TG Therapeutics, Inc. Provides Business Update and Reports Second Quarter 2018 Financial Results
Recent Developments and Highlights
- ULTIMATE I & II: Completed target enrollment into the ULTIMATE I & II Phase 3 trials in Multiple Sclerosis (MS).
- Anti-CD47/CD19 License: Entered into an exclusive global license agreement with
Novimmune SAto collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701).
- Ublituximab Data in Multiple Sclerosis: Presented updated clinical data from the Phase 2 trial of ublituximab in RMS at the 4th
Congressof European Academy of Neurology Meeting.
- TG-1701 Preclinical Data: Presented the first preclinical data presentation of TG-1701, the Company’s orally available and covalently-bound BTK inhibitor, at the 23rd
Congressof the European Hematology Association(EHA).
- Umbralisib Data in CLL Patients Intolerant to Prior BTK/PI3K: Presented clinical data from the Phase 2 trial of umbralisib in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at the 54th Annual Meeting of the
American Society of Clinical Oncologyand at the 23rd Congressof the EHA.
- Umbralisib plus RuxolitinibData in Patients with Myelofibrosis: Presented updated clinical data from its ongoing Phase I study evaluating umbralisib with ruxolitinib, the JAK 1/2 inhibitor, in ruxolitinib experienced patients with myelofibrosis at the 23rd Annual
- Umbralisib Safety Data: Presented an integrated analysis of long term safety data of umbralisib, either dosed as a single agent and in combination, in patients with relapsed or refractory lymphoid malignancies at the 23rd Annual
- Chief Commercial Officer: Announced the hiring of
Adam Waldman, former Celgeneexecutive, as our Chief Commercial Officer.
Key Remaining 2018 Milestones
- Present top-line overall response rate results from our UNITY-CLL Phase 3 trial in front line and relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
- Prepare and potentially file the Company’s first BLA and/or NDA.
- Complete enrollment in the current arms of the UNITY-
NHLtrial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.
- Present updated clinical data from ongoing oncology trials and final results from the Phase 2 trial of ublituximab in Multiple Sclerosis (MS) at major medical meetings during 2018.
Financial Results for the Second Quarter 2018
- Cash Position: Cash, cash equivalents, investment securities, and interest receivable were
$126.3 millionas of June 30, 2018.
- R&D Expenses: Research and development (R&D) expenses were
$38.7 millionand $73.7 millionfor the three and six months ended June 30, 2018, respectively, compared to $26.7 millionand $49.4 millionfor the three and six months ended June 30, 2017. The increase in R&D expense is primarily attributable to an increase in clinical trial expenses of $10.0 millionand $15.7 million, respectively during the three and six months ended June 30, 2018, as compared to prior periods. In addition, included in R&D expenses for the three and six months ended June 30, 2018are $1.8 millionand $11.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. Also included in R&D expense for the six months ended June 30, 2018was $4 million( $3 millionof which was recorded in the three months ended June 30, 2018) of non-cash stock expense recorded in conjunction with the licenses to the BTK and CD47/CD19 programs.
- G&A Expenses: General and administrative (G&A) expenses were
$5.7 millionand $12.3 millionfor the three and six months ended June 30, 2018, respectively, as compared to $1.8 millionand $6.8 millionfor the three and six months ended June 30, 2017. The increase in G&A expenses for the three and six months ended June 30, 2018relates primarily to non-cash compensation expenses related to equity incentive expense recognized during the three and six months ended June 30, 2018.
- Net Loss: Net loss was
$44.1 millionand $85.7 millionfor the three and six months ended June 30, 2018, respectively, compared to a net loss of $28.4 millionand $56.1 millionfor the three and six months ended June 30, 2017, respectively. Excluding non-cash items, the net loss for the three and six months ended June 30, 2018was approximately $36.9 millionand $70.1 million.
- Financial Guidance: Net cash utilized for operating activities during the six months ended 2018 was approximately
$62.2 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of June 30, 2018will be sufficient to fund the Company's planned operations into the second half of 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 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter 2018 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.
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 of1995. In addition to the risk factors identified from time to time in our reports filed with the
Senior VP, Corporate Communications
|TG Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (in thousands, except share and per share amounts; unaudited):|
|Three months ended June 30,||Six months ended June 30,
|Costs and expenses:|
|Research and development:|
|Non-cash stock expense associated with in-licensing agreements||3,000||-||4,000||-|
|Other research and development||34,812||25,440||65,971||45,815|
|Total research and development||38,700||26,706||73,718||49,388|
|General and administrative:|
|Other general and administrative||2,308||1,534||4,426||2,867|
|Total general and administrative||5,683||1,757||12,280||6,780|
|Total costs and expenses||44,383||28,463||85,998||56,168|
|Other (income) expense:|
|Other (income) expense||(14||)||(22||)||82||84|
|Total other (income) expense||(203||)||(72||)||(251||)||(11||)|
|Basic and diluted net loss per common share||$||(0.59||)||$||(0.45||)||$||(1.18||)||$||(0.96||)|
|Weighted average shares used in computing basic and diluted net loss per common share||72,256,348||63,288,269||72,456,657||58,251,045|
Condensed Balance Sheet Information (in thousands):
|June 30, 2018||December 31, 2017*|
|Cash, cash equivalents, investment securities and interest receivable||$||126,332||$||84,825|
Source: TG Therapeutics, Inc.