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): November 7, 2016
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 November 7,
2016, TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the third quarter ended September 30, 2016. TG also
announced that on Monday, November 7, 2016 at 8:30am ET, TG would
host an investor conference call during which the Company would
provide a brief overview of its third quarter financial results and
provide a business outlook for the remainder of 2016. 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 November 7,
2016.
- 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:
November 7, 2016
- 3 -
INDEX TO EXHIBITS
Exhibit
Number
Description
99.1
Press release issued by TG Therapeutics, Inc., dated
November 7, 2016.
- 4 -
Exhibit 99.1
TG Therapeutics, Inc. Provides
Business Update and Reports Third Quarter 2016 Financial
Results
Investor Conference Call to be Held Today, Monday, November 7, 2016
at 8:30am ET
New
York, NY, (November 7, 2016)
– TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the third quarter ended September 30, 2016
and recent company developments.
Michael
S. Weiss, the Company's Executive Chairman and Interim Chief
Executive Officer, stated, "The third quarter was a pivotal one for
the company, particularly with the amendment of the GENUINE Phase 3
trial that will enable the rapid conclusion of the study while also
maintaining the possibility for accelerated approval for TG-1101 in
combination with ibrutinib. Importantly, with GENUINE enrollment
wrapping up, we can dedicate our resources and focus to our
proprietary UNITY program, which we believe offers the potential
for highly active, well-tolerated therapy with certain pricing
advantages over competitors. As a result, we see our value
proposition rising as the concern around pharmaceutical pricing
continues to grow." Mr. Weiss continued, "We see important value
creating milestones over the next 12 months, including completion
of enrollment of GENUINE expected by year end 2016 to be followed
by top line data in the first half of 2017. During the course of
2017, we should also report early data from our UNITY-DLBCL study
and our MS pivotal program should take full form supported by
B-cell depletion data from our ongoing Phase 2 study in RRMS. With
all these events lining up, we believe 2017 will be our most
impactful year to date.”
Third Quarter and Recent Highlights
|
|
|
|
●
ASH 2016: The Company looks forward to the upcoming American
Society of Hematology (ASH) Annual Meeting where data presentations
will include three oral presentations and three poster
presentations. All clinical presentations will highlight the safety
and efficacy for combinations of TGR-1202 with novel targeted
agents including oral presentations with TGR-1202 in combination
with ibrutinib and TGR-1202 in combination with
ruxolitinib.
●
TGR-1202 Pre-Clinical
Differentiation: An October
publication in Blood presented preclinical data describing the synergy
of TGR-1202 with carfilzomib and the unique effects of the
combination to silence c-Myc in various preclinical lymphoma and
myeloma models. In addition, the publication described TGR-1202's
unique complimentary mechanism of inhibiting the protein kinase
casein kinase-1 (CK1) epsilon, which may contribute to the
silencing of c-Myc and explain TGR-1202's clinical activity in
aggressive lymphoma.
●
TGR-1202 + Carfilzomib:
Based on the pre-clinical work on
TGR-1202 published in Blood, a Phase 1/2 study of TGR-1202 and Carfilzomib in
patients with relapsed or refractory lymphoma was
launched.
●
GENUINE Study Amendment:
The Company amended the ongoing
GENUINE Phase 3 Clinical Trial by revising the primary endpoint to
Overall Response Rate (ORR), with enrollment expected to be
completed before year end 2016 and top-line data available in first
half of 2017. The study is well powered to detect a difference in
ORR, which, if successful, would potentially support a filing for
accelerated approval.
●
Clinical Data Presentation of
TG-1101 in NMO: During the 32nd
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis, the Company presented clinical data from the
Phase Ib study of TG-1101 in patients with NMO with TG-1101
demonstrating rapid and effective depletion of B-cells during acute
NMO relapse. The Company has an on-going Phase 2 study of TG-1101
in multiple sclerosis.
●
Orphan Drug
Designations: The Company
received Orphan Drug Designation for TGR-1202 for treatment of
Chronic Lymphocytic Leukemia and for TG-1101 for treatment of
Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum
Disorder (NMOSD).
●
UNITY-DLBCL:
Patient enrollment began for the
registration-directed UNITY-DLBCL Phase 2b clinical study
evaluating TG-1101 and TGR-1202 in combination compared to TGR-1202
monotherapy in patients with advanced relapsed/refractory
DLBCL.
Key Remaining 2016
Milestones
●
Complete enrollment
into the GENUINE Phase 3 clinical trial
●
Aggressively enroll
into the Company’s registration directed trials, including
the UNITY-CLL Phase 3, and the UNITY-DLBCL Phase 2b
●
Continue enrollment
into the Phase 2 clinical trial in Multiple Sclerosis
●
Present clinical
data from a variety of Phase 1 and 2 clinical trials at the
American Society of Hematology Annual Meeting in December 2016,
held in San Diego, CA
|
|
|
|
Financial Results for the Third Quarter 2016
●
Cash Position:
Cash, cash equivalents, investment
securities, and interest receivable were $60.7 million as of
September 30, 2016.
●
R&D Expenses:
Research and development (R&D)
expenses were $21.8 million and $46.9 million for the three and
nine months ended September 30, 2016, respectively, compared to
$11.6 million and $32.5 million for the three and nine months ended
September 30, 2015, respectively. Included in research and
development expenses for the three and nine months ended September
30, 2016, are $10.2 million and $17.9 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 nine months ended September 30, 2016, 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 $3.2 million and $8.1 million for the three and nine
months ended September 30, 2016, respectively, as compared to $2.3
million and $13.2 million for the three and nine months ended
September 30, 2015, respectively. The period-over-period decrease
in G&A expenses from the nine months ended September 30, 2015
relates primarily to non-cash compensation expenses related
to equity incentive grants recognized during 2015. G&A expenses for the three months ended
September 30, 2016 remained relatively flat compared to the second
quarter of 2015, and we expect G&A expenses to remain
relatively constant through the fourth quarter of
2016.
