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 12, 2019
(Exact
Name of Registrant as Specified in Charter)
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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(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:
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Title
of Class
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Trading
Symbol(s)
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Exchange
Name
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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 12, 2019, TG Therapeutics, Inc. (“TG” or the
“Company”) issued a press release announcing results of
operations for the three and nine months ended September 30, 2019.
The Company will host an investor conference call today, November
12, 2019, at 8:30am ET, during which the Company will provide a
brief overview of its third 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 November 12,
2019.
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.
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TG Therapeutics, Inc.
(Registrant)
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Date:
November 12, 2019
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By:
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/s/
Sean A. Power
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Sean A.
Power
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Chief
Financial Officer
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Exhibit 99.1
TG Therapeutics Provides Business Update and Reports Third Quarter
2019 Financial Results
Conference call to be held today, Tuesday, November 12, 2019 at
8:30 AM ET
New York, NY, (November 12,
2019) – TG Therapeutics,
Inc. (NASDAQ: TGTX) today announced its financial results for the
third quarter ended September 30, 2019 and recent company
developments.
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "In the third quarter our team continued
to execute on our core mission of developing combination therapies
for patients with B-cell diseases. With the announcement of
positive marginal zone lymphoma data earlier this year, and
positive follicular lymphoma data only a few weeks ago, we have our
first two foundational datasets for which we believe approval is in
our reach. Adding on top of this, will be our UNITY-CLL Phase 3
study, which we are targeting a PFS readout around year-end or into
the first quarter of next year. With these core pieces in place,
our broader combination approach should come into focus, as we
execute on a strategy to position U2 as an important stand-alone
treatment as well as one that can improve outcomes when combined
with other available therapies. We believe our recent ASH abstracts
contain some initial insights into the future of U2.” Mr.
Weiss continued, “With a pro forma cash
position of approximately $100 million at the end of the
third quarter, we believe we have sufficient capital resources
through our next two major pivotal data
releases including UNITY-CLL and the ULTIMATE
MS Phase 3 trials.”
Recent Developments and Highlights
●
ASH Presentations:
Two triple therapy data abstracts were
accepted for presentation at the upcoming 61st
American Society of Hematology (ASH)
annual meeting, including an oral presentation for the triple
combination of U2 (umbralisib and ublituximab) plus venetoclax, and
Phase 1 data for TG-1701, the Company’s novel BTK inhibitor,
monotherapy and in combination with U2.
●
Positive Interim Data from FL
Cohort of UNITY-NHL Trial: Positive interim data from the
follicular lymphoma (FL) cohort of the UNITY-NHL trial was
announced, with results meeting the Company’s prespecified
ORR target. The Company plans to present the data at a future
medical conference as well as discuss the data with the U.S. Food
and Drug Administration (FDA).
●
GENUINE Progression Free
Survival (PFS): Final long-term
results from the Phase 3 GENUINE study demonstrated that
ublituximab in combination with ibrutinib improved progression-free
survival (PFS), as determined by Independent Review Committee
(IRC).
●
U2 Published in Blood:
Phase I/Ib combination trial of U2 was
published in Blood, the Journal of the American Society of
Hematology.
●
Ublituximab Data in Multiple
Sclerosis: Updated Phase 2
extension trial data for ublituximab in relapsing forms of multiple
sclerosis (RMS), as well as the ULTIMATE I & II Phase 3 RMS
program study design and demographic data was presented at the
35th
Annual Congress of the European
Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS).
Remaining 2019 and Early 2020 Milestones
●
Initiate
a rolling New Drug Application (NDA) submission for umbralisib to
treat adult patients with previously treated marginal zone lymphoma
(MZL).
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Report
potential top-line PFS results from the Phase 3 UNITY-CLL trial
evaluating U2 in patients with frontline and previously treated
CLL.
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Share
results from the Phase 2b UNITY-NHL FL cohort with the FDA to
determine potential filing opportunities.
Financial Results for the Three and Nine Months Ended September 30,
2019
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R&D Expenses:
Other research and development
(R&D) expense (not including non-cash compensation and non-cash
in-licensing expense) was $56.5 million and $118.8 million for the
three and nine months ended September 30, 2019, respectively,
compared to $32.8 million and $98.7 million for the three and nine
months ended September 30, 2018, respectively. The increase in R&D expense is primarily
attributable to an increase in manufacturing expenses for Phase 3
clinical trials and potential commercialization (incurred during
2019) of $27 million and $31.6 million during the three and nine
months ended September 30, 2019, respectively, as compared to prior
periods. This was partially offset by a decrease in clinical trial
expense of $3.8 million and $14.2 million for the three and nine
months ended September 30, 2019, respectively, as compared to prior
periods. We expect our other R&D expenses to decrease during
the remainder of 2019 and into 2020 as our clinical trial expenses
continue to decrease and the bulk of our CMC expenditures have been
incurred during 2019.
