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): May 5, 2017
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.
Item
2.02. Results of Operations and Financial Condition.
On May 5, 2017, TG
Therapeutics, Inc. TG Therapeutics,
Inc. (“TG” or the “Company”) issued a press
release announcing results of operations for the first quarter
ended March 31, 2017. TG also announced that on Friday, May 5, 2017
at 8:30am ET, TG would host an investor conference call during
which the Company would provide a brief overview of its first
quarter financial results and provide a business outlook for the
remainder of 2017. 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 May 5, 2017.
- 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)
By: /s/ Sean A. Power
Sean A. Power
Chief Financial Officer
Date: May 5,
2017
- 3 -
INDEX TO EXHIBITS
Exhibit
Number
Description
99.1
Press release issued by TG Therapeutics, Inc., dated
May 5, 2017.
- 4 -
Exhibit 99.1
TG Therapeutics, Inc. Provides Business Update and Reports First
Quarter 2017 Financial Results
Investor Conference Call to be Held Today, Friday, May 5, 2017 at
8:30am ET
New
York, NY, (May 5, 2017)
– TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the first quarter ended March 31, 2017 and
recent company developments.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “2017 has been an exciting and busy year for
us already, with both the announcement of the positive topline data
from the Phase 3 GENUINE trial and the subsequent $89M capital
raise. Having achieved these two important milestones, we believe
the company is well positioned for a successful remainder of the
year and beyond.” Mr. Weiss continued, “We plan to
focus our attention on advancing our clinical programs towards
success and look forward to a data and news rich summer where we
will be presenting a more detailed analysis of the GENUINE data,
announcing the interim analysis data from both our UNITY-CLL Phase
3 trial and UNITY-DLBCL trial, as well as commencing our global
Phase 3 program in MS.”
Recent Developments and Highlights
●
Received orphan drug designation for the combination of TG-1101 and
TGR-1202 for the treatment of CLL and DLBCL
●
Announced the
publication of clinical data from the Phase 1/2 trial of TG-1101
monotherapy in the British Journal of Haematology
●
Announced positive
topline data from Phase 3 GENUINE study of TG-1101 in combination
with ibrutinib in patients with high risk CLL.
●
Solidified the
Company’s balance sheet raising approximately $89M in gross
proceeds through the combination of a public offering and an
at-the-market sales facility
●
Presented
preclinical data on our anti-PD-L1 monoclonal antibody at the
American
Association for Cancer Research (AACR) annual
meeting
●
Presented
preliminary results, including B-cell depletion data from ongoing
Phase 2 study of TG-1101 in patients with MS at the American
Academy of Neurology (AAN) annual meeting
Reaffirming 2017 Milestones
●
Present updated
clinical data including the full Phase 3 GENUINE data at a major
medical meeting in the first half of 2017
●
Present clinical
data from the Phase 2 Multiple Sclerosis (MS) trial
●
Initiate a global
Phase 3 trial in MS
●
Complete the first
interim analysis in the UNITY-CLL Phase 3 trial
●
Complete the first
interim analysis in the UNITY-DLBCL trial
●
Meet with the FDA
to review the Phase 3 GENUINE data and discuss suitability for
filing for accelerated approval
●
Present new and
updated data from ongoing trials at various scientific meetings
throughout the year, including the American Society of Hematology
(ASH) annual meeting in December
Financial Results for the Third Quarter 2016
●
Cash Position:
Cash, cash equivalents, investment
securities, and interest receivable were $109.5 million as of March
31, 2017.
●
R&D
Expenses: Research
and development (R&D) expense was $22.7 million for the three
months ended March 31, 2017 compared to $11.6 million for the three
months ended March 31, 2016. Included in research and development
expense for the three months ended March 31, 2017 and 2016, was
$5.3 million and $4.3 million, respectively, of manufacturing and
CMC expenses for Phase 3 clinical trials and potential
commercialization. The increase in R&D expenses for the three
months ended March 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) expense was
$5.0 million for the three months ended March 31, 2017 as compared
to $2.4 million for the three months ended March 31, 2016. The
period-over-period increase in G&A expenses for the three
months ended March 31, 2017 relates primarily to non-cash
compensation expenses related to equity incentive grants
recognized during 2017. Other G&A
expenses for the three months ended March 31, 2017 remained
relatively flat compared to the first quarter of 2016, and we
expect G&A expenses to remain relatively constant through the
remainder of 2017.
●
Net Loss: Net loss was $27.7 million for the three months
ended March 31, 2017 compared to a net loss of $13.8 million for
the three months ended March 31, 2016.
●
Financial
Guidance: The
Company believes its cash, cash equivalents, investment securities,
and interest receivable of $109.5 million as of March 31, 2017 will
be sufficient to fund the Company’s planned operations
through 2018.
Conference Call Information
The
Company will host an investor conference call today, May 5, 2017,
at 8:30am ET, to discuss the Company’s first quarter 2017
financial results and provide a business outlook for the remainder
of 2017.
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 2017 Earnings Call.
A live webcast of this 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. TG-1101 (ublituximab) 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 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 TG-1101 and TGR-1202 are in clinical
development for patients with hematologic malignancies, with
TG-1101 also in clinical development for autoimmune disorders. The
Company also has pre-clinical programs to develop IRAK4 inhibitors,
BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. 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 preclinical and
clinical trials; our ability to manage cash in line with our
expectations;the risk that early clinical trial results, that may
have supported the acceptance of our data for presentation or
influenced our decision to proceed with additional clinical trials,
will not be reproduced in future studies or in the final
presentations; the risk that the combination of TG-1101 and
TGR-1202, referred to as TG-1303 and being studied in the UNITY
clinical trials, will not prove to be a safe and efficacious
combination or backbone for triple and quad therapies; the risk
that any interim analyses from ongoing clinical trials will not
produce the desired or predicted result; the risk that we will not
obtain the benefit of receiving orphan drug designation. 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.
TGTX -
G
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
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 March 31, 2017
|
|
|
|
2017
|
2016
|
|
|
|
|
|
License
revenue
|
$38,095
|
$38,095
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
Research and
development:
|
|
|
|
Noncash
compensation
|
2,306,099
|
386,925
|
|
Other
research and development
|
20,375,794
|
11,230,415
|
|
Total research and
development
|
22,681,893
|
11,617,340
|
|
|
|
|
|
General and
administrative:
|
|
|
|
Noncash
compensation
|
3,689,356
|
1,312,040
|
|
Other general and
administrative
|
1,333,268
|
1,100,871
|
|
Total general and
administrative
|
5,022,624
|
2,412,911
|
|
|
|
|
|
Total costs and
expenses
|
27,704,517
|
14,030,251
|
|
|
|
|
|
Operating
loss
|
(27,666,422)
|
(13,992,156)
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
Interest
income
|
(44,696)
|
(84,862)
|
|
Other (income)
expense
|
105,783
|
(58,632)
|
|
Total other
income
|
61,087
|
(143,494)
|
|
|
|
|
|
Net
loss
|
$(27,727,509)
|
$(13,848,662)
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.52)
|
$(0.28)
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
53,157,851
|
48,908,278
|
Condensed Balance Sheet
Information:
|
|
March
31, 2017
(unaudited)
|
December
31, 2016*
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$109,483,728
|
$44,968,992
|
|
Total
assets
|
123,256,432
|
54,781,547
|
|
Accumulated
deficit
|
(264,114,329)
|
(236,386,820)
|
|
Total
equity
|
101,041,759
|
35,867,802
|
* Condensed from
audited financial statements.