Exhibit
99.1
GT Biopharma Reports Third Quarter 2018 Financial Results and
Provides Business Update
– Recent corporate, preclinical, clinical and regulatory
advancements expected to position Company for a transformational
2019 –
– FDA clearance of IND to advance first-in-class TriKE,
GTB-3550, into first-in-human Phase 1 study for the treatment of
AML, MDS and mastocytosis marks significant regulatory
milestone –
– Continued progress of Phase 2a study of GTB-1550 with
topline results expected in Q1 2019 –
LOS ANGELES, CA (November 15, 2018)
– GT
Biopharma, Inc. (OTCQB: GTBP and Euronext Paris GTBP.PA)
("GT Biopharma" or the "Company"), an immuno-oncology biotechnology
company focused on innovative treatments based on the Company's
proprietary NK-engager and Bispecific Antibody Drug Conjugate
platforms, announced today its financial results for the third
quarter ended September 30, 2018.
The
Company also provided an update on its corporate progress, clinical
status and anticipated milestones for its pipeline of
immuno-oncology products based off the Company’s proprietary
Tri-specific Killer Engager (TriKE), Tetra-specific Killer Engager
(TetraKE) and bi-specific Antibody Drug Conjugate (ADC) technology
platforms.
Recent Corporate Highlights:
●
Received FDA
clearance to commence first-in-human Phase 1 study of
first-in-class TriKE, GTB-3550 (OXS-3550), for the treatment of
acute myelogenous leukemia, myelodysplatic syndrome and
mastocytosis.
●
Announced positive
preclinical data for two next generation TriKEs in ovarian and head
and neck cancers. The studies were conducted by Dr. Daniel Vallera,
Director, Section of Molecular Cancer Therapeutics and Dr. Martin
Felices, Co-Director of the Translational Therapy Laboratory at the
Masonic Cancer Center, University of Minnesota.
●
Announced agreement
with major pharmaceutical company and initiated preclinical combination trial of
GTB-1550 (OXS-1550) and multi-billion dollar oncology drug for
testing in several hematologic malignancies.
●
Bolstered
leadership team with appointments of Dr. Raymond W. Urbanski M.D.,
Ph.D. as CEO and Chairman of the Board (formerly Chief Medical
Officer of the Company); well-respected industry veteran, Dr. John N. Bonfiglio as a new
independent Board Member and David Cardino, CPA, as VP,
Finance.
“We
have made significant progress in building a solid foundation for
the Company in what we believe is an important transitional phase
for GT Biopharma. The additions and changes to the leadership team
and execution of key preclinical, clinical and regulatory
milestones are a testament to this progress,” commented
Raymond
Urbanski, M.D., Ph.D., Chief Executive Officer of GT
Biopharma. “However, as we navigate through this phase, we
certainly face challenges, including ensuring we are properly
funded and have the right team in place to propel the Company to
our next phase of growth. Successfully completing a financing and
bolstering our management team and Board in the near term remains a
priority. I, along with our Board, believe GT Biopharma has a
first-in-class platform technology and the potential to provide
revolutionary advancements in the treatment of various cancers
where there remains significant unmet need. We are committed to
securing the necessary capital to continue to aggressively execute
on our strategy and advance our development programs to drive
significant shareholder value. I believe we are taking the
necessary steps to position GT Biopharma for a transformational
2019.”
Clinical Program Updates
The
Company’s TriKE product candidates are single-chain,
tri-specific scFv recombinant fusion proteins composed of the
variable regions of the heavy and light chains (or heavy chain
only) of anti-CD16 antibodies, wild-type or a modified form of
IL-15 and the variable regions of the heavy and light chains of an
antibody designed to precisely target a specific tumor antigen. GT
Biopharma utilizes the NK stimulating cytokine human IL-15 as a
crosslinker between the two scFvs which is designed to provide a
self-sustaining signal leading to the proliferation and activation
of NK cells thus enhancing their ability to kill cancer cells
mediated by antibody-dependent cell-mediated cytotoxicity
(ADCC).
