Full Press Release Details
TG Therapeutics, Inc. Provides Business Update and Reports First
Quarter 2018 Financial Results
Investor Conference Call to be Held Today, Tuesday, May 8, 2018 at
York, NY, (May 8, 2018)
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its
financial results for the first quarter ended March 31, 2018 and
recent company developments.
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "2018 is off to a great start as we continue to
advance our major pivotal programs and bolster our product
pipeline, most recently with the addition of a BTK inhibitor
program. As we move into the second quarter and the remainder of
the year, we look forward to the announcement of topline data from
our UNITY-CLL trial, completion of enrollment into the current
cohorts of the UNITY-NHL study, final MS Phase 2 data, significant
enrollment in our MS phase 3 program as well as filing decisions
related to the Company's first BLA/NDA later in the
year. Mr. Weiss continued, We believe 2018 will be a
pivotal year for the Company as approval pathways across multiple
indications become clearer and position us for future
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 Asia but
including Japan, for the development of Hengrui's Bruton's Tyrosine
Kinase (BTK) inhibitor program, including the lead candidate,
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 BET
inhibitor, 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) Forum 2018 and the American Academy of
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).
potentially file the Company's first BLA and/or
in the current arms of the UNITY-NHL trial, including the
Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large
B-Cell Lymphoma cohorts.
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, cash equivalents, investment
securities, and interest receivable were $109.2 million as 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 million of net proceeds from the utilization
of the Company's at-the-market ("ATM") sales facility during the
second quarter of 2018.
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
Other general and administrative
(G&A) expense (not including non-cash compensation) was $2.1
million for the three months ended March 31, 2018 as compared to
$1.3 million for the three months ended March 31, 2017.
Other G&A expenses for the three
months ended March 31, 2018 remained relatively flat compared to
the first quarter of 2017, and we expect Other G&A expenses to
increase modestly through the remainder of
Net Loss: Net loss was $41.5 million for the three months
ended March 31, 2018, compared to a net loss of $27.7 million for
the three months ended March 31, 2017. Excluding non-cash items the
net loss for the three months ended March 31, 2018 was
approximately $33.2 million.
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
Company will host an investor conference call today, May 8, 2018,
at 8:30am ET, to discuss the Company's first quarter 2018
financial results and provide a business outlook for the remainder
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