UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________
FORM
8-K
_____________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
report (Date of earliest event reported): March 8, 2018
TG
Therapeutics, Inc.
(Exact
Name of Registrant as Specified in Charter)
|
Delaware
(State
or Other Jurisdiction
of
Incorporation)
|
001-32639
(Commission File
Number)
|
36-3898269
(IRS
Employer Identification No.)
|
2
Gansevoort Street, 9th Floor
New
York, New York 10014
(Address of
Principal Executive Offices)
(212)
554-4484
(Registrant's
telephone number, including area code)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
Written
communications pursuant to Rule 425 under the Securities
Act.
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act.
Pre-commencement
communications pursuant to Rule 14d-2b under the Exchange
Act.
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange
Act.
Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (17 CFR
§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR §240.12b-2). Emerging growth company ☐
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial
Condition.
On
March 8, 2018, TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the fourth quarter and year ended December 31, 2017.
TG also announced that on Thursday, March 8, 2018 at 8:30am ET, TG
would host an investor conference call during which the Company
would provide a brief overview of its fourth quarter and year-end
financial results and provide a business outlook for 2018. A copy
of such press release is being furnished as Exhibit
99.1.
Item
9.01
Financial
Statements And Exhibits.
(d)
Exhibits.
99.1
Press release
issued by TG Therapeutics, Inc., dated March 8, 2018.
-
2
-
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
TG
Therapeutics, Inc.
(Registrant)
Date:
March 8, 2018
By:_/s/ Sean A.
Power__________
Sean A.
Power
Chief
Financial Officer
-
3
-
Exhibit 99.1
TG Therapeutics, Inc. Announces Fourth Quarter and Year-End 2017
Financial Results and Business Update
Investor conference call to be held today, Thursday March 8, 2018
at 8:30am ET
New
York, NY, (March 8, 2018)
– TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its
financial results for the fourth quarter and year ended December
31, 2017 and provided recent company developments along with a
business outlook for 2018.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “2017 was a truly pivotal year for our
company with the presentation of positive results from our first
Phase 3 trial, the GENUINE trial, the completion of enrollment in
our second Phase 3 trial, the UNITY-CLL trial, and the launch of
our Phase 3 ULTIMATE trials in Multiple Sclerosis. These major
milestones along with strong enrollment in our UNITY-NHL
registration directed program sets the stage for an even more
impactful 2018 and 2019.” Mr. Weiss continued, “We are
extremely pleased to enter 2018 with a healthy balance sheet and
look forward to multiple value creating milestones this year,
including presenting topline ORR data from our Phase 3 UNITY-CLL
trial and, ideally, filing our first BLA and/or NDA later in the
year.”
2017 Highlights
●
Orphan Drug Designation:
Orphan drug designation was granted
for the combination of ublituximab (TG-1101) and umbralisib
(TGR-1202) for the treatment of Chronic Lymphocytic Leukemia (CLL)
and Diffuse Large B-Cell Lymphoma (DLBCL).
●
Ublituximab Publication:
Data from the Phase 1/2 trial of
ublituximab was published in the British Journal of
Haematology.
●
GENUINE Phase 3 Data:
Positive data from the Phase 3 GENUINE
trial of ublituximab in combination with ibrutinib in patients with
high risk CLL was presented at the ASCO annual meeting and Lugano
Lymphoma Conference.
●
ULTIMATE Phase 3 Trials in MS: Received
a Special Protocol Assessment (SPA) for the Phase 3 ULTIMATE I and
II studies in relapsing forms of multiple sclerosis, commenced
enrollment into the global studies and presented clinical and MRI
data from the supportive Phase 2 trial of ublituximab in RMS at
various conferences throughout the year.
●
UNITY-CLL Phase 3 Enrollment: Full
enrollment in the UNITY-CLL Phase 3 Trial was completed in October
2017
●
Umbralisib Grant: Umbralisib was
selected for a grant by the National Multiple Sclerosis Society to
support the development of umbralisib as an oral B-Cell targeted
treatment option in progressive Multiple Sclerosis
(PMS).