The
Company’s TetraKE product candidates are single-chain fusion
proteins composed of human single-domain anti-CD16 antibody,
wild-type IL-15 and the variable regions of the heavy and light
chains of two antibodies that are designed to target two specific
tumor antigens expressed on specific types of cancer
cells.
GT
Biopharma’s TriKEs and TetraKEs are designed to act by
binding to a patient’s NK cells and a specific tumor antigen
enabling an immune synapse between the now IL-15-enhanced NK cell
and the targeted cancer cell. The formation of an immune synapse
can induce NK cell activation which can lead to the death of the
cancer cell. The Company believes the self-sustaining signal caused
by its IL-15 cross-linker may enable prolonged and enhanced
proliferation and activation of NK cells similar to the increased
proliferation of T-cells caused by 41BB-L or CD28 intracellular
domains in CAR-T therapy but without the need to enhance the
patient’s NK cells ex
vivo.
GTB-1550 (OXS-1550): Most Advanced Bi-specific ADC
Candidate
The
Company’s most advanced bi-specific ADC in development,
GTB-1550,
targets CD19+ and/or CD22+ hematological malignancies and is
currently in the Phase 2 component of a Phase 1/2
Non-Hodgkin’s Lymphoma (NHL)/Acute Lymphocytic Leukemia (ALL)
trial which is an open-label, investigator-led study.
GTB-1550
targets cancer cells expressing the CD19 receptor or CD22 receptor
or both receptors. When GTB-1550 binds to cancer cells, the cancer
cells internalize GTB-1550, and are killed due to the action of
drug’s cytotoxic diphtheria toxin payload. GTB-1550 has
demonstrated success in a Phase 1 human clinical trial in patients
with relapsed/refractory B-cell lymphoma or leukemia.
The
Company recently assembled a Bi-Specific ADC Advisory Board to
collaboratively assess and interpret the GTB-1550 pre-clinical and
clinical data, including an interim review of the Phase 1/2 study.
Eighteen patients have been enrolled to date, including 12 NHL and
six ALL patients. At the time of the interim review, 13 patients
met the evaluation criteria, including nine NHL and four ALL
patients. More than 50% of patients (seven of 13) exhibited a
clinical benefit, defined as stable disease, partial remission or
complete remission at Day 29. Of the seven patients, one
demonstrated a complete remission (CR), one demonstrated a partial
remission (PR) and five demonstrated stable disease
(SD).
The
efficacy signal was more prominent in ALL patients with 75% (three
of four) exhibiting clinical benefit including one CR, one PR and
one SD. In the NHL population, four of nine patients exhibited SD.
Adverse events were mostly grade 1 and 2 and reversible. One
patient had a grade 4 low platelet count, two patients had a grade
3 increase in liver function tests, or LFTs, and one patient had a
grade 3 capillary leak. The Company currently expects final data
for this trial to be available in the first quarter of
2019.
This
work is being conducted by and under the guidance of Dr. Veronika
Bachanova, Associate Professor of Medicine, Division of Hematology,
Oncology and Transplantation at the University of
Minnesota.
GTB-3550 (OXS-3550): TriKE product candidate
GTB-3550 is the Company’s first Tri-specific Killer
Engager (TriKE) product candidate being initially developed for the
treatment acute myelogenous leukemia (AML). GTB-3550 is a
single-chain, tri-specific scFv recombinant fusion protein
conjugate composed of the variable regions of the heavy and light
chains of anti-CD16 and anti-CD33 antibodies and a modified form of
IL-15. When the NK stimulating cytokine human IL-15 is used as a
crosslinker between the two scFvs, it provides a self-sustaining
signal that activates NK cells and enhances their ability to
kill.
