TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2017 Financial Results and Business Update
- Orphan Drug Designation: Orphan drug designation was granted for the combination of ublituximab (TG-1101) and umbralisib (TGR-1202) for the treatment of Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-Cell Lymphoma (DLBCL).
- Ublituximab Publication: Data from the Phase 1/2 trial of ublituximab was published in the
British Journal of Haematology.
- GENUINE Phase 3 Data: Positive data from the Phase 3 GENUINE trial of
ublituximab in combination with ibrutinib in patients with high risk CLL was presented at the ASCO annual meeting and
Lugano Lymphoma Conference.
- ULTIMATE Phase 3 Trials in MS: Received a Special Protocol Assessment (SPA) for the Phase 3 ULTIMATE I and II studies in relapsing forms of multiple sclerosis, commenced enrollment into the global studies and presented clinical and MRI data from the supportive Phase 2 trial of ublituximab in RMS at various conferences throughout the year.
- UNITY-CLL Phase 3 Enrollment: Full enrollment in the UNITY-CLL Phase 3 Trial was completed in
- Umbralisib Grant: Umbralisib was selected for a grant by the
National Multiple Sclerosis Societyto support the development of umbralisib as an oral B-Cell targeted treatment option in progressive Multiple Sclerosis (PMS).
- Anti-PD-L1 Entered the Clinic: The Company advanced its anti-PD-L1 monoclonal antibody into clinical development, with the first patient being dosed in a Phase I clinical trial.
Key Objectives for 2018
- UNITY-CLL Phase 3 Trial: We plan to present top-line overall response rate results from our UNITY-CLL Phase 3 trial in both front line and relapsed or refractory CLL and also prepare a BLA/NDA filing for accelerated approval.
- GENUINE Phase 3 BLA Filing: A Biologics Licensing Application (BLA) filing will be prepared for ublituximab plus ibrutinib for potential accelerated approval based on the results from GENUINE.
- UNITY-NHL: Aggressively enroll into all cohorts of the UNITY-NHL clinical trial with the goal of completing enrollment into all cohorts.
- ULTIMATE Phase 3 Trials: Aggressively recruit to our Phase 3 MS trials.
- Data Presentations: Present new and updated data from ongoing trials at various scientific meetings throughout the year.
Financial Results for the Fourth Quarter and Full Year 2017
- Cash Position: Cash, cash equivalents, investment securities, and interest receivable were
$84.8 millionas of December 31, 2017. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of December 31, 2017(excluding our first quarter 2018 operations) are approximately $114.6 million, after giving effect to $29.8 millionof net proceeds from the utilization of the Company's at-the-market ("ATM") sales facility during the first quarter of 2018.
- R&D Expenses: Research and development (R&D) expenses were
$26.0 millionand $102.5 millionfor the three and twelve months ended December 31, 2017, respectively, compared to $22.3 millionand $69.2 millionfor the three and twelve months ended December 31, 2016, respectively. Included in research and development expenses for the three and twelve months ended December 31, 2017, in addition to our other clinical expenses, are $6.1 millionand $26.6 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and twelve months ended December 31, 2017, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.
- G&A Expenses: General and administrative (G&A) expenses were
$5.1 millionand $16.3 millionfor the three and twelve months ended December 31, 2017, respectively, as compared to $1.8 millionand $9.9 millionfor the three and twelve months ended December 31, 2016, respectively. The increase in G&A expenses for the three and twelve months ended December 31, 2017relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2017.
Loss: Net loss was
$30.9 millionand $118.5 millionfor the three and twelve months ended December 31, 2017, respectively, compared to a net loss of $23.7 millionand $78.3 millionfor the three and twelve months ended December 31, 2016, respectively.
- Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of
December 31, 2017, inclusive of the proceeds raised subsequent to the year-end will be sufficient to fund the Company's planned operations through mid-2019.
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 (
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 and autoimmune diseases. Ublituximab (TG-1101) 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 umbralisib (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 ublituximab and umbralisib, or the combination of which is referred to as ‘U2', are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. TG Therapeutics is headquartered in New York City.
Some of the statements included in this press release 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. In addition to the risk factors identified from time to time in our reports filed with the
Senior VP, Corporate Communications
Selected Consolidated Financial Data
|Statements of Operations Information (Unaudited):|
|Three Months Ended ||Year Ended |
|Costs and expenses:|
|Research and development:|
|Other research and development||25,736,101||21,414,723||96,886,134||66,489,820|
|Total research and development||25,996,108||22,283,347||102,532,850||69,232,174|
|General and administrative:|
|Other general and administrative||1,766,747||1,322,831||6,032,714||5,121,690|
|Total general and administrative||5,076,718||1,782,806||16,331,282||9,889,335|
|Total costs and expenses||31,072,826||24,066,153||118,864,132||79,121,509|
|Other (income) expense:|
|Other (income) expense||(54,542||)||(296,339||)||58,739||(393,202||)|
|Total other (income) expense||(174,964||)||(353,915||)||(235,739||)||(716,234||)|
|Basic and diluted net loss per common share||$||(0.46||)||$||(0.48||)||$||(1.91||)||$||(1.60||)|
|Weighted average shares used in computing basic and diluted net loss per common share|| |
|Balance Sheet Information:|
|Cash, cash equivalents, investment securities and interest receivable||$||84,825,125||$||44,968,992|
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