GT Biopharma Reports Fourth Quarter and Year End 2020 Results and Business Update
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."
Fourth Quarter and Year End 2020 Financial Results:
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.
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.
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SOURCE GT Biopharma, Inc.
Company Codes: NASDAQ-NMS:GTBP