Connect Biopharma (CNTB) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Mechanism of action and clinical differentiation

• Rademikibart is an IL-4 receptor alpha monoclonal antibody with a unique binding profile, leading to greater internalization and faster eosinophil turnover compared to similar drugs.

• Unlike DUPIXENT, rademikibart lowers eosinophils and directly produces bronchodilation, resensitizing airways to beta-agonists.

• The drug demonstrates rapid onset of effect, with significant airway function improvement within 24 hours, and even faster with IV administration.

• IV data confirm the mechanism, showing dramatic improvements in airway function within minutes to hours.

Clinical data insights and durability

• Asthma and COPD patients showed rapid and durable FEV1 improvements, with COPD patients exhibiting particularly strong responses.

• Durability of effect extends beyond four weeks, supporting potential for once-monthly dosing.

• IV administration provides immediate drug exposure and confirms at least one month of efficacy.

• Transition from acute IV to chronic sub-Q dosing is feasible, with commercial success depending on strong coordination between hospital and outpatient care.

SEABREEZE study and regulatory pathway

• SEABREEZE readout is expected mid-2026, with primary focus on FEV1 and hospital readmissions as key endpoints.

• Interim review by the data monitoring committee found no safety concerns and recommended no change to sample size.

• Positive SEABREEZE results would prompt immediate FDA engagement to finalize phase III design for acute indications.

• Plans include leveraging data from a partner’s phase III chronic asthma study in China for regulatory submission.