Full Press Release Details
TG Therapeutics, Inc. Provides Business Update and Reports Third
Quarter 2018 Financial Results
Investor Conference Call to be Held Today, Friday, November 9, 2018
New York, NY, (November 9,
2018) TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
third quarter ended September 30, 2018 and recent company
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "We are pleased by the progress made in
the third quarter of 2018, most notably the completion of full
enrollment in the current cohorts of the UNITY-NHL trial, as well
as in the ULTIMATE Phase 3 program in MS. We now have five Phase 3
or registration directed trials fully enrolled across our three
major indications of interest, CLL, NHL and MS, and look forward to
significant value creating data releases in 2019 and 2020.
Mr. Weiss, continued, This is just the beginning for TG as
we solidify the foundation and look towards the future of building
proprietary triple combination therapies with our in-house early
Recent Developments and Highlights
Announced two triple therapy data
abstracts were accepted for presentation at the upcoming
American Society of Hematology (ASH)
Completed full enrollment into the
ULTIMATE I & II Phase 3 trials, evaluating ublituximab in
relapsing form of MS, which are being conducted under Special
Protocol Assessment (SPA) agreement with the
Ublituximab Data in Multiple
Sclerosis: Presented final data
from the Phase 2 trial of ublituximab in RMS at the 34th Congress
of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS) Annual Meeting in Berlin,
UNITY-NHL: Completed enrollment in the current arms of the
UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone
Lymphoma, and Diffuse Large B-Cell Lymphoma
Financial Results for the Third Quarter 2018
Position: Cash, cash
equivalents, investment securities, and interest receivable were
$97.8 million as of September 30, 2018.
Research and development (R&D)
expenses were $33.4 million and $107.1 million for the three and
nine months ended September 30, 2018, respectively, compared to
$27.1 million and $76.5 million for the three and nine months ended
September 30, 2017. The increase in R&D expense is primarily
attributable to an increase in clinical trial expenses of $4.4
million and $20.1 million, respectively, during the three and nine
months ended September 30, 2018, as compared to prior periods. In
addition, included in R&D expenses for the three and nine
months ended September 30, 2018 are $5.0 million and $16.4 million,
respectively, of manufacturing and CMC expenses for Phase 3
clinical trials and potential commercialization. Also included in
R&D expense for the nine months ended September 30, 2018 was
$4.0 million of non-cash stock expense recorded in conjunction with
the licenses to the BTK and CD47/CD19 programs.
G&A Expenses: General and
administrative (G&A) expenses were $1.0 million and $13.2
million for the three and nine months ended September 30, 2018,
respectively, as compared to $4.5 million and $11.3 million for the
three and nine months ended September 30, 2017. The decrease in
G&A expenses for the three months ended September 30, 2018
relates to a decrease in non-cash compensation expense related to
equity incentive expense recognized during the three months ended
September 30, 2018 as a result of a decrease in the measurement
date fair value of certain consultant restricted
Net Loss: Net loss was $34.0 million and
$119.6 million for the three and nine months ended September 30,
2018, respectively, compared to a net loss of $31.5 million and
$87.6 million for the three and nine months ended September 30,
2017, respectively. Excluding non-cash items, the net loss for the
three and nine months ended September 30, 2018 was approximately
$34.1 million and $104.2 million.
Financial Guidance: Net cash utilized
for operating activities during the nine months ended 2018 was
approximately $95.2 million. The Company believes its cash, cash
equivalents, investment securities, and interest receivable on hand
as of September 30, 2018 will be sufficient to fund the Company's
planned operations through the end of 2019.
Conference Call Information
The Company will host an investor conference call today, November
9, 2018, at 8:30am ET, to discuss the Company's third quarter
2018 financial results and provide a business outlook for the
In 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 2018 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.
TG Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments
for B-cell malignancies and autoimmune diseases. Currently, the
company is developing two therapies targeting hematological
malignancies and autoimmune diseases. Ublituximab (TG-1101) is a
novel, glycoengineered monoclonal antibody that targets a specific
and unique epitope on the CD20 antigen found on mature
B-lymphocytes. TG Therapeutics is also developing
umbralisib (TGR-1202), an orally available PI3K delta inhibitor.
The delta isoform of PI3K is strongly expressed in cells of
hematopoietic origin and is believed to be important in the