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 7, 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 August 7, 2018,
TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the second quarter ended June 30, 2018. TG also
announced that on Tuesday, August 7, 2018 at 4:30pm 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 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 August 7, 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: August
7, 2018
- 3
-
Exhibit 99.1
Investor Conference Call to be Held Today, Tuesday, August 7, 2018
at 4:30pm ET
New York, NY, (August 7,
2018) – TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
second quarter ended June 30, 2018 and recent company
developments.
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "We are extremely pleased with the
progress made in the first half of 2018 and believe we have many
value creating milestones achievable in the near future. This
morning’s announcement of complete target enrollment in the
ULTIMATE I & II Phase 3 trials in MS well ahead of our
projections, similar to the rapid enrollment we had seen in our
UNITY-CLL Phase 3 trial, reinforces our belief in the great need
for our product candidates.” Mr. Weiss continued, “We
believe TG has never been better positioned for success and look
forward to an impactful remainder of the year, and importantly the
announcement of topline overall response rate data from the
UNITY-CLL Phase 3 trial before the end of the
summer.”
Recent Developments and Highlights
●
ULTIMATE I & II:
Completed target enrollment into the
ULTIMATE I & II Phase 3 trials in Multiple Sclerosis
(MS).
●
Anti-CD47/CD19 License:
Entered into an exclusive global
license agreement with Novimmune SA to collaborate on the
development and commercialization of Novimmune’s novel
first-in-class anti-CD47/anti-CD19 bispecific antibody known as
TG-1801 (previously NI-1701).
●
Ublituximab Data in Multiple
Sclerosis: Presented updated
clinical data from the Phase 2 trial of ublituximab in RMS at the
4th
Congress of European Academy of
Neurology Meeting.
●
TG-1701 Preclinical
Data: Presented the first
preclinical data presentation of TG-1701, the Company’s
orally available and covalently-bound BTK inhibitor, at the 23rd
Congress of the European Hematology Association
(EHA).
●
Umbralisib Data in CLL Patients
Intolerant to Prior BTK/PI3K:
Presented clinical data from the Phase 2 trial of umbralisib in CLL
Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at
the 54th
Annual Meeting of the American Society
of Clinical Oncology and at the 23rd Congress of the
EHA.
●
Umbralisib plus
Ruxolitinib Data in Patients with
Myelofibrosis: Presented
updated clinical data from
its ongoing Phase I study evaluating umbralisib with ruxolitinib,
the JAK 1/2 inhibitor, in ruxolitinib experienced patients with
myelofibrosis at the 23rd Annual EHA Congress.
●
Umbralisib Safety
Data: Presented an integrated
analysis of long term safety data of umbralisib, either dosed as a
single agent and in combination, in patients with relapsed or
refractory lymphoid malignancies at the 23rd Annual EHA
Congress.
●
Chief Commercial
Officer: Announced the hiring
of Adam Waldman, former Celgene executive, as our Chief Commercial
Officer.
Key Remaining 2018 Milestones
●
Present
top-line overall response rate results from our UNITY-CLL Phase 3
trial in front line and relapsed or 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 Second Quarter 2018
●
Cash Position:
Cash, cash equivalents, investment
securities, and interest receivable were $126.3 million as of June
30, 2018.
●
R&D Expenses:
Research and development (R&D)
expenses were $38.7 million and $73.7 million for the three and six
months ended June 30, 2018, respectively, compared to $26.7 million
and $49.4 million for the three and six months ended June 30, 2017.
The increase in R&D expense is primarily attributable to an
increase in clinical trial expenses of $10.0 million and $15.7
million, respectively during the three and six months ended June
30, 2018, as compared to prior periods. In addition, included in
R&D expenses for the three and six months ended June 30, 2018
are $1.8 million and $11.4 million, respectively, of manufacturing
and CMC expenses for Phase 3 clinical trials and potential
commercialization. Also included in R&D expense for the six
months ended June 30, 2018 was $4 million ($3 million of which was
recorded in the three months ended June 30, 2018) 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 $5.7 million and $12.3 million for the three and six
months ended June 30, 2018, respectively, as compared to $1.8
million and $6.8 million for the three and six months ended June
30, 2017. The increase in G&A expenses for the three and six
months ended June 30, 2018 relates primarily to non-cash
compensation expenses related to equity incentive expense
recognized during the three and six months ended June 30,
2018.
