GT Biopharma Reports Third Quarter 2023 Financial Results
This is a paid press release. Contact the press release distributor directly with any inquiries.

GT Biopharma Reports Third Quarter 2023 Financial Results

GT Biopharma, Inc.
GT Biopharma, Inc.
  • IND submission for GTB-3650, 2nd generation nanobody TriKE® for treatment of CD33+ leukemia, expected in Q4 2023

  • Phase 1 clinical trial initiation evaluating GTB-3650 for treatment of CD33+ leukemia anticipated in 2024

  • Cash of approximately $16 million as of September 30, 2023, provides ample runway to fund operations into 2H 2024; anticipated to be sufficient to initiate clinical trial activities on GTB-3650

BRISBANE, CALIFORNIA, Nov. 01, 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 third quarter 2023 results for the period ended September 30, 2023.

“We continue to move forward in advancing our novel portfolio of TriKE® nanobody assets,” said Michael Breen, Executive Chairman and interim Chief Executive Office of GT Biopharma. “We remain on track to submit an IND to the U.S. Food and Drug Administration (FDA) in Q4 2023 for GTB-3650, a second generation nanobody TriKE® for the treatment of CD33+ leukemia. Following FDA acceptance, we plan to host a KOL event highlighting the anticipated Phase 1 clinical trial design and timelines for data. Our current cash runway is sufficient to progress through multiple upcoming milestones in 2024, and we continue to actively explore potential development partnerships for our programs.”

Third Quarter 2023 Financial Summary

Cash Position: The Company had cash, cash equivalents and short-term investments of $16.01 million as of September 30, 2023 compared to $17.97 million as of June 30, 2023. We expect ample runway to fund operations into 2H 2024.

Research and Development (R&D) Expenses: R&D expenses for the three months and nine months ended September 30, 2023 were $1.36 million and $5.11 million, compared to $2.57 million and $5.79 million for the same comparable periods of 2022. Research and development expenses are 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. R&D expenses decreased over the previous year primarily due to reduction of in-house staff offset with the increase in compensation to consultants as we prepare to advance our next generation GTB-3650 camelid nanobody product into the clinic.

General and Administrative (G&A) Expenses: G&A expenses for the three months and nine months ended September 30, 2023 were $1.76 million and $5.30 million, compared to $4.46 million and $9.69 million for the same comparable periods of 2022. The decrease in G&A expenses was primarily attributable to reduction in stock-based compensation to advisory board, investor relations consultants, legal and professional fees, and payroll expenses.