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 8, 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.
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 November 8,
2017, TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the third quarter ended September 30, 2017. TG also
announced that on Wednesday, November 8, 2017 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 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 November 8,
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:
November 8, 2017
- 3
-
Exhibit 99.1
TG Therapeutics, Inc. Provides Business Update and Reports Third
Quarter 2017 Financial Results
Investor Conference Call to be Held Today, Wednesday, November 8,
2017 at 8:30am ET
New
York, NY, (November 8, 2017)
– TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the third quarter ended September 30, 2017,
and recent company developments.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "The third quarter was an extremely productive and
exciting time for the Company highlighted by the completion of
enrollment into our UNITY-CLL Phase 3 study, the commencement of
our global Phase 3 trials in multiple sclerosis, and the additional
clarity we received from the FDA regarding the GENUINE study. We
look forward, over the next 6-12 months, to what we believe will be
a number of value creating milestones, including overall response
data from UNITY-CLL and additional data supporting our strategy in
NHL.” Mr. Weiss continued, "From a financial perspective, we
remain well positioned through these important
milestones.”
Third Quarter and Recent Highlights
●
ASH 2017: The Company looks forward to the upcoming American
Society of Hematology (ASH) Annual Meeting where data presentations
will include three clinical poster presentations and three
pre-clinical poster presentations.
●
TG-1101 Data at
ECTRIMS: Updated
results from the ongoing Phase 2 Study of TG-1101 in patients with
Multiple Sclerosis were presented at the 7th Joint
ECTRIMS-ACTRIMS Meeting demonstrating robust activity on B-cell
depletion, reduction of T1 Gd enhancing lesions, and positive
effects on disability measurements.
●
UNITY-CLL Enrollment: Full enrollment in
the UNITY-CLL Phase 3 Trial was completed in October, which should
allow for top-line data on Overall Response Rate (ORR) in Q2
2018.
●
GENUINE Update: The Company met with the
FDA and confirmed that accelerated approval based on the ORR
results from GENUINE would be a review issue and that the potential
may exist for full approval based on the PFS results from the
GENUINE study.
●
TGR-1202 Grant: TGR-1202 (umbralisib)
was selected for a grant by the National Multiple Sclerosis Society
to support the development of TGR-1202 as an oral B-Cell targeted
treatment option in progressive Multiple Sclerosis
(PMS).
●
Anti-PD-L1 Entered the Clinic: The
Company’s anti-PD-L1 monoclonal antibody commenced clinical
development, with the first patient being dosed in a Phase I
clinical trial.
●
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 and commenced
enrollment into the global studies.
●
UNITY-NHL: Announced successful outcome
from the first pre-planned interim analysis by independent DSMB of
the DLBCL cohort in the UNITY-NHL Phase 2b trial, where based on
pre-set hurdles of ORR, the DSMB recommended continued enrollment
in the TG-1101 plus TGR-1202 combination arm (also referred to as
the U2 combination) and replacement of the single agent TGR-1202
arm with U2 plus bendamustine.
Financial Results for the Third Quarter 2017
●
R&D Expenses:
Research and development (R&D)
expenses were $27.1 million and $76.5 million for the three and
nine months ended September 30, 2017, respectively, compared to
$21.8 million and $46.9 million for the three and nine months ended
September 30, 2016. Included in research and development expense
for the three and nine months ended September 30, 2017 was $7.1
million and $20.4 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, 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 $4.5 million and $11.3 million for the three and nine
months ended September 30, 2017, respectively, as compared to $3.2
million and $8.1 million for the three and nine months ended
September 30, 2016. The increase in G&A expenses for the nine
months ended September 30, 2017 relates primarily to non-cash
compensation expenses related to equity incentive grants
recognized during 2017. We expect
G&A expenses to remain relatively constant through the
remainder of 2017.
●
Net Loss: Net loss was $31.5 million and $87.6 million for
the three and nine months ended September 30, 2017, respectively,
compared to a net loss of $24.8 million and $54.6 million for the
three and nine months ended September 30, 2016,
respectively.
●
Financial Guidance:
The Company believes its cash and cash
equivalents will be sufficient to fund the Company’s planned
operations through 2018.
Conference Call Information
The
Company will host an investor conference call today, November 8,
2017, at 8:30am ET, to discuss the Company’s third 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 Third Quarter 2017 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
(umbralisib), 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, or the
combination of which is referred to as "U2," are in Phase 3
clinical development for patients with hematologic malignancies,
with TG-1101 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; 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 early clinical trial
results from interim analysis or from the review of a DSMB or
similar safety monitoring committee will not ultimately be
reflective of the results of the entire study when completed; 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 TG-1101 and 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 a safe and
efficacious for any indication or prove to be an 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 TG-1101 in combination with ibrutinib or that we choose not
to file a BLA based on the GENUINE trial; the risk that the early
Phase 2 data of TG-1101 in MS will not be reproduced in the Phase 3
MS trial. 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,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
|
|
|
|
|
|
License
revenue
|
$38,096
|
$38,096
|
$114,286
|
$114,286
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development:
|
|
|
|
|
|
Noncash
compensation
|
1,814,288
|
919,648
|
5,386,709
|
1,873,730
|
|
Other
research and development
|
25,334,762
|
20,878,108
|
71,150,033
|
45,075,097
|
|
Total research and
development
|
27,149,050
|
21,797,756
|
76,536,742
|
46,948,827
|
|
|
|
|
|
|
|
General and
administrative:
|
|
|
|
|
|
Noncash
compensation
|
3,075,835
|
1,914,390
|
6,988,597
|
4,307,670
|
|
Other general and
administrative
|
1,398,438
|
1,251,421
|
4,265,967
|
3,798,859
|
|
Total general and
administrative
|
4,474,273
|
3,165,811
|
11,254,564
|
8,106,529
|
|
|
|
|
|
|
|
Total costs and
expenses
|
31,623,323
|
24,963,567
|
87,791,306
|
55,055,356
|
|
|
|
|
|
|
|
Operating
loss
|
(31,585,227)
|
(24,925,471)
|
(87,677,020)
|
(54,941,070)
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
Interest
income
|
(79,163)
|
(87,965)
|
(174,056)
|
(265,456)
|
|
Other
|
29,588
|
(6,479)
|
113,281
|
(96,863)
|
|
Total other
income
|
(49,575)
|
(94,444)
|
(60,775)
|
(362,319)
|
|
|
|
|
|
|
|
Net
loss
|
$(31,535,652)
|
$(24,831,027)
|
$(87,616,245)
|
$(54,578,751)
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.48)
|
$(0.50)
|
$(1.45)
|
$(1.11)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
65,079,128
|
49,203,277
|
60,552,084
|
48,961,582
|
Condensed Balance Sheet Information:
|
|
September
30, 2017
(unaudited)
|
December
31, 2016*
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$91,842,167
|
$44,968,992
|
|
Total
assets
|
101,781,514
|
54,781,547
|
|
Accumulated
deficit
|
(324,003,065)
|
(236,386,820)
|
|
Total
equity
|
79,545,766
|
35,867,802
|
*
Condensed from audited financial statements.