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 8, 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 May 8, 2018, TG
Therapeutics, Inc. (“TG” or the “Company”)
issued a press release announcing results of operations for the
first quarter ended March 31, 2018. TG also announced that on
Tuesday, May 8, 2018 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 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 May 8, 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: May 8,
2018
- 3
-
Exhibit 99.1
TG Therapeutics, Inc. Provides Business Update and Reports First
Quarter 2018 Financial Results
Investor Conference Call to be Held Today, Tuesday, May 8, 2018 at
8:30am ET
New
York, NY, (May 8, 2018)
– TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its
financial results for the first quarter ended March 31, 2018 and
recent company developments.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "2018 is off to a great start as we continue to
advance our major pivotal programs and bolster our product
pipeline, most recently with the addition of a BTK inhibitor
program. As we move into the second quarter and the remainder of
the year, we look forward to the announcement of topline data from
our UNITY-CLL trial, completion of enrollment into the current
cohorts of the UNITY-NHL study, final MS Phase 2 data, significant
enrollment in our MS phase 3 program as well as filing decisions
related to the Company’s first BLA/NDA later in the
year.” Mr. Weiss continued, “We believe 2018 will be a
pivotal year for the Company as approval pathways across multiple
indications become clearer and position us for future
success.”
First Quarter and Recent Highlights
●
BTK License: Entered into an exclusive global
license agreement with Jiangsu Hengrui Medicine Co., Ltd. (or
"Hengrui”) to obtain worldwide rights, excluding Asia but
including Japan, for the development of Hengrui's Bruton's Tyrosine
Kinase (BTK) inhibitor program, including the lead candidate,
TG-1701.
●
Umbralisib Lancet Publication: Results
from the Phase 1 first-in-human study of umbralisib (TGR-1202), the
Company's novel once-daily PI3K delta inhibitor, were published in
The Lancet Oncology.
●
TG-1601 Preclinical Data: Presented the
first preclinical data from TG-1601, the Company’s novel BET
inhibitor, at the 2018 American Association for Cancer Research
(AACR) annual meeting.
●
Ublituximab Data in Multiple
Sclerosis: Presented clinical and MRI data from the Phase 2
trial of ublituximab (TG-1101) in RMS at the 3rd Annual Americas
Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) Forum 2018 and the American Academy of
Neurology (AAN)
70th Annual
Meeting.
●
Present top-line
overall response rate data from the UNITY-CLL Phase 3 trial of
ublituximab plus umbralisib in front line and relapsed/refractory
Chronic Lymphocytic Leukemia (CLL).
●
Prepare and
potentially file the Company’s first BLA and/or
NDA.
●
Complete enrollment
in the current arms of the UNITY-NHL trial, including the
Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large
B-Cell Lymphoma cohorts.
●
Present updated
clinical data from ongoing oncology trials and final results from
the Phase 2 trial of ublituximab in Multiple Sclerosis (MS) at
major medical meetings during 2018.
Financial Results for the First Quarter 2018
●
Cash Position:
Cash, cash equivalents, investment
securities, and interest receivable were $109.2 million as of March
31, 2018. Pro-forma cash, cash equivalents, investment securities,
and interest receivable as of March 31, 2018 (excluding our second
quarter 2018 operations) are approximately $123.3 million, after
giving effect to $14.1 million of net proceeds from the utilization
of the Company's at-the-market ("ATM") sales facility during the
second quarter of 2018.
●
Other R&D
Expenses: Other research and development
(R&D) expense (not including non-cash
compensation) was $32.2 million for the three
months ended March 31, 2018 compared to $20.4 million for
the three months ended March 31, 2017. Included
in other research and development expense for the
three months ended March 31, 2018 was $14.5 million
of clinical trial expense and $9.6 million of
manufacturing and CMC expenses for Phase 3 clinical trials and
potential commercialization. The current
period increase in Other R&D expenses is
primarily due to the ongoing clinical development
programs and related manufacturing costs for TG-1101 and
TGR-1202.
●
Other G&A Expenses:
Other general and administrative
(G&A) expense (not including non-cash compensation) was $2.1
million for the three months ended March 31, 2018 as compared to
$1.3 million for the three months ended March 31, 2017.
Other G&A expenses for the three
months ended March 31, 2018 remained relatively flat compared to
the first quarter of 2017, and we expect Other G&A expenses to
increase modestly through the remainder of
2018.
●
Net Loss: Net loss was $41.5 million for the three months
ended March 31, 2018, compared to a net loss of $27.7 million for
the three months ended March 31, 2017. Excluding non-cash items the
net loss for the three months ended March 31, 2018 was
approximately $33.2 million.
●
Financial Guidance:
Net cash utilized for operating
activities during the three months ended 2018 was approximately
$28.0 million. The Company believes its cash, cash equivalents,
investment securities, and interest receivable on hand as of March
31, 2018, inclusive of the proceeds raised subsequent to the first
quarter, will be sufficient to fund the Company's planned
operations through mid-2019.
Conference Call Information
The
Company will host an investor conference call today, May 8, 2018,
at 8:30am ET, to discuss the Company’s first 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 First 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 of1995. 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, including
early data 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 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. 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
SVP, 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 March
31,
|
|
|
|
2018
|
2017
|
|
|
|
|
|
License
revenue
|
$38
|
$38
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
Research and
development:
|
|
|
|
Noncash
compensation
|
2,859
|
2,306
|
|
Other
research and development
|
32,159
|
20,376
|
|
Total research and
development
|
35,018
|
22,382
|
|
|
|
|
|
General and
administrative:
|
|
|
|
Noncash
compensation
|
4,478
|
3,689
|
|
Other general and
administrative
|
2,119
|
1,333
|
|
Total general and
administrative
|
6,597
|
5,022
|
|
|
|
|
|
Total costs and
expenses
|
41,615
|
27,704
|
|
|
|
|
|
Operating
loss
|
(41,577)
|
(27,666)
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
Interest
income
|
(144)
|
(45)
|
|
Other
|
96
|
106
|
|
Total other
income
|
(48)
|
61
|
|
|
|
|
|
Net
loss
|
$(41,529)
|
$(27,727)
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.59)
|
$(0.52)
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
70,636,970
|
53,157,851
|
Condensed
Balance Sheet Information (in thousands):
|
|
March
31, 2018*
(unaudited)
|
December
31, 2017*
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$109,156
|
$84,825
|
|
Total
assets
|
120,994
|
97,382
|
|
Accumulated
deficit
|
(396,392)
|
(354,863)
|
|
Total
equity
|
85,232
|
66,993
|
* Condensed from
audited financial statements.