Cue Biopharma (CUE) investor relations material

Strategic vision and portfolio overview

• Focus on precision immunoengineering to develop therapies for allergic, autoimmune, and inflammatory diseases, leveraging a cohesive portfolio built around CUE-221 and CUE-401.

• Portfolio includes clinical-stage and preclinical programs, with additional partnered and discovery programs expanding into oncology and B cell depletion.

• Recent financing extends cash runway through key milestones, supporting acceleration as a clinical-stage company and projected to fund milestones through 2026.

• Partnerships for CUE-501 and CUE-100 series offer additional milestone and royalty payment opportunities.

• Team expertise supports strategic acceleration and value inflection across the pipeline.

CUE-221 program highlights

• CUE-221 is a novel anti-IgE antibody with a dual mechanism: neutralizes free IgE and downregulates new IgE production, aiming for deeper and more durable disease control.

• Demonstrated robust and durable IgE suppression, clinically meaningful efficacy in CSU, and favorable safety in early studies.

• CUE-221 maintains IgE interaction with CD23, preserving negative feedback to suppress new IgE synthesis, unlike omalizumab.

• Food allergy selected as lead indication due to high unmet need and IgE-driven disease biology; addresses significant unmet need in allergic diseases including CSU, atopic dermatitis, and asthma.

• CUE-221 offers higher binding affinity and unique IgE conformational targeting compared to omalizumab, with robust preclinical and clinical data.

CUE-221 clinical and market context

• Anti-IgE therapies are a validated market, with XOLAIR approved for food allergy in 2024 and strong physician adoption; food allergy market is rapidly growing.

• Achieving free IgE levels below 50 ng/mL is critical for clinical benefit; current therapies require individualized, frequent dosing and exclude patients with high baseline IgE.

• CUE-221 achieves rapid and durable IgE suppression below quantification limits after a single dose, with effects lasting up to three months.

• Phase II CSU study (Ascendant CSU Study) in China and globally includes 145 patients, comparing three CUE-221 doses, placebo, and omalizumab, with primary endpoint of complete hive symptom score at week 12; data expected in 2H 2026.

• Global Phase IIb in food allergy is planned.