TG Therapeutics, Inc. Provides Business Update and Reports First Quarter 2018 Financial Results
First Quarter and Recent Highlights
- BTK License: Entered into an exclusive global license agreement with
Jiangsu Hengrui Medicine Co., Ltd.(or "Hengrui”) to obtain worldwide rights, excluding Asiabut including Japan, for the development of Hengrui's Bruton's Tyrosine Kinase (BTK) inhibitor program, including the lead candidate, TG-1701.
- Umbralisib Lancet Publication: Results from the Phase 1 first-in-human study of umbralisib (TGR-1202), the Company's novel once-daily PI3K delta inhibitor, were published in The Lancet Oncology.
- TG-1601 Preclinical Data: Presented the first preclinical data from TG-1601, the Company’s novel
BETinhibitor, at the 2018 American Association for Cancer Research(AACR) annual meeting.
- Ublituximab Data in Multiple Sclerosis: Presented clinical and MRI data from the Phase 2 trial of ublituximab (TG-1101) in RMS at the 3rd Annual Americas Committee for
Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum2018 and the American Academyof Neurology (AAN) 70th Annual Meeting.
Remaining 2018 Milestones
- Present top-line overall response rate data from the UNITY-CLL Phase 3 trial of ublituximab plus umbralisib in front line and relapsed/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 First Quarter 2018
- Cash Position: Cash, cash equivalents, investment securities, and interest receivable were
$109.2 millionas of March 31, 2018. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of March 31, 2018(excluding our second quarter 2018 operations) are approximately $123.3 million, after giving effect to $14.1 millionof net proceeds from the utilization of the Company's at-the-market ("ATM") sales facility during the second quarter of 2018.
- Other R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $32.2 million for the three months ended March 31, 2018 compared to
$20.4 million for the three months ended March 31, 2017. Included in other research and development expense for the three months ended March 31, 2018 was $14.5 million of clinical trial expense and $9.6 million of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The current period increase in Other R&D expenses is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.
- Other G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was
$2.1 millionfor the three months ended March 31, 2018as compared to $1.3 millionfor the three months ended March 31, 2017. Other G&A expenses for the three months ended March 31, 2018remained relatively flat compared to the first quarter of 2017, and we expect Other G&A expenses to increase modestly through the remainder of 2018.
- Net Loss: Net loss was
$41.5 millionfor the three months ended March 31, 2018, compared to a net loss of $27.7 millionfor the three months ended March 31, 2017. Excluding non-cash items the net loss for the three months ended March 31, 2018was approximately $33.2 million.
- Financial Guidance: Net cash utilized for operating activities during the three months ended 2018 was approximately
$28.0 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of March 31, 2018, inclusive of the proceeds raised subsequent to the first quarter, 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 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics First 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
SVP, Corporate Communications
Selected Consolidated Financial Data
Statements of Operations Information (in thousands, except share and per share amounts; unaudited):
|Three months ended March 31,|
|Costs and expenses:|
|Research and development:|
|Other research and development||32,159||20,376|
|Total research and development||35,018||22,382|
|General and administrative:|
|Other general and administrative||2,119||1,333|
|Total general and administrative||6,597||5,022|
|Total costs and expenses||41,615||27,704|
|Other (income) expense:|
|Total other (income) expense||(48||)||61|
|Basic and diluted net loss per common share||$||(0.59||)||$||(0.52||)|
|Weighted average shares used in computing basic and diluted net loss per common share||
Condensed Balance Sheet Information (in thousands):
|March 31, 2018
|December 31, 2017*|
|Cash, cash equivalents, investment securities and interest receivable||$||109,156||$||84,825|
* Condensed from audited financial statements.
Source: TG Therapeutics, Inc.