GT
Biopharma recently announced that its Investigational New Drug
(IND) application to the U.S. Food and Drug Administration (FDA) is
now open and it is authorized to initiate a first-in-human Phase 1
study with GTB-3550, its first-in-class TriKE, for the treatment of
AML, myelodysplatic syndrome (MDS) and mastocytosis.
The study will be led by Principal Investigator, Sarah A. Cooley,
MD, MS, Associate Professor, Division of Hematology, Oncology and
Transplantation at Masonic Cancer Center, University of
Minnesota.
This
single center, first-in-human Phase 1 clinical trial of GTB-3550
will enroll up to 60 subjects with CD33-expressing
refractory/relapsed AML, high-risk MDS, or advanced systemic
mastocytosis. Subjects will receive a single course of GTB-3550
given as 3 weekly treatment blocks. Each block consists of four
consecutive 24-hour continuous infusions of GTB-3550 followed by a
72-hour break after Block #1 and #2. Disease response will be
assessed by bone marrow biopsy performed between Day 21 and Day 42
after the start of the 1st infusion. Follow-up
for response and survival continues through 6 months from treatment
start. The primary objective from the Phase 1 dose finding portion
of the study will be to identify the maximum tolerated dose (MTD)
of GTB-3550 defined as the dose level that most closely corresponds
to a dose limiting toxicity rate (DLT) of 20%. The primary
objective from the Phase 2 extended portion of the study will be
the potential efficacy of GTB-3550, measured using rates of
complete and partial remission. Subjects experiencing clinical
benefit and no unacceptable side effects may be considered for a
2nd course
of GTB-3550 on a compassionate basis.
The
Company believes that GTB-3550 could serve as a relatively safe,
cost-effective, and easy-to-use therapy for refractory/relapsed
AML, high-risk MDS and advanced systemic mastocytosis and could
also be combined with chemotherapy and/or other agents as frontline
therapy thus targeting a much larger patient
population.
GT
Biopharma’s initial and ongoing work is being conducted in
collaboration with the Masonic Cancer Center at the University of
Minnesota under research agreements led by Dr. Jeffrey Miller, the
Deputy Director and Dr. Daniel Vallera, Director, Section of
Molecular Cancer Therapeutics.
GT
Biopharma has an exclusive worldwide license agreement with the
University of Minnesota to further develop and commercialize cancer
therapies using proprietary TriKE technology developed by
researchers at the university to target NK cells to
cancer.
Upcoming Milestones Expected to Drive Value
●
Initiate Phase 1
first-in-human clinical trial of GTB-3550 for the treatment of
Relapse/Refractory AML, High Risk MDS, and Advanced Systemic
Mastocytosis in the first half of 2019;
●
Announce topline
results from Phase 2a trial of GTB-1550 in Q1 2019;
●
Conduct end of
Phase 2a (EOP2a) meeting for GTB-1550 with U.S. FDA in the first
half of 2019;
●
Advance ongoing
GTB-C3550 IND-enabling studies & TetraKE pre-clinical program
to target the larger solid tumor population and are working towards
beginning clinical trials in 2019;
●
Bolster executive
management team and board with key expertise to continue to
transform the Company;
●
Participate in key
scientific conferences;
●
Make progress in
advancing potential corporate and business development
opportunities; and
●
Uplist to a
National Exchange.
Summary of Financial Results for Third Quarter 2018
For the
quarter ended September 30, 2018, the Company reported a net loss
of approximately $235,783,000 or a net loss per diluted share of
$4.70, compared to a net loss of $130,625,000 or a net loss per
diluted share of $8.15 for the same quarter 2017. For the nine
months ended September 30, 2018, GT Biopharma reported a net loss
of approximately $254,955,000 or a net loss per diluted share of
$5.09, compared to $138,146,000 or a net loss per diluted share of
$24.54 for the same period 2017.
At
September 30, 2018, the Company has an accumulated deficit of
$524,453,000 and cash of $1,232,000.
About GT Biopharma, Inc.
