Connect Biopharma (CNTB) Leerink’s Global Healthcare Conference 2025 summary

Management and strategic direction

• Complete management overhaul in the past eight months, with nearly all senior roles replaced and a shift to a U.S.-centric focus.

• Transitioning to quarterly financial reporting, aiming to be perceived as a San Diego-based biotech by year-end.

• New leadership team has extensive experience, with a track record of bringing multiple drugs to market.

Rademikibart clinical development and differentiation

• Rademikibart, a next-generation IL-4 biologic, showed rapid and significant FEV1 improvement in phase 2 asthma studies.

• Unique opportunity to target acute exacerbations in asthma and COPD, a market with over 2.3 million annual emergency visits in the U.S.

• No current biologics are approved for acute exacerbation; competitors' labels explicitly exclude this use.

• Clinicians indicate high willingness to continue chronic treatment after acute use, potentially driving long-term adoption.

• Rademikibart demonstrates higher potency and potentially longer half-life compared to Dupixent, with similar efficacy at Q2 and Q4 week dosing in AD.

Clinical trial plans and logistics

• Two parallel phase 2 studies in acute asthma and COPD to start within months, with data expected in the first half of next year.

• Studies are designed for rapid execution and lower cost, with funding secured through 2027.

• Trial design leverages lessons from the ABRA study, including pre-enrollment and pre-consent strategies to streamline patient recruitment.

• Standardization efforts focus on ensuring timely blood tests and appropriate patient selection, especially in chaotic ED settings.

• Interim analysis built in to adjust sample size if needed, ensuring adequate power and flexibility.