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TG Therapeutics Provides Business Update and Reports Third Quarter 2019 Financial Results Conference call to be held today, Tuesday

Key Takeaway: TG Therapeutics Provides Business Update and Reports Third Quarter 2019 Financial Results Conference call to be held today, Tuesday, November 12, 2019 at New York, NY, (November 12, 2019) TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the thi

Full Press Release Details

TG Therapeutics Provides Business Update and Reports Third Quarter
2019 Financial Results
Conference call to be held today, Tuesday, November 12, 2019 at
New York, NY, (November 12,
2019) TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
third quarter ended September 30, 2019 and recent company
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "In the third quarter our team continued
to execute on our core mission of developing combination therapies
for patients with B-cell diseases. With the announcement of
positive marginal zone lymphoma data earlier this year, and
positive follicular lymphoma data only a few weeks ago, we have our
first two foundational datasets for which we believe approval is in
our reach. Adding on top of this, will be our UNITY-CLL Phase 3
study, which we are targeting a PFS readout around year-end or into
the first quarter of next year. With these core pieces in place,
our broader combination approach should come into focus, as we
execute on a strategy to position U2 as an important stand-alone
treatment as well as one that can improve outcomes when combined
with other available therapies. We believe our recent ASH abstracts
contain some initial insights into the future of U2. Mr.
Weiss continued, With a pro forma cash
position of approximately $100 million at the end of the
third quarter, we believe we have sufficient capital resources
through our next two major pivotal data
releases including UNITY-CLL and the ULTIMATE
Recent Developments and Highlights
Two triple therapy data abstracts were
accepted for presentation at the upcoming 61st
American Society of Hematology (ASH)
annual meeting, including an oral presentation for the triple
combination of U2 (umbralisib and ublituximab) plus venetoclax, and
Phase 1 data for TG-1701, the Company's novel BTK inhibitor,
monotherapy and in combination with U2.
Positive Interim Data from FL
Cohort of UNITY-NHL Trial: Positive interim data from the
follicular lymphoma (FL) cohort of the UNITY-NHL trial was
announced, with results meeting the Company's prespecified
ORR target. The Company plans to present the data at a future
medical conference as well as discuss the data with the U.S. Food
and Drug Administration (FDA).
GENUINE Progression Free
Survival (PFS): Final long-term
results from the Phase 3 GENUINE study demonstrated that
ublituximab in combination with ibrutinib improved progression-free
survival (PFS), as determined by Independent Review Committee
U2 Published in Blood:
Phase I/Ib combination trial of U2 was
published in Blood, the Journal of the American Society of
Ublituximab Data in Multiple
Sclerosis: Updated Phase 2
extension trial data for ublituximab in relapsing forms of multiple
sclerosis (RMS), as well as the ULTIMATE I & II Phase 3 RMS
program study design and demographic data was presented at the
Annual Congress of the European
Committee for Treatment and Research in Multiple Sclerosis
Remaining 2019 and Early 2020 Milestones
a rolling New Drug Application (NDA) submission for umbralisib to
treat adult patients with previously treated marginal zone lymphoma
potential top-line PFS results from the Phase 3 UNITY-CLL trial
evaluating U2 in patients with frontline and previously treated
results from the Phase 2b UNITY-NHL FL cohort with the FDA to
determine potential filing opportunities.
Financial Results for the Three and Nine Months Ended September 30,
Other research and development
(R&D) expense (not including non-cash compensation and non-cash
in-licensing expense) was $56.5 million and $118.8 million for the
three and nine months ended September 30, 2019, respectively,
compared to $32.8 million and $98.7 million for the three and nine
months ended September 30, 2018, respectively. The increase in R&D expense is primarily
attributable to an increase in manufacturing expenses for Phase 3
clinical trials and potential commercialization (incurred during
2019) of $27 million and $31.6 million during the three and nine
months ended September 30, 2019, respectively, as compared to prior
periods. This was partially offset by a decrease in clinical trial
expense of $3.8 million and $14.2 million for the three and nine
months ended September 30, 2019, respectively, as compared to prior
periods. We expect our other R&D expenses to decrease during
the remainder of 2019 and into 2020 as our clinical trial expenses
continue to decrease and the bulk of our CMC expenditures have been
incurred during 2019.
G&A Expenses: Other general and
administrative (G&A) expense (not including non-cash
compensation) was $2.3 million and $6.6 million for the three and
nine months ended September 30, 2019, respectively, as compared to
$1.8 million and $6.2 million for the three and nine months ended
September 30, 2018, respectively. Other G&A expenses remained
consistent with the prior period, and we expect Other G&A
expenses to increase modestly through the remainder of
Net Loss: Net loss was $61.9 million and
$133.3 million for the three and nine months ended September 30,
2019, respectively, compared to a net loss of $34.0 million and
$119.6 million for the three and nine months ended September 30,
2018, respectively. Excluding non-cash items, the net loss for the
three and nine months ended September 30, 2019 was approximately
$59.9 million and $127.5 million. Cash used in operations for the
three months ended September 30, 2019 was approximately $33
million, as the payments of much of the increase in manufacturing
expenses were deferred 12 months, having little impact on the
Last updated: Nov 12, 2019