Full Press Release Details
TG Therapeutics, Inc. Provides Business Update and Reports Third
Quarter 2017 Financial Results
Investor Conference Call to be Held Today, Wednesday, November 8,
York, NY, (November 8, 2017)
TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the third quarter ended September 30, 2017,
and recent company developments.
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "The third quarter was an extremely productive and
exciting time for the Company highlighted by the completion of
enrollment into our UNITY-CLL Phase 3 study, the commencement of
our global Phase 3 trials in multiple sclerosis, and the additional
clarity we received from the FDA regarding the GENUINE study. We
look forward, over the next 6-12 months, to what we believe will be
a number of value creating milestones, including overall response
data from UNITY-CLL and additional data supporting our strategy in
NHL. Mr. Weiss continued, "From a financial perspective, we
remain well positioned through these important
Third Quarter and Recent Highlights
ASH 2017: The Company looks forward to the upcoming American
Society of Hematology (ASH) Annual Meeting where data presentations
will include three clinical poster presentations and three
pre-clinical poster presentations.
results from the ongoing Phase 2 Study of TG-1101 in patients with
Multiple Sclerosis were presented at the 7th Joint
ECTRIMS-ACTRIMS Meeting demonstrating robust activity on B-cell
depletion, reduction of T1 Gd enhancing lesions, and positive
effects on disability measurements.
UNITY-CLL Enrollment: Full enrollment in
the UNITY-CLL Phase 3 Trial was completed in October, which should
allow for top-line data on Overall Response Rate (ORR) in Q2
GENUINE Update: The Company met with the
FDA and confirmed that accelerated approval based on the ORR
results from GENUINE would be a review issue and that the potential
may exist for full approval based on the PFS results from the
TGR-1202 Grant: TGR-1202 (umbralisib)
was selected for a grant by the National Multiple Sclerosis Society
to support the development of TGR-1202 as an oral B-Cell targeted
treatment option in progressive Multiple Sclerosis
Anti-PD-L1 Entered the Clinic: The
Company's anti-PD-L1 monoclonal antibody commenced clinical
development, with the first patient being dosed in a Phase I
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 and commenced
enrollment into the global studies.
UNITY-NHL: Announced successful outcome
from the first pre-planned interim analysis by independent DSMB of
the DLBCL cohort in the UNITY-NHL Phase 2b trial, where based on
pre-set hurdles of ORR, the DSMB recommended continued enrollment
in the TG-1101 plus TGR-1202 combination arm (also referred to as
the U2 combination) and replacement of the single agent TGR-1202
arm with U2 plus bendamustine.
Financial Results for the Third Quarter 2017
Cash, cash equivalents, investment
securities, and interest receivable were $91.8 million as of
September 30, 2017, as compared to $86.5 million at June 30,
Research and development (R&D)
expenses were $27.1 million and $76.5 million for the three and
nine months ended September 30, 2017, respectively, compared to
$21.8 million and $46.9 million for the three and nine months ended
September 30, 2016. Included in research and development expense
for the three and nine months ended September 30, 2017 was $7.1
million and $20.4 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 nine months ended September 30, 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 $4.5 million and $11.3 million for the three and nine
months ended September 30, 2017, respectively, as compared to $3.2
million and $8.1 million for the three and nine months ended
September 30, 2016. The increase in G&A expenses for the nine
months ended September 30, 2017 relates primarily to non-cash
compensation expenses related to equity incentive grants
recognized during 2017. We expect
G&A expenses to remain relatively constant through the
Net Loss: Net loss was $31.5 million and $87.6 million for
the three and nine months ended September 30, 2017, respectively,
compared to a net loss of $24.8 million and $54.6 million for the
three and nine months ended September 30, 2016,
The Company believes its cash and cash
equivalents will be sufficient to fund the Company's planned
operations through 2018.
Conference Call Information
Company will host an investor conference call today, November 8,
2017, at 8:30am ET, to discuss the Company's third quarter
2017 financial results and provide a business outlook for the
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 2017 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
ABOUT TG THERAPEUTICS, INC.
Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments