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GT Biopharma Reports First Quarter 2023 Financial Results and Provides Corporate Update
Cash of approximately $19.9 million as of March 31, 2023, provides ample runway to fund operations into Q2 2024; anticipated to be sufficient to achieve IND
About this update from Gt Biopharma, Inc.
[{"type":"text","content":"Cash of approximately $19.9 million as of March 31, 2023, provides ample runway to fund operations into Q2 2024; anticipated to be sufficient to achieve IND clearance for GTB-3650 and GTB-5550, and initiate clinical trial activities on GTB-3650. BRISBANE, CALIFORNIA, May 15, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (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® platform, today announced first quarter 2023 results for the period ended March 31, 2023. “Pipeline development progress continues to move forward in the advancement of GTB-3650, a second generation nanobody TriKE® for the treatment of CD33+ leukemia, followed by GTB-5550 for the treatment of B7H3+ solid tumors. Operationally, our development timeline remains aligned, and we expect to submit an investigational new drug (IND) filing with the U.S. Food and Drug Administration for GTB-3650 in the 2H 2023,” said Michael Breen, Executive Chairman and interim Chief Executive Officer. “Additionally, we reaffirm our current cash on hand, coupled with significant recent cost reduction efforts, is sufficient to provide ample runway to fund operations into Q2 2024, anticipated to be sufficient to achieve IND clearance for GTB-3650 and GTB-5550, and initiate clinical trial activities for GTB-3650. Concurrently, we continue to investigate and develop the Company’s TriKE® nanobody platform for multiple additional targets and indications, while actively exploring potential development partnerships for our programs.” Highlights and Recent Updates The Company was recently informed of a certain unforeseen complication at our contract manufacturing organization (CMO) which has since been resolved, and which was not specific to the work related to our products. The issue was not central to the manufacturing processes for any GT Biopharma-related molecules, and the specific processes remain unaffected. However, it has resulted in operational challenges at the CMO that will affect the anticipated IND submission timing for GTB-3650, which is now expected in the 2H of 2023. The Company anticipates that the IND submission of GTB-5550 will follow after GTB-3650.In May, Charles J. Casamento was named to the board of directors to fill the seat vacated...