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): August 9, 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 August 9, 2017,
TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the second quarter ended June 30, 2017. TG also
announced that on Wednesday, August 9, 2017 at 8:30am ET, TG would
host an investor conference call during which the Company would
provide a brief overview of its second 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 August 9, 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: August
9, 2017
- 3 -
INDEX TO EXHIBITS
Exhibit
Number
Description
99.1
Press release issued by TG Therapeutics, Inc., dated
August 9, 2017.
- 4 -
Exhibit 99.1
TG Therapeutics, Inc. Provides Business Update and Reports Second
Quarter 2017 Financial Results
Investor Conference Call to be Held Today, Wednesday, August 9,
2017 at 8:30am ET
New
York, NY, (August 9, 2017)
– TG Therapeutics, Inc. (NASDAQ:TGTX) today announced its
financial results for the second quarter ended June 30, 2017 and
recent company developments.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "The second quarter was a busy and exciting time
for the Company, with the full presentation of the GENUINE data at
ASCO coupled with additional important data presentations for
TGR-1202 in various combinations. In addition, we were pleased to
announce a successful outcome to the interim analysis in the
UNITY-CLL program, allowing us to drop the two single agent arms
and confirming that there were no safety issues requiring a
modification of the trial. The UNITY-CLL study continues to enroll
very robustly and we look forward to completing enrollment into the
study by the end of the year.” Mr. Weiss continued, "For the
remainder of the year we look forward to our discussions with the
FDA around the positive GENUINE Phase 3 results and the imminent
commencement of the Phase 3 program of TG-1101 in RMS, for which we
recently announced an SPA agreement with the
FDA.”
Recent Developments and Highlights
●
Presented positive
data from the Phase 3 GENUINE Trial of
TG-1101 in combination with Ibrutinib in patients with high risk
Chronic Lymphocytic Leukemia (CLL)
●
Presented
follow-up data for combination of
TGR-1202(umbralisib) plus
Ibrutinib in patients with relapsed or refractory CLL and Mantle
Cell Lymphoma (MCL)
●
Presented
follow-up data for the triple
combination of TG-1101, TGR-1202, and Bendamustine in patients with
DLBCL and FL
●
Presented
follow-up data from the chemo-free
triple combination of TG-1101, TGR-1202, and
Ibrutinib
●
Announced
the successful outcome from the pre-planned interim analysis by an
independent DSMB in the UNITY-CLL Phase 3 Trial which allowed for
closing of enrollment to the single agent arms in this
study
●
Presented
preliminary data from the ongoing Phase 2 study of TG-1101 in
patients with Multiple Sclerosis (MS)
●
Announced
a Special Protocol Assessment (SPA) agreement with the FDA for a
Phase 3 program for TG-1101 in relapsing forms of MS
Key Remaining 2017 Milestones
●
Complete the first
interim analysis in the UNITY-NHL trial for the DLBCL
cohort
●
Initiate a global
Phase 3 program in MS, to be conducted under SPA agreement with the
FDA
●
Present updated
clinical data from the Phase 2 MS trial
●
Meet with the FDA
to review the GENUINE Phase 3 data and discuss suitability for
filing for accelerated approval
●
Complete enrollment
into UNITY-CLL
●
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 Second Quarter 2017
●
Cash Position:
Cash, cash equivalents, investment
securities, and interest receivable were $86.5 million as of June
30, 2017. Pro-forma cash, cash equivalents, investment
securities, and interest receivable as of June 30, 2017 are
approximately $97.4 million, after giving effect to $10.9 million
of net proceeds from the utilization of the Company’s
at-the-market (“ATM”) sales facility during the third
quarter of 2017.
●
R&D Expenses:
Research and development (R&D)
expenses were $26.7 million and $49.4 million for the three and six
months ended June 30, 2017, respectively, compared to $13.5 million
and $25.2 million for the three and six months ended June 30, 2016.
