Full Press Release Details
TG Therapeutics, Inc. Announces First Quarter 2015 Financial
Results and Business Update
Investor Conference Call to be Held Tomorrow, Tuesday, May
5, 2015 at 8:00am EDT
New York, NY, (May 4, 2015) - TG Therapeutics,
Inc. (NASDAQ:TGTX) today announced its financial results for the first quarter ended March 31, 2015 and recent company developments.
Michael S. Weiss, the Company's Executive Chairman and Interim
Chief Executive Officer, stated, "During the first quarter, we focused on site initiation and enrollment into our GENUINE
Phase 3 clinical trial, as well as the continued enrollment into our Phase 1/2 trial of our proprietary combination of TG-1101
and TGR-1202, also referred to as 1303, and we look forward to presenting updated data from these studies next month. During the
quarter we were also excited to continue to add to our pipeline with the in-licensing of our anti-PD-L1 and anti-GITR antibody
research programs." Mr. Weiss continued, "Finally, we took advantage of continued favorable market conditions to bolster
our balance sheet, ending the quarter with over $110 million in cash on a pro forma basis, positioning us well to execute on our
aggressive business plan."
Recent Developments and Upcoming Events
Reaffirming 2015 Milestones
Financial Results for the First Quarter 2015
At March 31, 2015 the Company had cash, cash equivalents, investment
securities, and interest receivable of $105.2 million, which includes approximately $34.2
million of net proceeds from the utilization of the Company's at-the-market ("ATM")
sales facility during the first quarter, as compared to $78.9 million at December 31, 2014.
Pro-forma cash, cash equivalents, investment securities, and
interest receivable as of March 31, 2015 are approximately $113.2 million, including $8.0 million of net proceeds from the utilization
of the ATM sales facility during the second quarter of 2015.
Our consolidated net loss for the first quarter ended March
31, 2015, excluding non-cash items, was approximately $9.2 million, which included approximately $4.3 million of manufacturing
and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the first quarter
ended March 31, 2015, inclusive of non-cash items, was $14.6 million, or $0.39 per diluted share, compared to a consolidated net
loss of $7.5 million during the comparable quarter in 2014, representing an increase in consolidated net loss of $7.1 million.
The increase in consolidated net loss during the first quarter ended March 31, 2015 was primarily the result of other research
and development expenses for TG-1101 and TGR-1202 increasing approximately $4.1 million and $1.1 million, respectively, over the
comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result
of increased manufacturing and clinical trial expenses in preparation for the launch of Phase 3 registration programs. Also contributing
to the increase in consolidated net loss during the quarter ended March 31, 2015 was a $1.1 million increase in non-cash compensation
expense related to equity incentive grants.
Conference Call Information
The Company will host an investor conference call tomorrow,
Tuesday, May 5, 2015, at 8:00am EDT, to discuss the Company's first quarter 2015 financial results and provide a business
outlook for the remainder of 2015.
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 2015 Earnings Call. A
live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the
Company's website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com,
for a period of 30 days after the call.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. 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. The Company also has a pre-clinical program to develop
IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered
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 business prospects
for TG-1101, TGR-1202, 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, 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, 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 will not continue, 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 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
Director- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com
TG Therapeutics, Inc.
Selected Consolidated Financial Data
of Operations Information (Unaudited):
| Three Months Ended March 31, | ||||||||
| 2015 | 2014 | |||||||
| License revenue | $ | 38,095 | $ | 38,095 | ||||
| Costs and expenses: | ||||||||
| Research and development: | ||||||||
| Noncash compensation | 1,337,908 | 1,901,610 | ||||||
| Other research and development | 8,279,431 | 2,508,258 | ||||||
| Total research and development | 9,617,339 | 4,409,868 | ||||||
| General and administrative: | ||||||||
| Noncash compensation | 4,019,120 | 2,329,828 | ||||||
| Other general and administrative | 1,004,487 | 903,524 | ||||||
| Total general and administrative | 5,023,607 | 3,233,352 | ||||||
| Total costs and expenses | 14,640,946 | 7,643,220 | ||||||
| Operating loss | (14,602,851 | ) | (7,605,125 | ) | ||||
| Other (income) expense: | ||||||||
| Interest income | (22,132 | ) | (13,474 | ) | ||||
| Other income | -- | (95,427 | ) | |||||
| Interest expense | 237,657 | 226,340 | ||||||
| Change in fair value of notes payable | (240,641 | ) | (175,315 | ) | ||||
| Total other income | (25,116 | ) | (57,876 | ) | ||||
| Net loss | (14,577,735 | ) | (7,547,249 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.39 | ) | $ | (0.25 | ) | ||
| Weighted average shares used in computing basic and diluted net loss per common share | 37,850,459 | 30,091,000 |
Balance Sheet Information:
| March 31, 2015 (unaudited) | December 31, 2014* | |||||||
| Cash, cash equivalents, investment securities and interest receivable | $ | 105,225,592 | $ | 78,861,334 | ||||
| Total assets | 117,269,251 | 86,746,890 | ||||||
| Accumulated deficit | (109,763,015 | ) | (95,185,280 | ) | ||||
| Total equity | 106,230,512 | 80,101,884 |