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G&A Expenses: Other general and
administrative (G&A) expense (not including non-cash
compensation) was $2.3 million and $6.6 million for the three and
nine months ended September 30, 2019, respectively, as compared to
$1.8 million and $6.2 million for the three and nine months ended
September 30, 2018, respectively. Other G&A expenses remained
consistent with the prior period, and we expect Other G&A
expenses to increase modestly through the remainder of
2019.
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Net Loss: Net loss was $61.9 million and
$133.3 million for the three and nine months ended September 30,
2019, respectively, compared to a net loss of $34.0 million and
$119.6 million for the three and nine months ended September 30,
2018, respectively. Excluding non-cash items, the net loss for the
three and nine months ended September 30, 2019 was approximately
$59.9 million and $127.5 million. Cash used in operations for the
three months ended September 30, 2019 was approximately $33
million, as the payments of much of the increase in manufacturing
expenses were deferred 12 months, having little impact on the
quarter’s cash utilization.
●
Cash Position and Financial
Guidance: Cash, cash
equivalents and investment securities were $72.5 million as of
September 30, 2019. Pro forma cash, cash equivalents and investment
securities as of September 30, 2019 (excluding our fourth quarter
2019 operations) are approximately $96.3 million, after giving
effect to $23.8 million of net proceeds from the utilization of the
Company's at-the-market ("ATM") sales facility during the fourth
quarter of 2019. The Company believes its cash, cash
equivalents and investment securities on hand as of September 30,
2019, inclusive of the proceeds raised from the ATM facility
subsequent to the third quarter, as well as future availability
under the ATM facility, will be sufficient to fund the Company's
planned operations into the fourth quarter of 2020.
Conference Call Information
The Company will host a conference call today, November 12, 2019,
at 8:30 am ET, to discuss the Company’s third 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 Third 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 or FL cohorts 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 or FL cohorts 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 or FL cohorts; the risk that the
positive Interim Results from the UNITY-NHL MZL or FL cohorts 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 or FL
cohorts, 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 or approval of an NDA for
accelerated approval for patients with MZL or FL 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 the data contained in the recent
ASH abstracts will not be reproduced in the final presentations at
ASH; 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):
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Three months ended
September 30,
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Nine months ended
September 30,
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2019
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2018
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2019
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2018
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License
revenue
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$38
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$38
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$114
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$114
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Costs
and expenses:
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Research
and development:
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Noncash
stock expense associated with in-licensing agreements
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--
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--
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100
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4,000
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Noncash
compensation
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1,482
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644
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4,323
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4,391
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Other
research and development
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56,503
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32,754
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118,814
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98,724
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Total
research and development
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57,985
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33,398
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123,237
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107,115
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General
and administrative:
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Noncash
compensation
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593
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(817)
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1,391
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7,037
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Other
general and administrative
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2,321
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1,785
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6,580
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6,212
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Total
general and administrative
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2,914
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968
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7,971
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13,249
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Total
costs and expenses
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60,899
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34,366
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131,208
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120,364
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Operating
loss
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(60,861)
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(34,328)
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(131,094)
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(120,250)
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Other
expense (income):
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Interest
expense
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1,537
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221
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3,388
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657
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Other
income
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(468)
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(598)
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(1,183)
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(1,285)
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Total
other expense (income), net
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1,069
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(377)
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2,205
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(628)
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Net
loss
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$(61,930)
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$(33,951)
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$(133,299)
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$(119,622)
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Basic
and diluted net loss per common share
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$(0.69)
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$(0.43)
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$(1.55)
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$(1.61)
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Weighted
average shares used in computing basic and diluted net loss per
common share
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89,667,979
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78,221,069
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85,911,878
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74,399,243
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Condensed Balance Sheet Information (in thousands):
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September 30,
2019
(Unaudited)
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December 31,
2018*
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Cash,
cash equivalents and investment securities
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$72,451
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$68,901
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Total
assets
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93,327
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83,616
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Accumulated
deficit
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(661,643)
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(528,345)
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Total
(deficit) equity
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(25,791)
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24,036
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* Condensed from audited financial statements