Full Press Release Details
TG Therapeutics Provides Business Update and Reports Second Quarter
2019 Financial Results
Conference call to be held today, Friday, August 9, 2019 at 8:30 AM
New York, NY, (August 9,
2019) TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
second quarter ended June 30, 2019 and recent company
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "As we enter into the second half of the
year, we are pleased with the progress made thus far and excited
for the upcoming milestones. With a well-defined path to a
regulatory submission for umbralisib in marginal zone lymphoma, we
feel confident that we are at a pivotal point in our
Company's lifecycle. Mr. Weiss continued, As we
prepare for our first filing in MZL, we are also building a
top-notch commercial organization which will fuel the long-term
success of TG. And with pivotal data readouts also expected in CLL
and MS over the next 6-12 months, we believe we are at the
beginning of an extremely exciting transformational period for our
Recent Developments and Highlights
Marginal Zone Lymphoma -
Confirmed Registration Path: Announced confirmation of registration path to
submit umbralisib for accelerated approval based on data from the
marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b
Positive Interim Data from MZL
Cohort of UNITY-NHL Trial: Presented positive interim data
from the MZL cohort of the UNITY-NHL trial during oral
presentations at the 55th American Society of
Clinical Oncology (ASCO) annual meeting and the 2019 International
Conference on Malignant Lymphoma (ICML).
Ublituximab Data in Multiple
Sclerosis: Presented long-term follow-up data from the Phase
2 trial of ublituximab in patients with relapsing forms of multiple
sclerosis (RMS) at the 5th Congress of the European Academy of
Umbralisib Data in CLL and
RT: Presented Phase 2 data of
umbralisib in patients with chronic lymphocytic leukemia (CLL) who
are intolerant to prior BTK or PI3k delta inhibitor therapy, and
also presented data from patients with relapsed/refractory CLL or
Richter's Transformation (RT) treated with the triple
combination of ublituximab, umbralisib and
Data: Presented the first preclinical data of TG-1801, the
Company's first-in-class anti-CD47/CD19 bispecific antibody,
at the 24th European Hematology Association (EHA) annual
Remaining 2019 and Early 2020 Milestones
a rolling New Drug Application (NDA) submission for patients with
previously treated MZL
final data from the MZL cohort of the UNITY-NHL registration
directed trial evaluating umbralisib in MZL
top-line progression free survival (PFS) results from the Phase 3
UNITY-CLL trial evaluating U2 in patients with CLL
updated data from our pipeline products and combination studies at
upcoming major medical conferences
Financial Results for the Three and Six Months Ended June 30,
Other research and development
(R&D) expense (not including non-cash compensation and non-cash
in-licensing expense) was $31.4 million and $62.3 million for the
three and sixth months ended June 30, 2019 compared to $34.8
million and $66.0 million for the three and six months ended June
30, 2018. The decrease in other R&D expense is primarily
attributable to a decrease in clinical trial expenses of $9.7
million and $10.4 million, respectively during the three and six
months ended June 30, 2019, as compared to prior periods, offset by
an increase in manufacturing and CMC expenses for Phase 3 clinical
trials and potential commercialization of $7.9 million and $4.7
million, respectively during the three and six months ended June
30, 2019, as compared to prior periods. The current period decrease
in other R&D expenses is primarily due to full enrollment in
our pivotal Phase III clinical development programs completed in
the prior period. We expect other R&D expenses to
decrease through the remainder of 2019.
G&A Expenses: Other general and
administrative (G&A) expense (not including non-cash
compensation) was $2.3 million and $4.3 million for the three and
six months ended June 30, 2019 as compared to $2.3 million and $4.4
million for the three and six months ended June 30, 2018. Other
G&A expenses remained relatively flat compared to the prior
period, and we expect Other G&A expenses to increase modestly
through the remainder of 2019.
Net Loss: Net loss was $36.2 million and
$71.4 million for the three and six months ended June 30, 2019,
respectively, compared to a net loss of $44.1 million and $85.7
million for the three and six months ended June 30, 2018,
respectively. Excluding non-cash items, the net loss for the three
and six months ended June 30, 2019 was approximately $34.4 million
and $67.6 million. We expect our quarterly net loss to decrease
through the remainder of 2019.
Cash Position and Financial
Guidance: Cash, cash
equivalents and investment securities were $85.0 million as of June
30, 2019. Pro forma cash, cash equivalents and investment
securities as of June 30, 2019 (excluding our third quarter 2019
operations) are approximately $96.6 million, after giving effect to
$11.6 million of net proceeds from the utilization of the Company's
at-the-market ("ATM") sales facility during the third quarter of
2019. The Company believes its cash, cash equivalents and
investment securities on hand as of June 30, 2019, inclusive of the
proceeds raised from the ATM facility subsequent to the second
quarter, as well as future availability under the ATM facility,
will be sufficient to fund the Company's planned operations through