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GT Biopharma Reports Fourth Quarter and Full-Year 2023 Financial Results
Remain in active dialogue with the FDA regarding IND clearance for GTB-3650, a 2nd generation nanobody TriKE® for treatment of CD33+ leukemiaPhase 1 trial
About this update from Gt Biopharma, Inc.
[{"type":"text","content":"Remain in active dialogue with the FDA regarding IND clearance for GTB-3650, a 2nd generation nanobody TriKE® for treatment of CD33+ leukemiaPhase 1 trial with GTB-3650 anticipated to start in 2H 2024Anticipate submitting an IND for GTB-5550 targeting B7H3 for multiple solid tumors, including prostate and breast, in Q4 2024Cash of approximately $14 million as of December 31, 2023, provides sufficient runway to fund operations into 2025 BRISBANE, CALIFORNIA, March 26, 2024 (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 fourth quarter and full-year 2023 results for the period ended December 31, 2023. “We continue to make good progress with the FDA regarding IND clearance for GTB-3650, and eagerly anticipate the start of Phase 1 this year,” said Michael Breen, Executive Chairman and Interim Chief Executive Office of GT Biopharma. “We are also anticipating an IND submission for our 2nd asset, GTB-5550, for multiple solid tumors, including breast and prostate cancers, in Q4 of this year. We have sufficient cash runway into 2025 and anticipate having initial data from our Phase 1 trial with GTB-3650 by the end of 2024/early 2025.” Fourth Quarter and Year End 2023 Financial Summary Cash Position: The Company had cash, cash equivalents and short-term investments of $13.97 million as of December 31, 2023 compared to $16.51 million as of December 31, 2022. This is anticipated to provide sufficient runway to fund operations into 2025. Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $1.36 million compared to $2.84 million for the same quarter of 2022. R&D expenses for the year ended December 31, 2023 were $6.47 million compared to $8.81 million for the year ended December 31, 2022. The $2.34 million reduction in R&D for the year ended December 31, 2023 over 2022 was primarily due to a $3.59 million reduction in licensing and administrative costs, offset by an increase of $1.25 million in R&D costs related to our continued development and production of our most advanced TriKE® product candidates GTB-3650 and GTB-5550 along with the progression of other promising product candidates. The reduc...