BEVERLY HILLS, Calif.,
May 17, 2021 /PRNewswire/ -- GT
Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a
clinical stage immuno-oncology company focused on developing
innovative therapeutics based on the Company's proprietary natural
killer (NK) cell engager (TriKE™) protein biologic technology
platform, today reported financial results for the first quarter
ended March 31, 2021 and provided a
general business update.
"In the first quarter of 2021, and in the weeks since, we were
very pleased to report exciting and encouraging data from our
ongoing Phase I/II clinical trial of GTB-3550 in MDS and AML," said
Anthony J. Cataldo, GT Biopharma's
Chairman and Chief Executive Officer. "Both from efficacy and
safety perspectives, our GTB-3350 TriKE™ program appears to be
delivering the TriKE's unique therapeutic potential which has been
well tolerated in all of our patients. Our differentiated approach
stimulating NK cell activity, reinforces our rationale to proceed
with additional programs in solid tumor and hematologic cancers. In
addition, with our $28.7M financing
completed and a key strategic manufacturing partnership in place,
we are well equipped and positioned to capitalize on the potential
we are already seeing from these innovative new therapies. We again
thank the patients and their families for their contribution, as we
advance towards the prospect of an off-the-shelf monotherapy cancer
therapeutic that can be therapeutically effective without
supplemental engineered NK cells or the need for any combination
drugs."
Clinical Highlights
- Updated Interim Results from First-in-Human GTB-3550 TriKE™
Phase I/II Clinical Trial for the Treatment of High-Risk
Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute
Myeloid Leukemia (AML): In March and April 2021, GT Biopharma announced updated
interim results from the Phase I dose-escalation portion of the
Phase I/II expansion clinical trial of GTB-3550 TriKE™ from 9
patients with MDS and AML. Results demonstrated up to 63.7%
reduction in bone marrow blast levels, restoration of endogenous NK
cell function, proliferation and immune surveillance. All patients
treated displayed no signs of any grade of cytokine release
syndrome (CRS) across all dose cohorts. GTB-3550 TriKE™ is
currently being administered to patients at doses significantly
higher than the reported maximum tolerated dose (MTD) for
continuous infusion of recombinant human interleukin-15
(IL-15).
- Enrollment in Phase I Portion of GTB-3550 TriKE™ Phase I/II
Clinical Trial in MDS and AML Continues: In April 2021, GT Biopharma announced the enrollment
of patient 10 in its GTB-3550 TriKE™ Phase I/II Clinical Trial in
high-risk MDS and AML patients. The patient was dosed at
100mcg/kg/day.
- Additional New Findings Supporting GTB-3550 TriKE™
Monotherapy: In April 2021, GT
Biopharma announced additional interim results demonstrating that
GTB-3550 TriKE™ monotherapy is able to rescue the patient's
otherwise exhausted/inhibited/non-functional endogenous NK cell
population, and target direct killing of the patient's AML and MDS
cancer cells without the need for the co-administration addition of
supplemental progenitor-derived or autologous/allogenic engineered
NK cells.
- Announced Preliminary Phase II Clinical Trial Design: In
May 2021, GT Biopharma announced
updates to the Phase 2 design of the ongoing Phase I/II clinical
trial of GTB-3550 TriKE™ monotherapy. The Phase II portion intends
to enroll patients with CD33 expression ≥50% in independent cohorts
(higher-risk MDS and AML); treat patients with two cycles of
GTB-3550 therapy with a rest period between cycles as opposed to
the single-cycle used during Phase 1; enroll patients with fewer
prior treatment lines; and, (evaluate the potential use of minimal
residual disease (MRD) based endpoints that may allow for
accelerated approval.
Corporate Highlights
- Closed $28.7 Million Public
Offering and Successful Nasdaq Listing: In February 2021, GT Biopharma announced the closing
of an underwritten public offering extending GT Biopharma's cash
runway through 2022. The Company also retired over $32 million in debt and consolidated capital
structure to 28,637,000 shares issued and outstanding.
- Strengthened Leadership Team with Key Appointments: In
April 2021, GT Biopharma announced
the appointment of Gregory Berk,
M.D., as Chief Medical Officer and the transition of Jeffrey S. Miller, M.D., from Consulting Chief
Medical Officer to Consulting Chief Scientific Officer.
Additionally, in January 2021, GT
Biopharma announced the appointments of Michael Breen and Rajesh
Shrotriya, M.D., as independent directors to the Company's
Board of Directors.
- Expanded GMP Manufacturing Agreement with Cytovance
Biologics: In February 2021, GT
Biopharma announced that it signed an expanded GMP manufacturing
agreement with Cytovance Biologics for the manufacturing of all
TriKE™ product candidates.
First Quarter 2021 Financial Results:
- Cash Position: As of March 31,
2021, cash, cash equivalents and investments were
$27.6 million, compared to
$5.3 million as of December 31, 2020. The increase in cash, cash
equivalents and investments was primarily due to the completed
public offering of 4,945,000 shares of common stock for net
proceeds of $24,679,000 after
deducting underwriting discounts, commissions and other direct
offering expenses. As of May
14th, current cash position of $35,000,000.
- Research and Development Expenses: Research and
development expenses were $1.6
million for the first quarter of 2021, compared to
$.3 million for the same period in
2020. The increase in research and development expenses for the
first quarter 2021 was primarily due to the issuance of 189,753
shares of common stock as payment of a fee valued at $1,355,000. We anticipate our direct clinical
costs to increase in the remainder of 2021 upon the continuation of
a phase one/two clinical trial of our most advanced TriKE product
candidate, GTB-3550.
- General Administrative Expenses: General administrative
expenses were $27.3 million for first
quarter 2021, compared to $.7 million
for the same period in 2020. The increase in selling, general and
administrative expenses is primarily attributable the increase in
stock-based compensation. In the period ended March 31, 2021 we incurred $21,535,000 of stock-based compensation, we
incurred no such expenses during 2020.
- Net Loss: Net loss was $29.7million for the first quarter of 2021,
resulting in basic and diluted net loss per share of $1.83. Net loss was $1.7
million for the same period in 2020, resulting in basic and
diluted net loss per share of $0.41.
About GTB-3550 TriKE™
GTB-3550 is the Company's first TriKE™ product candidate being
initially developed for the treatment 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. The natural killer (NK) cell stimulating cytokine human
IL-15 portion of the molecule provides a self-sustaining signal
that activates NK cells and enhances their ability to kill. We
intend to study GTB-3550 in CD33 positive leukemias such as acute
myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other
CD33+ hematopoietic malignancies.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
therapeutic products based on our proprietary TriKE™ NK cell
engager platform. Our TriKE™ platform is designed to harness
and enhance the cancer killing abilities of a patient's immune
system's natural killer cells (NK cells). GT Biopharma has an
exclusive worldwide license agreement with the University of Minnesota to further develop and
commercialize therapies using TriKE™ technology. For more
information, please visit gtbiopharma.com.
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 a guarantee 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, 2020, in the section titled "Risk
Factors" in Part I, Item 1A, filed with the Securities and
Exchange Commission (the "SEC") on April 16,
2021 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 contemplated clinical trials,
or 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.
Contact:
Institutional Investors:
Brendan Payne
Stern Investor Relations, Inc.
brendan.payne@sternir.com
212-362-1200
Investor & Media Relations:
David Castaneda
David@gtbiopharma.com
414-351-9758
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SOURCE GT Biopharma, Inc.