Connect Biopharma (CNTB) investor relations material

Strategic pipeline and clinical development

• Advancing a next-generation IL-4 receptor alpha monoclonal antibody (rademikibart) with rapid onset in atopic dermatitis and asthma, showing dramatic FEV1 improvements within 24 hours and potential for acute exacerbation treatment.

• Phase II studies for acute asthma and COPD are underway, with topline results expected mid-year and IV formulation data anticipated late this quarter; Phase 3 studies are planned to follow.

• Unique binding profile leads to greater receptor internalization, resulting in differentiated safety (modest eosinophil decline) and efficacy compared to existing therapies, with improved outcomes over dupilumab.

• Product demonstrates longer functional half-life, maintaining efficacy at Q4 week dosing, with significant, sustained FEV1 gains as early as Day 1 and over 60% reduction in exacerbation rates compared to placebo.

• Enrollment strategies include both ER-based and pre-enrollment through specialists, with global site activation to ensure timely data delivery.

Key scientific and clinical insights

• Rademikibart rapidly reverses IL-13-induced hyporesponsiveness to β-agonists, resulting in faster and greater FEV1 improvement.

• Rademikibart lowers eosinophil counts, reducing risk of serious adverse events, unlike dupilumab which increases eosinophils.

• Q4W dosing in atopic dermatitis maintained efficacy, supporting less frequent dosing regimens.

Development pipeline and regulatory milestones

• NDA approval for atopic dermatitis in China anticipated mid-2026, with global rights (outside Greater China) secured and partnership with Simcere including $110 million in milestones and tiered royalties.

• FDA has agreed rademikibart can proceed to Phase 3 for chronic asthma and to parallel Phase 2 studies for acute exacerbations.

• Manufacturing process improvements and tech transfer to US CMO completed, supporting future commercialization.

• Patent and regulatory exclusivity extend into the 2040s, supporting long-term value.