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TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2017 Financial Results and Business Update Investor conference call to be held today, Thursday

Key Takeaway: TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2017 Financial Results and Business Update Investor conference call to be held today, Thursday March 8, 2018 York, NY, (March 8, 2018) TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for t

Full Press Release Details

TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2017
Financial Results and Business Update
Investor conference call to be held today, Thursday March 8, 2018
York, NY, (March 8, 2018)
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its
financial results for the fourth quarter and year ended December
31, 2017 and provided recent company developments along with a
business outlook for 2018.
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, 2017 was a truly pivotal year for our
company with the presentation of positive results from our first
Phase 3 trial, the GENUINE trial, the completion of enrollment in
our second Phase 3 trial, the UNITY-CLL trial, and the launch of
our Phase 3 ULTIMATE trials in Multiple Sclerosis. These major
milestones along with strong enrollment in our UNITY-NHL
registration directed program sets the stage for an even more
impactful 2018 and 2019. Mr. Weiss continued, We are
extremely pleased to enter 2018 with a healthy balance sheet and
look forward to multiple value creating milestones this year,
including presenting topline ORR data from our Phase 3 UNITY-CLL
trial and, ideally, filing our first BLA and/or NDA later in the
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
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 October
Umbralisib Grant: Umbralisib was
selected for a grant by the National Multiple Sclerosis Society to
support the development of umbralisib as an oral B-Cell targeted
treatment option in progressive Multiple Sclerosis
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
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
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
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
Cash, cash equivalents, investment
securities, and interest receivable were $84.8 million as 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 million of net proceeds from the utilization of the
Company's at-the-market ("ATM") sales facility during the first
Research and development (R&D)
expenses were $26.0 million and $102.5 million for the three and
twelve months ended December 31, 2017, respectively, compared to
$22.3 million and $69.2 million for 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
million and $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.
General and administrative (G&A)
expenses were $5.1 million and $16.3 million for the three and
twelve months ended December 31, 2017, respectively, as compared to
$1.8 million and $9.9 million for 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, 2017 relates
primarily to non-cash compensation expenses related to
equity incentive expense recognized during 2017.
Net Loss: Net loss was $30.9 million and $118.5 million for
the three and twelve months ended December 31, 2017, respectively,
compared to a net loss of $23.7 million and $78.3 million for the
three and twelve months ended December 31, 2016,
The Company believes its cash, cash
Last updated: Mar 8, 2018