●
Net Loss: Net loss was $44.1 million and $85.7 million for
the three and six months ended June 30, 2018, respectively,
compared to a net loss of $28.4 million and $56.1 million for the
three and six months ended June 30, 2017, respectively. Excluding
non-cash items, the net loss for the three and six months ended
June 30, 2018 was approximately $36.9 million and $70.1
million.
●
Financial Guidance:
Net cash utilized for operating
activities during the six months ended 2018 was approximately $62.2
million. The Company believes its cash, cash equivalents,
investment securities, and interest receivable on hand as of June
30, 2018 will be sufficient to fund the Company's planned
operations into the second half of 2019.
Conference Call Information
The Company will host an investor conference call today, August 7,
2018, at 4:30pm ET, to discuss the Company’s second 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 Second 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 we are
unable to present overall response rate data from the UNITY-CLL
trial within the projected timeline;the risk that the final data
from either GENUINE or UNITY-CLL will not support a regulatory
filing or approval or that the company will choose not to file a
BLA/NDA or seek accelerated approval based on those studies; the
risk that the topline overall response rate data from the UNITY-CLL
trial is not be statistically significant;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 the ULTIMATE Phase 3 trials will
not complete full enrollment on time; the risk that top-line data
from the ULTIMATE Phase 3 trials will not be available within
projected timelines, 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
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 June 30,
|
Six months
ended June 30,
|
||
|
|
2018
|
2017
|
2018
|
2017
|
|
|
|
|
|
|
|
License
revenue
|
$38
|
$38
|
$76
|
$76
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Research and
development:
|
|
|
|
|
|
Non-cash
stock expense associated with in-licensing agreements
|
3,000
|
-
|
4,000
|
-
|
|
Noncash
compensation
|
888
|
1,266
|
3,747
|
3,573
|
|
Other
research and development
|
34,812
|
25,440
|
65,971
|
45,815
|
|
Total research and
development
|
38,700
|
26,706
|
73,718
|
49,388
|
|
|
|
|
|
|
|
General and
administrative:
|
|
|
|
|
|
Noncash
compensation
|
3,375
|
223
|
7,854
|
3,913
|
|
Other general and
administrative
|
2,308
|
1,534
|
4,426
|
2,867
|
|
Total general and
administrative
|
5,683
|
1,757
|
12,280
|
6,780
|
|
|
|
|
|
|
|
Total costs and
expenses
|
44,383
|
28,463
|
85,998
|
56,168
|
|
|
|
|
|
|
|
Operating
loss
|
(44,345)
|
(28,425)
|
(85,922)
|
(56,092)
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
Interest
income
|
(189)
|
(50)
|
(333)
|
(95)
|
|
Other
(income) expense
|
(14)
|
(22)
|
82
|
84
|
|
Total other
(income) expense
|
(203)
|
(72)
|
(251)
|
(11)
|
|
|
|
|
|
|
|
Net
loss
|
$(44,142)
|
$(28,353)
|
$(85,671)
|
$(56,081)
|
|
|
|
|
|
|
|
Basic and diluted
net loss per common share
|
$(0.59)
|
$(0.45)
|
$(1.18)
|
$(0.96)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per common
share
|
72,256,348
|
63,288,269
|
72,456,657
|
58,251,045
|
Condensed Balance Sheet Information (in thousands):
|
|
June 30, 2018
(unaudited) |
December
31, 2017*
|
|
Cash, cash
equivalents, investment securities and interest
receivable
|
$126,332
|
$84,825
|
|
Total
assets
|
140,715
|
97,381
|
|
Accumulated
deficit
|
(440,534)
|
(354,863)
|
|
Total
equity
|
101,376
|
66,993
|