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, 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.
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
|
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, 2019,
TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the three and six months ended June 30, 2019. The
Company will host an investor conference call today, August 9,
2019, at 8:30am ET, during which the Company will provide a brief
overview of its second 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 August 9, 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: August
9, 2019
- 3
-
Exhibit
99.1
TG Therapeutics Provides Business Update and Reports Second Quarter
2019 Financial Results
Conference call to be held today, Friday, August 9, 2019 at 8:30 AM
ET
New York, NY, (August 9,
2019) – TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
second quarter ended June 30, 2019 and recent company
developments.
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "As we enter into the second half of the
year, we are pleased with the progress made thus far and excited
for the upcoming milestones. With a well-defined path to a
regulatory submission for umbralisib in marginal zone lymphoma, we
feel confident that we are at a pivotal point in our
Company’s lifecycle.” Mr. Weiss continued, “As we
prepare for our first filing in MZL, we are also building a
top-notch commercial organization which will fuel the long-term
success of TG. And with pivotal data readouts also expected in CLL
and MS over the next 6-12 months, we believe we are at the
beginning of an extremely exciting transformational period for our
Company.”
Recent Developments and Highlights
●
Marginal Zone Lymphoma -
Confirmed Registration Path: Announced confirmation of registration path to
submit umbralisib for accelerated approval based on data from the
marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b
trial.
●
Positive Interim Data from MZL
Cohort of UNITY-NHL Trial: Presented positive interim data
from the MZL cohort of the UNITY-NHL trial during oral
presentations at the 55th American Society of
Clinical Oncology (ASCO) annual meeting and the 2019 International
Conference on Malignant Lymphoma (ICML).
●
Ublituximab Data in Multiple
Sclerosis: Presented long-term follow-up data from the Phase
2 trial of ublituximab in patients with relapsing forms of multiple
sclerosis (RMS) at the 5th Congress of the European Academy of
Neurology (EAN).
●
Umbralisib Data in CLL and
RT: Presented Phase 2 data of
umbralisib in patients with chronic lymphocytic leukemia (CLL) who
are intolerant to prior BTK or PI3k delta inhibitor therapy, and
also presented data from patients with relapsed/refractory CLL or
Richter’s Transformation (RT) treated with the triple
combination of ublituximab, umbralisib and
pembrolizumab.
Remaining 2019 and Early 2020 Milestones
●
Initiate
a rolling New Drug Application (NDA) submission for patients with
previously treated MZL
●
Present
final data from the MZL cohort of the UNITY-NHL registration
directed trial evaluating umbralisib in MZL
●
Potential
top-line progression free survival (PFS) results from the Phase 3
UNITY-CLL trial evaluating U2 in patients with CLL
●
Present
updated data from our pipeline products and combination studies at
upcoming major medical conferences
Financial Results for the Three and Six Months Ended June 30,
2019
●
R&D Expenses:
Other research and development
(R&D) expense (not including non-cash compensation and non-cash
in-licensing expense) was $31.4 million and $62.3 million for the
three and sixth months ended June 30, 2019 compared to $34.8
million and $66.0 million for the three and six months ended June
30, 2018. The decrease in other R&D expense is primarily
attributable to a decrease in clinical trial expenses of $9.7
million and $10.4 million, respectively during the three and six
months ended June 30, 2019, as compared to prior periods, offset by
an increase in manufacturing and CMC expenses for Phase 3 clinical
trials and potential commercialization of $7.9 million and $4.7
million, respectively during the three and six months ended June
30, 2019, as compared to prior periods. 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 other R&D expenses to
decrease through the remainder of 2019.
●
G&A Expenses: Other general and
administrative (G&A) expense (not including non-cash
compensation) was $2.3 million and $4.3 million for the three and
six months ended June 30, 2019 as compared to $2.3 million and $4.4
million for the three and six months ended June 30, 2018. Other
G&A expenses remained relatively flat compared to the prior
period, and we expect Other G&A expenses to increase modestly
through the remainder of 2019.
●
Net Loss: Net loss was $36.2 million and
$71.4 million for the three and six months ended June 30, 2019,
respectively, compared to a net loss of $44.1 million and $85.7
million for the three and six months ended June 30, 2018,
respectively. Excluding non-cash items, the net loss for the three
and six months ended June 30, 2019 was approximately $34.4 million
and $67.6 million. We expect our quarterly net loss to decrease
through the remainder of 2019.
●
Cash Position and Financial
Guidance: Cash, cash
equivalents and investment securities were $85.0 million as of June
30, 2019. Pro forma cash, cash equivalents and investment
securities as of June 30, 2019 (excluding our third quarter 2019
operations) are approximately $96.6 million, after giving effect to
$11.6 million of net proceeds from the utilization of the Company's
at-the-market ("ATM") sales facility during the third quarter of
2019. The Company believes its cash, cash equivalents and
investment securities on hand as of June 30, 2019, inclusive of the
proceeds raised from the ATM facility subsequent to the second
quarter, as well as future availability under the ATM facility,
will be sufficient to fund the Company's planned operations through
the third quarter of 2020.