GT
Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
products based off our proprietary Tri-specific Killer Engager
(TriKE), Tetra-specific Killer Engager (TetraKE) and bi-specific
Antibody Drug Conjugate (ADC) technology platforms. Our TriKE and
TetraKE platforms generate proprietary moieties designed to harness
and enhance the cancer killing abilities of a patient's own natural
killer, or NK, cells. Once bound to a NK cell, our moieties are
designed to enhance the NK cell and precisely direct it to one or
more specifically-targeted proteins (tumor antigens) expressed on a
specific type of cancer, ultimately resulting in the cancer cell's
death. TriKEs and TetraKEs are made up of recombinant fusion
proteins, can be designed to target certain tumor antigens on
hematologic malignancies, sarcomas or solid tumors and do not
require patient-specific customization. They are designed to be
dosed in a common outpatient setting similar to modern antibody
therapeutics and are expected to have reasonably low cost of goods.
Our ADC platform can generate product candidates that are
bi-specific, ligand-directed single-chain fusion proteins that, we
believe, represent the next generation of ADCs.
For
more information, please visit www.gtbiopharma.com.
|
GT Biopharma, Inc. and Subsidiaries
|
||
|
Consolidated Balance Sheets
|
||
|
(Unaudited)
|
||
|
(In thousands, except par value and share data)
|
||
|
|
|
|
|
|
September 30, 2018
|
December 31, 2017
|
|
ASSETS
|
|
|
|
Current
Assets:
|
|
|
|
Cash
and cash equivalents
|
$1,232
|
$576
|
|
Prepaid
expenses
|
15
|
-
|
|
Total
Current Assets
|
1,247
|
576
|
|
|
|
|
|
Intangible
assets
|
25,263
|
253,777
|
|
Deposits
|
21
|
9
|
|
Fixed
assets, net
|
5
|
6
|
|
Total
Other Assets
|
25,289
|
253,792
|
|
TOTAL
ASSETS
|
$26,536
|
$254,368
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
Current
Liabilities:
|
|
|
|
Accounts
payable
|
$2,251
|
$2,546
|
|
Accrued
expenses
|
344
|
102
|
|
Line
of credit
|
31
|
31
|
|
Convertible
debentures, net of discount of $488
|
10,597
|
-
|
|
Total
Current Liabilities
|
13,223
|
2,679
|
|
|
|
|
|
Total
liabilities
|
13,223
|
2,679
|
|
|
|
|
|
Stockholders’
Equity:
|
|
|
|
Convertible
preferred stock - $0.001 par value; 15,000,000 shares
authorized:
|
|
|
|
Series
C - 96,230 and 96,230 shares issued and outstanding at September
30, 2018 and December 31, 2017, respectively
|
1
|
1
|
|
Series
J – 1,163,548 shares issued and outstanding at September 30,
2018 and December 31, 2017, respectively
|
1
|
1
|
|
Common stock - $0.001 par value; 750,000,000
shares authorized; and 50,227,978 and 50,117,977 shares issued and outstanding at
September 30, 2018 and December 31, 2017,
respectively
|
50
|
50
|
|
Additional
paid-in capital
|
537,883
|
521,305
|
|
Accumulated
deficit
|
(524,453)
|
(269,499)
|
|
Noncontrolling
interest
|
(169)
|
(169)
|
|
Total
Stockholders’ Equity
|
13,313
|
251,689
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$26,536
|
$254,368
|
GT BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
|
|
Three Months
Ended September 30,
|
Nine Months
Ended September 30,
|
||
|
|
2018
|
2017
|
2018
|
2017
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
1,111
|
526
|
7,835
|
911
|
|
Selling, general
and administrative expenses
|
5,035
|
126,330
|
10,628
|
128,768
|
|
Loss on
impairment
|
228,514
|
-
|
228,514
|
-
|
|
Total operating
expenses
|
234,660
|
126,856
|
246,977
|
129,679
|
|
Loss from
operations
|
(234,660)
|
(126,856)
|
(246,977)
|
(129,679)
|
|
Other
income (expense):
|
|
|
|
|
|
Interest
expense
|
(1,123)
|
(3,769)
|
(7,978)
|
(8,467)
|
|
Total other income
(expense)
|
(1,123)
|
(3,769)
|
(7,978)
|
(8,467)
|
|
Loss before
provision for income taxes
|
(235,783)
|
(130,625)
|
(254,955)
|
(138,146)
|
|
Provision for
income tax
|
-
|
-
|
-
|
-
|
|
Net
loss
|
(235,783)
|
(130,625)
|
(254,955)
|
(138,146)
|
|
Net loss per common
share – basic and diluted
|
$(4.70)
|
$(8.15)
|
$(5.09)
|
$(24.54)
|
|
Weighted average
common shares outstanding – basic and diluted
|
50,154,516
|
16,027,687
|
50,130,202
|
5,628,529
|
The accompanying condensed notes are an integral part of these
consolidated financial statements.
