Cue Biopharma, Inc. Q4 FY2023 earnings call

Daniel Passeri outlined the agenda, including overviews of the therapeutic platform, competitive positioning, clinical datasets, preclinical autoimmune programs, and financials. Anish Suri discussed the Immuno-STAT platform's ability to selectively modulate immune cells for oncology and autoimmunity. Matteo Levisetti provided updates on oncology clinical trials, including CUE-101 and CUE-102, their data, FDA meetings, and registrational paths. Anish Suri covered preclinical autoimmune programs like CUE-401 and CUE-500 series. Kerri-Ann Millar gave financial updates, including revenue, expenses, and cash position.

No detailed breakdown of product segments with revenue percentages provided in the transcript.

CUE-101 moving into a randomized Phase 2 study with intent to confirm enhanced efficacy, with interim analysis at 14 months and overall response rate/median progression-free survival analysis between 22-24 months. CUE-102 patient expansion and potential combinations with checkpoint inhibitors in large unmet need indications. Autoimmune programs like CUE-401 and CUE-500 series with potential milestones.

Q: About the randomized phase 2 combo study patient numbers and progression to registrational phase 3 A: Matteo Levisetti stated the patient sample size for the entire trial is planned to be less than 100 patients (approximately 25 per arm) and that the first interim analysis by the data safety monitoring board will inform progression to a registrational trial Q: Potential partnering stage and structure A: Daniel Passeri mentioned it's a dynamic analysis with discussions ongoing, considering factors like requisite insight on disease indication, economic structures, and board decision; used Ono partnership with CUE-401 as an example Q: Preclinical development of 500 series and partnering A: Anish Suri noted clear evidence of the scaffold being biologically active, testing across memory T cell specificities like CMV and SARS-CoV-2, with potential to extend beyond B cells and into oncology; inbound interest in the 500 series Q: Phase 2 vs Phase 2/3 considerations and Pembro survival A: Daniel Passeri discussed Phase 2 offering opportunity to generate data confirming dose for Phase 3, and Matteo Levisetti mentioned uncertainty around Pembro survival data but emphasized value of Phase 2 trial to gain confidence Q: Autoimmune T-cell depletion and preclinical data A: Anish Suri explained T-cell mediated depletion is due to CD-19 anchoring on B-cells, focusing on virus-specific T-cells for rapid response and high frequency in population; preclinical data plans for later this year or early next year