●
Net Loss: Net loss was $24.8 million and $54.6 million for
the three and nine months ended September 30, 2016, respectively,
compared to a net loss of $13.7 million and $45.3 million for the
three and nine months ended September 30, 2015,
respectively.
●
Financial Guidance:
The Company believes its cash, cash
equivalents, investment securities, and interest receivable of
$60.7 million as of September 30, 2016 will be sufficient to fund
the Company’s planned operations into the first half of
2018.
Conference Call Information
The
Company will host an investor conference call today, November 7,
2016, at 8:30am ET, to discuss the Company’s third quarter
2016 financial results and provide a business outlook for the
remainder of 2016.
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 2016 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
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 recently entering 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, particularly those with respect to anticipating the timing
of the completion of the GENUINE study, timing of topline data for
the GENUINE study, the usability of the results from GENUINE for
accelerated approval, timing of initial data from the UNITY-DLBCL
study, timing of the release of data and commencement of our MS
pivotal program 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. Among the factors that could cause our actual
results to differ materially are the following: our ability to
successfully and cost-effectively complete the GENUINE, the
UNITY-CLL or the UNITY-DLBCL trials; the risk that the clinical
results from the GENUINE, UNITY-CLL and/or UNITY-DLBCL studies will
be not positive and/or will not support regulatory approval of
TG-1101 or TGR-1202; the risk that the FDA will not grant
us a pre-BLA meeting to discuss the results of the GENUINE study;
the risk that we will not file a BLA for TG-1101 or an NDA for
TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk
that despite early positive trends in enrollment in the UNITY-CLL
study that enrollment will be delayed beyond our projections; the
risk that the planned interim analysis will not allow early closure
of the single agent arms in the UNITY-CLL study, necessitating
enrollment beyond the projected 450 patients, which would extend
enrollment beyond our projections; the risk that safety issues or
trends will be observed in the GENUINE study, the UNITY-CLL and/or
the UNITY-DLBCL study that prevent approval of either TG-1101
and/or TGR-1202 or require us to terminate either the GENUINE study
or the UNITY-CLL or the UNITY-DLBCL study prior to completion; the
risk that the data (both safety and efficacy) from future clinical
trials will not coincide with the data produced from prior
pre-clinical and clinical trials; the risk that the GENUINE study,
as amended or the UNITY-CLL or the UNITY-DLBCL studies, or any of
our other registration-directed clinical trials as designed or
amended may not be sufficient or acceptable to support regulatory
approval; the risk that trials will take longer to enroll than
expected; the risk that the projected cost savings to be realized
by amending the GENUINE trial will not be realized; our ability to
achieve the milestones we project over the next year; our ability
to manage our cash in line with our projections, and other risk
factors identified from time to time in our reports filed with
the Securities and Exchange Commission. 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 September 30,
|
Nine
months ended September 30,
|
||
|
|
2016
|
2015
|
2016
|
2015
|
|
|
|
|
|
|
|
License
revenue
|
$38,096
|
$38,096
|
$114,286
|
$114,286
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development:
|
|
|
|
|
|
Noncash
compensation
|
919,648
|
35,756
|
1,873,730
|
2,733,110
|
|
Other
research and development
|
20,878,108
|
11,538,246
|
45,075,097
|
29,719,891
|
|
Total research and
development
|
21,797,756
|
11,574,002
|
46,948,827
|
32,453,001
|
|
|
|
|
|
|
|
General and
administrative:
|
|
|
|
|
|
Noncash
compensation
|
1,914,390
|
1,204,278
|
4,307,670
|
10,106,938
|
|
Other general and
administrative
|
1,251,421
|
1,085,400
|
3,798,859
|
3,094,362
|
|
Total general and
administrative
|
3,165,811
|
2,289,678
|
8,106,529
|
13,201,300
|
|
|
|
|
|
|
|
Total costs and
expenses
|
24,963,567
|
13,863,680
|
55,055,356
|
45,654,301
|
|
|
|
|
|
|
|
Operating
loss
|
(24,925,471)
|
(13,825,584)
|
(54,941,070)
|
(45,540,015)
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
Interest
income
|
(87,965)
|
(55,977)
|
(265,456)
|
(109,660)
|
|
Other income
|
(33,042)
|
--
|
(33,042)
|
--
|
|
Interest
expense
|
211,538
|
246,527
|
674,699
|
730,710
|
|
Change in fair
value of notes payable
|
(184,975)
|
(360,218)
|
(738,520)
|
(824,231)
|
|
Total other
income
|
(94,444)
|
(169,668)
|
(362,319)
|
(203,181)
|
|
|
|
|
|
|
|
Net
loss
|
$(24,831,027)
|
$(13,655,916)
|
$(54,578,751)
|
$(45,336,834)
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.50)
|
$(0.28)
|
$(1.11)
|
$(1.01)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
49,203,277
|
47,946,309
|
48,961,582
|
44,810,352
|
Condensed Balance Sheet
Information:
|
|
September
30, 2016
(unaudited)
|
December
31, 2015*
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$ 60,710,595
|
$102,416,894
|
|
Total
assets
|
75,687,094
|
113,473,201
|
|
Accumulated
deficit
|
(212,712,677)
|
(158,133,926)
|
|
Total
equity
|
56,754,721
|
101,573,302
|
* Condensed from
audited financial statements.