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TG Therapeutics, Inc. Provides Business Update and Reports Second Quarter 2018 Financial Results Investor Conference Call to be Held Today, Tuesday

Key Takeaway: Therapeutics, Inc. Provides Business Update and Reports Second Quarter 2018 Financial Results Investor Conference Call to be Held Today, Tuesday, August 7, 2018 New York, NY, (August 7, 2018) TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the

Full Press Release Details

Therapeutics, Inc. Provides Business Update and Reports Second
Quarter 2018 Financial Results
Investor Conference Call to be Held Today, Tuesday, August 7, 2018
New York, NY, (August 7,
2018) TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
second quarter ended June 30, 2018 and recent company
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "We are extremely pleased with the
progress made in the first half of 2018 and believe we have many
value creating milestones achievable in the near future. This
morning's announcement of complete target enrollment in the
ULTIMATE I & II Phase 3 trials in MS well ahead of our
projections, similar to the rapid enrollment we had seen in our
UNITY-CLL Phase 3 trial, reinforces our belief in the great need
for our product candidates. Mr. Weiss continued, We
believe TG has never been better positioned for success and look
forward to an impactful remainder of the year, and importantly the
announcement of topline overall response rate data from the
UNITY-CLL Phase 3 trial before the end of the
Recent Developments and Highlights
Completed target enrollment into the
ULTIMATE I & II Phase 3 trials in Multiple Sclerosis
Anti-CD47/CD19 License:
Entered into an exclusive global
license agreement with Novimmune SA to collaborate on the
development and commercialization of Novimmune's novel
first-in-class anti-CD47/anti-CD19 bispecific antibody known as
TG-1801 (previously NI-1701).
Ublituximab Data in Multiple
Sclerosis: Presented updated
clinical data from the Phase 2 trial of ublituximab in RMS at the
Congress of European Academy of
Data: Presented the first
preclinical data presentation of TG-1701, the Company's
orally available and covalently-bound BTK inhibitor, at the 23rd
Congress of the European Hematology Association
Umbralisib Data in CLL Patients
Intolerant to Prior BTK/PI3K:
Presented clinical data from the Phase 2 trial of umbralisib in CLL
Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at
Annual Meeting of the American Society
of Clinical Oncology and at the 23rd Congress of the
Ruxolitinib Data in Patients with
Myelofibrosis: Presented
updated clinical data from
its ongoing Phase I study evaluating umbralisib with ruxolitinib,
the JAK 1/2 inhibitor, in ruxolitinib experienced patients with
myelofibrosis at the 23rd Annual EHA Congress.
Data: Presented an integrated
analysis of long term safety data of umbralisib, either dosed as a
single agent and in combination, in patients with relapsed or
refractory lymphoid malignancies at the 23rd Annual EHA
Officer: Announced the hiring
of Adam Waldman, former Celgene executive, as our Chief Commercial
Key Remaining 2018 Milestones
top-line overall response rate results from our UNITY-CLL Phase 3
trial in front line and relapsed or refractory Chronic Lymphocytic
and potentially file the Company's first BLA and/or
enrollment in the current arms of the UNITY-NHL trial, including
the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large
B-Cell Lymphoma cohorts.
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 Second Quarter 2018
Cash, cash equivalents, investment
securities, and interest receivable were $126.3 million as of June
Research and development (R&D)
expenses were $38.7 million and $73.7 million for the three and six
months ended June 30, 2018, respectively, compared to $26.7 million
and $49.4 million for the three and six months ended June 30, 2017.
The increase in R&D expense is primarily attributable to an
increase in clinical trial expenses of $10.0 million and $15.7
million, respectively during the three and six months ended June
30, 2018, as compared to prior periods. In addition, included in
R&D expenses for the three and six months ended June 30, 2018
are $1.8 million and $11.4 million, respectively, of manufacturing
and CMC expenses for Phase 3 clinical trials and potential
commercialization. Also included in R&D expense for the six
months ended June 30, 2018 was $4 million ($3 million of which was
recorded in the three months ended June 30, 2018) of non-cash stock
expense recorded in conjunction with the licenses to the BTK and
General and administrative (G&A)
expenses were $5.7 million and $12.3 million for the three and six
months ended June 30, 2018, respectively, as compared to $1.8
million and $6.8 million for the three and six months ended June
30, 2017. The increase in G&A expenses for the three and six
months ended June 30, 2018 relates primarily to non-cash
compensation expenses related to equity incentive expense
recognized during the three and six months ended June 30,
Net Loss: Net loss was $44.1 million and $85.7 million for
the three and six months ended June 30, 2018, respectively,
compared to a net loss of $28.4 million and $56.1 million for the
three and six months ended June 30, 2017, respectively. Excluding
non-cash items, the net loss for the three and six months ended
June 30, 2018 was approximately $36.9 million and $70.1
Net cash utilized for operating
activities during the six months ended 2018 was approximately $62.2
million. The Company believes its cash, cash equivalents,
Last updated: Aug 7, 2018