Welcome to our dedicated page for GT Biopharma news (Ticker: GTBP), a resource for investors and traders seeking the latest updates and insights on GT Biopharma stock.
GT Biopharma develops clinical-stage immuno-oncology therapeutics based on its proprietary TriKE® natural killer cell engager platform. News around GTBP focuses on candidate-specific development updates for GTB-3650, a TriKE® program for relapsed or refractory CD33-expressing hematologic malignancies, and GTB-5550, a B7-H3-targeted TriKE® program for solid tumors known to express B7-H3.
Company updates also cover FDA investigational new drug activity, Phase 1 trial enrollment and safety-review disclosures, R&D spending, liquidity commentary and periodic financial results. GT Biopharma also issues investor-conference announcements as it presents its NK cell engager strategy and clinical pipeline to the capital markets.
GT Biopharma announced the presentation of new research at ASH 2022, focusing on a dual antigen targeting method for treating acute myeloid leukemia (AML). The study combines GTB-3650, a CD33 targeting TriKE, with Fate Therapeutics' iPSC-derived CAR NK cells targeting MICA/B. Preclinical data indicate that the combination enhances the anticancer activity of CAR NK cells against AML cell lines. The poster presentation will occur on December 12, 2022, in New Orleans.
GT Biopharma (GTBP) announced its third quarter fiscal 2022 results, reporting a cash position of $20.8 million as of September 30, 2022, down from $23.7 million in June 2022. This funding is anticipated to support operations into 2023. R&D expenses increased to $2.8 million for Q3 2022, a rise of $1.8 million year-over-year, reflecting investments in developing second-generation TriKE® products. The company recorded a net loss of $6.9 million for the quarter, compared to a $5.5 million loss in Q3 2021.
GT Biopharma announced two poster presentations for the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022) in Boston from November 8-12, 2022. The presentations will feature preclinical data on their tri-specific NK cell engagers targeting mesothelioma and prostate cancer. The first poster, focusing on mesothelioma, will be presented by Pippa Kennedy and Martin Felices, while the second, addressing prostate cancer, will be presented by Shee Kwan Phung and Martin Felices. These developments showcase GT Biopharma's commitment to advancing immunotherapy.
GT Biopharma, Inc. (NASDAQ: GTBP) has adjourned its 2022 Special Shareholders Meeting to October 10, 2022, at 11 a.m. PST due to a lack of quorum. The meeting aims to ratify the inclusion of discretionary votes by brokers for a proposal to reduce the company’s authorized shares of common stock from 750 million to 250 million. Shareholders on record as of August 8, 2022, are encouraged to vote by 11:59 p.m. PST on October 9, 2022. Those who have already voted do not need to recast their votes unless wishing to change them.
GT Biopharma (NASDAQ: GTBP) announced key findings from its accepted abstract at the ESMO Congress 2022, highlighting the efficacy of its product candidate GTB-5550. This compound specifically targets B7-H3+ solid tumors, generating a strong NK cell proliferation signal surpassing that of IL-15 alone. GTB-5550 has shown promising results in inducing NK cell degranulation and interferon gamma production against various malignancies. Ongoing in vivo activity in human tumor xenogeneic models further supports these findings. The company anticipates submitting an IND application in 2023.
GT Biopharma, Inc. (NASDAQ: GTBP) will present at H.C. Wainwright’s 24th Annual Global Investment Conference, scheduled for September 12-14, 2022, at the Lotte New York Palace. The presentation is set for September 13, from 10:30 to 11:00 am EDT. This clinical-stage immuno-oncology company focuses on innovative therapeutics utilizing its proprietary NK cell engager, TriKE®. Management will also engage in 1x1 meetings with attendees. A webcast of the presentation will be available for replay for 90 days following the event.
GT Biopharma, Inc. (NASDAQ: GTBP) announced a Settlement and Investment Agreement with Cytovance Biologics for the registration of its investigational new drug GTB-3650. The IND application with the FDA is expected by March 31, 2023. GTB-3650 aims to treat relapsed/refractory acute myelogenous leukemia and high-risk myelodysplastic syndrome, and offers several advantages over its predecessor, GTB-3550, including improved potency and a fully owned proprietary molecule. Payments to Cytovance will be limited to 4.9% of total shares outstanding.
GT Biopharma reported its Q2 fiscal 2022 results, revealing a net loss of $3.0 million, down from $8.4 million in Q2 2021. Total cash as of June 30, 2022, stands at $23.7 million, providing a runway into 2023. R&D expenses increased to $1.1 million for Q2, while S,G&A expenses decreased to $1.9 million from $3.7 million year-over-year. The company showcased promising preclinical data at EHA 2022 and has plans for IND applications for GTB-3650 and GTB-5550 in 2023, focusing on advancing their TriKE® platform.
GT Biopharma announced its preclinical findings on GTB-7550, a CD19-targeted tri-specific killer engager, at the EHA 2022 Congress. The research indicates that GTB-7550 enhances NK cell function against B-cell malignancies, particularly chronic lymphocytic leukemia (CLL). CLL, which accounts for a significant portion of leukemia cases, currently has limited effective treatment options. The results suggest GTB-7550 could address these shortcomings in CLL therapy. Future studies will assess GTB-7550's efficacy against other hematologic cancers.
GT Biopharma reported significant progress in its TriKE® platform at the AACR 2022, showcasing preclinical data for GTB-5550, which activates NK cells against head and neck squamous cell carcinomas. The company has $26.7 million in cash as of March 31, 2022, ensuring funding into 2023. R&D expenses rose to $2.1 million due to expanded staffing and product development. General and Administrative expenses fell to $3.4 million, reflecting reduced stock-based compensation. The net loss narrowed to $5.4 million, or $0.17 per share, compared to a loss of $29.7 million a year prior.