●
Anti-PD-L1 Entered the Clinic: The
Company advanced its anti-PD-L1 monoclonal antibody into clinical
development, with the first patient being dosed in a Phase I
clinical trial.
Key Objectives for 2018
●
UNITY-CLL Phase 3 Trial: We plan to
present top-line overall response rate results from our UNITY-CLL
Phase 3 trial in both front line and relapsed or refractory CLL and
also prepare a BLA/NDA filing for accelerated
approval.
●
GENUINE Phase 3 BLA Filing: A Biologics Licensing Application (BLA)
filing will be prepared for ublituximab plus ibrutinib for
potential accelerated approval based on the results from
GENUINE.
●
UNITY-NHL: Aggressively enroll into all
cohorts of the UNITY-NHL clinical trial with the goal of completing
enrollment into all cohorts.
●
ULTIMATE Phase 3 Trials: Aggressively
recruit to our Phase 3 MS trials.
●
Data Presentations: Present new and
updated data from ongoing trials at various scientific meetings
throughout the year.
Financial Results for the Fourth Quarter and Full Year
2017
●
Cash Position:
Cash, cash equivalents, investment
securities, and interest receivable were $84.8 million as of
December 31, 2017. Pro-forma
cash, cash equivalents, investment securities, and interest
receivable as of December 31, 2017 (excluding our first quarter
2018 operations) are approximately $114.6 million, after giving
effect to $29.8 million of net proceeds from the utilization of the
Company's at-the-market ("ATM") sales facility during the first
quarter of 2018.
●
R&D Expenses:
Research and development (R&D)
expenses were $26.0 million and $102.5 million for the three and
twelve months ended December 31, 2017, respectively, compared to
$22.3 million and $69.2 million for the three and twelve months
ended December 31, 2016, respectively. Included in research and
development expenses for the three and twelve months ended December
31, 2017, in addition to our other clinical expenses, are $6.1
million and $26.6 million, respectively, of manufacturing and CMC
expenses for Phase 3 clinical trials and potential
commercialization. The increase in R&D expenses for both the
three and twelve months ended December 31, 2017, is primarily due
to the ongoing clinical development programs and related
manufacturing costs for TG-1101 and TGR-1202.
●
G&A Expenses:
General and administrative (G&A)
expenses were $5.1 million and $16.3 million for the three and
twelve months ended December 31, 2017, respectively, as compared to
$1.8 million and $9.9 million for the three and twelve months ended
December 31, 2016, respectively. The increase in G&A expenses
for the three and twelve months ended December 31, 2017 relates
primarily to non-cash compensation expenses related to
equity incentive expense recognized during 2017.
●
Net Loss: Net loss was $30.9 million and $118.5 million for
the three and twelve months ended December 31, 2017, respectively,
compared to a net loss of $23.7 million and $78.3 million for the
three and twelve months ended December 31, 2016,
respectively.
●
Financial Guidance:
The Company believes its cash, cash
equivalents, investment securities, and interest receivable on hand
as of December 31, 2017, inclusive of the proceeds raised
subsequent to the year-end will be sufficient to fund the Company's
planned operations through mid-2019.
Conference Call Information
The
Company will host an investor conference call today, Thursday,
March 8, 2018 at 8:30am ET, to discuss the Company’s 2017
financial results and provide a business outlook for
2018.
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 Year-End 2017 Earnings Call. A
live audio webcast of this conference call 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
call.
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
proliferation and survival of B‐lymphocytes. Both ublituximab
and umbralisib, or the combination of which is referred to as
‘U2', are in Phase 3 clinical development for patients with
hematologic malignancies, with ublituximab also in Phase 3 clinical
development for Multiple Sclerosis. Additionally, the Company has
recently brought its anti-PD-L1 monoclonal antibody into Phase 1
development and aims to bring additional pipeline assets into the
clinic in the future. TG Therapeutics is headquartered
in New York City.
