GT Biopharma, Inc. Q2 FY2021 earnings call

• The company was added to the Russell 2000 and Chicago Options Exchange, and has approximately $40 million to execute business plans for the next couple of years.
• Completed a sponsored research agreement with the University of Minnesota involving Dr. Jeffrey Miller's team to enhance the TriKE platform.
• The GTB-3550 TriKE clinical trial shows safety and clinical results, is well-tolerated by patients, activates NK cells, and is a monotherapy.
• Pipeline includes TriKE product candidates targeting solid tumor cancers, undergoing GMP manufacturing and preclinical evaluation.
• Greg Berk discussed the GTB-3550 Phase I trial details, including safety, biologic activity, NK cell activation, and upcoming dose escalation to the 200 microgram cohort.

No detailed financial performance for product segments is provided in the transcript as it focuses on company progress and clinical trials rather than traditional product segment financials.

• Escalation to the 200 microgram cohort in the GTB-3550 Phase I trial is planned for next week.
• Updated safety and efficacy data from the GTB-3550 Phase I trial will be presented at the ESMO conference in September.
• The Phase I trial is expected to conclude later in the fall, with final data potentially presented in winter/spring, possibly released as a press release.
• Intend to pursue Phase II with monotherapy if a compelling efficacy signal is observed, and consider combination with standard of care chemotherapy, starting with AML and venetoclax/azacitidine.

• Operate in a competitive and rapidly changing environment where new risks emerge periodically.
• Actual results may materially differ from forward-looking statements due to various uncertainties, factors, and assumptions.

Q: Can you provide color on what to expect at ESMO?

A: Greg Berk stated they will present updated safety data on up to 12 patients at ESMO in September, with patient 13 being dosed next week.

Q: Details on the Grade 1 CRS observed in the GTB-3550 trial?

A: Greg Berk said it was just fever, ruled out infection, and was not a dose limiting toxicity.

Q: Dr. Miller's involvement evolution and platform advancement?

A: Martin Schroeder said Jeff Miller's involvement will continue strongly, with a Sponsored Research Agreement to further understand TriKE's capabilities and develop new dual-targeting TriKEs.

Q: Timing of final data release from the GTB-3550 trial?

A: Greg Berk said they won't determine the MTD until later in the fall, with final data potentially in winter/spring, possibly released as a press release.

Q: Deployment of GTB-3550 in the AML treatment continuum?

A: Tony Cataldo said monotherapy is the base case initially, with potential combination with standard of care chemotherapy later, including the MRD cohort in Phase II.

Q: B7H3 targeted TriKE preclinical data and conference presentation?

A: Martin Schroeder said the B7H3 TriKE has preclinical data showing good killing in vitro and animal models, positioning as an additional therapeutic agent, with data potentially presented at conferences.

Q: ClinicalTrials.gov status for GTB-3550 and second-generation TriKEs?

A: Tony Cataldo said sites in Wisconsin were on hold and ready for Phase II; Martin Schroeder discussed second-generation TriKEs using nanobodies for improved potency and steric interaction.