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 9, 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 November 9,
2018, TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the third quarter ended September 30, 2018. TG also
announced that on Friday, November 9, 2018 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 2018. A copy of
such press release is being furnished as Exhibit 99.1.
Item
9.01 Financial Statements And Exhibits.
(d)
Exhibits.
Press release
issued by TG Therapeutics, Inc., dated November 9,
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)
By: /s/ Sean A. Power
Sean A. Power
Chief Financial Officer
Date:
November 9, 2018
- 3
-
Exhibit
99.1
TG Therapeutics, Inc. Provides Business Update and Reports Third
Quarter 2018 Financial Results
Investor Conference Call to be Held Today, Friday, November 9, 2018
at 8:30 AM ET
New York, NY, (November 9,
2018) – TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
third quarter ended September 30, 2018 and recent company
developments.
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "We are pleased by the progress made in
the third quarter of 2018, most notably the completion of full
enrollment in the current cohorts of the UNITY-NHL trial, as well
as in the ULTIMATE Phase 3 program in MS. We now have five Phase 3
or registration directed trials fully enrolled across our three
major indications of interest, CLL, NHL and MS, and look forward to
significant value creating data releases in 2019 and 2020.”
Mr. Weiss, continued, “This is just the beginning for TG as
we solidify the foundation and look towards the future of building
proprietary triple combination therapies with our in-house early
stage pipeline.”
Recent Developments and Highlights
●
ASH Presentations:
Announced two triple therapy data
abstracts were accepted for presentation at the upcoming
60th
American Society of Hematology (ASH)
annual meeting.
●
ULTIMATE Trials:
Completed full enrollment into the
ULTIMATE I & II Phase 3 trials, evaluating ublituximab in
relapsing form of MS, which are being conducted under Special
Protocol Assessment (SPA) agreement with the
FDA.
●
Ublituximab Data in Multiple
Sclerosis: Presented final data
from the Phase 2 trial of ublituximab in RMS at the 34th Congress
of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS) Annual Meeting in Berlin,
Germany.
●
UNITY-NHL: Completed enrollment in the current arms of the
UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone
Lymphoma, and Diffuse Large B-Cell Lymphoma
cohorts.
Financial Results for the Third Quarter 2018
●
Cash
Position: Cash, cash
equivalents, investment securities, and interest receivable were
$97.8 million as of September 30, 2018.
●
R&D Expenses:
Research and development (R&D)
expenses were $33.4 million and $107.1 million for the three and
nine months ended September 30, 2018, respectively, compared to
$27.1 million and $76.5 million for the three and nine months ended
September 30, 2017. The increase in R&D expense is primarily
attributable to an increase in clinical trial expenses of $4.4
million and $20.1 million, respectively, during the three and nine
months ended September 30, 2018, as compared to prior periods. In
addition, included in R&D expenses for the three and nine
months ended September 30, 2018 are $5.0 million and $16.4 million,
respectively, of manufacturing and CMC expenses for Phase 3
clinical trials and potential commercialization. Also included in
R&D expense for the nine months ended September 30, 2018 was
$4.0 million of non-cash stock expense recorded in conjunction with
the licenses to the BTK and CD47/CD19 programs.
●
G&A Expenses: General and
administrative (G&A) expenses were $1.0 million and $13.2
million for the three and nine months ended September 30, 2018,
respectively, as compared to $4.5 million and $11.3 million for the
three and nine months ended September 30, 2017. The decrease in
G&A expenses for the three months ended September 30, 2018
relates to a decrease in non-cash compensation expense related to
equity incentive expense recognized during the three months ended
September 30, 2018 as a result of a decrease in the measurement
date fair value of certain consultant restricted
stock.
●
Net Loss: Net loss was $34.0 million and
$119.6 million for the three and nine months ended September 30,
2018, respectively, compared to a net loss of $31.5 million and
$87.6 million for the three and nine months ended September 30,
2017, respectively. Excluding non-cash items, the net loss for the
three and nine months ended September 30, 2018 was approximately
$34.1 million and $104.2 million.