Included in research and development expense for the three and six
months ended June 30, 2017 was $8.1 million and $13.3 million,
respectively, of manufacturing and CMC expenses for Phase 3
clinical trials and potential commercialization, and $2.4 million
and $3.4 million, respectively, in expenses related to commencement
of the Phase 3 program for TG-1101 in MS. The increase in R&D
expenses for both the three and six months ended June 30, 2017, is
primarily due to the ongoing clinical development programs,
including the start-up costs in preparation for the TG-1101 MS
Phase 3 program, as well as manufacturing costs for both TG-1101
and TGR-1202.
●
G&A Expenses:
General and administrative (G&A)
expenses were $1.8 million and $6.8 million for the three and six
months ended June 30, 2017, respectively, as compared to $2.5
million and $4.9 million for the three and six months ended June
30, 2016. The increase in G&A expenses for the six months ended
June 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 $28.4 million and $56.1 million for
the three and six months ended June 30, 2017, respectively,
compared to a net loss of $15.9 million and $29.7 million for the
three and six months ended June 30, 2016,
respectively.
●
Financial Guidance:
The Company believes its cash, cash
equivalents, investment securities, and interest receivable
inclusive of the proceeds raised subsequent to the quarter-end will
be sufficient to fund the Company’s planned operations
through 2018.
Conference Call Information
The
Company will host an investor conference call today, August 9,
2017, at 8:30am ET, to discuss the Company’s second 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 Second 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 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 clinical trials; our
ability to manage cash in line with our expectations; 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; 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 June 30,
|
Six
months ended June 30,
|
||
|
|
2017
|
2016
|
2017
|
2016
|
|
|
|
|
|
|
|
License
revenue
|
$38,095
|
$38,095
|
$76,190
|
$76,190
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development:
|
|
|
|
|
|
Noncash
compensation
|
1,266,322
|
567,157
|
3,572,421
|
954,082
|
|
Other
research and development
|
25,439,477
|
12,966,574
|
45,815,271
|
24,196,989
|
|
Total research and
development
|
26,705,799
|
13,533,731
|
49,387,692
|
25,151,071
|
|
|
|
|
|
|
|
General and
administrative:
|
|
|
|
|
|
Noncash
compensation
|
223,406
|
1,081,240
|
3,912,762
|
2,393,280
|
|
Other general and
administrative
|
1,534,261
|
1,446,567
|
2,867,529
|
2,547,438
|
|
Total general and
administrative
|
1,757,667
|
2,527,807
|
6,780,291
|
4,940,718
|
|
|
|
|
|
|
|
Total costs and
expenses
|
28,463,466
|
16,061,538
|
56,167,983
|
30,091,789
|
|
|
|
|
|
|
|
Operating
loss
|
(28,425,371)
|
(16,023,443)
|
(56,091,793)
|
(30,015,599)
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
Interest
income
|
(50,197)
|
(92,629)
|
(94,893)
|
(177,491)
|
|
Other
(income) expense
|
(22,090)
|
(31,752)
|
83,693
|
(90,384)
|
|
Total other
(income) expense
|
(72,287)
|
(124,381)
|
(11,200)
|
(267,875)
|
|
|
|
|
|
|
|
Net
loss
|
$(28,353,084)
|
$(15,899,062)
|
$(56,080,593)
|
$(29,747,724)
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.45)
|
$(0.33)
|
$(0.96)
|
$(0.61)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
63,288,269
|
48,769,948
|
58,251,045
|
48,838,731
|
Condensed Balance Sheet
Information:
|
|
June
30 2017
(unaudited)
|
December
31, 2016*
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$86.454.583
|
$44,968,992
|
|
Total
assets
|
101,197,751
|
54,781,547
|
|
Accumulated
deficit
|
(292,467,413)
|
(236,386,820)
|
|
Total
equity
|
77,975,018
|
35,867,802
|
* Condensed from
audited financial statements.