Cue Biopharma, Inc. Q4 FY2022 earnings call

• CUE-101 demonstrates single-agent clinical activity in late-stage cancer patients refractory to chemotherapies and checkpoint inhibitors, with at least a doubling of overall response when combined with checkpoint inhibition. • Favorable tolerability with no evidence of vascular leak syndrome or cytokine release syndrome; antibody-based design offers favorable cost of goods and manufacturability, with stability out to >36 months. • CUE-102 is in a dose escalation trial for advanced colorectal, gastric, pancreatic, and ovarian cancers, well-tolerated with no DLTs observed, anticipating preliminary data midyear. • Collaboration with Ono Pharmaceuticals for CUE-401, a bispecific biologic for autoimmune diseases, with milestones and a U.S. co-development option. • CUE-101 has Fast Track designation, and FDA authorized CUE-102 IND based on CUE-101's safety data. • Immuno-STAT platform targets T cell receptor for targeted cytokine delivery, avoiding deleterious side effects of nonselective modalities.

No specific product segment financial performance with revenue contributions detailed in the transcript.

• Anticipate completing dose escalation of CUE-102 by midyear and presenting preliminary data. • CUE-101 combination trial expected to complete enrollment of 20 patients midyear with potential registrational trial by year-end. • Current cash reserves will fund operations into the second half of 2024.

Q: Thoughts on potential relapse and drivers of responses in CUE-101?

A: Ken discussed tumor cells left behind after treatment and interest in neoadjuvant studies.

Q: Timing of neoadjuvant study results?

A: Matteo said first cohort enrolled, Schedule B recruiting, completing enrollment by year-end.

Q: Registrational trial considerations?

A: Dan discussed multiple potential paths, considering market size, data strength, and capital access.

Q: Timing of CUE-102 data and CUE-401 comparisons?

A: Dan said CUE-102 dose escalation completion midyear, Anish discussed CUE-401 comparisons in Treg meetings.

Q: CUE-102 combination plans?

A: Dan said plans to initiate combination dose escalation in parallel with monotherapy, stratifying by WT1 positivity.