Conference Call Information
The Company will host a conference call today, August 9, 2019, at
8:30 am ET, to discuss the Company’s second 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 Second 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:
the risk that the interim data (the “Interim Results”)
from the UNITY-NHL MZL cohort will not be reproduced when the final
analysis is conducted on all patients, including the risk that the
final results will demonstrate a lower ORR and/or enhanced
toxicities, which may not support a filing for accelerated
approval; the risk that even if the Interim Results are reproduced
in the final analysis of the UNITY-NHL MZL cohort or that the final
results otherwise meet the Company’s target ORR of 40-50%,
that the final results will still be insufficient to support a
filing for accelerated approval; the risk that umbralisib will not
be accepted for filing or receive accelerated approval based on
data from the UNITY-NHL MZL cohort even if the final results are
deemed positive by the Company and support a filing for accelerated
approval; the risk that duration of response or progression free
survival data from the UNITY-NHL cohort when available for all
patients will not be positive or supportive of accelerated
approval; the risk that safety issues will arise when the final
safety data are cleaned and analyzed for all patients in the
UNITY-NHL MZL cohort; the risk that the positive Interim Results
from the UNITY-NHL MZL cohort will not be reproduced in other
cohorts of the UNITY-NHL study or in other studies being
conducted by the Company; the risk that our belief that umbralisib
has a differentiated safety profile will not be shared by
physicians or the FDA or will not be reproduced in the
final analysis of the UNITY-NHL MZL cohort, in other cohorts of the
UNITY-NHL study, in the UNITY-CLL study or in any other of our
on-going studies; the risk that the anticipated timeline for filing
an NDA for accelerated approval for patients with MZL based on
UNITY-NHL data and the timeline for data releases for
UNITY-CLL and ULTIMATE-MS trials will be delayed due to a variety
of factors, including, without limitation, available resources,
program reprioritization, slower than expected event rates for
UNITY-CLL and/or requests from FDA or foreign regulators;
the risk that we are not able to successfully and cost effectively
complete all the preclinical, clinical and CMC requirements
necessary to support accelerated approval. 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, 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 June 30,
|
Six months ended June 30,
|
||
|
|
2019
|
2018
|
2019
|
2018
|
|
|
|
|
|
|
|
License
revenue
|
$38
|
$38
|
$76
|
$76
|
|
|
|
|
|
|
|
Costs
and expenses:
|
|
|
|
|
|
Research
and development:
|
|
|
|
|
|
Noncash
stock expense associated with in-licensing agreements
|
100
|
3,000
|
100
|
4,000
|
|
Noncash
compensation
|
1,352
|
888
|
2,841
|
3,747
|
|
Other
research and development
|
31,414
|
34,812
|
62,310
|
65,971
|
|
Total
research and development
|
32,866
|
38,700
|
65,251
|
73,718
|
|
|
|
|
|
|
|
General
and administrative:
|
|
|
|
|
|
Noncash
compensation
|
405
|
3,375
|
797
|
7,854
|
|
Other
general and administrative
|
2,311
|
2,308
|
4,260
|
4,426
|
|
Total
general and administrative
|
2,716
|
5,683
|
5,057
|
12,280
|
|
|
|
|
|
|
|
Total
costs and expenses
|
35,582
|
44,383
|
70,308
|
85,998
|
|
|
|
|
|
|
|
Operating
loss
|
(35,544)
|
(44,345)
|
(70,232)
|
(85,922)
|
|
|
|
|
|
|
|
Other
(income) expense:
|
|
|
|
|
|
Interest
expense
|
1,077
|
223
|
1,851
|
436
|
|
Other
income
|
(408)
|
(426)
|
(715)
|
(687)
|
|
Total
other (income) expense, net
|
669
|
(203)
|
1,136
|
(251)
|
|
|
|
|
|
|
|
Net
loss
|
$(36,213)
|
$(44,142)
|
$(71,368)
|
$(85,671)
|
|
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
$(0.42)
|
$(0.59)
|
$(0.85)
|
$(1.18)
|
|
|
|
|
|
|
|
Weighted
average shares used in computing basic and diluted net loss per
common share
|
86,800,017
|
74,256,348
|
84,002,700
|
72,456,657
|
Condensed Balance Sheet Information (in thousands):
|
|
June 30, 2019
(Unaudited)
|
December 31, 2018*
|
|
Cash,
cash equivalents and investment securities
|
$84,976
|
$68,901
|
|
Total
assets
|
106,585
|
83,616
|
|
Accumulated
deficit
|
(599,713)
|
(528,345)
|
|
Total
equity
|
13,205
|
24,036
|
* Condensed from audited financial statements