Forward-Looking Statements
This
press release contains certain forward-looking statements that
involve risks, uncertainties and assumptions that are difficult to
predict, including statements regarding the potential acquisition,
the likelihood of closing the potential transaction, our clinical
focus, and our current and proposed trials. Words and expressions
reflecting optimism, satisfaction or disappointment with current
prospects, as well as words such as “believes,”
“hopes,” “intends,”
“estimates,” “expects,”
“projects,” “plans,”
“anticipates” and variations thereof, or the use of
future tense, identify forward-looking statements, but their
absence does not mean that a statement is not forward-looking. Our
forward-looking statements are not guarantees of performance and
actual results could differ materially from those contained in or
expressed by such statements. In evaluating all such statements, we
urge you to specifically consider the various risk factors
identified in our Form 10-K for the fiscal year ended
December 31, 2017 in the section titled “Risk
Factors” in Part I, Item 1A and in our subsequent filings
with the Securities and Exchange Commission, any of which could
cause actual results to differ materially from those indicated by
our forward-looking statements.
Our
forward-looking statements reflect our current views with respect
to future events and are based on currently available financial,
economic, scientific, and competitive data and information on
current business plans. You should not place undue reliance on our
forward-looking statements, which are subject to risks and
uncertainties relating to, among other things: (i) the
sufficiency of our cash position and our ongoing ability to raise
additional capital to fund our operations, (ii) our ability to
complete our Phase 1 study of TriKe, GTB-3550 and or our Phase 2
trial of CTB-1550 and to meet the FDA’s requirements with
respect to safety and efficacy, (iii) our ability to
identify patients to enroll in our clinical trials in a timely
fashion, (iv) our ability to achieve approval of a marketable
product, (v) design, implementation and conduct of clinical trials,
(vii) the results of our clinical trials, including the
possibility of unfavorable clinical trial results, (vii) the
market for, and marketability of, any product that is approved,
(viii) the existence or development of treatments that are
viewed by medical professionals or patients as superior to our
products, (ix) regulatory initiatives, compliance with
governmental regulations and the regulatory approval process, and
social conditions, and (x) various other matters, many of
which are beyond our control. Should one or more of these risks or
uncertainties develop, or should underlying assumptions prove to be
incorrect, actual results may vary materially and adversely from
those anticipated, believed, estimated, or otherwise indicated by
our forward-looking statements.
We
intend that all forward-looking statements made in this press
release will be subject to the safe harbor protection of the
federal securities laws pursuant to Section 27A of the
Securities Act, to the extent applicable. Except as required by
law, we do not undertake any responsibility to update these
forward-looking statements to take into account events or
circumstances that occur after the date of this press release.
Additionally, we do not undertake any responsibility to update you
on the occurrence of any unanticipated events which may cause
actual results to differ from those expressed or implied by these
forward-looking statements.
Investor and Media Contact:
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (833) 475-8247
Email:
gtbp@jtcir.com
Source:
GT Biopharma, Inc.
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