on the ASH website at www.hematology.org. The following abstracts were accepted for presentation: |
| o | Ublituximab (TG-1101), an Optimized Anti-CD20 Monoclonal Antibody, Demonstrates Greater NK-Mediated ADCC Than Rituximab in Waldenstrom's Macroglobulinemia Patients Supporting a Therapeutic Strategy with Ublituximab (#1654) |
| o | Ublituximab (TG-1101), A Novel Anti-CD20 Monoclonal Antibody (mAb), Demonstrates Activity in Rituximab-sensitive and Rituximab–resistant B Non-Hodgkin Lymphoma (B-NHL) Pre-clinical In Vitro and In Vivo Models (#2756) |
| o | Ublituximab (TG-1101), a Novel, Third-Generation Anti-CD20 Antibody Demonstrates Enhanced Antitumor Activity Compared to Rituximab in Primary CNS and Intraocular Lymphoma Murine Models (#2755) |
| o | TGR-1202 Suppresses AML and ALL Cells Via Selective Inhibition of PI3K-delta Kinase (#2610) |
| o | Comparison of the PI3K-delta Inhibitors TGR-1202 and GS-1101 in Inducing Cytotoxicity and Inhibiting Phosphorylation of Akt in CLL Cells in Vitro (#3914) |
| o | Novel PI3K Inhibitors Demonstrated Marked Cytotoxicity in T Cell Lymphoma Models, Caused Apoptosis and Were Synergistic with A Novel Anti-CD20 Monoclonal Antibody Ublituximab in B Cell Lymphoma Models (#3725) |
| · | Completed a Joint Venture with Rhizen Pharmaceuticals for TGR-1202, the Company’s second product, a novel PI3K delta inhibitor. |
| · | Commenced our U.S.-based clinical program for TG-1101, including: |
| o | Filed an IND in the United States for Ublituximab (TG-1101) and received clearance by the FDA to commence clinical trials in the U.S. (May 2012) |
| o | Initiated a Phase I/II clinical trial of Ublituximab (TG-1101) in patients with relapsed or refractory B-cell Non Hodgkins lymphoma (September 2012) |
The Company will host an investor conference call tomorrow, Friday, November 9, 2012, at 8:30am EDT, to discuss the Company’s third quarter financial results and provide a business outlook for the remainder of 2012.
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 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 TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative and medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two advanced therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, third generation monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes, currently in clinical development for patients with relapsed and refractory non-Hodgkin's lymphoma. TG Therapeutics is also developing TGR-1202, a highly specific, 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. TG Therapeutics is headquartered in New York City.
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 and 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 the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials; 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
CONTACT:
Jenna Bosco
Director- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4484
Email: ir@tgtxinc.com
TG Therapeutics, Inc.
Selected Consolidated Financial Data
Statements of Operations Information (Unaudited):
| Three months ended September 30, 2012 | Nine months ended September 30, 2012 | |||||||
| Costs and expenses: | ||||||||
| Research and development: | ||||||||
| Noncash stock expense associated with in-licensing agreement | $ | -- | $ | 16,578,000 | ||||
| Noncash compensation | 127,091 | 236,289 | ||||||
| Other research and development | 1,433,711 | 3,133,960 | ||||||
| Total research and development | 1,560,802 | 19,948,249 | ||||||
| General and administrative: | ||||||||
| Noncash compensation | 690,999 | 1,942,301 | ||||||
| Other general and administrative | 462,425 | 1,313,960 | ||||||
| Total general and administrative | 1,153,424 | 3,256,261 | ||||||
| Total costs and expenses | 2,714,226 | 23,204,510 | ||||||
| Operating loss | (2,714,226 | ) | (23,204,510 | ) | ||||
| Other (income) expense: | ||||||||
| Interest income | (4,951 | ) | (12,711 | ) | ||||
| Other income | -- | (272,232 | ) | |||||
| Interest expense | 228,585 | 676,843 | ||||||
| Change in fair value of notes payable | (227,659 | ) | (915,512 | ) | ||||
| Total other (income) | (4,025 | ) | (523,612 | ) | ||||
| Consolidated net loss | (2,710,201 | ) | (22,680,898 | ) | ||||
| Net loss attributable to noncontrolling interest | (247,962 | ) | (8,067,916 | ) | ||||
| Net loss attributable to TG Therapeutics, Inc. and subsidiaries | $ | (2,462,239 | ) | $ | (14,612,982 | ) | ||
| Basic and diluted net loss per common share | $ | (0.16 | ) | $ | (1.34 | ) | ||
| Weighted average shares used in computing basic and diluted net loss per common share | 15,810,299 | 10,901,070 | ||||||
Balance Sheet Information:
September 30, 2012 | December 31, 2011* | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 17,373,866 | $ | 9,748,491 | ||||
| Total assets | 25,231,218 | 15,907,258 | ||||||
| Accumulated deficit | (15,466,056 | ) | (853,074 | ) | ||||
| Total equity | 17,893,300 | 9,636,202 | ||||||
* Condensed from audited financial statements.