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 10, 2019
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. ☐
Securities filed pursuant to
Section 12(b) of the Act:
|
Title of
Class
|
Trading
Symbol(s)
|
Exchange
Name
|
|
Common Stock, par value
$0.001
|
TGTX
|
Nasdaq Capital
Market
|
Item
2.02. Results of Operations and Financial Condition.
On May 10, 2019, TG
Therapeutics, Inc. (“TG” or the “Company”)
issued a press release announcing results of operations for the
first quarter ended March 31, 2019. The Company will host an
investor conference call today, May 10, 2019, at 8:00am ET, during
which the Company will provide a brief overview of its first
quarter financial results and provide a business outlook for the
remainder of 2019. 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 10, 2019.
- 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 10,
2019
- 3
-
Exhibit
99.1
TG Therapeutics Provides Business Update and Reports First Quarter
2019 Financial Results
Conference Call to be held today, Friday, May 10, 2019 at 8:00 AM
ET
New York, NY, (May 10, 2019) – TG Therapeutics, Inc. (NASDAQ: TGTX)
today announced its financial results for the first quarter ended
March 31, 2019 and recent company developments.
Michael S. Weiss, the Company's Executive Chairman
and Chief Executive Officer, stated, "2019 has been an
extremely productive year thus far with the achievement
of many key milestones, the most important of which has been
the significant progress made with our Marginal Zone Lymphoma
program, including the release of positive top-line results and the
receipt of breakthrough therapy designation and orphan drug
designation. Moving forward, we believe further clarity on our
potential MZL NDA filing by year-end along with the presentation of
final MZL data later this year has the potential to unlock
significant value for our shareholders.” Mr. Weiss continued, “Between now and the
middle of next year, we expect to have pivotal data readouts across
three trials, including umbralisib in non-Hodgkin’s lymphoma,
umbralisib plus ublituximab (U2) in chronic lymphocytic leukemia
and ublituximab in multiple sclerosis. This is an extremely
exciting time for us and we look forward to an impactful remainder
of 2019 and 2020.”
Recent Developments and Highlights
●
Marginal Zone Lymphoma –
Breakthrough Therapy and Orphan Drug Designations: Received
breakthrough therapy designation (BTD) and orphan drug designation
for umbralisib (TGR-1202), for the treatment of patients with all
three types of marginal zone lymphoma (MZL): nodal, extranodal and
splenic MZL.
●
Positive Results from MZL
Cohort of UNITY-NHL Trial: Announced positive outcome from
the MZL cohort of the UNITY-NHL trial, which met the primary
endpoint of Overall Response Rate (ORR). Interim safety and
efficacy data from this study were presented in an oral
presentation at the American Association of Cancer Research (AACR)
annual meeting in Atlanta.
●
DSMB Updates:
Meetings held by the independent Data
Safety Monitoring Boards (DSMBs) for both the UNITY-CLL trial and
the UNITY-NHL trial did not raise any safety concerns and
recommended that both trials continue
unmodified.
●
TG-1801
(Anti-CD47/CD19): Commenced a
Phase 1 first-in-human, dose-escalation study of TG-1801 in
patients with relapsed or refractory B-cell
lymphoma.
●
Multiple Sclerosis
Data: Presented long-term
safety data from the open label extension (OLE) of the Phase 2
trial of ublituximab in multiple sclerosis, which demonstrated that
ublituximab continues to be well tolerated.
Remaining 2019 Milestones
●
Potential
top-line progression free survival (PFS) results from the Phase 3
UNITY-CLL trial evaluating U2 in patients with CLL
●
Present
final data from the MZL cohort of the UNITY-NHL registration
directed trial evaluating umbralisib in MZL
●
Potential
UNITY-NHL NDA filing in MZL
●
Present
updated data from our pipeline products and combination studies at
upcoming major medical conferences
Financial Results for the First Quarter 2019
●
Cash
Position: Cash, cash
equivalents and investment securities were $92.5 million as of
March 31, 2019. Pro-forma cash, cash equivalents and investment
securities as of March 31, 2019 (excluding our second quarter 2019
operations) are approximately $116.7 million, after giving effect
to $24.2 million of net proceeds from the utilization of the
Company's at-the-market ("ATM") sales facility during the second
quarter of 2019.
