TG Therapeutics, Inc. Provides Business Update and Reports Third Quarter 2018 Financial Results
Investor Conference Call to be Held Today,
Recent Developments and Highlights
- ASH Presentations: Announced two triple therapy data abstracts were accepted for presentation at the upcoming 60th
American Society of Hematology(ASH) annual meeting.
- ULTIMATE Trials: Completed full enrollment into the ULTIMATE I & II Phase 3 trials, evaluating ublituximab in relapsing form of MS, which are being conducted under Special Protocol Assessment (SPA) agreement with the
- Ublituximab Data in Multiple Sclerosis: Presented final data from the Phase 2 trial of ublituximab in RMS at the 34th
Congressof the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting in Berlin, Germany.
NHL: Completed enrollment in the current arms of the UNITY- NHLtrial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.
Financial Results for the Third Quarter 2018
- Cash Position: Cash, cash equivalents, investment securities, and interest receivable were
$97.8 millionas of September 30, 2018.
- R&D Expenses: Research and development (R&D) expenses were
$33.4 millionand $107.1 millionfor the three and nine months ended September 30, 2018, respectively, compared to $27.1 millionand $76.5 millionfor the three and nine months ended September 30, 2017. The increase in R&D expense is primarily attributable to an increase in clinical trial expenses of $4.4 millionand $20.1 million, respectively, during the three and nine months ended September 30, 2018, as compared to prior periods. In addition, included in R&D expenses for the three and nine months ended September 30, 2018are $5.0 millionand $16.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. Also included in R&D expense for the nine months ended September 30, 2018was $4.0 millionof 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
$1.0 millionand $13.2 millionfor the three and nine months ended September 30, 2018, respectively, as compared to $4.5 millionand $11.3 millionfor the three and nine months ended September 30, 2017. The decrease in G&A expenses for the three months ended September 30, 2018relates to a decrease in non-cash compensation expense related to equity incentive expense recognized during the three months ended September 30, 2018as a result of a decrease in the measurement date fair value of certain consultant restricted stock.
- Net Loss: Net loss was
$34.0 millionand $119.6 millionfor the three and nine months ended September 30, 2018, respectively, compared to a net loss of $31.5 millionand $87.6 millionfor the three and nine months ended September 30, 2017, respectively. Excluding non-cash items, the net loss for the three and nine months ended September 30, 2018was approximately $34.1 millionand $104.2 million.
- Financial Guidance: Net cash utilized for operating activities during the nine months ended 2018 was approximately
$95.2 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of September 30, 2018will be sufficient to fund the Company's planned operations through the end 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 Third 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 of 1995. In addition to the risk factors identified from time to time in our reports filed with the
|Senior Vice President,|
|TG Therapeutics, Inc.|
|TG Therapeutics, Inc.|
|Selected Consolidated Financial Data|
|Statements of Operations Information (in thousands, except share and per share amounts; unaudited):
|Three months ended September 30,
||Nine months ended September 30,
|Costs and expenses:|
|Research and development:|
|Non-cash stock expense associated with in-licensing agreements||--||--||4,000||--|
|Other research and development||32,754||25,335||98,724||71,150|
|Total research and development||33,398||27,149||107,115||76,537|
|General and administrative:|
|Other general and administrative||1,785||1,398||6,212||4,266|
|Total general and administrative||968||4,474||13,249||11,254|
|Total costs and expenses||34,366||31,623||120,364||87,791|
|Other (income) expense:|
|Other (income) expense||(119||)||30||(37||)||113|
|Total other income, net||(377||)||(49||)||(628||)||(61||)|
|Basic and diluted net loss per common share||$||(0.43||)||$||(0.48||)||$||(1.61||)||$||(1.45||)|
|Weighted average shares used in computing basic and diluted net loss per common share||78,221,069||65,079,128||74,399,243||60,552,084|
|Condensed Balance Sheet Information (in thousands):|
|September 30, 2018||December 31, 2017*|
|Cash, cash equivalents, investment securities and interest receivable||$||97,822||$||84,825|
|* Condensed from audited financial statements.|
Source: TG Therapeutics, Inc.