BEVERLY HILLS, Calif.,
April 19, 2021 /PRNewswire/
-- GT Biopharma, Inc. (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,
reported financial results for the fourth quarter and year ended
December 31, 2020.
"2020 was a year of robust clinical progress and milestone
achievements for GT Biopharma, which allowed us to accomplish a
major corporate milestone in listing GT Biopharma on NASDAQ at the
beginning of 2021. The emerging data from our GTB-3550 TriKE™
program in hematological malignancies, MDS and AML, are encouraging
in both safety and efficacy profiles. The ongoing data
profile has demonstrated significant differences from all other NK
cell therapies and NK engager companies, making TriKE™ a
monotherapy, off-the-shelf platform therapeutic. TriKE™
exerts its therapeutic effect without the need for outside
assistance in the form of combination therapies or the addition of
supplemental progenitor-derived or autologous/allogenic NK cells.
As a result, TriKE™ therapy cost to patients will be far
superior, significantly more economic than progenitor-derived or
autologous/allogenic NK cell therapy companies' offerings.
Additionally, the results generated from the GTB-3550 TriKE™
clinical trial reinforces its versatility, providing a clear
rationale to proceed with additional programs in solid tumor and
hematologic cancers. As a result, in 2020 we formed a strong
GMP manufacturing partnership with Cytovance Biologics to bring our
TriKE™ product candidates forward for evaluation in the clinic,"
said Anthony J. Cataldo, GT
Biopharma's Chairman and Chief Executive Officer. "In the
first quarter of 2021, we have achieved numerous clinical and
operational milestones, which included garnering the attention of
institutional investors and analyst research coverage as a result
of our successful NASDAQ listing and public offering. We
transferred all TriKE™ GMP manufacturing to Cytovance, as we
progress our solid tumor TriKE™ product candidates.
Additionally, the interim results from our ongoing Phase I/II
clinical trial of GTB-3550 TriKE™ showed a 63.7% reduction in bone
marrow blast (cancer cell killing) levels in patient 9; up from 61%
in patient 7 at a lower dose for patients with MDS and AML.
We also added the University of
Wisconsin-Madison as a second clinical trial site.
There will be more trials sites added, as we will soon
proceed to the Phase II portion of our ongoing GTB-3550 TriKE™
clinical trial. We look forward to building on this momentum
throughout the year, particularly as we continue to dose escalate
our GTB-3550 TriKETM in these incredibly
difficult-to-treat relapsed/refractory AML and high-risk MDS
patient populations. We thank the patients and their families
for their contribution, as we progress this novel, off-the-shelf
monotherapy cancer therapeutic that uniquely works without outside
supplemental engineered NK cells or the need for any combination
drugs."
Corporate Highlights
- Strengthened Leadership Team with Key Appointments to
Executive Management, Board of Directors, and Scientific and
Medical Advisory Board: In November
2020, GT Biopharma announced the appointment of Michael Handelman, CPA as Chief Financial
Officer. Mr. Handelman was the former CFO of Iovance
Biotherapeutics. Throughout 2020, GT Biopharma announced multiple
appointments to its two boards. Bruce J.
Wendel was named Vice Chairman and Independent Director of
the Board of Directors, and Greg
Berk, M.D., Michael Breen and
Rajesh Shrotriya, M.D. were
appointed as independent directors. Samir
Taneja, M.D. and Philip
Werthman, M.D., M.M.H. were appointed to the Company's
Scientific and Medical Advisory Board.
- Established and Expanded TriKE™ Partnership with Cytovance
Biologics: In October 2020,
GT Biopharma announced a partnership agreement with Cytovance
Biologics for the exclusive GMP manufacturing of three TriKE™
product candidates. Under the terms of the agreement, Cytovance
will manufacture TriKE™ product candidates in accordance with its
proprietary Keystone® bacterial or mammalian expression systems.
Subject to certain milestones by Cytovance, GT Biopharma has the
option to pay Cytovance up to a total of $6
million. In December 2020, GT
Biopharma issued $1 million to
Cytovance as a first milestone payment. GT Biopharma's agreement
with Cytovance was further expanded in February 2021 for the manufacturing of all TriKE™
products.
Subsequent Event:
- Closed $28.7 Million Public
Offering and Successful Listing on NASDAQ: In February 2021, GT Biopharma announced the
successful completion of its NASDAQ up list, in addition to the
simultaneous closing of its public offering, in which it raised
$28.7 million. Further, the Company
retired over $32 million in debt and
consolidated its capital structure.
Clinical Highlights
- Presented Interim Results for GTB-3550 TriKETM
for the Treatment of High-Risk MDS and Refractory/Relapsed AML at
the 62nd American Society of Hematology (ASH) Annual
Meeting:
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- In December 2020, GT Biopharma
presented promising proof-of-principle interim results from its
lead product candidate, GTB-3550 TriKE™, at ASH in an oral
presentation. As of the data cut-off date, six out of seven
enrolled patients were evaluable and displayed no signs of clinical
immune activation or serious adverse events across all dose
cohorts. Data demonstrated that the first patient from the 5
mcg/kg/day cohort achieved stable disease after one course of
GTB-3550 TriKE™ therapy and the first patient from the 25
mcg/kg/day cohort achieved AML blast level decrease from 18% to 12%
by morphological analysis after one course of GTB-3550 TriKE™
therapy. Correlative studies also have shown reproducible NK
cell activity across all evaluable patients with NK cell activation
increasing during early treatment. Of note, NK cell proliferation
started at day 3, is maximal at day 8 and maintained above baseline
at days 15 and 22.