●
Financial Guidance: Net cash utilized
for operating activities during the nine months ended 2018 was
approximately $95.2 million. The Company believes its cash, cash
equivalents, investment securities, and interest receivable on hand
as of September 30, 2018 will be sufficient to fund the Company's
planned operations through the end of 2019.
Conference Call Information
The Company will host an investor conference call today, November
9, 2018, at 8:30am ET, to discuss the Company’s third quarter
2018 financial results and provide a business outlook for the
remainder of 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 Third Quarter 2018 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. 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 preclinical and
clinical trials; the risk that the combination of ublituximab
(TG-1101) and umbralisib (TGR-1202), referred to as U2 or formerly
TG-1303, 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 the early
Phase 2 data of ublituximab in MS will not be reproduced in the
Phase 3 MS trial; the risk that top-line data from the ULTIMATE
Phase 3 trials will not be available within projected timelines,
the risk that current or additional double or potential planned
triple combination therapy trials will not commence as planned or
at all;the risk that the UNITY-CLL study, or any of our other
registration directed clinical trials as designed or amended may
not be sufficient or acceptable to support regulatory submission or
approval; the risk that a filing based on GENUINE, UNITY-CLL,
UNITY-NHL, ULTIMATE clinical trials or any other registration
directed trials cannot be made on schedule as targeted or at all;
the risk that we are unable to manage cash in line with our
expectations and meet our development milestones and/or continue
our operations without raising capital; the risk that we are unable
to raise capital on acceptable terms; the risk that early clinical
trial results that may have influenced our decision to proceed with
additional clinical trials, will not be reproduced in the final
data presented 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.
CONTACT:
Jenna
Bosco
Senior
Vice President,
Corporate
Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com
TG
Therapeutics, Inc.
Selected Consolidated Financial Data
Statements of Operations Information (in thousands, except share
and per share amounts; unaudited):
|
|
Three months
ended September 30,
|
Nine months
ended September 30,
|
||
|
|
2018
|
2017
|
2018
|
2017
|
|
|
|
|
|
|
|
License
revenue
|
$38
|
$38
|
$114
|
$114
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development:
|
|
|
|
|
|
Non-cash
stock expense associated with in-licensing agreements
|
--
|
--
|
4,000
|
--
|
|
Noncash
compensation
|
644
|
1,814
|
4,391
|
5,387
|
|
Other
research and development
|
32,754
|
25,335
|
98,724
|
71,150
|
|
Total research and
development
|
33,398
|
27,149
|
107,115
|
76,537
|
|
|
|
|
|
|
|
General and
administrative:
|
|
|
|
|
|
Noncash
compensation
|
(817)
|
3,076
|
7,037
|
6,988
|
|
Other general and
administrative
|
1,785
|
1,398
|
6,212
|
4,266
|
|
Total general and
administrative
|
968
|
4,474
|
13,249
|
11,254
|
|
|
|
|
|
|
|
Total costs and
expenses
|
34,366
|
31,623
|
120,364
|
87,791
|
|
|
|
|
|
|
|
Operating
loss
|
(34,328)
|
(31,585)
|
(120,250)
|
(87,677)
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
Interest
income
|
(258)
|
(79)
|
(591)
|
(174)
|
|
Other
(income) expense
|
(119)
|
30
|
(37)
|
113
|
|
Total other income,
net
|
(377)
|
(49)
|
(628)
|
(61)
|
|
|
|
|
|
|
|
Net
loss
|
$(33,951)
|
$(31,536)
|
$(119,622)
|
$(87,616)
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.43)
|
$(0.48)
|
$(1.61)
|
$(1.45)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
78,221,069
|
65,079,128
|
74,399,243
|
60,552,084
|
Condensed Balance Sheet Information (in thousands):
|
|
September 31,
2018
|
|
|
|
(Unaudited)
|
December 31,
2017*
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$97,822
|
$84,825
|
|
Total
assets
|
114,374
|
97,381
|
|
Accumulated
deficit
|
(474,485)
|
(354,863)
|
|
Total
equity
|
71,744
|
66,993
|
*
Condensed from audited financial statements