Full Press Release Details
TG Therapeutics Provides Business Update and Reports First Quarter
2019 Financial Results
Conference Call to be held today, Friday, May 10, 2019 at 8:00 AM
New York, NY, (May 10, 2019) TG Therapeutics, Inc. (NASDAQ: TGTX)
today announced its financial results for the first quarter ended
March 31, 2019 and recent company developments.
Michael S. Weiss, the Company's Executive Chairman
and Chief Executive Officer, stated, "2019 has been an
extremely productive year thus far with the achievement
of many key milestones, the most important of which has been
the significant progress made with our Marginal Zone Lymphoma
program, including the release of positive top-line results and the
receipt of breakthrough therapy designation and orphan drug
designation. Moving forward, we believe further clarity on our
potential MZL NDA filing by year-end along with the presentation of
final MZL data later this year has the potential to unlock
significant value for our shareholders. Mr. Weiss continued, Between now and the
middle of next year, we expect to have pivotal data readouts across
three trials, including umbralisib in non-Hodgkin's lymphoma,
umbralisib plus ublituximab (U2) in chronic lymphocytic leukemia
and ublituximab in multiple sclerosis. This is an extremely
exciting time for us and we look forward to an impactful remainder
Recent Developments and Highlights
Marginal Zone Lymphoma
Breakthrough Therapy and Orphan Drug Designations: Received
breakthrough therapy designation (BTD) and orphan drug designation
for umbralisib (TGR-1202), for the treatment of patients with all
three types of marginal zone lymphoma (MZL): nodal, extranodal and
Positive Results from MZL
Cohort of UNITY-NHL Trial: Announced positive outcome from
the MZL cohort of the UNITY-NHL trial, which met the primary
endpoint of Overall Response Rate (ORR). Interim safety and
efficacy data from this study were presented in an oral
presentation at the American Association of Cancer Research (AACR)
annual meeting in Atlanta.
Meetings held by the independent Data
Safety Monitoring Boards (DSMBs) for both the UNITY-CLL trial and
the UNITY-NHL trial did not raise any safety concerns and
recommended that both trials continue
(Anti-CD47/CD19): Commenced a
Phase 1 first-in-human, dose-escalation study of TG-1801 in
patients with relapsed or refractory B-cell
Data: Presented long-term
safety data from the open label extension (OLE) of the Phase 2
trial of ublituximab in multiple sclerosis, which demonstrated that
ublituximab continues to be well tolerated.
Remaining 2019 Milestones
top-line progression free survival (PFS) results from the Phase 3
UNITY-CLL trial evaluating U2 in patients with CLL
final data from the MZL cohort of the UNITY-NHL registration
directed trial evaluating umbralisib in MZL
UNITY-NHL NDA filing in MZL
updated data from our pipeline products and combination studies at
upcoming major medical conferences
Financial Results for the First Quarter 2019
Position: Cash, cash
equivalents and investment securities were $92.5 million as of
March 31, 2019. Pro-forma cash, cash equivalents and investment
securities as of March 31, 2019 (excluding our second quarter 2019
operations) are approximately $116.7 million, after giving effect
to $24.2 million of net proceeds from the utilization of the
Company's at-the-market ("ATM") sales facility during the second
research and development (R&D) expense (not including non-cash
compensation) was $30.9 million for the three months ended March
31, 2019 compared to $32.2 million for the three months ended March
31, 2018. Included in other research and development expense for
the three months ended March 31, 2019 was $13.8 million of clinical
trial expense and $6.4 million of manufacturing and CMC expenses
for Phase 3 clinical trials and potential commercialization. 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 the decrease in
other R&D expenses to continue over the next several
G&A Expenses: Other general and
administrative (G&A) expense (not including non-cash
compensation) was $1.9 million for the three months ended March 31,
2019 as compared to $2.1 million for the three months ended March
31, 2018. Other G&A expenses for the three months ended March
31, 2019 remained relatively flat compared to the first quarter of
2018, and we expect Other G&A expenses to increase modestly
through the remainder of 2019.
Net Loss: Net loss was $35.2 million for
the three months ended March 31, 2019, compared to a net loss of
$41.5 million for the three months ended March 31, 2018. Excluding
non-cash items, the net loss for the three months ended March 31,
2019 was approximately $33.3 million.
Financial Guidance: Net cash utilized
for operating activities during the three months ended March 31,
2019 was approximately $33.5 million. The Company believes its
cash, cash equivalents and investment securities on hand as of
March 31, 2019, inclusive of the proceeds raised subsequent to the
first quarter, will be sufficient to fund the Company's planned
operations through mid-2020.
Conference Call Information
The Company will host a conference call today, May 10, 2019, at
8:00 am ET, to discuss the Company's first quarter 2019
financial results and provide a business outlook for the remainder
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 First Quarter 2019