- Additional clinical data from a patient with HR-MDS were
presented, demonstrating that GTB-3550 TriKE™ safely activated and
harnessed native NK cell's cancer killing ability in a
target-directed fashion with no adverse events or dose limiting
toxicities. Successful bone marrow blast level reduction from 12%
prior to treatment to 4.6% post-treatment was determined by
morphological assessment. The patient also achieved stable
hematologic parameters, including normal platelet counts throughout
therapy.
- Expanded Clinical Programs with HER2 TriKETM for
the Treatment of Breast and Gastrointestinal
Cancers: In December
2020, GT Biopharma announced the initiation of clinical
development for TriKETM therapy for the treatment of
HER2+, HER3+ and HER2+/HER3+ heterodimer complex breast cancer and
gastrointestinal cancers.
- Published Results on B7H3-Targeted TriKETM
Potential to Enhance NK-Cell Immunotherapy in Solid Tumors:
In October 2020, GT Biopharma
announced the publication of results conducted by researchers at
the University of Minnesota and
Massachusetts General
Hospital/Harvard Medical School in the
journal, Cancers, in an article entitled
"NK-Cell-Mediated Targeting of Various Solid Tumors Using B7-H3
Tri-Specific Killer Engager In Vitro and In Vivo." Results
indicated that a B7H3-targeted TriKETM has the potential
to enhance NK cell immunotherapy in solid tumor settings,
particularly where B7H3 is highly expressed on solid tumor
surfaces.
Subsequent Events:
- Updated Interim Results from GTB-3550 TriKETM
Clinical Program for the Treatment of MDS and AML: In
March 2021, GT Biopharma announced
updated interim results from the Phase I/II Expansion clinical
trial of GTB-3550 TriKE™ for the treatment of high-risk
myelodysplastic syndromes (MDS) and refractory/relapsed acute
myeloid leukemia (AML) from 9 patients. Results demonstrated
up to 63.7% reduction in bone marrow blast levels. All
patients treated to date 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).
- GTB-3550 TriKE™ Interim Results Presented at Innate Killer
Summit 2021: In March 2021, Dr. Jeffrey S. Miller, M.D., GT Biopharma's
Consulting Chief Medical Officer and Deputy Director of the Masonic
Cancer Center at the University of
Minnesota, presented updated interim Phase I/II clinical
trial results for GTB-3550 TriKE™, being evaluated for the
treatment of MDS and AML at the Innate Killer Summit 2021. Dr.
Miller's presentation "NK Cell Therapeutics: Off-the-shelf
Strategies to Increase Activity and Specificity" highlighted the
clinical power of immune engagement with IL-15 containing
TriKEs.
- Announced Preclinical Results from ROR1 TriKETM
for the Treatment of Prostate Cancer: In
March 2021, GT Biopharma announced
preclinical in vitro cell assay results demonstrating the ROR1
TriKETM was found to be effective at promoting NK cell
killing of prostate cells. Significant NK cell activation and
interferon gamma production was also observed as a result of ROR1
TriKETM engagement.
Fourth Quarter and Year End 2020 Financial Results:
- Cash Position: As of December 31, 2020, cash, cash equivalents and
investments were $5.3 million,
compared to $0.3 million as of
December 31, 2019. The increase
in cash, cash equivalents and investments was primarily due to
proceeds from the issuance of convertible notes payable of
$12.5 million, offset by cash used in
operating activities of $7.3
million.
- Research and Development Expenses: Research
and development expenses were $233
thousand for the fourth quarter of 2020, compared to
$8 thousand for the same period in
2019. Research and development expenses were $485 thousand for the full year 2020, compared to
$1.7 million for the full year 2019.
The decrease in research and development expenses for the
full year 2020 was primarily due to the reduction of consultant and
clinical expenses. The Company anticipates clinical costs to
increase significantly in 2021.
- General Administrative Expenses: General
administrative expenses were $2.0
million for the fourth quarter of 2020, compared to
$0.9 million for the same period in
2019. General administrative expenses were $6.3 million for the full year 2020, compared to
$9.8 million for the full year
2019. The decrease in general administrative expenses for the
full year 2020 was primarily attributable to the reduction of stock
compensation costs.
- Net Income (Loss): Net loss was $14.9 million for the fourth quarter of 2020,
compared to a net loss of $1.5
million for the same period in 2019. Net loss was
$28.3 million for the full year 2020,
resulting in basic and diluted net loss per share of $(6.45). Net loss was $38.6 million for the full year 2019, resulting
in basic and diluted net loss per share of $(11.42) before effect of reverse split. Net loss
for the full year 2020 was attributable to a loss from operations
of $6.8 million and total other
expenses of $21.5 million. Net
loss for the full year 2019 was primarily attributable to the loss
from operations of $16.0 million and
total other expenses of $22.6
million.
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:
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Institutional
Investors:
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Julie
Seidel
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Stern Investor
Relations, Inc.
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Julie.seidel@sternir.com
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212-362-1200
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Investor
Relations:
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Media
Relations
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David
Castaneda
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Susan
Roush
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David@gtbiopharma.com
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Susan@gtbiopharma.com
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414-351-9758
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805-624-7624
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SOURCE GT Biopharma, Inc.