●
R&D Expenses:
Other
research and development (R&D) expense (not including non-cash
compensation) was $30.9 million for the three months ended March
31, 2019 compared to $32.2 million for the three months ended March
31, 2018. Included in other research and development expense for
the three months ended March 31, 2019 was $13.8 million of clinical
trial expense and $6.4 million of manufacturing and CMC expenses
for Phase 3 clinical trials and potential commercialization. The
current period decrease in Other R&D expenses is primarily due
to full enrollment in our pivotal Phase III clinical development
programs completed in the prior period. We expect the decrease in
other R&D expenses to continue over the next several
quarters.
●
G&A Expenses: Other general and
administrative (G&A) expense (not including non-cash
compensation) was $1.9 million for the three months ended March 31,
2019 as compared to $2.1 million for the three months ended March
31, 2018. Other G&A expenses for the three months ended March
31, 2019 remained relatively flat compared to the first quarter of
2018, and we expect Other G&A expenses to increase modestly
through the remainder of 2019.
●
Net Loss: Net loss was $35.2 million for
the three months ended March 31, 2019, compared to a net loss of
$41.5 million for the three months ended March 31, 2018. Excluding
non-cash items, the net loss for the three months ended March 31,
2019 was approximately $33.3 million.
●
Financial Guidance: Net cash utilized
for operating activities during the three months ended March 31,
2019 was approximately $33.5 million. The Company believes its
cash, cash equivalents and investment securities on hand as of
March 31, 2019, inclusive of the proceeds raised subsequent to the
first quarter, will be sufficient to fund the Company's planned
operations through mid-2020.
Conference Call Information
The Company will host a conference call today, May 10, 2019, at
8:00 am ET, to discuss the Company’s first quarter 2019
financial results and provide a business outlook for the remainder
of 2019.
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 2019
Business Update Call. A live audio
webcast will be available on the Events page, located within the
Investors & Media section, of the Company's website at
http://ir.tgtherapeutics.com/events.
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 multiple 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 oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. 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 into
Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal
antibody, TG-1701, its covalently-bound Bruton’s Tyrosine
Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific
antibody. 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 March 31,
|
|
|
|
2019
|
2018
|
|
|
|
|
|
License
revenue
|
$38
|
$38
|
|
|
|
|
|
Costs
and expenses:
|
|
|
|
Research
and development:
|
|
|
|
Noncash
compensation
|
1,489
|
2,859
|
|
Other
research and development
|
30,896
|
32,159
|
|
Total
research and development
|
32,385
|
35,018
|
|
|
|
|
|
General
and administrative:
|
|
|
|
Noncash
compensation
|
393
|
4,478
|
|
Other
general and administrative
|
1,949
|
2,119
|
|
Total
general and administrative
|
2,342
|
6,597
|
|
|
|
|
|
Total
costs and expenses
|
34,727
|
41,615
|
|
|
|
|
|
Operating
loss
|
(34,689)
|
(41,577)
|
|
|
|
|
|
Other
(income) expense:
|
|
|
|
Interest
income
|
(149)
|
(144)
|
|
Other
(income) expense
|
616
|
96
|
|
Total
other income, net
|
467
|
(48)
|
|
|
|
|
|
Net
loss
|
$(35,156)
|
$(41,529)
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
$(0.43)
|
$(0.59)
|
|
|
|
|
|
Weighted
average shares used in computing basic and diluted net loss per
common share
|
81,174,301
|
70,636,970
|
Condensed Balance Sheet Information (in thousands):
|
|
March 31,
2019
(Unaudited) |
December 31,
2018*
|
|
Cash,
cash equivalents and investment securities
|
$92,474
|
$68,900
|
|
Total
assets
|
117,538
|
83,616
|
|
Accumulated
deficit
|
(563,501)
|
(528,345)
|
|
Total
equity
|
19,254
|
24,036
|
* Condensed from audited financial statements