Cue Biopharma (CUE) Piper Sandler 36th Annual Healthcare Conference summary

Platform overview and technology

• Immuno-STAT platform enables precise modulation of immune responses by engineering proteins to selectively activate or suppress specific T cell populations for oncology and autoimmune indications.

• Dual signaling approach targets T cell receptors for specificity, avoiding broad activation and reducing collateral damage.

• Platform modularity allows for rapid adaptation to different disease targets by swapping epitopes or cytokine components.

Oncology program highlights

• CUE-101 demonstrated proof of concept in heavily pretreated head and neck cancer, showing T cell activation, anti-tumor activity, and durable responses.

• Median overall survival reached 22 months, significantly exceeding the typical 8 months for standard therapies.

• Combination with Keytruda doubled overall response rate to 46% and increased 12-month survival to over 90%.

• Notably effective in low PD-L1 expressors, turning immunologically 'cold' tumors 'hot' and differentiating from competitors.

• Registration path includes a randomized Phase 2 trial, but resource allocation is currently focused on data maturation and autoimmune programs.

Autoimmune and partnering initiatives

• CUE-401, partnered with Ono, uses a bispecific approach to induce regulatory T cells, with a 50% U.S. interest retained and clinical entry targeted for late 2026 to early 2027.

• 401's mechanism enables conversion of autoreactive T cells to Tregs, with potential for broad autoimmune disease applications.

• CUE-501 leverages viral epitope painting to ablate autoreactive B cells, redirecting existing antiviral T cells for targeted cell destruction with improved safety.

• Deep partnering discussions are ongoing for 501, with potential for capital infusion and expansion to other cell types, such as pathogenic fibroblasts.