Connect Biopharma (CNTB) investor relations material

Differentiation and clinical profile of rademikibart

• Rademikibart, a next-generation anti-IL-4Ra antibody, demonstrates higher binding affinity and broader epitope coverage on IL-4Ra compared to dupilumab, resulting in more effective blockade of IL-4/IL-13 signaling and improved clinical outcomes in asthma and COPD patients.

• Clinical and preclinical data show rademikibart provides faster onset of action, greater improvement in FEV₁, and a reduction in eosinophils, which may lower the risk of serious adverse events and conjunctivitis compared to dupilumab.

• Rademikibart rapidly reverses IL-13-induced hyporesponsiveness to β-agonists, supporting its use in combination with standard of care for acute exacerbations and maintenance therapy.

• Phase 2b studies in moderate-to-severe asthma demonstrated rapid and sustained FEV₁ improvement, with 73% of the Day 7 benefit observed by the morning after the first dose.

• Rademikibart’s Q4W dosing in atopic dermatitis maintained efficacy comparable to Q2W, supporting less frequent dosing regimens.

Market opportunity and clinical development

• Asthma and COPD represent large, underserved markets, with over 22 million and 16 million adults affected in the US, respectively, and high rates of exacerbations requiring urgent care or hospitalization.

• Rademikibart is being developed for both acute and chronic indications, with Phase 2 studies in acute asthma and COPD underway and topline data expected mid-2026.

• US clinicians view the acute indication as a key differentiator, with expectations to maintain 75% of acutely treated patients on chronic rademikibart therapy.

• The product’s high-yield manufacturing process enables hospital-friendly pricing, supporting penetration into the acute care setting.

• Global commercialization rights (outside Greater China) and a robust exclusivity timeline support long-term value creation.

Financial position and regulatory milestones

• Cash, cash equivalents, and short-term investments of $54.8 million as of September 30, 2025, are expected to fund operations into 2027, including ongoing Phase 2 studies.

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

• NDA approval for atopic dermatitis in China is expected, with Simcere conducting ongoing studies at no cost.

• Manufacturing process improvements and tech transfer to a US CMO have been completed, with a new high-yield cell line expected to be transferred starting in 2026.

• Key upcoming catalysts include completion of IV pharmacology studies and Phase 2 acute studies in 2026.