Full Press Release Details
TG Therapeutics, Inc. Provides Business Update and Reports Second
Quarter 2017 Financial Results
Investor Conference Call to be Held Today, Wednesday, August 9,
York, NY, (August 9, 2017)
TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the second quarter ended June 30, 2017 and
recent company developments.
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "The second quarter was a busy and exciting time
for the Company, with the full presentation of the GENUINE data at
ASCO coupled with additional important data presentations for
TGR-1202 in various combinations. In addition, we were pleased to
announce a successful outcome to the interim analysis in the
UNITY-CLL program, allowing us to drop the two single agent arms
and confirming that there were no safety issues requiring a
modification of the trial. The UNITY-CLL study continues to enroll
very robustly and we look forward to completing enrollment into the
study by the end of the year. Mr. Weiss continued, "For the
remainder of the year we look forward to our discussions with the
FDA around the positive GENUINE Phase 3 results and the imminent
commencement of the Phase 3 program of TG-1101 in RMS, for which we
recently announced an SPA agreement with the
Recent Developments and Highlights
data from the Phase 3 GENUINE Trial of
TG-1101 in combination with Ibrutinib in patients with high risk
Chronic Lymphocytic Leukemia (CLL)
follow-up data for combination of
TGR-1202(umbralisib) plus
Ibrutinib in patients with relapsed or refractory CLL and Mantle
follow-up data for the triple
combination of TG-1101, TGR-1202, and Bendamustine in patients with
follow-up data from the chemo-free
triple combination of TG-1101, TGR-1202, and
the successful outcome from the pre-planned interim analysis by an
independent DSMB in the UNITY-CLL Phase 3 Trial which allowed for
closing of enrollment to the single agent arms in this
preliminary data from the ongoing Phase 2 study of TG-1101 in
patients with Multiple Sclerosis (MS)
a Special Protocol Assessment (SPA) agreement with the FDA for a
Phase 3 program for TG-1101 in relapsing forms of MS
Key Remaining 2017 Milestones
interim analysis in the UNITY-NHL trial for the DLBCL
Phase 3 program in MS, to be conducted under SPA agreement with the
clinical data from the Phase 2 MS trial
to review the GENUINE Phase 3 data and discuss suitability for
filing for accelerated approval
updated data from ongoing trials at various scientific meetings
throughout the year, including the American Society of Hematology
(ASH) annual meeting in December
Financial Results for the Second Quarter 2017
Cash, cash equivalents, investment
securities, and interest receivable were $86.5 million as of June
30, 2017. Pro-forma cash, cash equivalents, investment
securities, and interest receivable as of June 30, 2017 are
approximately $97.4 million, after giving effect to $10.9 million
of net proceeds from the utilization of the Company's
at-the-market ( ATM ) sales facility during the third
Research and development (R&D)
expenses were $26.7 million and $49.4 million for the three and six
months ended June 30, 2017, respectively, compared to $13.5 million
and $25.2 million for the three and six months ended June 30, 2016.
Included in research and development expense for the three and six
months ended June 30, 2017 was $8.1 million and $13.3 million,
respectively, of manufacturing and CMC expenses for Phase 3
clinical trials and potential commercialization, and $2.4 million
and $3.4 million, respectively, in expenses related to commencement
of the Phase 3 program for TG-1101 in MS. The increase in R&D
expenses for both the three and six months ended June 30, 2017, is
primarily due to the ongoing clinical development programs,
including the start-up costs in preparation for the TG-1101 MS
Phase 3 program, as well as manufacturing costs for both TG-1101
General and administrative (G&A)
expenses were $1.8 million and $6.8 million for the three and six
months ended June 30, 2017, respectively, as compared to $2.5
million and $4.9 million for the three and six months ended June
30, 2016. The increase in G&A expenses for the six months ended
June 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 remainder of
Net Loss: Net loss was $28.4 million and $56.1 million for
the three and six months ended June 30, 2017, respectively,
compared to a net loss of $15.9 million and $29.7 million for the
three and six months ended June 30, 2016,
The Company believes its cash, cash
equivalents, investment securities, and interest receivable
inclusive of the proceeds raised subsequent to the quarter-end will
be sufficient to fund the Company's planned operations
Conference Call Information
Company will host an investor conference call today, August 9,
2017, at 8:30am ET, to discuss the Company's second 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 Second 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