Cautionary Statement
Some of
the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. In addition to the risk
factors identified from time to time in our reports filed with the
Securities and Exchange Commission, factors that could cause our
actual results to differ materially are the following: our ability
to successfully and cost effectively complete clinical trials
on-time and to announce clinical trial results in the projected
timeframes; our ability to manage cash in line with our
expectations; the risk that we don't achieve expected milestones or
that even if achieved they are not value creating; the risk that
results from earlier clinical trials, including those that may have
supported the acceptance of our data for presentation or
publication or may have influenced our decision to proceed with
additional clinical trials, will not be reproduced in future
studies; the risk that the combination of ublituximab (TG-1101) and
umbralisib (TGR-1202), referred to as TG-1303 or "U2" and being
studied in the UNITY clinical trials and other studies, will not
prove to be safe and efficacious for any indication or will not
prove to be safe and effective for use as part of triple and quad
treatment regimens; the risk that any interim analyses from ongoing
clinical trials will not produce the desired or predicted result;
the risk the results of the GENUINE trial will not be adequate to
support the filing of a BLA of ublituximab in combination with
ibrutinib or that we choose not to file a BLA based on the GENUINE
trial; the risk the results of the UNITY-CLL trial will not be
adequate to support the filing of a BLA/NDA of the U2 combination
for accelerated approval or that we choose not to file a BLA/NDA
based on the UNITY-CLL trial results;the risk that the early Phase
2 data of ublituximab in MS will not be reproduced in the Phase 3
MS trials. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
This press release and prior releases are available at
www.tgtherapeutics.com. The information found on our website is not
incorporated by reference into this press release and is included
for reference purposes only.
CONTACT:
Jenna
Bosco
Senior VP,
Corporate Communications
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com
TG Therapeutics, Inc.
Selected Consolidated Financial Data
Statements of Operations Information
(Unaudited):
|
|
Three
Months Ended
December
31,
|
Year
Ended
December
31,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
License
revenue
|
$38,095
|
$38,095
|
$152,381
|
$152,381
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development:
|
|
|
|
|
|
Noncash
compensation
|
260,007
|
868,624
|
5,646,716
|
2,742,354
|
|
Other
research and development
|
25,736,101
|
21,414,723
|
96,886,134
|
66,489,820
|
|
Total research and
development
|
25,996,108
|
22,283,347
|
102,532,850
|
69,232,174
|
|
|
|
|
|
|
|
General and
administrative:
|
|
|
|
|
|
Noncash
compensation
|
3,309,971
|
459,975
|
10,298,568
|
4,767,645
|
|
Other general and
administrative
|
1,766,747
|
1,322,831
|
6,032,714
|
5,121,690
|
|
Total general and
administrative
|
5,076,718
|
1,782,806
|
16,331,282
|
9,889,335
|
|
|
|
|
|
|
|
Total costs and
expenses
|
31,072,826
|
24,066,153
|
118,864,132
|
79,121,509
|
|
|
|
|
|
|
|
Operating
loss
|
(31,034,731)
|
(24,028,058)
|
(118,711,751)
|
(78,969,128)
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
Interest
income
|
(120,422)
|
(57,576)
|
(294,478)
|
(323,032)
|
|
Other
(income) expense
|
(54,542)
|
(296,339)
|
58,739
|
(393,202)
|
|
Total other
(income) expense
|
(174,964)
|
(353,915)
|
(235,739)
|
(716,234)
|
|
|
|
|
|
|
|
Net
loss
|
$(30,859,767)
|
$(23,674,143)
|
$(118,476,012)
|
$(78,252,894)
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.46)
|
$(0.48)
|
$(1.91)
|
$(1.60)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
66,572,544
|
49,278,068
|
62,069,570
|
49,041,354
|
Balance Sheet Information:
|
|
December
31, 2017
(Unaudited)
|
December
31, 2016
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$84,825,125
|
$44,968,992
|
|
Total
assets
|
97,381,536
|
54,781,547
|
|
Accumulated
deficit
|
(354,862,832)
|
(236,386,820)
|
|
Total
equity
|
66,993,055
|
35,867,802
|